Doug Brunk

Major Finding: The median maternal serum concentration of 1% tenofovir vaginal gel was 4.3 ng/mL, which is about 100-times lower than a single 600-mg dose of oral tenofovir.

Data Source: A phase I trial of 16 healthy pregnant women who were scheduled to undergo cesarean delivery at term gestation and who received a single 4-g application of tenofovir 1% vaginal gel preoperatively.

Disclosures: The study was funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. The nonprofit organization CONRAD supplied the tenofovir gel. Dr. Beigi said that he had no relevant financial disclosures to make.

SANTA FE, N.M. — A single application of tenofovir 1% vaginal gel in term pregnancy produces low serum levels consistent with those reported in nonpregnant women, results from a small single-center trial demonstrated.

The findings come just weeks after a study published online in the journal Science found that 1% tenofovir gel used before and after sexual intercourse reduced HIV in women by 39% and reduced the incidence of herpes simplex virus type 2 infections by 50% (Science 2010 July 20 [doi:10.1126/science.1193748]). “It does appear that tenofovir gel, once absorbed, does get to the fetal compartment, with very low overall cord blood levels—approximately 40-fold lower than you see after oral dosing—with a very similar cord:maternal blood ratio,” Dr. Richard Beigi said at the meeting.

“In addition, it appears that single-dose tenofovir appears very safe in term pregnancy. These findings justify continued investigation of this product in pregnancy,” he said.

In a phase I trial conducted by the Microbicide Trials Network, researchers evaluated 16 healthy pregnant women who were scheduled to undergo cesarean delivery at term gestation between August 2008 and January 2010.

The women received a single 4-g application of tenofovir 1% vaginal gel preoperatively.

“Oral tenofovir has a growing record of safety,” he said. “It's a category B drug, with close to 1,000 exposures collected in the Antiretroviral Pregnancy Registry. So we felt very comfortable moving [the gel form of] this drug into pregnancy trials.”

Dr. Beigi of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh and his associates collected maternal blood for serum drug concentrations at baseline and at 1, 2, 4, 6, 8, 12, and 24 hours. They also collected specimens of amniotic fluid, cord blood, placenta, and endometrium during surgery, and collected data on maternal and neonatal adverse events.

All 16 women had detectable levels in the serum after vaginal placement. The median maternal concentration of tenofovir was 4.3 ng/mL, “which is very low,” Dr. Beigi said. “The median time to get that concentration was approximately 4 hours. To put this in perspective, when a mom takes a single oral dose of 600-mg tenofovir, their median concentration is 440 ng/mL. So we're looking at levels that are approximately 100-fold lower.”

The median cord:maternal blood ratio was 0.53, which is approximately the same as with oral dosing of tenofovir.

'Single-dose tenofovir appears very safe in term pregnancy. These findings justify continued investigation.'

Source DR. BEIGI

Major Finding: The median maternal serum concentration of 1% tenofovir vaginal gel was 4.3 ng/mL, which is about 100-times lower than a single 600-mg dose of oral tenofovir.

Data Source: A phase I trial of 16 healthy pregnant women who were scheduled to undergo cesarean delivery at term gestation and who received a single 4-g application of tenofovir 1% vaginal gel preoperatively.

Disclosures: The study was funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. The nonprofit organization CONRAD supplied the tenofovir gel. Dr. Beigi said that he had no relevant financial disclosures to make.

SANTA FE, N.M. — A single application of tenofovir 1% vaginal gel in term pregnancy produces low serum levels consistent with those reported in nonpregnant women, results from a small single-center trial demonstrated.

The findings come just weeks after a study published online in the journal Science found that 1% tenofovir gel used before and after sexual intercourse reduced HIV in women by 39% and reduced the incidence of herpes simplex virus type 2 infections by 50% (Science 2010 July 20 [doi:10.1126/science.1193748]). “It does appear that tenofovir gel, once absorbed, does get to the fetal compartment, with very low overall cord blood levels—approximately 40-fold lower than you see after oral dosing—with a very similar cord:maternal blood ratio,” Dr. Richard Beigi said at the meeting.

“In addition, it appears that single-dose tenofovir appears very safe in term pregnancy. These findings justify continued investigation of this product in pregnancy,” he said.

In a phase I trial conducted by the Microbicide Trials Network, researchers evaluated 16 healthy pregnant women who were scheduled to undergo cesarean delivery at term gestation between August 2008 and January 2010.

The women received a single 4-g application of tenofovir 1% vaginal gel preoperatively.

“Oral tenofovir has a growing record of safety,” he said. “It's a category B drug, with close to 1,000 exposures collected in the Antiretroviral Pregnancy Registry. So we felt very comfortable moving [the gel form of] this drug into pregnancy trials.”

Dr. Beigi of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh and his associates collected maternal blood for serum drug concentrations at baseline and at 1, 2, 4, 6, 8, 12, and 24 hours. They also collected specimens of amniotic fluid, cord blood, placenta, and endometrium during surgery, and collected data on maternal and neonatal adverse events.

All 16 women had detectable levels in the serum after vaginal placement. The median maternal concentration of tenofovir was 4.3 ng/mL, “which is very low,” Dr. Beigi said. “The median time to get that concentration was approximately 4 hours. To put this in perspective, when a mom takes a single oral dose of 600-mg tenofovir, their median concentration is 440 ng/mL. So we're looking at levels that are approximately 100-fold lower.”

The median cord:maternal blood ratio was 0.53, which is approximately the same as with oral dosing of tenofovir.

'Single-dose tenofovir appears very safe in term pregnancy. These findings justify continued investigation.'

Source DR. BEIGI

Major Finding: The median maternal serum concentration of 1% tenofovir vaginal gel was 4.3 ng/mL, which is about 100-times lower than a single 600-mg dose of oral tenofovir.

Data Source: A phase I trial of 16 healthy pregnant women who were scheduled to undergo cesarean delivery at term gestation and who received a single 4-g application of tenofovir 1% vaginal gel preoperatively.

Disclosures: The study was funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. The nonprofit organization CONRAD supplied the tenofovir gel. Dr. Beigi said that he had no relevant financial disclosures to make.

SANTA FE, N.M. — A single application of tenofovir 1% vaginal gel in term pregnancy produces low serum levels consistent with those reported in nonpregnant women, results from a small single-center trial demonstrated.

The findings come just weeks after a study published online in the journal Science found that 1% tenofovir gel used before and after sexual intercourse reduced HIV in women by 39% and reduced the incidence of herpes simplex virus type 2 infections by 50% (Science 2010 July 20 [doi:10.1126/science.1193748]). “It does appear that tenofovir gel, once absorbed, does get to the fetal compartment, with very low overall cord blood levels—approximately 40-fold lower than you see after oral dosing—with a very similar cord:maternal blood ratio,” Dr. Richard Beigi said at the meeting.

“In addition, it appears that single-dose tenofovir appears very safe in term pregnancy. These findings justify continued investigation of this product in pregnancy,” he said.

In a phase I trial conducted by the Microbicide Trials Network, researchers evaluated 16 healthy pregnant women who were scheduled to undergo cesarean delivery at term gestation between August 2008 and January 2010.

The women received a single 4-g application of tenofovir 1% vaginal gel preoperatively.

“Oral tenofovir has a growing record of safety,” he said. “It's a category B drug, with close to 1,000 exposures collected in the Antiretroviral Pregnancy Registry. So we felt very comfortable moving [the gel form of] this drug into pregnancy trials.”

Dr. Beigi of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh and his associates collected maternal blood for serum drug concentrations at baseline and at 1, 2, 4, 6, 8, 12, and 24 hours. They also collected specimens of amniotic fluid, cord blood, placenta, and endometrium during surgery, and collected data on maternal and neonatal adverse events.

All 16 women had detectable levels in the serum after vaginal placement. The median maternal concentration of tenofovir was 4.3 ng/mL, “which is very low,” Dr. Beigi said. “The median time to get that concentration was approximately 4 hours. To put this in perspective, when a mom takes a single oral dose of 600-mg tenofovir, their median concentration is 440 ng/mL. So we're looking at levels that are approximately 100-fold lower.”

The median cord:maternal blood ratio was 0.53, which is approximately the same as with oral dosing of tenofovir.

'Single-dose tenofovir appears very safe in term pregnancy. These findings justify continued investigation.'

Source DR. BEIGI

Major Finding: Researchers found only 13 studies that met their search criteria.

Data Source: A meta-analysis of studies published between Jan. 1, 1998 and Sept. 1, 2008.

Disclosures: The study was funded by Galderma Laboratories. Dr. Feldman said he has received funding and consulting fees from the company.

Medication adherence among acne patients is so poorly studied that it is difficult to draw any solid conclusions about the topic, results from a new meta-analysis suggest.

“That's a critical issue, because it would be nice to have new treatments, but getting people to be more compliant with existing drugs would be another great way to get people better,” one of the study authors, Dr. Steven R. Feldman, said in an interview. “We need more studies, especially those that tell us how to improve adherence.”

A recurring theme in some of the studies reviewed was that acne patients with a better quality of life tended to take their acne medication as prescribed. “Physicians think, 'acne really bothers teenagers, so they're going to be more likely to use their medicine,'” said Dr. Feldman of Wake Forest University, Winston-Salem, N.C. “In fact, we found that the people who were most bothered by their acne were least likely to use their medicine. Maybe psychologically they don't want to think about their disease. Who knows? But you can't just assume that people will use their medicines just because the disease bothers them.”

For the study, Dr. Feldman and his associates conducted a Medline search of articles published between Jan. 1, 1998, and Sept. 1, 2008, that contained the keywords acne and adherence or compliance (J. Cos. Dermatol. 2010;9:160-6).

The researchers found only 13 studies that met their criteria. Of these, six used patient questionnaires to measure adherence, two used patient diaries, and the remaining five used electronic medical records.

Investigators of the largest study in the review asked 2,221 patients to rate their acne medication adherence as daily, almost daily, or rarely (Dermatol. 2008;217:309-14). More than half (57%) rated their adherence as every day, and 38% rated it as almost every day. Forgetting to take the medication was the most common reason cited for low adherence, followed by a perceived lack of time.

A more recent study contained in the review measured acne medication adherence in 152 teens who returned for follow-up at 2 months (J. Cutan. Med. Surg. 2009;13:204-8). Patients were considered to have high adherence if they reported using their acne medication as prescribed 100% of the time, medium adherence 75%-99% of the time, and low adherence 74% of the time and below.

The investigators of this study reported that 24% of patients were rated as having high adherence, 49% had medium adherence, and 26% had low adherence. Patients rated side effects from the medication as the most common reason for low adherence, followed by forgetfulness.

Major Finding: Researchers found only 13 studies that met their search criteria.

Data Source: A meta-analysis of studies published between Jan. 1, 1998 and Sept. 1, 2008.

Disclosures: The study was funded by Galderma Laboratories. Dr. Feldman said he has received funding and consulting fees from the company.

Medication adherence among acne patients is so poorly studied that it is difficult to draw any solid conclusions about the topic, results from a new meta-analysis suggest.

“That's a critical issue, because it would be nice to have new treatments, but getting people to be more compliant with existing drugs would be another great way to get people better,” one of the study authors, Dr. Steven R. Feldman, said in an interview. “We need more studies, especially those that tell us how to improve adherence.”

A recurring theme in some of the studies reviewed was that acne patients with a better quality of life tended to take their acne medication as prescribed. “Physicians think, 'acne really bothers teenagers, so they're going to be more likely to use their medicine,'” said Dr. Feldman of Wake Forest University, Winston-Salem, N.C. “In fact, we found that the people who were most bothered by their acne were least likely to use their medicine. Maybe psychologically they don't want to think about their disease. Who knows? But you can't just assume that people will use their medicines just because the disease bothers them.”

For the study, Dr. Feldman and his associates conducted a Medline search of articles published between Jan. 1, 1998, and Sept. 1, 2008, that contained the keywords acne and adherence or compliance (J. Cos. Dermatol. 2010;9:160-6).

The researchers found only 13 studies that met their criteria. Of these, six used patient questionnaires to measure adherence, two used patient diaries, and the remaining five used electronic medical records.

Investigators of the largest study in the review asked 2,221 patients to rate their acne medication adherence as daily, almost daily, or rarely (Dermatol. 2008;217:309-14). More than half (57%) rated their adherence as every day, and 38% rated it as almost every day. Forgetting to take the medication was the most common reason cited for low adherence, followed by a perceived lack of time.

A more recent study contained in the review measured acne medication adherence in 152 teens who returned for follow-up at 2 months (J. Cutan. Med. Surg. 2009;13:204-8). Patients were considered to have high adherence if they reported using their acne medication as prescribed 100% of the time, medium adherence 75%-99% of the time, and low adherence 74% of the time and below.

The investigators of this study reported that 24% of patients were rated as having high adherence, 49% had medium adherence, and 26% had low adherence. Patients rated side effects from the medication as the most common reason for low adherence, followed by forgetfulness.

Major Finding: Researchers found only 13 studies that met their search criteria.

Data Source: A meta-analysis of studies published between Jan. 1, 1998 and Sept. 1, 2008.

Disclosures: The study was funded by Galderma Laboratories. Dr. Feldman said he has received funding and consulting fees from the company.

Medication adherence among acne patients is so poorly studied that it is difficult to draw any solid conclusions about the topic, results from a new meta-analysis suggest.

“That's a critical issue, because it would be nice to have new treatments, but getting people to be more compliant with existing drugs would be another great way to get people better,” one of the study authors, Dr. Steven R. Feldman, said in an interview. “We need more studies, especially those that tell us how to improve adherence.”

A recurring theme in some of the studies reviewed was that acne patients with a better quality of life tended to take their acne medication as prescribed. “Physicians think, 'acne really bothers teenagers, so they're going to be more likely to use their medicine,'” said Dr. Feldman of Wake Forest University, Winston-Salem, N.C. “In fact, we found that the people who were most bothered by their acne were least likely to use their medicine. Maybe psychologically they don't want to think about their disease. Who knows? But you can't just assume that people will use their medicines just because the disease bothers them.”

For the study, Dr. Feldman and his associates conducted a Medline search of articles published between Jan. 1, 1998, and Sept. 1, 2008, that contained the keywords acne and adherence or compliance (J. Cos. Dermatol. 2010;9:160-6).

The researchers found only 13 studies that met their criteria. Of these, six used patient questionnaires to measure adherence, two used patient diaries, and the remaining five used electronic medical records.

Investigators of the largest study in the review asked 2,221 patients to rate their acne medication adherence as daily, almost daily, or rarely (Dermatol. 2008;217:309-14). More than half (57%) rated their adherence as every day, and 38% rated it as almost every day. Forgetting to take the medication was the most common reason cited for low adherence, followed by a perceived lack of time.

A more recent study contained in the review measured acne medication adherence in 152 teens who returned for follow-up at 2 months (J. Cutan. Med. Surg. 2009;13:204-8). Patients were considered to have high adherence if they reported using their acne medication as prescribed 100% of the time, medium adherence 75%-99% of the time, and low adherence 74% of the time and below.

The investigators of this study reported that 24% of patients were rated as having high adherence, 49% had medium adherence, and 26% had low adherence. Patients rated side effects from the medication as the most common reason for low adherence, followed by forgetfulness.

The federal government this summer has taken a two-pronged approach to reinvigorating its efforts in addressing HIV/AIDS.

In June, the Centers for Disease Control and Prevention launched an initiative aimed at helping physicians make HIV testing a routine part of medical care. The initiative, known as “HIV Screening. Standard Care.” aims to increase the use of opt-out screening strategies over risk-based screening, which previously has been the more common practice.

In an interview, Dr. Jonathan Mermin, director of the CDC's division of HIV/AIDS prevention, Atlanta, said the goal of the new initiative is to increase implementation of the CDC's 2006 HIV screening guidelines, which recommend that all patients aged 13-64 years be tested for HIV at least once in their lives—regardless of perceived risk of infection—and that individuals at high risk be tested at least annually (MMWR 2006;55[RR-14]:1-17).

“In the end, HIV testing is one of the most important interventions we have, both for HIV care and HIV prevention,” Dr. Mermin said.

“The need for HIV screening is an ongoing issue,” said Dr. Amir Qaseem, senior medical associate at the American College of Physicians, which recently published a guidance statement for HIV screening (Ann. Intern. Med. 2009;150:125-31). “It's a major public health problem worldwide, even within the United States, where almost 1 million people are living with HIV. Almost 25% of these people are unaware of their HIV infection.”

He acknowledged certain challenges to providing routine screening in primary care, including addressing multiple issues in a limited amount of time during the office visit.

“Risk-based screening has been an unsuccessful strategy and has failed to identify a substantial number of patients with HIV,” Dr. Qaseem said. “Routine HIV screening is easier to implement in busy practice settings.”

Yet few physicians do it. A 2009 Web-based survey from the public relations firm Porter Novelli found that only 17% of primary care physicians routinely screen their patients for HIV.

And in a study from 2007, investigators from the bureau of HIV/AIDS prevention and control in the New York City Department of Health and Mental Hygiene reviewed published and unpublished literature on HIV testing barriers.

They divided studies into three categories: prenatal, emergency department, and other medical settings (AIDS 2007;21:1617-24). Several barriers were identified in all three settings: lack of knowledge/training, lack of patient acceptance, pretest counseling requirements, competing priorities, and inadequate reimbursement.

“Some providers [feel] awkward raising issues about HIV testing or sexuality with their patients, because they think someone who's 55 years old may not be at risk,” Dr. Mermin said. “But in fact, people of all ages are at risk for HIV infection. Some of that is because it's a chronic disease and people can live with HIV for many years without showing symptoms. Some of it is that the majority of Americans are sexually active throughout their life, and can acquire HIV regardless of age.”

Laws and regulations in some states pose another challenge to adoption of routine HIV screening. In a recent study, researchers led by Dr. John G. Bartlett of Johns Hopkins University, Baltimore, reported that at the time of the CDC's 2006 HIV screening guidelines, 20 states had laws or regulations that required separate written consent for HIV testing of nonpregnant adults (JAMA 2008;300:945-51).

“Legislation or regulations to remove these barriers have been enacted in 11 states (Arizona, California, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, New Hampshire, New Mexico, and North Carolina),” the researchers wrote. Since publication of that article, Connecticut, Hawaii, Rhode Island, and Wisconsin have changed laws to remove these barriers, according to Dr. Bernard M. Branson of the CDC, one of the study's authors. Similar legislation has been introduced but not enacted in Massachusetts, Michigan, Nebraska, and New York.

Routine HIV screening is supported in the government's National HIV/AIDS Strategy for the United States—the summer's other major federal HIV/AIDS effort.

Released in July, the national strategy is a 45-page blueprint with three main goals: reducing the number of people who become infected with HIV, increasing access to care and optimizing health outcomes for people living with HIV, and reducing HIV health-related disparities.

The strategy emphasizes reduction of new HIV infections by intensifying prevention efforts in communities where HIV is most prevalent, expanding targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches, and educating all Americans about the threat of HIV and how to prevent it.

“This has been a long time coming,” said Dr. Donna Sweet, professor of internal medicine at the University of Kansas–Wichita. “It reflects, I think, what we all think needs to be done. It really is about reducing new HIV infections, improving care for the people living with HIV/AIDS, and perhaps even most importantly, narrowing the health disparities, because this epidemic has moved into corners of our country where there are very little resources and a lack of education.

“It's important to address the disparities in what's going on so that all Americans, regardless of color or sexual orientation, truly are considered important,” Dr. Sweet continued.

“We need to work to maintain their health, both by helping stop the spread of infections in our minority communities as well as making sure people in all communities have access to the best of care,” she said.

The strategy sets certain benchmarks to be reached by 2015, including lowering the annual number of new infections by 25%, reducing the HIV transmission rate by 30%, and increasing the percentage of persons living with HIV who know their serostatus from 79% to 90%.

“What the strategy is doing is asking the nation to use a tiered approach to HIV prevention so that certain interventions should be offered to everyone in the nation,” Dr. Mermin said. “Some interventions should be applied only to people at very high risk of acquiring HIV, such as intensive behavioral counseling or intensive case management that would take a lot more clinical or social resources. They should be reserved for people at the most risk. Some interventions should be offered to people with HIV, to help them reduce the chance that they are going to transmit HIV and to help them live longer, healthier lives.”

Not all HIV/AIDS leaders support the new national strategy. In a prepared statement, Dr. Michael Weinstein, president of the Los Angeles–based AIDS Healthcare Foundation called it a “real disappointment” and criticized it for lack of funding. He pointed out that as of July 9, 2,291 people in 12 states were on wait lists to receive medications through the nation's AIDS Drug Assistance Programs (ADAP).

“The vast majority of people in the United States who know that they have HIV are accessing care,” Dr. Mermin pointed out.

“We can increase that number over time. The Department of Health and Human Services is making efforts to address the ADAP waiting list. In the long run it's important that people with HIV do access high-quality care and prevention services. But just knowing that someone has HIV—even if it will be a few months before they can access care—is critical. People with HIV who know that they have the infection reduce their risk behavior by over 60%. So I think it's a mistake to say that there's no reason to screen for HIV anymore,” he said.

One challenge that worries Dr. Sweet is recruiting young physicians to the field of HIV/AIDS medicine.

“We're going to have an increasing problem finding doctors to take care of HIV/AIDS, simply because the people who have been doing this for 30 years are starting to age out,” she said. “It's tough to get young people into this, because it's in a group of people that are oftentimes socioeconomically disenfranchised, and they have a difficult time finding doctors anyway.”

'Some interventions should be applied only to people at very high risk of acquiring HIV.'

Source DR. MERMIN

Almost 25% of the nearly 1 million Americans with HIV 'are unaware of their HIV infection.'

Source DR. QASEEM

HIV Testing: Start the Conversation

Dr. Mermin suggested the following approach to starting the conversation on HIV testing with a patient: “The CDC recommends that all patients are offered an HIV test. Would you like to know your HIV status?”

That approach, known as opt-out offering of HIV testing, “is very successful,” Dr. Mermin said.

“Very few people will ask not to be tested under those circumstances. It takes the onus away from the provider to assess people's risk, and it takes the burden and awkwardness from the patient of having to raise the question of wanting an HIV test. Many patients don't know that they are at risk,” he told this newspaper.

The CDC testing initiative, which is supported by the American College of Physicians, the National Medical Association, the Society for General Internal Medicine, the HIV Medicine Association, and the American Academy of HIV Medicine, provides free a resource kit for physicians to use in primary care settings, including an annotated guide to CDC recommendations and the rationale for screening as well as patient materials such as brochures and posters.

To access the material, visit

www.cdc.gov/hivstandardcare

The federal government this summer has taken a two-pronged approach to reinvigorating its efforts in addressing HIV/AIDS.

In June, the Centers for Disease Control and Prevention launched an initiative aimed at helping physicians make HIV testing a routine part of medical care. The initiative, known as “HIV Screening. Standard Care.” aims to increase the use of opt-out screening strategies over risk-based screening, which previously has been the more common practice.

In an interview, Dr. Jonathan Mermin, director of the CDC's division of HIV/AIDS prevention, Atlanta, said the goal of the new initiative is to increase implementation of the CDC's 2006 HIV screening guidelines, which recommend that all patients aged 13-64 years be tested for HIV at least once in their lives—regardless of perceived risk of infection—and that individuals at high risk be tested at least annually (MMWR 2006;55[RR-14]:1-17).

“In the end, HIV testing is one of the most important interventions we have, both for HIV care and HIV prevention,” Dr. Mermin said.

“The need for HIV screening is an ongoing issue,” said Dr. Amir Qaseem, senior medical associate at the American College of Physicians, which recently published a guidance statement for HIV screening (Ann. Intern. Med. 2009;150:125-31). “It's a major public health problem worldwide, even within the United States, where almost 1 million people are living with HIV. Almost 25% of these people are unaware of their HIV infection.”

He acknowledged certain challenges to providing routine screening in primary care, including addressing multiple issues in a limited amount of time during the office visit.

“Risk-based screening has been an unsuccessful strategy and has failed to identify a substantial number of patients with HIV,” Dr. Qaseem said. “Routine HIV screening is easier to implement in busy practice settings.”

Yet few physicians do it. A 2009 Web-based survey from the public relations firm Porter Novelli found that only 17% of primary care physicians routinely screen their patients for HIV.

And in a study from 2007, investigators from the bureau of HIV/AIDS prevention and control in the New York City Department of Health and Mental Hygiene reviewed published and unpublished literature on HIV testing barriers.

They divided studies into three categories: prenatal, emergency department, and other medical settings (AIDS 2007;21:1617-24). Several barriers were identified in all three settings: lack of knowledge/training, lack of patient acceptance, pretest counseling requirements, competing priorities, and inadequate reimbursement.

“Some providers [feel] awkward raising issues about HIV testing or sexuality with their patients, because they think someone who's 55 years old may not be at risk,” Dr. Mermin said. “But in fact, people of all ages are at risk for HIV infection. Some of that is because it's a chronic disease and people can live with HIV for many years without showing symptoms. Some of it is that the majority of Americans are sexually active throughout their life, and can acquire HIV regardless of age.”

Laws and regulations in some states pose another challenge to adoption of routine HIV screening. In a recent study, researchers led by Dr. John G. Bartlett of Johns Hopkins University, Baltimore, reported that at the time of the CDC's 2006 HIV screening guidelines, 20 states had laws or regulations that required separate written consent for HIV testing of nonpregnant adults (JAMA 2008;300:945-51).

“Legislation or regulations to remove these barriers have been enacted in 11 states (Arizona, California, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, New Hampshire, New Mexico, and North Carolina),” the researchers wrote. Since publication of that article, Connecticut, Hawaii, Rhode Island, and Wisconsin have changed laws to remove these barriers, according to Dr. Bernard M. Branson of the CDC, one of the study's authors. Similar legislation has been introduced but not enacted in Massachusetts, Michigan, Nebraska, and New York.

Routine HIV screening is supported in the government's National HIV/AIDS Strategy for the United States—the summer's other major federal HIV/AIDS effort.

Released in July, the national strategy is a 45-page blueprint with three main goals: reducing the number of people who become infected with HIV, increasing access to care and optimizing health outcomes for people living with HIV, and reducing HIV health-related disparities.

The strategy emphasizes reduction of new HIV infections by intensifying prevention efforts in communities where HIV is most prevalent, expanding targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches, and educating all Americans about the threat of HIV and how to prevent it.

“This has been a long time coming,” said Dr. Donna Sweet, professor of internal medicine at the University of Kansas–Wichita. “It reflects, I think, what we all think needs to be done. It really is about reducing new HIV infections, improving care for the people living with HIV/AIDS, and perhaps even most importantly, narrowing the health disparities, because this epidemic has moved into corners of our country where there are very little resources and a lack of education.

“It's important to address the disparities in what's going on so that all Americans, regardless of color or sexual orientation, truly are considered important,” Dr. Sweet continued.

“We need to work to maintain their health, both by helping stop the spread of infections in our minority communities as well as making sure people in all communities have access to the best of care,” she said.

The strategy sets certain benchmarks to be reached by 2015, including lowering the annual number of new infections by 25%, reducing the HIV transmission rate by 30%, and increasing the percentage of persons living with HIV who know their serostatus from 79% to 90%.

“What the strategy is doing is asking the nation to use a tiered approach to HIV prevention so that certain interventions should be offered to everyone in the nation,” Dr. Mermin said. “Some interventions should be applied only to people at very high risk of acquiring HIV, such as intensive behavioral counseling or intensive case management that would take a lot more clinical or social resources. They should be reserved for people at the most risk. Some interventions should be offered to people with HIV, to help them reduce the chance that they are going to transmit HIV and to help them live longer, healthier lives.”

Not all HIV/AIDS leaders support the new national strategy. In a prepared statement, Dr. Michael Weinstein, president of the Los Angeles–based AIDS Healthcare Foundation called it a “real disappointment” and criticized it for lack of funding. He pointed out that as of July 9, 2,291 people in 12 states were on wait lists to receive medications through the nation's AIDS Drug Assistance Programs (ADAP).

“The vast majority of people in the United States who know that they have HIV are accessing care,” Dr. Mermin pointed out.

“We can increase that number over time. The Department of Health and Human Services is making efforts to address the ADAP waiting list. In the long run it's important that people with HIV do access high-quality care and prevention services. But just knowing that someone has HIV—even if it will be a few months before they can access care—is critical. People with HIV who know that they have the infection reduce their risk behavior by over 60%. So I think it's a mistake to say that there's no reason to screen for HIV anymore,” he said.

One challenge that worries Dr. Sweet is recruiting young physicians to the field of HIV/AIDS medicine.

“We're going to have an increasing problem finding doctors to take care of HIV/AIDS, simply because the people who have been doing this for 30 years are starting to age out,” she said. “It's tough to get young people into this, because it's in a group of people that are oftentimes socioeconomically disenfranchised, and they have a difficult time finding doctors anyway.”

'Some interventions should be applied only to people at very high risk of acquiring HIV.'

Source DR. MERMIN

Almost 25% of the nearly 1 million Americans with HIV 'are unaware of their HIV infection.'

Source DR. QASEEM

HIV Testing: Start the Conversation

Dr. Mermin suggested the following approach to starting the conversation on HIV testing with a patient: “The CDC recommends that all patients are offered an HIV test. Would you like to know your HIV status?”

That approach, known as opt-out offering of HIV testing, “is very successful,” Dr. Mermin said.

“Very few people will ask not to be tested under those circumstances. It takes the onus away from the provider to assess people's risk, and it takes the burden and awkwardness from the patient of having to raise the question of wanting an HIV test. Many patients don't know that they are at risk,” he told this newspaper.

The CDC testing initiative, which is supported by the American College of Physicians, the National Medical Association, the Society for General Internal Medicine, the HIV Medicine Association, and the American Academy of HIV Medicine, provides free a resource kit for physicians to use in primary care settings, including an annotated guide to CDC recommendations and the rationale for screening as well as patient materials such as brochures and posters.

To access the material, visit

www.cdc.gov/hivstandardcare

The federal government this summer has taken a two-pronged approach to reinvigorating its efforts in addressing HIV/AIDS.

In June, the Centers for Disease Control and Prevention launched an initiative aimed at helping physicians make HIV testing a routine part of medical care. The initiative, known as “HIV Screening. Standard Care.” aims to increase the use of opt-out screening strategies over risk-based screening, which previously has been the more common practice.

In an interview, Dr. Jonathan Mermin, director of the CDC's division of HIV/AIDS prevention, Atlanta, said the goal of the new initiative is to increase implementation of the CDC's 2006 HIV screening guidelines, which recommend that all patients aged 13-64 years be tested for HIV at least once in their lives—regardless of perceived risk of infection—and that individuals at high risk be tested at least annually (MMWR 2006;55[RR-14]:1-17).

“In the end, HIV testing is one of the most important interventions we have, both for HIV care and HIV prevention,” Dr. Mermin said.

“The need for HIV screening is an ongoing issue,” said Dr. Amir Qaseem, senior medical associate at the American College of Physicians, which recently published a guidance statement for HIV screening (Ann. Intern. Med. 2009;150:125-31). “It's a major public health problem worldwide, even within the United States, where almost 1 million people are living with HIV. Almost 25% of these people are unaware of their HIV infection.”

He acknowledged certain challenges to providing routine screening in primary care, including addressing multiple issues in a limited amount of time during the office visit.

“Risk-based screening has been an unsuccessful strategy and has failed to identify a substantial number of patients with HIV,” Dr. Qaseem said. “Routine HIV screening is easier to implement in busy practice settings.”

Yet few physicians do it. A 2009 Web-based survey from the public relations firm Porter Novelli found that only 17% of primary care physicians routinely screen their patients for HIV.

And in a study from 2007, investigators from the bureau of HIV/AIDS prevention and control in the New York City Department of Health and Mental Hygiene reviewed published and unpublished literature on HIV testing barriers.

They divided studies into three categories: prenatal, emergency department, and other medical settings (AIDS 2007;21:1617-24). Several barriers were identified in all three settings: lack of knowledge/training, lack of patient acceptance, pretest counseling requirements, competing priorities, and inadequate reimbursement.

“Some providers [feel] awkward raising issues about HIV testing or sexuality with their patients, because they think someone who's 55 years old may not be at risk,” Dr. Mermin said. “But in fact, people of all ages are at risk for HIV infection. Some of that is because it's a chronic disease and people can live with HIV for many years without showing symptoms. Some of it is that the majority of Americans are sexually active throughout their life, and can acquire HIV regardless of age.”

Laws and regulations in some states pose another challenge to adoption of routine HIV screening. In a recent study, researchers led by Dr. John G. Bartlett of Johns Hopkins University, Baltimore, reported that at the time of the CDC's 2006 HIV screening guidelines, 20 states had laws or regulations that required separate written consent for HIV testing of nonpregnant adults (JAMA 2008;300:945-51).

“Legislation or regulations to remove these barriers have been enacted in 11 states (Arizona, California, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, New Hampshire, New Mexico, and North Carolina),” the researchers wrote. Since publication of that article, Connecticut, Hawaii, Rhode Island, and Wisconsin have changed laws to remove these barriers, according to Dr. Bernard M. Branson of the CDC, one of the study's authors. Similar legislation has been introduced but not enacted in Massachusetts, Michigan, Nebraska, and New York.

Routine HIV screening is supported in the government's National HIV/AIDS Strategy for the United States—the summer's other major federal HIV/AIDS effort.

Released in July, the national strategy is a 45-page blueprint with three main goals: reducing the number of people who become infected with HIV, increasing access to care and optimizing health outcomes for people living with HIV, and reducing HIV health-related disparities.

The strategy emphasizes reduction of new HIV infections by intensifying prevention efforts in communities where HIV is most prevalent, expanding targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches, and educating all Americans about the threat of HIV and how to prevent it.

“This has been a long time coming,” said Dr. Donna Sweet, professor of internal medicine at the University of Kansas–Wichita. “It reflects, I think, what we all think needs to be done. It really is about reducing new HIV infections, improving care for the people living with HIV/AIDS, and perhaps even most importantly, narrowing the health disparities, because this epidemic has moved into corners of our country where there are very little resources and a lack of education.

“It's important to address the disparities in what's going on so that all Americans, regardless of color or sexual orientation, truly are considered important,” Dr. Sweet continued.

“We need to work to maintain their health, both by helping stop the spread of infections in our minority communities as well as making sure people in all communities have access to the best of care,” she said.

The strategy sets certain benchmarks to be reached by 2015, including lowering the annual number of new infections by 25%, reducing the HIV transmission rate by 30%, and increasing the percentage of persons living with HIV who know their serostatus from 79% to 90%.

“What the strategy is doing is asking the nation to use a tiered approach to HIV prevention so that certain interventions should be offered to everyone in the nation,” Dr. Mermin said. “Some interventions should be applied only to people at very high risk of acquiring HIV, such as intensive behavioral counseling or intensive case management that would take a lot more clinical or social resources. They should be reserved for people at the most risk. Some interventions should be offered to people with HIV, to help them reduce the chance that they are going to transmit HIV and to help them live longer, healthier lives.”

Not all HIV/AIDS leaders support the new national strategy. In a prepared statement, Dr. Michael Weinstein, president of the Los Angeles–based AIDS Healthcare Foundation called it a “real disappointment” and criticized it for lack of funding. He pointed out that as of July 9, 2,291 people in 12 states were on wait lists to receive medications through the nation's AIDS Drug Assistance Programs (ADAP).

“The vast majority of people in the United States who know that they have HIV are accessing care,” Dr. Mermin pointed out.

“We can increase that number over time. The Department of Health and Human Services is making efforts to address the ADAP waiting list. In the long run it's important that people with HIV do access high-quality care and prevention services. But just knowing that someone has HIV—even if it will be a few months before they can access care—is critical. People with HIV who know that they have the infection reduce their risk behavior by over 60%. So I think it's a mistake to say that there's no reason to screen for HIV anymore,” he said.

One challenge that worries Dr. Sweet is recruiting young physicians to the field of HIV/AIDS medicine.

“We're going to have an increasing problem finding doctors to take care of HIV/AIDS, simply because the people who have been doing this for 30 years are starting to age out,” she said. “It's tough to get young people into this, because it's in a group of people that are oftentimes socioeconomically disenfranchised, and they have a difficult time finding doctors anyway.”

'Some interventions should be applied only to people at very high risk of acquiring HIV.'

Source DR. MERMIN

Almost 25% of the nearly 1 million Americans with HIV 'are unaware of their HIV infection.'

Source DR. QASEEM

HIV Testing: Start the Conversation

Dr. Mermin suggested the following approach to starting the conversation on HIV testing with a patient: “The CDC recommends that all patients are offered an HIV test. Would you like to know your HIV status?”

That approach, known as opt-out offering of HIV testing, “is very successful,” Dr. Mermin said.

“Very few people will ask not to be tested under those circumstances. It takes the onus away from the provider to assess people's risk, and it takes the burden and awkwardness from the patient of having to raise the question of wanting an HIV test. Many patients don't know that they are at risk,” he told this newspaper.

The CDC testing initiative, which is supported by the American College of Physicians, the National Medical Association, the Society for General Internal Medicine, the HIV Medicine Association, and the American Academy of HIV Medicine, provides free a resource kit for physicians to use in primary care settings, including an annotated guide to CDC recommendations and the rationale for screening as well as patient materials such as brochures and posters.

To access the material, visit

www.cdc.gov/hivstandardcare

Mutations in two genes, ARID1A and PPP2R1A, appear to be linked to ovarian clear cell carcinoma, one of the most aggressive forms of ovarian cancer, investigators reported online Sept. 8 in Science Express.

In a separate study published online the same day in the New England Journal of Medicine, another team of researchers found an association between mutations in ARID1A and the development of ovarian clear cell and endometrioid carcinomas.

Although these two cancers are known to be associated with endometriosis, the genetic events tied to the transformation of endometriosis into cancer are unknown.

The ARID1A and PPP2R1A genes had not previously been linked to ovarian cancer, and the findings “may provide opportunities for developing new biomarkers and therapies that target those genes,” Siân Jones, Ph.D., lead author of the Science Express study, noted in a written statement.

The researchers speculated that ARID1A functions as a tumor suppressor gene and, when mutated, is “likely to directly lead to epigenetic changes in cancer cells.” PPP2R1A is an oncogene that, when altered, helps turn normal cells into tumor cells, they said.

Dr. Jones, a research associate at the Johns Hopkins Kimmel Cancer Center, Baltimore, and associates evaluated 18,000 protein-encoding genes in ovarian clear cell tumors from eight patients (Science 2010 Sept. 8 [doi:10.1126/science.1196333]). They purified the cancer cells and then analyzed the exomic sequences from those cells as well as normal cells obtained from the blood or unaffected tissues of the same patients.

There were 268 mutations in 253 genes among the eight tumors. The four genes with the most prevalent mutations were PIK3CA and KRAS, which had been previously linked to ovarian clear cell carcinoma, and ARID1A and PPP2R1A, which had not.

The researchers used polymerase chain reaction amplification and gene sequencing to determine the sequences of these four genes in an additional 34 patients with ovarian clear cell cancer. ARID1A mutations were identified in 57% of the 42 tumors, while 7.1% contained PPP2R1A mutations, 40% contained PIK3CA mutations, and 4.7% contained KRAS mutations.

“Discovery of tumor suppressor genes such as ARID1A that are mutated in cancers ... are likely to directly lead to epigenetic changes in cancer cells through specific modifications of chromatin proteins,” the researchers concluded. “They additionally provide a potential approach to determine which of the numerous epigenetic changes in cancers confer a selective growth advantage and which are simply ‘passengers’ that do not play a causal role. The identification of the genes whose expression is specifically modulated by ARID1A inactivation will be the next crucial step in this line of research.”

In the second study, investigators performed RNA sequencing on 18 ovarian clear cell carcinomas and one ovarian clear cell carcinoma cell line to identify variants in ARID1A. Next, they performed targeted exon resequencing in this cohort as well as in a validation cohort containing samples of ovarian clear cell carcinoma from 101 patients, endometrioid carcinoma from 33 patients, and high-grade serous carcinoma from 76 patients. The ovarian clear cell carcinoma-derived cell line ES2 also was included, wrote Kimberly C. Wiegand of the British Columbia Cancer Agency, Vancouver, and associates (N. Engl. J. Med 2010 Sept. 8 [doi:10.1056/NEJMoa1008433]).

ARID1A mutations were observed in 55 of 119 ovarian clear cell carcinoma (46%), 10 of 33 endometrioid carcinomas (30%), and none of the 76 high-grade serous ovarian carcinomas. Twelve of the ovarian clear cell carcinomas and five of the endometrioid carcinomas had two somatic mutations each.

Loss of BAF250a expression was seen in 42% of the ovarian clear cell carcinoma samples and 21% of the endometrioid carcinoma samples, compared with just 1% of the high-grade serous carcinoma samples. “This suggests that the mutations may be pathogenic, rather than random events,” they wrote.

The presence of ARID1A mutations was strongly correlated with loss of the BAF250a protein. Loss of BAF250a expression was seen in 73% and 50% of samples of ovarian clear cell carcinoma and endometrioid carcinoma with an ARID1A mutation, respectively, but in only 11% and 9% of samples without such a mutation.

The investigators suggested that defects in genes that alter the accessibility of transcription factors to chromatin, such as ARID1A, “will help to define ovarian clear cell carcinomas and endometrial carcinomas. If such a model is correct, other abnormalities affecting the ARID1A locus or dysregulation of other chromatin remodeling genes may be found in ovarian clear cell and endometrioid carcinomas that are negative for an ARID1A mutation. This idea is supported by the clinical similarities between ovarian clear cell carcinomas positive for and those negative for an ARID1A mutation.”

The study published in Science Express was funded by the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, the AACR Stand Up to Cancer-Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, the U.S. Department of Defense, and the U.S. National Institutes of Health.

The study published in the New England Journal of Medicine was funded by the British Columbia Cancer Foundation, the Vancouver General Hospital–University of British Columbia Hospital Foundation, and the Canadian Institute of Health Research.

Mutations in two genes, ARID1A and PPP2R1A, appear to be linked to ovarian clear cell carcinoma, one of the most aggressive forms of ovarian cancer, investigators reported online Sept. 8 in Science Express.

In a separate study published online the same day in the New England Journal of Medicine, another team of researchers found an association between mutations in ARID1A and the development of ovarian clear cell and endometrioid carcinomas.

Although these two cancers are known to be associated with endometriosis, the genetic events tied to the transformation of endometriosis into cancer are unknown.

The ARID1A and PPP2R1A genes had not previously been linked to ovarian cancer, and the findings “may provide opportunities for developing new biomarkers and therapies that target those genes,” Siân Jones, Ph.D., lead author of the Science Express study, noted in a written statement.

The researchers speculated that ARID1A functions as a tumor suppressor gene and, when mutated, is “likely to directly lead to epigenetic changes in cancer cells.” PPP2R1A is an oncogene that, when altered, helps turn normal cells into tumor cells, they said.

Dr. Jones, a research associate at the Johns Hopkins Kimmel Cancer Center, Baltimore, and associates evaluated 18,000 protein-encoding genes in ovarian clear cell tumors from eight patients (Science 2010 Sept. 8 [doi:10.1126/science.1196333]). They purified the cancer cells and then analyzed the exomic sequences from those cells as well as normal cells obtained from the blood or unaffected tissues of the same patients.

There were 268 mutations in 253 genes among the eight tumors. The four genes with the most prevalent mutations were PIK3CA and KRAS, which had been previously linked to ovarian clear cell carcinoma, and ARID1A and PPP2R1A, which had not.

The researchers used polymerase chain reaction amplification and gene sequencing to determine the sequences of these four genes in an additional 34 patients with ovarian clear cell cancer. ARID1A mutations were identified in 57% of the 42 tumors, while 7.1% contained PPP2R1A mutations, 40% contained PIK3CA mutations, and 4.7% contained KRAS mutations.

“Discovery of tumor suppressor genes such as ARID1A that are mutated in cancers ... are likely to directly lead to epigenetic changes in cancer cells through specific modifications of chromatin proteins,” the researchers concluded. “They additionally provide a potential approach to determine which of the numerous epigenetic changes in cancers confer a selective growth advantage and which are simply ‘passengers’ that do not play a causal role. The identification of the genes whose expression is specifically modulated by ARID1A inactivation will be the next crucial step in this line of research.”

In the second study, investigators performed RNA sequencing on 18 ovarian clear cell carcinomas and one ovarian clear cell carcinoma cell line to identify variants in ARID1A. Next, they performed targeted exon resequencing in this cohort as well as in a validation cohort containing samples of ovarian clear cell carcinoma from 101 patients, endometrioid carcinoma from 33 patients, and high-grade serous carcinoma from 76 patients. The ovarian clear cell carcinoma-derived cell line ES2 also was included, wrote Kimberly C. Wiegand of the British Columbia Cancer Agency, Vancouver, and associates (N. Engl. J. Med 2010 Sept. 8 [doi:10.1056/NEJMoa1008433]).

ARID1A mutations were observed in 55 of 119 ovarian clear cell carcinoma (46%), 10 of 33 endometrioid carcinomas (30%), and none of the 76 high-grade serous ovarian carcinomas. Twelve of the ovarian clear cell carcinomas and five of the endometrioid carcinomas had two somatic mutations each.

Loss of BAF250a expression was seen in 42% of the ovarian clear cell carcinoma samples and 21% of the endometrioid carcinoma samples, compared with just 1% of the high-grade serous carcinoma samples. “This suggests that the mutations may be pathogenic, rather than random events,” they wrote.

The presence of ARID1A mutations was strongly correlated with loss of the BAF250a protein. Loss of BAF250a expression was seen in 73% and 50% of samples of ovarian clear cell carcinoma and endometrioid carcinoma with an ARID1A mutation, respectively, but in only 11% and 9% of samples without such a mutation.

The investigators suggested that defects in genes that alter the accessibility of transcription factors to chromatin, such as ARID1A, “will help to define ovarian clear cell carcinomas and endometrial carcinomas. If such a model is correct, other abnormalities affecting the ARID1A locus or dysregulation of other chromatin remodeling genes may be found in ovarian clear cell and endometrioid carcinomas that are negative for an ARID1A mutation. This idea is supported by the clinical similarities between ovarian clear cell carcinomas positive for and those negative for an ARID1A mutation.”

The study published in Science Express was funded by the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, the AACR Stand Up to Cancer-Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, the U.S. Department of Defense, and the U.S. National Institutes of Health.

The study published in the New England Journal of Medicine was funded by the British Columbia Cancer Foundation, the Vancouver General Hospital–University of British Columbia Hospital Foundation, and the Canadian Institute of Health Research.

Mutations in two genes, ARID1A and PPP2R1A, appear to be linked to ovarian clear cell carcinoma, one of the most aggressive forms of ovarian cancer, investigators reported online Sept. 8 in Science Express.

In a separate study published online the same day in the New England Journal of Medicine, another team of researchers found an association between mutations in ARID1A and the development of ovarian clear cell and endometrioid carcinomas.

Although these two cancers are known to be associated with endometriosis, the genetic events tied to the transformation of endometriosis into cancer are unknown.

The ARID1A and PPP2R1A genes had not previously been linked to ovarian cancer, and the findings “may provide opportunities for developing new biomarkers and therapies that target those genes,” Siân Jones, Ph.D., lead author of the Science Express study, noted in a written statement.

The researchers speculated that ARID1A functions as a tumor suppressor gene and, when mutated, is “likely to directly lead to epigenetic changes in cancer cells.” PPP2R1A is an oncogene that, when altered, helps turn normal cells into tumor cells, they said.

Dr. Jones, a research associate at the Johns Hopkins Kimmel Cancer Center, Baltimore, and associates evaluated 18,000 protein-encoding genes in ovarian clear cell tumors from eight patients (Science 2010 Sept. 8 [doi:10.1126/science.1196333]). They purified the cancer cells and then analyzed the exomic sequences from those cells as well as normal cells obtained from the blood or unaffected tissues of the same patients.

There were 268 mutations in 253 genes among the eight tumors. The four genes with the most prevalent mutations were PIK3CA and KRAS, which had been previously linked to ovarian clear cell carcinoma, and ARID1A and PPP2R1A, which had not.

The researchers used polymerase chain reaction amplification and gene sequencing to determine the sequences of these four genes in an additional 34 patients with ovarian clear cell cancer. ARID1A mutations were identified in 57% of the 42 tumors, while 7.1% contained PPP2R1A mutations, 40% contained PIK3CA mutations, and 4.7% contained KRAS mutations.

“Discovery of tumor suppressor genes such as ARID1A that are mutated in cancers ... are likely to directly lead to epigenetic changes in cancer cells through specific modifications of chromatin proteins,” the researchers concluded. “They additionally provide a potential approach to determine which of the numerous epigenetic changes in cancers confer a selective growth advantage and which are simply ‘passengers’ that do not play a causal role. The identification of the genes whose expression is specifically modulated by ARID1A inactivation will be the next crucial step in this line of research.”

In the second study, investigators performed RNA sequencing on 18 ovarian clear cell carcinomas and one ovarian clear cell carcinoma cell line to identify variants in ARID1A. Next, they performed targeted exon resequencing in this cohort as well as in a validation cohort containing samples of ovarian clear cell carcinoma from 101 patients, endometrioid carcinoma from 33 patients, and high-grade serous carcinoma from 76 patients. The ovarian clear cell carcinoma-derived cell line ES2 also was included, wrote Kimberly C. Wiegand of the British Columbia Cancer Agency, Vancouver, and associates (N. Engl. J. Med 2010 Sept. 8 [doi:10.1056/NEJMoa1008433]).

ARID1A mutations were observed in 55 of 119 ovarian clear cell carcinoma (46%), 10 of 33 endometrioid carcinomas (30%), and none of the 76 high-grade serous ovarian carcinomas. Twelve of the ovarian clear cell carcinomas and five of the endometrioid carcinomas had two somatic mutations each.

Loss of BAF250a expression was seen in 42% of the ovarian clear cell carcinoma samples and 21% of the endometrioid carcinoma samples, compared with just 1% of the high-grade serous carcinoma samples. “This suggests that the mutations may be pathogenic, rather than random events,” they wrote.

The presence of ARID1A mutations was strongly correlated with loss of the BAF250a protein. Loss of BAF250a expression was seen in 73% and 50% of samples of ovarian clear cell carcinoma and endometrioid carcinoma with an ARID1A mutation, respectively, but in only 11% and 9% of samples without such a mutation.

The investigators suggested that defects in genes that alter the accessibility of transcription factors to chromatin, such as ARID1A, “will help to define ovarian clear cell carcinomas and endometrial carcinomas. If such a model is correct, other abnormalities affecting the ARID1A locus or dysregulation of other chromatin remodeling genes may be found in ovarian clear cell and endometrioid carcinomas that are negative for an ARID1A mutation. This idea is supported by the clinical similarities between ovarian clear cell carcinomas positive for and those negative for an ARID1A mutation.”

The study published in Science Express was funded by the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, the AACR Stand Up to Cancer-Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, the U.S. Department of Defense, and the U.S. National Institutes of Health.

The study published in the New England Journal of Medicine was funded by the British Columbia Cancer Foundation, the Vancouver General Hospital–University of British Columbia Hospital Foundation, and the Canadian Institute of Health Research.

SANTA FE, N.M - Imiquimod 2.5% and 3.75% creams applied daily for up to 8 weeks were both well tolerated and more efficacious, compared with placebo in treating external genital warts in women, results from two combined randomized studies showed.

In particular, the 3.75% formulation "fulfills a need for a shorter and simpler imiquimod treatment for external genital warts and provides a clinically meaningful benefit with respect to complete clearance of all baseline and new warts and a rapid reduction in wart counts, with an acceptability safety profile," Dr. David A. Baker said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Currently, imiquimod 5% cream is approved to treat external genital warts and actinic keratoses. While this formation has been shown to be safe and effective, Dr. Baker noted that the efficacy end points "were based on the analysis of baseline target warts only, and the compliance with three times per week dosing frequency up to 16-week treatment duration may be difficult for some patients to follow, adversely affecting patient adherence to prescribed therapy."

In two identical phase III studies, Dr. Baker and his associates at 73 sites in the United States randomized 534 women to placebo, imiquimod 2.5% cream, or imiquimod 3.75% cream for the treatment of genital warts. Graceway Pharmaceuticals, which manufactures imiquimod, developed the formulations "to allow daily dosing to treat external genital warts as well as actinic keratoses," explained Dr. Baker, professor of obstetrics, gynecology, and reproductive medicine at Stony Brook University Medical Center, N.Y.

The 3.75% imiquimod cream has Food and Drug Administration approval to treat actinic keratoses. Graceway is waiting FDA approval of the 3.75% cream to treat external genital warts, Dr. Baker said in a later interview.

To be eligible for the trial, the women had to be at least 12 years of age, have 2-30 external genital warts, and have a total wart area of 10 mm² or greater.

Up to 250 mg of cream per dose was applied once daily to warts for up to 8 weeks or until complete clearance, if earlier. At 12 weeks, sustained complete clearance was assessed in women who had initial complete clearance.

The mean age of study participants was 33 years, the mean duration of disease was 5.6 years, the mean wart count was 7.9, and the mean total wart area was 166.3 mm².

In the intent to treat analysis, Dr. Baker reported that initial complete clearance of all external genital warts was achieved in 14% of the placebo group, 28% of the imiquimod 2.5% group, and 37% of the imiquimod 3.75% group. Results of the per protocol analysis were similar (16%, 35%, and 43%, respectively).

Of the women who achieved initial complete clearance and entered the 12-week follow-up, complete clearance was sustained in 100% of the placebo group, 60% of the imiquimod 2.5% group, and 65% of the imiquimod 3.75% group.

In terms of safety, 0.9% of women in the placebo group, 1% of women in the imiquimod 2.5% group, and 2% of the women imiquimod 3.75% group discontinued the study early due to safety-related reasons. The most common adverse event was severe local skin reaction, which occurred in 1% of women in the placebo group, 14% of women in the imiquimod 2.5% group, and 18% of the women imiquimod 3.75% group.

Disclosures: Dr. Baker disclosed that he is a research consultant for Graceway Pharmaceuticals.

SANTA FE, N.M - Imiquimod 2.5% and 3.75% creams applied daily for up to 8 weeks were both well tolerated and more efficacious, compared with placebo in treating external genital warts in women, results from two combined randomized studies showed.

In particular, the 3.75% formulation "fulfills a need for a shorter and simpler imiquimod treatment for external genital warts and provides a clinically meaningful benefit with respect to complete clearance of all baseline and new warts and a rapid reduction in wart counts, with an acceptability safety profile," Dr. David A. Baker said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Currently, imiquimod 5% cream is approved to treat external genital warts and actinic keratoses. While this formation has been shown to be safe and effective, Dr. Baker noted that the efficacy end points "were based on the analysis of baseline target warts only, and the compliance with three times per week dosing frequency up to 16-week treatment duration may be difficult for some patients to follow, adversely affecting patient adherence to prescribed therapy."

In two identical phase III studies, Dr. Baker and his associates at 73 sites in the United States randomized 534 women to placebo, imiquimod 2.5% cream, or imiquimod 3.75% cream for the treatment of genital warts. Graceway Pharmaceuticals, which manufactures imiquimod, developed the formulations "to allow daily dosing to treat external genital warts as well as actinic keratoses," explained Dr. Baker, professor of obstetrics, gynecology, and reproductive medicine at Stony Brook University Medical Center, N.Y.

The 3.75% imiquimod cream has Food and Drug Administration approval to treat actinic keratoses. Graceway is waiting FDA approval of the 3.75% cream to treat external genital warts, Dr. Baker said in a later interview.

To be eligible for the trial, the women had to be at least 12 years of age, have 2-30 external genital warts, and have a total wart area of 10 mm² or greater.

Up to 250 mg of cream per dose was applied once daily to warts for up to 8 weeks or until complete clearance, if earlier. At 12 weeks, sustained complete clearance was assessed in women who had initial complete clearance.

The mean age of study participants was 33 years, the mean duration of disease was 5.6 years, the mean wart count was 7.9, and the mean total wart area was 166.3 mm².

In the intent to treat analysis, Dr. Baker reported that initial complete clearance of all external genital warts was achieved in 14% of the placebo group, 28% of the imiquimod 2.5% group, and 37% of the imiquimod 3.75% group. Results of the per protocol analysis were similar (16%, 35%, and 43%, respectively).

Of the women who achieved initial complete clearance and entered the 12-week follow-up, complete clearance was sustained in 100% of the placebo group, 60% of the imiquimod 2.5% group, and 65% of the imiquimod 3.75% group.

In terms of safety, 0.9% of women in the placebo group, 1% of women in the imiquimod 2.5% group, and 2% of the women imiquimod 3.75% group discontinued the study early due to safety-related reasons. The most common adverse event was severe local skin reaction, which occurred in 1% of women in the placebo group, 14% of women in the imiquimod 2.5% group, and 18% of the women imiquimod 3.75% group.

Disclosures: Dr. Baker disclosed that he is a research consultant for Graceway Pharmaceuticals.

SANTA FE, N.M - Imiquimod 2.5% and 3.75% creams applied daily for up to 8 weeks were both well tolerated and more efficacious, compared with placebo in treating external genital warts in women, results from two combined randomized studies showed.

In particular, the 3.75% formulation "fulfills a need for a shorter and simpler imiquimod treatment for external genital warts and provides a clinically meaningful benefit with respect to complete clearance of all baseline and new warts and a rapid reduction in wart counts, with an acceptability safety profile," Dr. David A. Baker said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Currently, imiquimod 5% cream is approved to treat external genital warts and actinic keratoses. While this formation has been shown to be safe and effective, Dr. Baker noted that the efficacy end points "were based on the analysis of baseline target warts only, and the compliance with three times per week dosing frequency up to 16-week treatment duration may be difficult for some patients to follow, adversely affecting patient adherence to prescribed therapy."

In two identical phase III studies, Dr. Baker and his associates at 73 sites in the United States randomized 534 women to placebo, imiquimod 2.5% cream, or imiquimod 3.75% cream for the treatment of genital warts. Graceway Pharmaceuticals, which manufactures imiquimod, developed the formulations "to allow daily dosing to treat external genital warts as well as actinic keratoses," explained Dr. Baker, professor of obstetrics, gynecology, and reproductive medicine at Stony Brook University Medical Center, N.Y.

The 3.75% imiquimod cream has Food and Drug Administration approval to treat actinic keratoses. Graceway is waiting FDA approval of the 3.75% cream to treat external genital warts, Dr. Baker said in a later interview.

To be eligible for the trial, the women had to be at least 12 years of age, have 2-30 external genital warts, and have a total wart area of 10 mm² or greater.

Up to 250 mg of cream per dose was applied once daily to warts for up to 8 weeks or until complete clearance, if earlier. At 12 weeks, sustained complete clearance was assessed in women who had initial complete clearance.

The mean age of study participants was 33 years, the mean duration of disease was 5.6 years, the mean wart count was 7.9, and the mean total wart area was 166.3 mm².

In the intent to treat analysis, Dr. Baker reported that initial complete clearance of all external genital warts was achieved in 14% of the placebo group, 28% of the imiquimod 2.5% group, and 37% of the imiquimod 3.75% group. Results of the per protocol analysis were similar (16%, 35%, and 43%, respectively).

Of the women who achieved initial complete clearance and entered the 12-week follow-up, complete clearance was sustained in 100% of the placebo group, 60% of the imiquimod 2.5% group, and 65% of the imiquimod 3.75% group.

In terms of safety, 0.9% of women in the placebo group, 1% of women in the imiquimod 2.5% group, and 2% of the women imiquimod 3.75% group discontinued the study early due to safety-related reasons. The most common adverse event was severe local skin reaction, which occurred in 1% of women in the placebo group, 14% of women in the imiquimod 2.5% group, and 18% of the women imiquimod 3.75% group.

Disclosures: Dr. Baker disclosed that he is a research consultant for Graceway Pharmaceuticals.

Major Finding: In longitudinal analysis, after adjustment for covariates, only low free-testosterone levels at baseline predicted frailty at follow-up (OR, 1.22).

Data Source: A prospective cohort study of 3,616 men aged 70-88 years in Perth, Australia, who were enrolled in a longitudinal study of community-dwelling older men.

Disclosures: The study was supported by grants from the Australian National Health and Medical Research Council. Hormone assays were funded by an award from the Sylvia and Charles Viertel Charitable Foundation and by a research grant from the Fremantle Hospital Medical Research Foundation.

SAN DIEGO — Low levels of free testosterone are an independent predictor of frailty in older men, results from a large Australian study showed.

“We know that lower testosterone levels in older men predict a variety of poorer health outcomes, including reduced bone mineral density, fracture risk, cardiovascular risk, and mortality. The question that intrigued was whether low free testosterone would predispose to frailty in aging men,” Dr. Bu Beng Yeap said at the meeting.

To find out, Dr. Yeap, head of the department of endocrinology at Fremantle (Western Australia) Hospital and his associates conducted a prospective cohort study of 3,616 men aged 70-88 years who were enrolled in HIMS (Health in Men Study), a longitudinal study of community-dwelling older men. They excluded men with prostate cancer, as well as those who were taking androgens or hormone therapy.

During 2001-2004, the researchers used the FRAIL scale to assess the men for frailty. This scale comprises five domains, including fatigue, difficulty climbing a single flight of stairs, difficulty walking more than 100 meters, presence of more than five illnesses, or weight loss of more than 5% (J. Nutr. Health Aging 2008;12:29-37). Testosterone, sex hormone–binding globulin, and luteinizing hormone were assayed in early morning sera collected at baseline. Free testosterone was calculated based on mass action equations.

During 2008-2009, the researchers reassessed frailty in 1,586 of the men who were then aged 76-93 years, and compared their results from baseline.

Dr. Yeap reported that at baseline, 15.2% (548) of the men were frail, which increased to 23% (364) at follow-up. At baseline, after adjustment for age, body mass index, smoking, diabetes, social support, and impairments in vision and hearing, each decrease of one standard deviation in the level of total testosterone was associated with significantly increased odds of frailty (odds ratio, 1.23), as was each decrease of one standard deviation in the level of free testosterone (OR, 1.29).

At the same time, lower luteinizing hormone was associated with reduced odds of frailty (OR, 0.88). Sex hormone–binding globulin was not associated with frailty.

In longitudinal analysis, after adjustment for covariates, only lower free testosterone at baseline predicted frailty at follow-up (OR, 1.22).

“We need randomized, controlled clinical trials to explore whether testosterone therapy can prevent the development of frailty in aging men,” concluded Dr. Yeap, also of the University of Western Australia, Crawley.

Dr. Yeap said he had no conflicts of interest to disclose.

In longitudinal analysis, only lower free testosterone at baseline predicted frailty at follow-up.

Source DR. YEAP

Major Finding: In longitudinal analysis, after adjustment for covariates, only low free-testosterone levels at baseline predicted frailty at follow-up (OR, 1.22).

Data Source: A prospective cohort study of 3,616 men aged 70-88 years in Perth, Australia, who were enrolled in a longitudinal study of community-dwelling older men.

Disclosures: The study was supported by grants from the Australian National Health and Medical Research Council. Hormone assays were funded by an award from the Sylvia and Charles Viertel Charitable Foundation and by a research grant from the Fremantle Hospital Medical Research Foundation.

SAN DIEGO — Low levels of free testosterone are an independent predictor of frailty in older men, results from a large Australian study showed.

“We know that lower testosterone levels in older men predict a variety of poorer health outcomes, including reduced bone mineral density, fracture risk, cardiovascular risk, and mortality. The question that intrigued was whether low free testosterone would predispose to frailty in aging men,” Dr. Bu Beng Yeap said at the meeting.

To find out, Dr. Yeap, head of the department of endocrinology at Fremantle (Western Australia) Hospital and his associates conducted a prospective cohort study of 3,616 men aged 70-88 years who were enrolled in HIMS (Health in Men Study), a longitudinal study of community-dwelling older men. They excluded men with prostate cancer, as well as those who were taking androgens or hormone therapy.

During 2001-2004, the researchers used the FRAIL scale to assess the men for frailty. This scale comprises five domains, including fatigue, difficulty climbing a single flight of stairs, difficulty walking more than 100 meters, presence of more than five illnesses, or weight loss of more than 5% (J. Nutr. Health Aging 2008;12:29-37). Testosterone, sex hormone–binding globulin, and luteinizing hormone were assayed in early morning sera collected at baseline. Free testosterone was calculated based on mass action equations.

During 2008-2009, the researchers reassessed frailty in 1,586 of the men who were then aged 76-93 years, and compared their results from baseline.

Dr. Yeap reported that at baseline, 15.2% (548) of the men were frail, which increased to 23% (364) at follow-up. At baseline, after adjustment for age, body mass index, smoking, diabetes, social support, and impairments in vision and hearing, each decrease of one standard deviation in the level of total testosterone was associated with significantly increased odds of frailty (odds ratio, 1.23), as was each decrease of one standard deviation in the level of free testosterone (OR, 1.29).

At the same time, lower luteinizing hormone was associated with reduced odds of frailty (OR, 0.88). Sex hormone–binding globulin was not associated with frailty.

In longitudinal analysis, after adjustment for covariates, only lower free testosterone at baseline predicted frailty at follow-up (OR, 1.22).

“We need randomized, controlled clinical trials to explore whether testosterone therapy can prevent the development of frailty in aging men,” concluded Dr. Yeap, also of the University of Western Australia, Crawley.

Dr. Yeap said he had no conflicts of interest to disclose.

In longitudinal analysis, only lower free testosterone at baseline predicted frailty at follow-up.

Source DR. YEAP

Major Finding: In longitudinal analysis, after adjustment for covariates, only low free-testosterone levels at baseline predicted frailty at follow-up (OR, 1.22).

Data Source: A prospective cohort study of 3,616 men aged 70-88 years in Perth, Australia, who were enrolled in a longitudinal study of community-dwelling older men.

Disclosures: The study was supported by grants from the Australian National Health and Medical Research Council. Hormone assays were funded by an award from the Sylvia and Charles Viertel Charitable Foundation and by a research grant from the Fremantle Hospital Medical Research Foundation.

SAN DIEGO — Low levels of free testosterone are an independent predictor of frailty in older men, results from a large Australian study showed.

“We know that lower testosterone levels in older men predict a variety of poorer health outcomes, including reduced bone mineral density, fracture risk, cardiovascular risk, and mortality. The question that intrigued was whether low free testosterone would predispose to frailty in aging men,” Dr. Bu Beng Yeap said at the meeting.

To find out, Dr. Yeap, head of the department of endocrinology at Fremantle (Western Australia) Hospital and his associates conducted a prospective cohort study of 3,616 men aged 70-88 years who were enrolled in HIMS (Health in Men Study), a longitudinal study of community-dwelling older men. They excluded men with prostate cancer, as well as those who were taking androgens or hormone therapy.

During 2001-2004, the researchers used the FRAIL scale to assess the men for frailty. This scale comprises five domains, including fatigue, difficulty climbing a single flight of stairs, difficulty walking more than 100 meters, presence of more than five illnesses, or weight loss of more than 5% (J. Nutr. Health Aging 2008;12:29-37). Testosterone, sex hormone–binding globulin, and luteinizing hormone were assayed in early morning sera collected at baseline. Free testosterone was calculated based on mass action equations.

During 2008-2009, the researchers reassessed frailty in 1,586 of the men who were then aged 76-93 years, and compared their results from baseline.

Dr. Yeap reported that at baseline, 15.2% (548) of the men were frail, which increased to 23% (364) at follow-up. At baseline, after adjustment for age, body mass index, smoking, diabetes, social support, and impairments in vision and hearing, each decrease of one standard deviation in the level of total testosterone was associated with significantly increased odds of frailty (odds ratio, 1.23), as was each decrease of one standard deviation in the level of free testosterone (OR, 1.29).

At the same time, lower luteinizing hormone was associated with reduced odds of frailty (OR, 0.88). Sex hormone–binding globulin was not associated with frailty.

In longitudinal analysis, after adjustment for covariates, only lower free testosterone at baseline predicted frailty at follow-up (OR, 1.22).

“We need randomized, controlled clinical trials to explore whether testosterone therapy can prevent the development of frailty in aging men,” concluded Dr. Yeap, also of the University of Western Australia, Crawley.

Dr. Yeap said he had no conflicts of interest to disclose.

In longitudinal analysis, only lower free testosterone at baseline predicted frailty at follow-up.

Source DR. YEAP

Major Finding: Postmenopausal women who took oral micronized progesterone for 12 weeks had a 56% decrease in vasomotor symptoms from baseline, compared with 28% who took placebo.

Data Source: Randomized, placebo-controlled study of 133 postmenopausal women seeking hormonal therapy for hot flashes and night sweats.

Disclosures: The trial was funded by the Centre for Menstrual Cycle and Ovulation Research. Besins Healthcare and Schering Canada donated the progesterone and placebo used in the study.

SAN DIEGO — Postmenopausal women who took oral micronized progesterone for 12 weeks had significant improvements in vasomotor symptom scores as well as significant reductions in the number of daily vasomotor symptoms, results from a randomized, placebo-controlled trial showed.

“If we know that progestin works, why would we investigate oral micronized progesterone?” mused Dr. Jerilynn C. Prior of the Centre for Menstrual Cycle and Ovulation Research at the University of British Columbia, Vancouver, at the meeting. Firstly, “it's molecularly identical to what our own bodies make, so we can make clear inferences about the metabolism of this hormone in our bodies.” Also, it's approved by the Food and Drug Administration, and it has been shown in randomized controlled trials to improve sleep and cause no problems with cognition.

During June 2003 through October 2009, she and Christine Hitchcock, Ph.D., recruited 133 healthy postmenopausal women seeking hormone therapy for hot flashes and night sweats and randomized them to receive three 100-mg capsules of oral micronized progesterone (Prometrium) or placebo at bedtime nightly for 12 weeks. The time since their last menstrual flow was 1-10 years.

Study participants were asked to record the intensity and number of vasomotor symptoms in a daily diary, and the researchers calculated their average daily vasomotor symptom score during the last 28 days of therapy, as well as the average number of vasomotor symptoms they experienced per day.

Women who had been on any kind of hormonal therapy within the previous 6 months were excluded from the trial, as were those with cardiovascular disease at baseline, and those who had difficulty completing the Daily Menopause Diary.

At baseline, the mean age of the 127 women with complete data was 55, their mean body mass index was 25 kg/m

At the end of 12 weeks, women in the oral micronized progesterone group had a 56% improvement in vasomotor symptom scores and a 48% reduction in the number of vasomotor symptoms per day, while those in the placebo group had a 28% improvement in vasomotor symptom scores and a 22% reduction in the number of vasomotor symptoms per day.

“Oral micronized progesterone is highly effective therapy for hot flashes and night sweats,” Dr. Prior concluded. “We saw no serious side effects in this trial, and there were numerically more dropouts in the placebo arm than in the treatment arm.” The investigators are evaluating several other measures collected during the trial, “including what happens when women stop oral micronized progesterone, since we know that some women experience a rebound greater increase when they stop estrogen.”

Micronized progesterone is 'molecularly identical to what our own bodies make.'

Source DR. PRIOR

Major Finding: Postmenopausal women who took oral micronized progesterone for 12 weeks had a 56% decrease in vasomotor symptoms from baseline, compared with 28% who took placebo.

Data Source: Randomized, placebo-controlled study of 133 postmenopausal women seeking hormonal therapy for hot flashes and night sweats.

Disclosures: The trial was funded by the Centre for Menstrual Cycle and Ovulation Research. Besins Healthcare and Schering Canada donated the progesterone and placebo used in the study.

SAN DIEGO — Postmenopausal women who took oral micronized progesterone for 12 weeks had significant improvements in vasomotor symptom scores as well as significant reductions in the number of daily vasomotor symptoms, results from a randomized, placebo-controlled trial showed.

“If we know that progestin works, why would we investigate oral micronized progesterone?” mused Dr. Jerilynn C. Prior of the Centre for Menstrual Cycle and Ovulation Research at the University of British Columbia, Vancouver, at the meeting. Firstly, “it's molecularly identical to what our own bodies make, so we can make clear inferences about the metabolism of this hormone in our bodies.” Also, it's approved by the Food and Drug Administration, and it has been shown in randomized controlled trials to improve sleep and cause no problems with cognition.

During June 2003 through October 2009, she and Christine Hitchcock, Ph.D., recruited 133 healthy postmenopausal women seeking hormone therapy for hot flashes and night sweats and randomized them to receive three 100-mg capsules of oral micronized progesterone (Prometrium) or placebo at bedtime nightly for 12 weeks. The time since their last menstrual flow was 1-10 years.

Study participants were asked to record the intensity and number of vasomotor symptoms in a daily diary, and the researchers calculated their average daily vasomotor symptom score during the last 28 days of therapy, as well as the average number of vasomotor symptoms they experienced per day.

Women who had been on any kind of hormonal therapy within the previous 6 months were excluded from the trial, as were those with cardiovascular disease at baseline, and those who had difficulty completing the Daily Menopause Diary.

At baseline, the mean age of the 127 women with complete data was 55, their mean body mass index was 25 kg/m

At the end of 12 weeks, women in the oral micronized progesterone group had a 56% improvement in vasomotor symptom scores and a 48% reduction in the number of vasomotor symptoms per day, while those in the placebo group had a 28% improvement in vasomotor symptom scores and a 22% reduction in the number of vasomotor symptoms per day.

“Oral micronized progesterone is highly effective therapy for hot flashes and night sweats,” Dr. Prior concluded. “We saw no serious side effects in this trial, and there were numerically more dropouts in the placebo arm than in the treatment arm.” The investigators are evaluating several other measures collected during the trial, “including what happens when women stop oral micronized progesterone, since we know that some women experience a rebound greater increase when they stop estrogen.”

Micronized progesterone is 'molecularly identical to what our own bodies make.'

Source DR. PRIOR

Major Finding: Postmenopausal women who took oral micronized progesterone for 12 weeks had a 56% decrease in vasomotor symptoms from baseline, compared with 28% who took placebo.

Data Source: Randomized, placebo-controlled study of 133 postmenopausal women seeking hormonal therapy for hot flashes and night sweats.

Disclosures: The trial was funded by the Centre for Menstrual Cycle and Ovulation Research. Besins Healthcare and Schering Canada donated the progesterone and placebo used in the study.

SAN DIEGO — Postmenopausal women who took oral micronized progesterone for 12 weeks had significant improvements in vasomotor symptom scores as well as significant reductions in the number of daily vasomotor symptoms, results from a randomized, placebo-controlled trial showed.

“If we know that progestin works, why would we investigate oral micronized progesterone?” mused Dr. Jerilynn C. Prior of the Centre for Menstrual Cycle and Ovulation Research at the University of British Columbia, Vancouver, at the meeting. Firstly, “it's molecularly identical to what our own bodies make, so we can make clear inferences about the metabolism of this hormone in our bodies.” Also, it's approved by the Food and Drug Administration, and it has been shown in randomized controlled trials to improve sleep and cause no problems with cognition.

During June 2003 through October 2009, she and Christine Hitchcock, Ph.D., recruited 133 healthy postmenopausal women seeking hormone therapy for hot flashes and night sweats and randomized them to receive three 100-mg capsules of oral micronized progesterone (Prometrium) or placebo at bedtime nightly for 12 weeks. The time since their last menstrual flow was 1-10 years.

Study participants were asked to record the intensity and number of vasomotor symptoms in a daily diary, and the researchers calculated their average daily vasomotor symptom score during the last 28 days of therapy, as well as the average number of vasomotor symptoms they experienced per day.

Women who had been on any kind of hormonal therapy within the previous 6 months were excluded from the trial, as were those with cardiovascular disease at baseline, and those who had difficulty completing the Daily Menopause Diary.

At baseline, the mean age of the 127 women with complete data was 55, their mean body mass index was 25 kg/m

At the end of 12 weeks, women in the oral micronized progesterone group had a 56% improvement in vasomotor symptom scores and a 48% reduction in the number of vasomotor symptoms per day, while those in the placebo group had a 28% improvement in vasomotor symptom scores and a 22% reduction in the number of vasomotor symptoms per day.

“Oral micronized progesterone is highly effective therapy for hot flashes and night sweats,” Dr. Prior concluded. “We saw no serious side effects in this trial, and there were numerically more dropouts in the placebo arm than in the treatment arm.” The investigators are evaluating several other measures collected during the trial, “including what happens when women stop oral micronized progesterone, since we know that some women experience a rebound greater increase when they stop estrogen.”

Micronized progesterone is 'molecularly identical to what our own bodies make.'

Source DR. PRIOR

SAN DIEGO — Delivering devastating news about a pediatric patient to loved ones is arguably one of the toughest parts of a physician's job. According to one pediatric social worker, a lot of physicians struggle with how to present such difficult information and to do so with just the right compassion.

“It's unpleasant because you don't want to take away hope from the family,” Jill Farabelli said during the meeting.

“Families are never prepared, and doctors are equally unprepared. They know the medical information, but how to deal with the emotional part of it is really tough.”

Ms. Farabelli, a social worker for the pediatric intensive care unit at Rady Children's Hospital, San Diego, offered the following tips for communicating with families of pediatric patients during difficult times:

▸ Be upfront about the diagnosis or prognosis. Parents “want and need to know what's going on with their child, whether it's good news or bad news,” she said.

“The other day a family came in whose child was in crisis. The doctor kept beating around the bush about the information that he wanted to give the parents. The dad finally said, 'Just tell me how it is. Give me the details.'”

Ms. Farabelli emphasized that a physician's communication skills “play a crucial role in how families cope.” Most families, she continued, pay close attention to how physicians act toward them, “their body language, their attitude, whether they seem that they want to be there, and whether they seem that they care.”

▸ Use a quiet, comfortable place to deliver the news. “On a trauma unit, that may not be possible, but be prepared with the medical information,” she said. Review the medical chart and know what your options are. Consult with specialty services before giving the medical information to families, if applicable.

“Often it happens that doctors don't communicate with one another, and they give conflicting information to the family,” Ms. Farabelli said. “The family gets very confused because everyone's saying something different.”

▸ Prepare yourself from an emotional standpoint. Consider meeting with social workers before you meet with the family, “to know the right words to say, or to discuss background on the family,” she advised. “When you're working with a family that's in a trauma situation, no one really knows that family; no one's had the chance to build a relationship. But when you're working with kids who are in critical care for months at a time or chronically ill patients, that's when that information can come in handy.”

▸ Allow for uninterrupted time. It might not be possible to turn off pagers, but they can be silenced while you meet with the patient's loved ones.

“Many times I've had crucial conversations with families with pagers going wild,” Ms. Farabelli said. “It really takes away from the parents' ability to focus on the information that's being given to them, and it's distracting to the doctors for being able to answer questions [or to] give diagnosis and prognosis.”

▸ Know the names of the family members who are present. When you are delivering bad news, it helps if both parents can be present. “There are times when a child may be brought into the trauma unit, and the mom is there and the dad is a couple of hours away,” she said.

“It's important that, when possible, both parents hear the same information at the same time.”

After you've delivered the news, ask family members to tell you their understanding of the information. Often, they don't digest it all at first. “Medical jargon is hard to understand for a lot of families,” she said.

“Also, if you tell them something ultimately devastating, they are probably not going to process the rest of what you have to say, so you might have to ease into it.”

▸ Use touch when appropriate. Sometimes parents “will grab your hand or need to hug you” for consolation, she said. Be aware of personal preferences and be sensitive to cultural differences.

▸ Allow time for questions. Tears are appropriate, “as is silence,” Ms. Farabelli said. “Sometimes you don't know what to say. You may cry. Sometimes you cannot help but be touched or overwhelmed by what a family is going through. “After the news is given, how do you support the family?

“Hush, hug, and hang out. Your presence means so much to these families.”

Ms. Farabelli said she had no relevant conflict to disclose.

Most families pay close attention to how physicians act toward them, 'their body language, their attitude.'

Source MS. FARABELLI

SAN DIEGO — Delivering devastating news about a pediatric patient to loved ones is arguably one of the toughest parts of a physician's job. According to one pediatric social worker, a lot of physicians struggle with how to present such difficult information and to do so with just the right compassion.

“It's unpleasant because you don't want to take away hope from the family,” Jill Farabelli said during the meeting.

“Families are never prepared, and doctors are equally unprepared. They know the medical information, but how to deal with the emotional part of it is really tough.”

Ms. Farabelli, a social worker for the pediatric intensive care unit at Rady Children's Hospital, San Diego, offered the following tips for communicating with families of pediatric patients during difficult times:

▸ Be upfront about the diagnosis or prognosis. Parents “want and need to know what's going on with their child, whether it's good news or bad news,” she said.

“The other day a family came in whose child was in crisis. The doctor kept beating around the bush about the information that he wanted to give the parents. The dad finally said, 'Just tell me how it is. Give me the details.'”

Ms. Farabelli emphasized that a physician's communication skills “play a crucial role in how families cope.” Most families, she continued, pay close attention to how physicians act toward them, “their body language, their attitude, whether they seem that they want to be there, and whether they seem that they care.”

▸ Use a quiet, comfortable place to deliver the news. “On a trauma unit, that may not be possible, but be prepared with the medical information,” she said. Review the medical chart and know what your options are. Consult with specialty services before giving the medical information to families, if applicable.

“Often it happens that doctors don't communicate with one another, and they give conflicting information to the family,” Ms. Farabelli said. “The family gets very confused because everyone's saying something different.”

▸ Prepare yourself from an emotional standpoint. Consider meeting with social workers before you meet with the family, “to know the right words to say, or to discuss background on the family,” she advised. “When you're working with a family that's in a trauma situation, no one really knows that family; no one's had the chance to build a relationship. But when you're working with kids who are in critical care for months at a time or chronically ill patients, that's when that information can come in handy.”

▸ Allow for uninterrupted time. It might not be possible to turn off pagers, but they can be silenced while you meet with the patient's loved ones.

“Many times I've had crucial conversations with families with pagers going wild,” Ms. Farabelli said. “It really takes away from the parents' ability to focus on the information that's being given to them, and it's distracting to the doctors for being able to answer questions [or to] give diagnosis and prognosis.”

▸ Know the names of the family members who are present. When you are delivering bad news, it helps if both parents can be present. “There are times when a child may be brought into the trauma unit, and the mom is there and the dad is a couple of hours away,” she said.

“It's important that, when possible, both parents hear the same information at the same time.”

After you've delivered the news, ask family members to tell you their understanding of the information. Often, they don't digest it all at first. “Medical jargon is hard to understand for a lot of families,” she said.

“Also, if you tell them something ultimately devastating, they are probably not going to process the rest of what you have to say, so you might have to ease into it.”

▸ Use touch when appropriate. Sometimes parents “will grab your hand or need to hug you” for consolation, she said. Be aware of personal preferences and be sensitive to cultural differences.

▸ Allow time for questions. Tears are appropriate, “as is silence,” Ms. Farabelli said. “Sometimes you don't know what to say. You may cry. Sometimes you cannot help but be touched or overwhelmed by what a family is going through. “After the news is given, how do you support the family?

“Hush, hug, and hang out. Your presence means so much to these families.”

Ms. Farabelli said she had no relevant conflict to disclose.

Most families pay close attention to how physicians act toward them, 'their body language, their attitude.'

Source MS. FARABELLI

SAN DIEGO — Delivering devastating news about a pediatric patient to loved ones is arguably one of the toughest parts of a physician's job. According to one pediatric social worker, a lot of physicians struggle with how to present such difficult information and to do so with just the right compassion.

“It's unpleasant because you don't want to take away hope from the family,” Jill Farabelli said during the meeting.

“Families are never prepared, and doctors are equally unprepared. They know the medical information, but how to deal with the emotional part of it is really tough.”

Ms. Farabelli, a social worker for the pediatric intensive care unit at Rady Children's Hospital, San Diego, offered the following tips for communicating with families of pediatric patients during difficult times:

▸ Be upfront about the diagnosis or prognosis. Parents “want and need to know what's going on with their child, whether it's good news or bad news,” she said.

“The other day a family came in whose child was in crisis. The doctor kept beating around the bush about the information that he wanted to give the parents. The dad finally said, 'Just tell me how it is. Give me the details.'”

Ms. Farabelli emphasized that a physician's communication skills “play a crucial role in how families cope.” Most families, she continued, pay close attention to how physicians act toward them, “their body language, their attitude, whether they seem that they want to be there, and whether they seem that they care.”

▸ Use a quiet, comfortable place to deliver the news. “On a trauma unit, that may not be possible, but be prepared with the medical information,” she said. Review the medical chart and know what your options are. Consult with specialty services before giving the medical information to families, if applicable.

“Often it happens that doctors don't communicate with one another, and they give conflicting information to the family,” Ms. Farabelli said. “The family gets very confused because everyone's saying something different.”

▸ Prepare yourself from an emotional standpoint. Consider meeting with social workers before you meet with the family, “to know the right words to say, or to discuss background on the family,” she advised. “When you're working with a family that's in a trauma situation, no one really knows that family; no one's had the chance to build a relationship. But when you're working with kids who are in critical care for months at a time or chronically ill patients, that's when that information can come in handy.”

▸ Allow for uninterrupted time. It might not be possible to turn off pagers, but they can be silenced while you meet with the patient's loved ones.

“Many times I've had crucial conversations with families with pagers going wild,” Ms. Farabelli said. “It really takes away from the parents' ability to focus on the information that's being given to them, and it's distracting to the doctors for being able to answer questions [or to] give diagnosis and prognosis.”

▸ Know the names of the family members who are present. When you are delivering bad news, it helps if both parents can be present. “There are times when a child may be brought into the trauma unit, and the mom is there and the dad is a couple of hours away,” she said.

“It's important that, when possible, both parents hear the same information at the same time.”

After you've delivered the news, ask family members to tell you their understanding of the information. Often, they don't digest it all at first. “Medical jargon is hard to understand for a lot of families,” she said.

“Also, if you tell them something ultimately devastating, they are probably not going to process the rest of what you have to say, so you might have to ease into it.”

▸ Use touch when appropriate. Sometimes parents “will grab your hand or need to hug you” for consolation, she said. Be aware of personal preferences and be sensitive to cultural differences.

▸ Allow time for questions. Tears are appropriate, “as is silence,” Ms. Farabelli said. “Sometimes you don't know what to say. You may cry. Sometimes you cannot help but be touched or overwhelmed by what a family is going through. “After the news is given, how do you support the family?

“Hush, hug, and hang out. Your presence means so much to these families.”

Ms. Farabelli said she had no relevant conflict to disclose.

Most families pay close attention to how physicians act toward them, 'their body language, their attitude.'

Source MS. FARABELLI

SAN DIEGO —The dismal survival rate of out-of-hospital cardiac arrest—only 5%-10%—varies from region to region, according to a database study.

“I don't think the public really thinks about or understands that you have a 500% better chance of survival if you collapse in one city than another,” Dr. Ben Bobrow said at the meeting.

“I believe that making cardiac arrest a reportable illness would help improve survival rates,” he noted. “Why shouldn't people in the community know what their survival rates are? [It is] similar to knowing what the crime rates are,” said Dr. Bobrow, medical director of the Bureau of Emergency Medical Services and Trauma System for the Arizona Department of Health Services, Phoenix.

In 2004, Dr. Bobrow led an effort to regionalize the state's cardiac arrest care by collecting and analyzing data from first care reports of out-of-hospital cardiac arrest (OHCA) patients on whom resuscitation was attempted in the field (Prehosp. Emerg. Care 2008;12:381-7). Data for the effort, known as the Save Hearts in Arizona Registry and Education (SHARE) program, were initially obtained voluntarily from 35 EMS agencies and are now obtained from more than 80 EMS agencies (www.azshare.gov

Dr. Bobrow found that between Jan. 1, 2005, and April 1, 2006, 1,484 cases of OHCA were reported by the 35 departments, of which 1,104 were of presumed cardiac etiology occurring prior to arrival of EMS. Only 37 (3.4%) of 1,076 OHCA patients survived to hospital discharge. Bystander CPR had a positive effect on survival (odds ratio of 3.0), yet was provided only 25% of the time.

Because there were so few OHCA survivors, the SHARE program's directors decided to modify the state's OHCA protocol based on current evidence, and to track the results closely.

The program's directors adopted a multipronged strategy that was disseminated to the state's EMS agencies: training EMS dispatchers to provide chest compression–only instructions to 911 callers; advocating for chest compression–only CPR to increase the likelihood that bystanders will provide CPR; increasing the odds of early defibrillation by establishing a more structured public-access defibrillation program; enabling minimally interrupted cardiac resuscitation by EMS providers; and a creating a statewide system of cardiac receiving centers where patients would get guideline-based postarrest care such as therapeutic hypothermia.

One of the main changes was the shift from conventional CPR (with breaths) to chest compression–only CPR (without mouth to mouth). “There's a lot of data to show that even brief, 10-second interruptions in chest compressions are enough to decrease the chance of successful defibrillation,” Dr. Bobrow said.

The program used a series of public service announcements to educate citizens in Arizona about how to perform chest compression–only CPR. The state also partnered with the American Heart Association to launch a hands-only CPR campaign (handsonlycpr.org

At the AHA's 2009 Resuscitation Science Symposium, the SHARE team presented data showing that the overall incidence of bystander CPR rose from 25% to 40% after the program, while the overall incidence of hands-only CPR rose from 16% to 77%.

“This really simple intervention of bystander chest compression–only CPR was incredibly powerful,” Dr. Bobrow remarked. “Survival was significantly better for OHCA victims if they received chest compression–only CPR than no CPR or conventional CPR.”

Evaluation of the initial 1,500 OHCA cases in the state revealed that the rate of survival to discharge for the subset of patients with a witnessed collapse and ventricular fibrillation upon EMS arrival increased significantly, from 20.3% to 39.5%, after centers earned a CRC designation. The all-rhythm survival rate to hospital discharge also rose significantly, from 10.1% to 20.1%.

Disclosures: Dr. Bobrow disclosed that he has received funding from the National Institutes of Health, the American Heart Association, and the Medtronic Foundation.

'This really simple intervention of bystander chest compression–only CPR was incredibly powerful.'

Source DR. BOBROW

SAN DIEGO —The dismal survival rate of out-of-hospital cardiac arrest—only 5%-10%—varies from region to region, according to a database study.

“I don't think the public really thinks about or understands that you have a 500% better chance of survival if you collapse in one city than another,” Dr. Ben Bobrow said at the meeting.

“I believe that making cardiac arrest a reportable illness would help improve survival rates,” he noted. “Why shouldn't people in the community know what their survival rates are? [It is] similar to knowing what the crime rates are,” said Dr. Bobrow, medical director of the Bureau of Emergency Medical Services and Trauma System for the Arizona Department of Health Services, Phoenix.

In 2004, Dr. Bobrow led an effort to regionalize the state's cardiac arrest care by collecting and analyzing data from first care reports of out-of-hospital cardiac arrest (OHCA) patients on whom resuscitation was attempted in the field (Prehosp. Emerg. Care 2008;12:381-7). Data for the effort, known as the Save Hearts in Arizona Registry and Education (SHARE) program, were initially obtained voluntarily from 35 EMS agencies and are now obtained from more than 80 EMS agencies (www.azshare.gov

Dr. Bobrow found that between Jan. 1, 2005, and April 1, 2006, 1,484 cases of OHCA were reported by the 35 departments, of which 1,104 were of presumed cardiac etiology occurring prior to arrival of EMS. Only 37 (3.4%) of 1,076 OHCA patients survived to hospital discharge. Bystander CPR had a positive effect on survival (odds ratio of 3.0), yet was provided only 25% of the time.

Because there were so few OHCA survivors, the SHARE program's directors decided to modify the state's OHCA protocol based on current evidence, and to track the results closely.

The program's directors adopted a multipronged strategy that was disseminated to the state's EMS agencies: training EMS dispatchers to provide chest compression–only instructions to 911 callers; advocating for chest compression–only CPR to increase the likelihood that bystanders will provide CPR; increasing the odds of early defibrillation by establishing a more structured public-access defibrillation program; enabling minimally interrupted cardiac resuscitation by EMS providers; and a creating a statewide system of cardiac receiving centers where patients would get guideline-based postarrest care such as therapeutic hypothermia.

One of the main changes was the shift from conventional CPR (with breaths) to chest compression–only CPR (without mouth to mouth). “There's a lot of data to show that even brief, 10-second interruptions in chest compressions are enough to decrease the chance of successful defibrillation,” Dr. Bobrow said.

The program used a series of public service announcements to educate citizens in Arizona about how to perform chest compression–only CPR. The state also partnered with the American Heart Association to launch a hands-only CPR campaign (handsonlycpr.org

At the AHA's 2009 Resuscitation Science Symposium, the SHARE team presented data showing that the overall incidence of bystander CPR rose from 25% to 40% after the program, while the overall incidence of hands-only CPR rose from 16% to 77%.

“This really simple intervention of bystander chest compression–only CPR was incredibly powerful,” Dr. Bobrow remarked. “Survival was significantly better for OHCA victims if they received chest compression–only CPR than no CPR or conventional CPR.”

Evaluation of the initial 1,500 OHCA cases in the state revealed that the rate of survival to discharge for the subset of patients with a witnessed collapse and ventricular fibrillation upon EMS arrival increased significantly, from 20.3% to 39.5%, after centers earned a CRC designation. The all-rhythm survival rate to hospital discharge also rose significantly, from 10.1% to 20.1%.

Disclosures: Dr. Bobrow disclosed that he has received funding from the National Institutes of Health, the American Heart Association, and the Medtronic Foundation.

'This really simple intervention of bystander chest compression–only CPR was incredibly powerful.'

Source DR. BOBROW

SAN DIEGO —The dismal survival rate of out-of-hospital cardiac arrest—only 5%-10%—varies from region to region, according to a database study.

“I don't think the public really thinks about or understands that you have a 500% better chance of survival if you collapse in one city than another,” Dr. Ben Bobrow said at the meeting.

“I believe that making cardiac arrest a reportable illness would help improve survival rates,” he noted. “Why shouldn't people in the community know what their survival rates are? [It is] similar to knowing what the crime rates are,” said Dr. Bobrow, medical director of the Bureau of Emergency Medical Services and Trauma System for the Arizona Department of Health Services, Phoenix.

In 2004, Dr. Bobrow led an effort to regionalize the state's cardiac arrest care by collecting and analyzing data from first care reports of out-of-hospital cardiac arrest (OHCA) patients on whom resuscitation was attempted in the field (Prehosp. Emerg. Care 2008;12:381-7). Data for the effort, known as the Save Hearts in Arizona Registry and Education (SHARE) program, were initially obtained voluntarily from 35 EMS agencies and are now obtained from more than 80 EMS agencies (www.azshare.gov

Dr. Bobrow found that between Jan. 1, 2005, and April 1, 2006, 1,484 cases of OHCA were reported by the 35 departments, of which 1,104 were of presumed cardiac etiology occurring prior to arrival of EMS. Only 37 (3.4%) of 1,076 OHCA patients survived to hospital discharge. Bystander CPR had a positive effect on survival (odds ratio of 3.0), yet was provided only 25% of the time.

Because there were so few OHCA survivors, the SHARE program's directors decided to modify the state's OHCA protocol based on current evidence, and to track the results closely.

The program's directors adopted a multipronged strategy that was disseminated to the state's EMS agencies: training EMS dispatchers to provide chest compression–only instructions to 911 callers; advocating for chest compression–only CPR to increase the likelihood that bystanders will provide CPR; increasing the odds of early defibrillation by establishing a more structured public-access defibrillation program; enabling minimally interrupted cardiac resuscitation by EMS providers; and a creating a statewide system of cardiac receiving centers where patients would get guideline-based postarrest care such as therapeutic hypothermia.

One of the main changes was the shift from conventional CPR (with breaths) to chest compression–only CPR (without mouth to mouth). “There's a lot of data to show that even brief, 10-second interruptions in chest compressions are enough to decrease the chance of successful defibrillation,” Dr. Bobrow said.

The program used a series of public service announcements to educate citizens in Arizona about how to perform chest compression–only CPR. The state also partnered with the American Heart Association to launch a hands-only CPR campaign (handsonlycpr.org

At the AHA's 2009 Resuscitation Science Symposium, the SHARE team presented data showing that the overall incidence of bystander CPR rose from 25% to 40% after the program, while the overall incidence of hands-only CPR rose from 16% to 77%.

“This really simple intervention of bystander chest compression–only CPR was incredibly powerful,” Dr. Bobrow remarked. “Survival was significantly better for OHCA victims if they received chest compression–only CPR than no CPR or conventional CPR.”

Evaluation of the initial 1,500 OHCA cases in the state revealed that the rate of survival to discharge for the subset of patients with a witnessed collapse and ventricular fibrillation upon EMS arrival increased significantly, from 20.3% to 39.5%, after centers earned a CRC designation. The all-rhythm survival rate to hospital discharge also rose significantly, from 10.1% to 20.1%.

Disclosures: Dr. Bobrow disclosed that he has received funding from the National Institutes of Health, the American Heart Association, and the Medtronic Foundation.

'This really simple intervention of bystander chest compression–only CPR was incredibly powerful.'

Source DR. BOBROW

Major Finding: Nearly three-quarters of infants aged 5 months (72%) are receiving at least one dose of rotavirus vaccine.

Data Source: Analysis of data from 23,532 infants enrolled at one of eight Immunization Information System sentinel sites.

Disclosures: Immunization Information System sentinel sites receive support from the Centers for Disease Control and Prevention.

Rotavirus vaccination coverage among infants aged 5 months is averaging 72% nationwide, results from a recent analysis of eight Immunization Information System sites demonstrated.

However, vaccination rates varied widely between sites, and site-specific rotavirus vaccine coverage remained an average of 13 percentage points lower than that of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine and 7-valent pneumococcal conjugate vaccine (PCV7) in June 2009.

“[Rotavirus vaccine] is unique among vaccines recommended during infancy in having a maximum age for beginning the series,” researchers led by Diana L. Bartlett of the Immunization Services Division at the National Center for Immunization and Respiratory Diseases, Atlanta, reported. “This age restriction could account, in part, for the lower RV coverage because an infant aged 15 weeks–5 months could still receive a first dose of DTaP or PCV7 (but not RV), according to ACIP recommendations.”M

Ms. Bartlett and her associates analyzed data from eight Immunization Information System (IIS) sentinel sites to assess trends in coverage with one or more doses of rotavirus vaccine between June 2006 and June 2009 among infants aged 5 months and to compare RV coverage in the second quarter of 2009 with that of DTaP and PCV7 (MMWR 2010:59:521–4).

Supported by the Centers for Disease Control and Prevention, IIS sentinel sites are population based and cover more than 1.8 million children younger than age 6. The sites are unique for their high health care provider participation (greater than 85%), child enrollment (more than 85% are younger than age 19), and timely capture of administered vaccines (more than 70% of doses are reported to the IIS within 30 days of vaccination). Sites included in the analysis since 2008 were located in Arizona, Colorado, Michigan, Minnesota, New York City, North Dakota, Oregon, and Wisconsin. Four of these sites have continuously served as IIS sentinel sites since 2004 (Arizona, Michigan, Minnesota, and Oregon).

As of June 30, 2009, 23,532 infants aged 5 months were enrolled at the eight IIS sites. After introduction of the RV vaccine, coverage among infants enrolled at the four continuously serving IIS sentinel sites rose to 50%–60% within the first year, and steadily thereafter, to 74% by the second quarter of 2009. As of June 20, 2009, RV coverage at all eight IIS sentinel sites averaged 72%. Colorado had the lowest rate of coverage (48%) while North Dakota had the highest (86%).

At the same time, coverage for one or more doses of DTaP or PCV7 vaccines at all eight IIS sentinel sites was 85%, or 13% higher than RV coverage. New York had the lowest coverage rates for DTaP and PCV7 (71% and 72%, respectively), while North Dakota had the highest coverage rate for DTaP (93%) and Michigan had the highest coverage rate for PCV7 (91%).

The researchers acknowledged certain limitations of the study, including the fact that coverage rates of DTaP and PCV7 at some IIS sites “were lower than expected based on 2008 [National Immunization Survey] data. These lower rates could result from persons who left the IIS sentinel site area before receipt of their vaccination, but who were still counted as enrolled and unvaccinated. Second, although IIS sentinel sites data are monitored for accuracy and completeness, RV might be less reliably entered into IIS than other infant vaccines because it is a relatively new vaccine. This could result in an underestimate of RV coverage levels.”

They concluded by noting that continued monitoring of RV coverage “will be crucial to provide information useful to policy makers and help focus efforts to achieve RV rates at least as high as other routinely recommended vaccines for U.S. infants.”

Major Finding: Nearly three-quarters of infants aged 5 months (72%) are receiving at least one dose of rotavirus vaccine.

Data Source: Analysis of data from 23,532 infants enrolled at one of eight Immunization Information System sentinel sites.

Disclosures: Immunization Information System sentinel sites receive support from the Centers for Disease Control and Prevention.

Rotavirus vaccination coverage among infants aged 5 months is averaging 72% nationwide, results from a recent analysis of eight Immunization Information System sites demonstrated.

However, vaccination rates varied widely between sites, and site-specific rotavirus vaccine coverage remained an average of 13 percentage points lower than that of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine and 7-valent pneumococcal conjugate vaccine (PCV7) in June 2009.

“[Rotavirus vaccine] is unique among vaccines recommended during infancy in having a maximum age for beginning the series,” researchers led by Diana L. Bartlett of the Immunization Services Division at the National Center for Immunization and Respiratory Diseases, Atlanta, reported. “This age restriction could account, in part, for the lower RV coverage because an infant aged 15 weeks–5 months could still receive a first dose of DTaP or PCV7 (but not RV), according to ACIP recommendations.”M

Ms. Bartlett and her associates analyzed data from eight Immunization Information System (IIS) sentinel sites to assess trends in coverage with one or more doses of rotavirus vaccine between June 2006 and June 2009 among infants aged 5 months and to compare RV coverage in the second quarter of 2009 with that of DTaP and PCV7 (MMWR 2010:59:521–4).

Supported by the Centers for Disease Control and Prevention, IIS sentinel sites are population based and cover more than 1.8 million children younger than age 6. The sites are unique for their high health care provider participation (greater than 85%), child enrollment (more than 85% are younger than age 19), and timely capture of administered vaccines (more than 70% of doses are reported to the IIS within 30 days of vaccination). Sites included in the analysis since 2008 were located in Arizona, Colorado, Michigan, Minnesota, New York City, North Dakota, Oregon, and Wisconsin. Four of these sites have continuously served as IIS sentinel sites since 2004 (Arizona, Michigan, Minnesota, and Oregon).

As of June 30, 2009, 23,532 infants aged 5 months were enrolled at the eight IIS sites. After introduction of the RV vaccine, coverage among infants enrolled at the four continuously serving IIS sentinel sites rose to 50%–60% within the first year, and steadily thereafter, to 74% by the second quarter of 2009. As of June 20, 2009, RV coverage at all eight IIS sentinel sites averaged 72%. Colorado had the lowest rate of coverage (48%) while North Dakota had the highest (86%).

At the same time, coverage for one or more doses of DTaP or PCV7 vaccines at all eight IIS sentinel sites was 85%, or 13% higher than RV coverage. New York had the lowest coverage rates for DTaP and PCV7 (71% and 72%, respectively), while North Dakota had the highest coverage rate for DTaP (93%) and Michigan had the highest coverage rate for PCV7 (91%).

The researchers acknowledged certain limitations of the study, including the fact that coverage rates of DTaP and PCV7 at some IIS sites “were lower than expected based on 2008 [National Immunization Survey] data. These lower rates could result from persons who left the IIS sentinel site area before receipt of their vaccination, but who were still counted as enrolled and unvaccinated. Second, although IIS sentinel sites data are monitored for accuracy and completeness, RV might be less reliably entered into IIS than other infant vaccines because it is a relatively new vaccine. This could result in an underestimate of RV coverage levels.”

They concluded by noting that continued monitoring of RV coverage “will be crucial to provide information useful to policy makers and help focus efforts to achieve RV rates at least as high as other routinely recommended vaccines for U.S. infants.”

Major Finding: Nearly three-quarters of infants aged 5 months (72%) are receiving at least one dose of rotavirus vaccine.

Data Source: Analysis of data from 23,532 infants enrolled at one of eight Immunization Information System sentinel sites.

Disclosures: Immunization Information System sentinel sites receive support from the Centers for Disease Control and Prevention.

Rotavirus vaccination coverage among infants aged 5 months is averaging 72% nationwide, results from a recent analysis of eight Immunization Information System sites demonstrated.

However, vaccination rates varied widely between sites, and site-specific rotavirus vaccine coverage remained an average of 13 percentage points lower than that of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine and 7-valent pneumococcal conjugate vaccine (PCV7) in June 2009.

“[Rotavirus vaccine] is unique among vaccines recommended during infancy in having a maximum age for beginning the series,” researchers led by Diana L. Bartlett of the Immunization Services Division at the National Center for Immunization and Respiratory Diseases, Atlanta, reported. “This age restriction could account, in part, for the lower RV coverage because an infant aged 15 weeks–5 months could still receive a first dose of DTaP or PCV7 (but not RV), according to ACIP recommendations.”M

Ms. Bartlett and her associates analyzed data from eight Immunization Information System (IIS) sentinel sites to assess trends in coverage with one or more doses of rotavirus vaccine between June 2006 and June 2009 among infants aged 5 months and to compare RV coverage in the second quarter of 2009 with that of DTaP and PCV7 (MMWR 2010:59:521–4).

Supported by the Centers for Disease Control and Prevention, IIS sentinel sites are population based and cover more than 1.8 million children younger than age 6. The sites are unique for their high health care provider participation (greater than 85%), child enrollment (more than 85% are younger than age 19), and timely capture of administered vaccines (more than 70% of doses are reported to the IIS within 30 days of vaccination). Sites included in the analysis since 2008 were located in Arizona, Colorado, Michigan, Minnesota, New York City, North Dakota, Oregon, and Wisconsin. Four of these sites have continuously served as IIS sentinel sites since 2004 (Arizona, Michigan, Minnesota, and Oregon).

As of June 30, 2009, 23,532 infants aged 5 months were enrolled at the eight IIS sites. After introduction of the RV vaccine, coverage among infants enrolled at the four continuously serving IIS sentinel sites rose to 50%–60% within the first year, and steadily thereafter, to 74% by the second quarter of 2009. As of June 20, 2009, RV coverage at all eight IIS sentinel sites averaged 72%. Colorado had the lowest rate of coverage (48%) while North Dakota had the highest (86%).

At the same time, coverage for one or more doses of DTaP or PCV7 vaccines at all eight IIS sentinel sites was 85%, or 13% higher than RV coverage. New York had the lowest coverage rates for DTaP and PCV7 (71% and 72%, respectively), while North Dakota had the highest coverage rate for DTaP (93%) and Michigan had the highest coverage rate for PCV7 (91%).

The researchers acknowledged certain limitations of the study, including the fact that coverage rates of DTaP and PCV7 at some IIS sites “were lower than expected based on 2008 [National Immunization Survey] data. These lower rates could result from persons who left the IIS sentinel site area before receipt of their vaccination, but who were still counted as enrolled and unvaccinated. Second, although IIS sentinel sites data are monitored for accuracy and completeness, RV might be less reliably entered into IIS than other infant vaccines because it is a relatively new vaccine. This could result in an underestimate of RV coverage levels.”

They concluded by noting that continued monitoring of RV coverage “will be crucial to provide information useful to policy makers and help focus efforts to achieve RV rates at least as high as other routinely recommended vaccines for U.S. infants.”