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Barriers loom for HCV care in young people who inject drugs
Young adults who inject drugs and are infected with hepatitis C virus “face unique barriers to HCV testing, counseling, and treatment,” according to Margie R. Skeer, ScD, of Tufts University, Boston, and her fellow researchers.
Dr. Skeer and her colleagues found five themes in 24 in-depth interviews with people aged 22-30 years who inject drugs and have HCV infection. At the time of the interviews, none of the patients had received the newer HCV treatment regimens (Drug Alcohol Depend. 2018 Sep 1;190:246-54).
These themes captured the knowledge of and experience of HCV along the continuum of care:
1. Deservingness of HCV treatment and stigma.
2. Dissatisfaction with provider interactions.
3. Perceived lack of referral to treatment and care continuity.
4. Disincentives around HCV treatment for PWID.
5. Perceived need for treatment.
The interviewees were largely uninformed about HCV prior to diagnosis and reported learning more about the virus after their diagnosis. They also tended to affirm the belief that they did not deserve treatment. They felt stigmatized by insurance companies and clinicians, thereby reducing their engagement in the care continuum. And, at the time, insurance companies enforced “sobriety” restrictions dictating the length of time patients had to be off drugs before qualifying for HCV treatment. In the words of one interviewee: “[Caregivers] have a big stigma when it comes to addicts. ... Their whole demeanor changes. They rush you, they slam things, they are very impatient with you, and it is very saddening to see.”
Interviewees reported no or incomplete referrals or being given pamphlets and flyers. They reported little follow-up as to whether they sought additional care, and experienced a lack of confidence from medical professionals that they could be counted on to adhere to an HCV treatment regimen.
Interviewees stated that injection drug use and HCV are inevitably linked, and that IV drug users will eventually contract HCV infections.
“Hep C’s no big deal, Hep C’s like the common cold for the junkie. ... It might take 5 years away from your, you know, life but, you know, we’re not even gonna live that long anyways, so who cares about it anyway,” remarked a 28-year old woman, who was not currently injecting drugs.
The study authors said there is an increased need to provide patient-oriented care for young injection drug users and described the potential benefits of some insurance companies reducing their sobriety and disease severity restrictions.
“Reducing stigma among healthcare professionals, which cuts across the different levels of the HCV care continuum, improving referral patterns and continuity of care, better informing people about their HCV status through patient-oriented testing and disclosure experiences, and reducing perceptions of personal responsibility for disease are crucial next steps to increasing treatment as prevention,” Dr. Skeer and her colleagues concluded.
The authors reported that they had no conflicts of interest.
Young adults who inject drugs and are infected with hepatitis C virus “face unique barriers to HCV testing, counseling, and treatment,” according to Margie R. Skeer, ScD, of Tufts University, Boston, and her fellow researchers.
Dr. Skeer and her colleagues found five themes in 24 in-depth interviews with people aged 22-30 years who inject drugs and have HCV infection. At the time of the interviews, none of the patients had received the newer HCV treatment regimens (Drug Alcohol Depend. 2018 Sep 1;190:246-54).
These themes captured the knowledge of and experience of HCV along the continuum of care:
1. Deservingness of HCV treatment and stigma.
2. Dissatisfaction with provider interactions.
3. Perceived lack of referral to treatment and care continuity.
4. Disincentives around HCV treatment for PWID.
5. Perceived need for treatment.
The interviewees were largely uninformed about HCV prior to diagnosis and reported learning more about the virus after their diagnosis. They also tended to affirm the belief that they did not deserve treatment. They felt stigmatized by insurance companies and clinicians, thereby reducing their engagement in the care continuum. And, at the time, insurance companies enforced “sobriety” restrictions dictating the length of time patients had to be off drugs before qualifying for HCV treatment. In the words of one interviewee: “[Caregivers] have a big stigma when it comes to addicts. ... Their whole demeanor changes. They rush you, they slam things, they are very impatient with you, and it is very saddening to see.”
Interviewees reported no or incomplete referrals or being given pamphlets and flyers. They reported little follow-up as to whether they sought additional care, and experienced a lack of confidence from medical professionals that they could be counted on to adhere to an HCV treatment regimen.
Interviewees stated that injection drug use and HCV are inevitably linked, and that IV drug users will eventually contract HCV infections.
“Hep C’s no big deal, Hep C’s like the common cold for the junkie. ... It might take 5 years away from your, you know, life but, you know, we’re not even gonna live that long anyways, so who cares about it anyway,” remarked a 28-year old woman, who was not currently injecting drugs.
The study authors said there is an increased need to provide patient-oriented care for young injection drug users and described the potential benefits of some insurance companies reducing their sobriety and disease severity restrictions.
“Reducing stigma among healthcare professionals, which cuts across the different levels of the HCV care continuum, improving referral patterns and continuity of care, better informing people about their HCV status through patient-oriented testing and disclosure experiences, and reducing perceptions of personal responsibility for disease are crucial next steps to increasing treatment as prevention,” Dr. Skeer and her colleagues concluded.
The authors reported that they had no conflicts of interest.
Young adults who inject drugs and are infected with hepatitis C virus “face unique barriers to HCV testing, counseling, and treatment,” according to Margie R. Skeer, ScD, of Tufts University, Boston, and her fellow researchers.
Dr. Skeer and her colleagues found five themes in 24 in-depth interviews with people aged 22-30 years who inject drugs and have HCV infection. At the time of the interviews, none of the patients had received the newer HCV treatment regimens (Drug Alcohol Depend. 2018 Sep 1;190:246-54).
These themes captured the knowledge of and experience of HCV along the continuum of care:
1. Deservingness of HCV treatment and stigma.
2. Dissatisfaction with provider interactions.
3. Perceived lack of referral to treatment and care continuity.
4. Disincentives around HCV treatment for PWID.
5. Perceived need for treatment.
The interviewees were largely uninformed about HCV prior to diagnosis and reported learning more about the virus after their diagnosis. They also tended to affirm the belief that they did not deserve treatment. They felt stigmatized by insurance companies and clinicians, thereby reducing their engagement in the care continuum. And, at the time, insurance companies enforced “sobriety” restrictions dictating the length of time patients had to be off drugs before qualifying for HCV treatment. In the words of one interviewee: “[Caregivers] have a big stigma when it comes to addicts. ... Their whole demeanor changes. They rush you, they slam things, they are very impatient with you, and it is very saddening to see.”
Interviewees reported no or incomplete referrals or being given pamphlets and flyers. They reported little follow-up as to whether they sought additional care, and experienced a lack of confidence from medical professionals that they could be counted on to adhere to an HCV treatment regimen.
Interviewees stated that injection drug use and HCV are inevitably linked, and that IV drug users will eventually contract HCV infections.
“Hep C’s no big deal, Hep C’s like the common cold for the junkie. ... It might take 5 years away from your, you know, life but, you know, we’re not even gonna live that long anyways, so who cares about it anyway,” remarked a 28-year old woman, who was not currently injecting drugs.
The study authors said there is an increased need to provide patient-oriented care for young injection drug users and described the potential benefits of some insurance companies reducing their sobriety and disease severity restrictions.
“Reducing stigma among healthcare professionals, which cuts across the different levels of the HCV care continuum, improving referral patterns and continuity of care, better informing people about their HCV status through patient-oriented testing and disclosure experiences, and reducing perceptions of personal responsibility for disease are crucial next steps to increasing treatment as prevention,” Dr. Skeer and her colleagues concluded.
The authors reported that they had no conflicts of interest.
FROM DRUG AND ALCOHOL DEPENDENCE
Genetic composition of HCV changes with HIV coinfection
Marked differences were seen in the composition of hepatitis C virus hypervariable region 1 (HVR1) when comparing HIV-coinfected (CIP) with HCV-monoinfected (MIP) individuals, according to the results of a genetic analysis of nearly 300 patients.
Intrahost HCV HVR1 evolution varies between these two groups, which suggests that HIV-inflicted changes in the host environment exact a strong HCV genetic response, according to a report published online in Infection, Genetics, and Evolution.
“A high prevalence of HIV-HCV coinfection and its impact on mortality among such populations groups as PWID [people who inject drugs] and MSM [men who have sex with men] is of major concern to public health,” according to the researchers.
Previous studies using the Global Hepatitis Outbreak and Surveillance Technology, a Web-based system for the detection of HCV transmission developed by the researchers, analyzed sequences of intrahost variants of the HVR1 region using next-generation sequencing. They found that genetic variation in the HVR1 of intrahost HCV variants was strongly associated with host sex and ethnicity, resistance to interferon, and stages of HCV infection.
In this particular study, the researchers assessed 28,622 nucleotide sequences of intrahost HCV HVR1 variants from 113 CIP and 176 MIP individuals.
They examined 148 physical-chemical indexes of DNA nucleotide dimers and found that there were significant differences in the means and frequency distributions of seven physical-chemical properties between HVR1 variants from both groups.
The significant majority of these profiles (98%-99%) were found to be specific to CIP or MIP, indicating that coevolution among HVR1 sites reflects HCV adaptation to HIV among coinfected individuals. “This observation suggests substantial differences in fitness between HVR1 variants circulating in infected hosts in the presence or absence of HIV, according to the researchers from the Centers for Disease Control and Prevention.
“HCV strains circulating in high-risk groups need to be carefully monitored for the identification of potentially new traits of clinical and public health relevance,” the researchers concluded.
This study was supported by CDC intramural funding. The authors reported that they had no disclosures.
SOURCE: Lara J et al. doi: 10.1016/j.meegid.2018.07.039.
Marked differences were seen in the composition of hepatitis C virus hypervariable region 1 (HVR1) when comparing HIV-coinfected (CIP) with HCV-monoinfected (MIP) individuals, according to the results of a genetic analysis of nearly 300 patients.
Intrahost HCV HVR1 evolution varies between these two groups, which suggests that HIV-inflicted changes in the host environment exact a strong HCV genetic response, according to a report published online in Infection, Genetics, and Evolution.
“A high prevalence of HIV-HCV coinfection and its impact on mortality among such populations groups as PWID [people who inject drugs] and MSM [men who have sex with men] is of major concern to public health,” according to the researchers.
Previous studies using the Global Hepatitis Outbreak and Surveillance Technology, a Web-based system for the detection of HCV transmission developed by the researchers, analyzed sequences of intrahost variants of the HVR1 region using next-generation sequencing. They found that genetic variation in the HVR1 of intrahost HCV variants was strongly associated with host sex and ethnicity, resistance to interferon, and stages of HCV infection.
In this particular study, the researchers assessed 28,622 nucleotide sequences of intrahost HCV HVR1 variants from 113 CIP and 176 MIP individuals.
They examined 148 physical-chemical indexes of DNA nucleotide dimers and found that there were significant differences in the means and frequency distributions of seven physical-chemical properties between HVR1 variants from both groups.
The significant majority of these profiles (98%-99%) were found to be specific to CIP or MIP, indicating that coevolution among HVR1 sites reflects HCV adaptation to HIV among coinfected individuals. “This observation suggests substantial differences in fitness between HVR1 variants circulating in infected hosts in the presence or absence of HIV, according to the researchers from the Centers for Disease Control and Prevention.
“HCV strains circulating in high-risk groups need to be carefully monitored for the identification of potentially new traits of clinical and public health relevance,” the researchers concluded.
This study was supported by CDC intramural funding. The authors reported that they had no disclosures.
SOURCE: Lara J et al. doi: 10.1016/j.meegid.2018.07.039.
Marked differences were seen in the composition of hepatitis C virus hypervariable region 1 (HVR1) when comparing HIV-coinfected (CIP) with HCV-monoinfected (MIP) individuals, according to the results of a genetic analysis of nearly 300 patients.
Intrahost HCV HVR1 evolution varies between these two groups, which suggests that HIV-inflicted changes in the host environment exact a strong HCV genetic response, according to a report published online in Infection, Genetics, and Evolution.
“A high prevalence of HIV-HCV coinfection and its impact on mortality among such populations groups as PWID [people who inject drugs] and MSM [men who have sex with men] is of major concern to public health,” according to the researchers.
Previous studies using the Global Hepatitis Outbreak and Surveillance Technology, a Web-based system for the detection of HCV transmission developed by the researchers, analyzed sequences of intrahost variants of the HVR1 region using next-generation sequencing. They found that genetic variation in the HVR1 of intrahost HCV variants was strongly associated with host sex and ethnicity, resistance to interferon, and stages of HCV infection.
In this particular study, the researchers assessed 28,622 nucleotide sequences of intrahost HCV HVR1 variants from 113 CIP and 176 MIP individuals.
They examined 148 physical-chemical indexes of DNA nucleotide dimers and found that there were significant differences in the means and frequency distributions of seven physical-chemical properties between HVR1 variants from both groups.
The significant majority of these profiles (98%-99%) were found to be specific to CIP or MIP, indicating that coevolution among HVR1 sites reflects HCV adaptation to HIV among coinfected individuals. “This observation suggests substantial differences in fitness between HVR1 variants circulating in infected hosts in the presence or absence of HIV, according to the researchers from the Centers for Disease Control and Prevention.
“HCV strains circulating in high-risk groups need to be carefully monitored for the identification of potentially new traits of clinical and public health relevance,” the researchers concluded.
This study was supported by CDC intramural funding. The authors reported that they had no disclosures.
SOURCE: Lara J et al. doi: 10.1016/j.meegid.2018.07.039.
FROM INFECTION, GENETICS, AND EVOLUTION
World off track for meeting 2020 HIV prevention, mortality goals
Globally, new HIV infections have declined by just 18% in the past 7 years, but the decline is not quick enough to reach the United Nations’ target goal of reduced deaths and infections by 2020, according to a warning issued by UNAIDS in its July 2018 AIDS update report, Miles to Go: Closing gaps, breaking barriers, righting injustices.
“We are sounding the alarm. Entire regions are falling behind, the huge gains we made for children are not being sustained, women are still most affected, resources are still not matching political commitments, and key populations continue to be ignored,” Michel Sidibé, executive director of UNAIDS, said in a press release.
Even though almost 60% of the 36.9 million people living with HIV were on treatment in 2017, to reach the 30 million target an annual increase of 2.8 million people is required, and indications are that the rate of scale-up is slowing down, according to the report. 
Not meeting the 2020 United Nations self-imposed fast-track deadline for reducing HIV infections and AIDS-related deaths by 5 years (moving it to 2025), will mean an additional 2.1 million infections and 1.0 million more AIDS-related deaths.
Part of the problem is localization of new therapies for prevention. For example, two-thirds of the estimated 350,000 people globally who have ever started pre-exposure prophylaxis (PrEP) are in the United States.
In Africa, little progress in preventing new infections has been achieved outside of the sub-Saharan region, and in eastern Europe and central Asia, the annual number of new HIV infections approximately doubled since 2000, according to the report.
Other portions of the report deal with the impact of law and politics, including the stigmatization and criminalization around the world of men who have sex with men, and the role of poverty and inequality as it affects the scope of the HIV goals, especially the problem of food insecurity, and how women and children are put at special risk by socioeconomic factors.
Globally, new HIV infections have declined by just 18% in the past 7 years, but the decline is not quick enough to reach the United Nations’ target goal of reduced deaths and infections by 2020, according to a warning issued by UNAIDS in its July 2018 AIDS update report, Miles to Go: Closing gaps, breaking barriers, righting injustices.
“We are sounding the alarm. Entire regions are falling behind, the huge gains we made for children are not being sustained, women are still most affected, resources are still not matching political commitments, and key populations continue to be ignored,” Michel Sidibé, executive director of UNAIDS, said in a press release.
Even though almost 60% of the 36.9 million people living with HIV were on treatment in 2017, to reach the 30 million target an annual increase of 2.8 million people is required, and indications are that the rate of scale-up is slowing down, according to the report.
Not meeting the 2020 United Nations self-imposed fast-track deadline for reducing HIV infections and AIDS-related deaths by 5 years (moving it to 2025), will mean an additional 2.1 million infections and 1.0 million more AIDS-related deaths.
Part of the problem is localization of new therapies for prevention. For example, two-thirds of the estimated 350,000 people globally who have ever started pre-exposure prophylaxis (PrEP) are in the United States.
In Africa, little progress in preventing new infections has been achieved outside of the sub-Saharan region, and in eastern Europe and central Asia, the annual number of new HIV infections approximately doubled since 2000, according to the report.
Other portions of the report deal with the impact of law and politics, including the stigmatization and criminalization around the world of men who have sex with men, and the role of poverty and inequality as it affects the scope of the HIV goals, especially the problem of food insecurity, and how women and children are put at special risk by socioeconomic factors.
Globally, new HIV infections have declined by just 18% in the past 7 years, but the decline is not quick enough to reach the United Nations’ target goal of reduced deaths and infections by 2020, according to a warning issued by UNAIDS in its July 2018 AIDS update report, Miles to Go: Closing gaps, breaking barriers, righting injustices.
“We are sounding the alarm. Entire regions are falling behind, the huge gains we made for children are not being sustained, women are still most affected, resources are still not matching political commitments, and key populations continue to be ignored,” Michel Sidibé, executive director of UNAIDS, said in a press release.
Even though almost 60% of the 36.9 million people living with HIV were on treatment in 2017, to reach the 30 million target an annual increase of 2.8 million people is required, and indications are that the rate of scale-up is slowing down, according to the report.
Not meeting the 2020 United Nations self-imposed fast-track deadline for reducing HIV infections and AIDS-related deaths by 5 years (moving it to 2025), will mean an additional 2.1 million infections and 1.0 million more AIDS-related deaths.
Part of the problem is localization of new therapies for prevention. For example, two-thirds of the estimated 350,000 people globally who have ever started pre-exposure prophylaxis (PrEP) are in the United States.
In Africa, little progress in preventing new infections has been achieved outside of the sub-Saharan region, and in eastern Europe and central Asia, the annual number of new HIV infections approximately doubled since 2000, according to the report.
Other portions of the report deal with the impact of law and politics, including the stigmatization and criminalization around the world of men who have sex with men, and the role of poverty and inequality as it affects the scope of the HIV goals, especially the problem of food insecurity, and how women and children are put at special risk by socioeconomic factors.
Real-time microarrays can simultaneously detect HCV and HIV-1, -2 infections
The use of TaqMan Array Card (TAC) microarrays has been extended to permit simultaneous detection of HIV-1, HIV-2, and five hepatitis viruses from a small amount of extracted nucleic acid, according to a study by Timothy C. Granade, MD, and his colleagues at the Centers for Disease Control and Prevention, Atlanta.
This is particularly important for dealing with HIV-infected individuals, because HIV-1 and HIV-2 require different treatment interventions, and approximately one-third of HIV-infected patients have been found to be coinfected with hepatitis C or hepatitis B, according to the study report, published in the Journal of Virological Methods (J Virol Methods. 2018 Sep;259:60-5).
HIV-1-positive plasma samples from a variety of subtypes as well as whole blood specimens were confirmed for HIV-1-infection serologically or by nucleic amplification methods. HIV-2 whole blood and plasma specimens were also obtained.
TAC cards contained one positive control, one negative control, three HIV-1 replicates, and two HIV-2 replicates. In addition, the five common hepatitis viruses (A-E) were each replicated three times on each card. The cards were used to test the RNA isolates obtained from the various samples.
Ninety-five of the 104 known HIV-1-positive specimens were assayed positive using TAC; 23 of 26 HIV-2-seeded specimens were detectable using TAC and no cross-reactivity was seen between HIV-1-positive and HIV-2-positive specimens.
Eighteen of the HIV-1-positive specimens were also reactive in triplicate for HCV; three of the HIV-1-positive specimens were reactive to HBV and one specimen was reactive to HIV-1, HBV, and HCV.
“The TAC assay could be invaluable in large-scale screening environments or in surveying local outbreaks such as the recent HIV cluster found in Indiana. Many of these individuals were later determined to be infected with hepatitis C. The use of TAC could shorten the time to identifying and confirming such cases and permit the detection of multiple blood-borne infections in a single test. Application of TAC technology to general population surveillance could identify problem areas for both HIV prevention and intervention efforts in a variety of global environs,” the researchers concluded.
The authors were employed by the Centers for Disease Control and Prevention, Atlanta, which funded the study.
The use of TaqMan Array Card (TAC) microarrays has been extended to permit simultaneous detection of HIV-1, HIV-2, and five hepatitis viruses from a small amount of extracted nucleic acid, according to a study by Timothy C. Granade, MD, and his colleagues at the Centers for Disease Control and Prevention, Atlanta.
This is particularly important for dealing with HIV-infected individuals, because HIV-1 and HIV-2 require different treatment interventions, and approximately one-third of HIV-infected patients have been found to be coinfected with hepatitis C or hepatitis B, according to the study report, published in the Journal of Virological Methods (J Virol Methods. 2018 Sep;259:60-5).
HIV-1-positive plasma samples from a variety of subtypes as well as whole blood specimens were confirmed for HIV-1-infection serologically or by nucleic amplification methods. HIV-2 whole blood and plasma specimens were also obtained.
TAC cards contained one positive control, one negative control, three HIV-1 replicates, and two HIV-2 replicates. In addition, the five common hepatitis viruses (A-E) were each replicated three times on each card. The cards were used to test the RNA isolates obtained from the various samples.
Ninety-five of the 104 known HIV-1-positive specimens were assayed positive using TAC; 23 of 26 HIV-2-seeded specimens were detectable using TAC and no cross-reactivity was seen between HIV-1-positive and HIV-2-positive specimens.
Eighteen of the HIV-1-positive specimens were also reactive in triplicate for HCV; three of the HIV-1-positive specimens were reactive to HBV and one specimen was reactive to HIV-1, HBV, and HCV.
“The TAC assay could be invaluable in large-scale screening environments or in surveying local outbreaks such as the recent HIV cluster found in Indiana. Many of these individuals were later determined to be infected with hepatitis C. The use of TAC could shorten the time to identifying and confirming such cases and permit the detection of multiple blood-borne infections in a single test. Application of TAC technology to general population surveillance could identify problem areas for both HIV prevention and intervention efforts in a variety of global environs,” the researchers concluded.
The authors were employed by the Centers for Disease Control and Prevention, Atlanta, which funded the study.
The use of TaqMan Array Card (TAC) microarrays has been extended to permit simultaneous detection of HIV-1, HIV-2, and five hepatitis viruses from a small amount of extracted nucleic acid, according to a study by Timothy C. Granade, MD, and his colleagues at the Centers for Disease Control and Prevention, Atlanta.
This is particularly important for dealing with HIV-infected individuals, because HIV-1 and HIV-2 require different treatment interventions, and approximately one-third of HIV-infected patients have been found to be coinfected with hepatitis C or hepatitis B, according to the study report, published in the Journal of Virological Methods (J Virol Methods. 2018 Sep;259:60-5).
HIV-1-positive plasma samples from a variety of subtypes as well as whole blood specimens were confirmed for HIV-1-infection serologically or by nucleic amplification methods. HIV-2 whole blood and plasma specimens were also obtained.
TAC cards contained one positive control, one negative control, three HIV-1 replicates, and two HIV-2 replicates. In addition, the five common hepatitis viruses (A-E) were each replicated three times on each card. The cards were used to test the RNA isolates obtained from the various samples.
Ninety-five of the 104 known HIV-1-positive specimens were assayed positive using TAC; 23 of 26 HIV-2-seeded specimens were detectable using TAC and no cross-reactivity was seen between HIV-1-positive and HIV-2-positive specimens.
Eighteen of the HIV-1-positive specimens were also reactive in triplicate for HCV; three of the HIV-1-positive specimens were reactive to HBV and one specimen was reactive to HIV-1, HBV, and HCV.
“The TAC assay could be invaluable in large-scale screening environments or in surveying local outbreaks such as the recent HIV cluster found in Indiana. Many of these individuals were later determined to be infected with hepatitis C. The use of TAC could shorten the time to identifying and confirming such cases and permit the detection of multiple blood-borne infections in a single test. Application of TAC technology to general population surveillance could identify problem areas for both HIV prevention and intervention efforts in a variety of global environs,” the researchers concluded.
The authors were employed by the Centers for Disease Control and Prevention, Atlanta, which funded the study.
FROM THE JOURNAL OF VIROLOGICAL METHODS
FDA: Krintafel approved as ‘radical cure’ for preventing malaria relapse
The Food and Drug Administration has approved, under priority review, single-dose tafenoquine (to be marketed as Krintafel) for the prevention of relapse in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute Plasmodium vivax infection, according to an announcement by research partners GSK and the nonprofit Medicines for Malaria Venture.
Clinical efficacy and safety of the 300-mg single-dose tablet was provided by three randomized, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564). The results of the two phase III studies were announced in June 2017.
Tafenoquine is referred to as a “radical cure,” because it targets the dormant liver forms of P. vivax and is coadministered with currently available antimalarials such as chloroquine or artemisinin-based combination therapies.
“The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single-dose for this indication, Krintafel will help improve patient compliance,” David Reddy, MD, CEO of MMV stated.
The FDA approval letter and the Krintafel label information are available online.
The Food and Drug Administration has approved, under priority review, single-dose tafenoquine (to be marketed as Krintafel) for the prevention of relapse in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute Plasmodium vivax infection, according to an announcement by research partners GSK and the nonprofit Medicines for Malaria Venture.
Clinical efficacy and safety of the 300-mg single-dose tablet was provided by three randomized, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564). The results of the two phase III studies were announced in June 2017.
Tafenoquine is referred to as a “radical cure,” because it targets the dormant liver forms of P. vivax and is coadministered with currently available antimalarials such as chloroquine or artemisinin-based combination therapies.
“The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single-dose for this indication, Krintafel will help improve patient compliance,” David Reddy, MD, CEO of MMV stated.
The FDA approval letter and the Krintafel label information are available online.
The Food and Drug Administration has approved, under priority review, single-dose tafenoquine (to be marketed as Krintafel) for the prevention of relapse in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute Plasmodium vivax infection, according to an announcement by research partners GSK and the nonprofit Medicines for Malaria Venture.
Clinical efficacy and safety of the 300-mg single-dose tablet was provided by three randomized, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564). The results of the two phase III studies were announced in June 2017.
Tafenoquine is referred to as a “radical cure,” because it targets the dormant liver forms of P. vivax and is coadministered with currently available antimalarials such as chloroquine or artemisinin-based combination therapies.
“The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single-dose for this indication, Krintafel will help improve patient compliance,” David Reddy, MD, CEO of MMV stated.
The FDA approval letter and the Krintafel label information are available online.
Female survivor transmits Ebola virus 1 year after outbreak
Molecular analysis showed that a Liberian woman who survived Ebola virus disease in 2014 had viral persistence or recurrent disease and transmitted the virus to other family members a year later, according to a study published online in The Lancet Infectious Diseases.
Although the original 2014-2015 Ebola virus disease epidemic in West Africa had been contained, subsequent clusters of infection continued to occur in the region, according to researchers. A particular cluster in Liberia in November 2015 was identified after a 15-year-old boy in Monrovia tested positive.
Based on serology and epidemiological and genomic data, the researchers concluded that this cluster was caused by a woman who survived Ebola virus disease in 2014 and transmitted the virus to three family members a year later.
Ebola transmission from persistently infected male survivors is well documented, but this is the first confirmed evidence for Ebola transmission from a persistently infected female survivor, according to Emily Kainne Dokubo, MD, of the Centers for Disease Control and Prevention and her colleagues.
“The findings from this and recent Ebola virus disease clusters highlight the risk of Ebola virus disease flare-ups even after an outbreak is declared over. Risk assessment and focused prevention efforts are needed for Ebola survivors and their close contacts,” Dr. Dokubo and her colleagues concluded.
The study was funded by the CDC, Defense Threat Reduction Agency, and WHO.
SOURCE: Dokubo EK et al. The Lancet Infectious Diseases, July 23, 2018.
Molecular analysis showed that a Liberian woman who survived Ebola virus disease in 2014 had viral persistence or recurrent disease and transmitted the virus to other family members a year later, according to a study published online in The Lancet Infectious Diseases.
Although the original 2014-2015 Ebola virus disease epidemic in West Africa had been contained, subsequent clusters of infection continued to occur in the region, according to researchers. A particular cluster in Liberia in November 2015 was identified after a 15-year-old boy in Monrovia tested positive.
Based on serology and epidemiological and genomic data, the researchers concluded that this cluster was caused by a woman who survived Ebola virus disease in 2014 and transmitted the virus to three family members a year later.
Ebola transmission from persistently infected male survivors is well documented, but this is the first confirmed evidence for Ebola transmission from a persistently infected female survivor, according to Emily Kainne Dokubo, MD, of the Centers for Disease Control and Prevention and her colleagues.
“The findings from this and recent Ebola virus disease clusters highlight the risk of Ebola virus disease flare-ups even after an outbreak is declared over. Risk assessment and focused prevention efforts are needed for Ebola survivors and their close contacts,” Dr. Dokubo and her colleagues concluded.
The study was funded by the CDC, Defense Threat Reduction Agency, and WHO.
SOURCE: Dokubo EK et al. The Lancet Infectious Diseases, July 23, 2018.
Molecular analysis showed that a Liberian woman who survived Ebola virus disease in 2014 had viral persistence or recurrent disease and transmitted the virus to other family members a year later, according to a study published online in The Lancet Infectious Diseases.
Although the original 2014-2015 Ebola virus disease epidemic in West Africa had been contained, subsequent clusters of infection continued to occur in the region, according to researchers. A particular cluster in Liberia in November 2015 was identified after a 15-year-old boy in Monrovia tested positive.
Based on serology and epidemiological and genomic data, the researchers concluded that this cluster was caused by a woman who survived Ebola virus disease in 2014 and transmitted the virus to three family members a year later.
Ebola transmission from persistently infected male survivors is well documented, but this is the first confirmed evidence for Ebola transmission from a persistently infected female survivor, according to Emily Kainne Dokubo, MD, of the Centers for Disease Control and Prevention and her colleagues.
“The findings from this and recent Ebola virus disease clusters highlight the risk of Ebola virus disease flare-ups even after an outbreak is declared over. Risk assessment and focused prevention efforts are needed for Ebola survivors and their close contacts,” Dr. Dokubo and her colleagues concluded.
The study was funded by the CDC, Defense Threat Reduction Agency, and WHO.
SOURCE: Dokubo EK et al. The Lancet Infectious Diseases, July 23, 2018.
FROM THE LANCET INFECTIOUS DISEASES
National Academies issues 5-step plan to address infections linked to opioid use disorder
Widespread opioid use disorder (OUD) has spawned new epidemics of hepatitis C virus (HCV) and HIV infections as well as increased hospitalizations for bacteremia, endocarditis, skin and soft tissue infections, and osteomyelitis, according to a report arising from a National Academies of Science, Engineering and Medicine (NASEM) workshop titled Integrating Infectious Disease Considerations with Response to the Opioid Epidemic.
Optimal treatment of these infections is often impeded by untreated OUD, Sandra A. Springer, MD, and her colleagues wrote in an article published online in the Annals of Internal Medicine. Failing to address OUD can result in longer hospital stays; frequent readmissions because of a lack of adherence to antibiotic regimens; or reinfection, morbidity, and high costs. “Medical settings that manage such infections offer a potential means of engaging people in treatment of OUD; however, few providers and hospitals treating such infections have the needed resources and capabilities,” Dr. Springer, director, infectious disease outpatient clinic, Veterans Administration, Newington, and of Yale University, New Haven, both in Conn., and her colleagues wrote.
The authors outlined five action steps resulting from the NASEM workshop:
- Implement screening for OUD in all relevant health care settings.
- For patients with positive screening results, immediately prescribe effective medication for OUD and/or opioid withdrawal symptoms.
- Develop hospital-based protocols that facilitate OUD treatment initiation and linkage to community-based treatment upon discharge.
- Hospitals, medical schools, physician assistant schools, nursing schools, and residency programs should increase training to identify and treat OUD.
- Increase access to addiction care and funding to states to provide effective medications to treat OUD.
Opioid withdrawal and pain syndromes should be addressed with opioid agonist therapies to optimize infectious disease (ID) treatment and relieve pain, according to Dr. Springer and her colleagues. In addition, “Because ID specialists are likely to be consulted for anyone requiring long-term antibiotic therapy or patients with HIV and HCV infection, OUD screening should be a standard part of an ID consult assessment,” the authors wrote.
“All health care providers have a role in combating the OUD epidemic and its ID consequences. Those who treat infectious complications of OUD are well suited to screen for OUD and begin treatment with effective FDA-approved medications,” the authors concluded.
The workshop was held in March 2018 in Washington and videos and slide presentations from the meeting are available.
Dr. Springer and her colleagues reported grant funding from the National Institutes of Health, but no commercial conflicts.
SOURCE: Springer SA et al. Ann Intern Med. 2018 Jul 13. doi: 10.7326/M18-1203.
Widespread opioid use disorder (OUD) has spawned new epidemics of hepatitis C virus (HCV) and HIV infections as well as increased hospitalizations for bacteremia, endocarditis, skin and soft tissue infections, and osteomyelitis, according to a report arising from a National Academies of Science, Engineering and Medicine (NASEM) workshop titled Integrating Infectious Disease Considerations with Response to the Opioid Epidemic.
Optimal treatment of these infections is often impeded by untreated OUD, Sandra A. Springer, MD, and her colleagues wrote in an article published online in the Annals of Internal Medicine. Failing to address OUD can result in longer hospital stays; frequent readmissions because of a lack of adherence to antibiotic regimens; or reinfection, morbidity, and high costs. “Medical settings that manage such infections offer a potential means of engaging people in treatment of OUD; however, few providers and hospitals treating such infections have the needed resources and capabilities,” Dr. Springer, director, infectious disease outpatient clinic, Veterans Administration, Newington, and of Yale University, New Haven, both in Conn., and her colleagues wrote.
The authors outlined five action steps resulting from the NASEM workshop:
- Implement screening for OUD in all relevant health care settings.
- For patients with positive screening results, immediately prescribe effective medication for OUD and/or opioid withdrawal symptoms.
- Develop hospital-based protocols that facilitate OUD treatment initiation and linkage to community-based treatment upon discharge.
- Hospitals, medical schools, physician assistant schools, nursing schools, and residency programs should increase training to identify and treat OUD.
- Increase access to addiction care and funding to states to provide effective medications to treat OUD.
Opioid withdrawal and pain syndromes should be addressed with opioid agonist therapies to optimize infectious disease (ID) treatment and relieve pain, according to Dr. Springer and her colleagues. In addition, “Because ID specialists are likely to be consulted for anyone requiring long-term antibiotic therapy or patients with HIV and HCV infection, OUD screening should be a standard part of an ID consult assessment,” the authors wrote.
“All health care providers have a role in combating the OUD epidemic and its ID consequences. Those who treat infectious complications of OUD are well suited to screen for OUD and begin treatment with effective FDA-approved medications,” the authors concluded.
The workshop was held in March 2018 in Washington and videos and slide presentations from the meeting are available.
Dr. Springer and her colleagues reported grant funding from the National Institutes of Health, but no commercial conflicts.
SOURCE: Springer SA et al. Ann Intern Med. 2018 Jul 13. doi: 10.7326/M18-1203.
Widespread opioid use disorder (OUD) has spawned new epidemics of hepatitis C virus (HCV) and HIV infections as well as increased hospitalizations for bacteremia, endocarditis, skin and soft tissue infections, and osteomyelitis, according to a report arising from a National Academies of Science, Engineering and Medicine (NASEM) workshop titled Integrating Infectious Disease Considerations with Response to the Opioid Epidemic.
Optimal treatment of these infections is often impeded by untreated OUD, Sandra A. Springer, MD, and her colleagues wrote in an article published online in the Annals of Internal Medicine. Failing to address OUD can result in longer hospital stays; frequent readmissions because of a lack of adherence to antibiotic regimens; or reinfection, morbidity, and high costs. “Medical settings that manage such infections offer a potential means of engaging people in treatment of OUD; however, few providers and hospitals treating such infections have the needed resources and capabilities,” Dr. Springer, director, infectious disease outpatient clinic, Veterans Administration, Newington, and of Yale University, New Haven, both in Conn., and her colleagues wrote.
The authors outlined five action steps resulting from the NASEM workshop:
- Implement screening for OUD in all relevant health care settings.
- For patients with positive screening results, immediately prescribe effective medication for OUD and/or opioid withdrawal symptoms.
- Develop hospital-based protocols that facilitate OUD treatment initiation and linkage to community-based treatment upon discharge.
- Hospitals, medical schools, physician assistant schools, nursing schools, and residency programs should increase training to identify and treat OUD.
- Increase access to addiction care and funding to states to provide effective medications to treat OUD.
Opioid withdrawal and pain syndromes should be addressed with opioid agonist therapies to optimize infectious disease (ID) treatment and relieve pain, according to Dr. Springer and her colleagues. In addition, “Because ID specialists are likely to be consulted for anyone requiring long-term antibiotic therapy or patients with HIV and HCV infection, OUD screening should be a standard part of an ID consult assessment,” the authors wrote.
“All health care providers have a role in combating the OUD epidemic and its ID consequences. Those who treat infectious complications of OUD are well suited to screen for OUD and begin treatment with effective FDA-approved medications,” the authors concluded.
The workshop was held in March 2018 in Washington and videos and slide presentations from the meeting are available.
Dr. Springer and her colleagues reported grant funding from the National Institutes of Health, but no commercial conflicts.
SOURCE: Springer SA et al. Ann Intern Med. 2018 Jul 13. doi: 10.7326/M18-1203.
FROM ANNALS OF INTERNAL MEDICINE
Mosaic HIV-1 vaccine stimulates broad antigenicity, enters phase 2b human efficacy trial
A mosaic adenovirus human immunodeficiency virus-1 (HIV-1) vaccine induced robust immune responses in humans and rhesus monkeys, and significantly protected the monkeys against repetitive simian/HIV (SHIV) mosaic challenges in rhesus monkeys. This vaccine concept is currently being evaluated in a phase 2b clinical efficacy study in sub-Saharan Africa, according to a report published online in The Lancet.
Because a mosaic combination of antigens can induce an immunogenic response to a broad geographic range of viral subtypes, such a vaccine can offer the theoretical possibility of developing a global HIV-1 vaccine, according to Dan H. Barouch, MD, of Harvard Medical School, Boston, and his colleagues.
The researchers conducted a multicenter, randomized, double-blind, placebo-controlled, phase 1/2a trial (APPROACH) with 393 healthy, HIV-1-uninfected participants (aged 18-50 years) who were considered at low risk for HIV-1 infection and were recruited from 12 clinics in East Africa, South Africa, Thailand, and the United States. Participants were primed at weeks 0 and 12 with Ad26.Mos.HIV (5 × 1010 viral particles per 0.5 mL) expressing mosaic HIV-1 envelope (Env)/Gag/Pol antigens and given boosters at weeks 24 and 48 with Ad26.Mos.HIV or modified vaccinia Ankara (MVA; 108 plaque-forming units per 0.5 mL) vectors with or without adjuvanted Env gp140 protein. The placebo group received 0.9% saline.
Eligible participants were randomly assigned to one of eight study groups: Ad26/Ad26 plus high-dose gp140; Ad26/Ad26 plus low-dose gp140; Ad26/Ad26; Ad26/MVA plus high-dose gp140; Ad26/MVA plus low-dose gp140; Ad26/MVA; Ad26/high-dose gp140; and placebo. “Overall, no substantial differences in safety or tolerability of any of the seven active vaccine groups were observed,” according to Dr. Barouch and his colleagues.
In addition, the researchers vaccinated 72 Indian-origin rhesus monkeys (Macaca mulatta) using a study design that was similar to that of the human APPROACH clinical study.
The mosaic HIV-1 vaccine “induced robust humoral and cellular immune responses in both humans and rhesus monkeys,” which were similar in both species in “magnitude, durability, and phenotype,” the investigators reported. In addition, the vaccine “provided 67% protection against acquisition of six intrarectal SHIV challenges in rhesus monkeys.”
Based on these results, the mosaic Ad26/Ad26 plus gp140 HIV-1 vaccine sufficiently met “pre-established safety and immunogenicity criteria to advance into a phase 2b clinical efficacy study in sub-Saharan Africa, which is now underway (NCT03060629),” according to the authors.
“Previous HIV-1 vaccine candidates have typically been limited to specific regions of the world. Optimized mosaic antigens offer the theoretical possibility of developing a global HIV-1 vaccine,” Dr. Barouch and his colleagues concluded.
This study was funded in part by Janssen Vaccines & Prevention BV and the National Institutes of Health. Dr. Barouch has received grant funding from Janssen Vaccines & Prevention BV and is a co-inventor on HIV-1 vaccine antigen patents that have been licensed to Janssen Vaccines & Prevention.
SOURCE: Barouch DH et al., The Lancet. 2018 July 6. doi: 10.1016/S0140-6736(18)31364-3.
A mosaic adenovirus human immunodeficiency virus-1 (HIV-1) vaccine induced robust immune responses in humans and rhesus monkeys, and significantly protected the monkeys against repetitive simian/HIV (SHIV) mosaic challenges in rhesus monkeys. This vaccine concept is currently being evaluated in a phase 2b clinical efficacy study in sub-Saharan Africa, according to a report published online in The Lancet.
Because a mosaic combination of antigens can induce an immunogenic response to a broad geographic range of viral subtypes, such a vaccine can offer the theoretical possibility of developing a global HIV-1 vaccine, according to Dan H. Barouch, MD, of Harvard Medical School, Boston, and his colleagues.
The researchers conducted a multicenter, randomized, double-blind, placebo-controlled, phase 1/2a trial (APPROACH) with 393 healthy, HIV-1-uninfected participants (aged 18-50 years) who were considered at low risk for HIV-1 infection and were recruited from 12 clinics in East Africa, South Africa, Thailand, and the United States. Participants were primed at weeks 0 and 12 with Ad26.Mos.HIV (5 × 1010 viral particles per 0.5 mL) expressing mosaic HIV-1 envelope (Env)/Gag/Pol antigens and given boosters at weeks 24 and 48 with Ad26.Mos.HIV or modified vaccinia Ankara (MVA; 108 plaque-forming units per 0.5 mL) vectors with or without adjuvanted Env gp140 protein. The placebo group received 0.9% saline.
Eligible participants were randomly assigned to one of eight study groups: Ad26/Ad26 plus high-dose gp140; Ad26/Ad26 plus low-dose gp140; Ad26/Ad26; Ad26/MVA plus high-dose gp140; Ad26/MVA plus low-dose gp140; Ad26/MVA; Ad26/high-dose gp140; and placebo. “Overall, no substantial differences in safety or tolerability of any of the seven active vaccine groups were observed,” according to Dr. Barouch and his colleagues.
In addition, the researchers vaccinated 72 Indian-origin rhesus monkeys (Macaca mulatta) using a study design that was similar to that of the human APPROACH clinical study.
The mosaic HIV-1 vaccine “induced robust humoral and cellular immune responses in both humans and rhesus monkeys,” which were similar in both species in “magnitude, durability, and phenotype,” the investigators reported. In addition, the vaccine “provided 67% protection against acquisition of six intrarectal SHIV challenges in rhesus monkeys.”
Based on these results, the mosaic Ad26/Ad26 plus gp140 HIV-1 vaccine sufficiently met “pre-established safety and immunogenicity criteria to advance into a phase 2b clinical efficacy study in sub-Saharan Africa, which is now underway (NCT03060629),” according to the authors.
“Previous HIV-1 vaccine candidates have typically been limited to specific regions of the world. Optimized mosaic antigens offer the theoretical possibility of developing a global HIV-1 vaccine,” Dr. Barouch and his colleagues concluded.
This study was funded in part by Janssen Vaccines & Prevention BV and the National Institutes of Health. Dr. Barouch has received grant funding from Janssen Vaccines & Prevention BV and is a co-inventor on HIV-1 vaccine antigen patents that have been licensed to Janssen Vaccines & Prevention.
SOURCE: Barouch DH et al., The Lancet. 2018 July 6. doi: 10.1016/S0140-6736(18)31364-3.
A mosaic adenovirus human immunodeficiency virus-1 (HIV-1) vaccine induced robust immune responses in humans and rhesus monkeys, and significantly protected the monkeys against repetitive simian/HIV (SHIV) mosaic challenges in rhesus monkeys. This vaccine concept is currently being evaluated in a phase 2b clinical efficacy study in sub-Saharan Africa, according to a report published online in The Lancet.
Because a mosaic combination of antigens can induce an immunogenic response to a broad geographic range of viral subtypes, such a vaccine can offer the theoretical possibility of developing a global HIV-1 vaccine, according to Dan H. Barouch, MD, of Harvard Medical School, Boston, and his colleagues.
The researchers conducted a multicenter, randomized, double-blind, placebo-controlled, phase 1/2a trial (APPROACH) with 393 healthy, HIV-1-uninfected participants (aged 18-50 years) who were considered at low risk for HIV-1 infection and were recruited from 12 clinics in East Africa, South Africa, Thailand, and the United States. Participants were primed at weeks 0 and 12 with Ad26.Mos.HIV (5 × 1010 viral particles per 0.5 mL) expressing mosaic HIV-1 envelope (Env)/Gag/Pol antigens and given boosters at weeks 24 and 48 with Ad26.Mos.HIV or modified vaccinia Ankara (MVA; 108 plaque-forming units per 0.5 mL) vectors with or without adjuvanted Env gp140 protein. The placebo group received 0.9% saline.
Eligible participants were randomly assigned to one of eight study groups: Ad26/Ad26 plus high-dose gp140; Ad26/Ad26 plus low-dose gp140; Ad26/Ad26; Ad26/MVA plus high-dose gp140; Ad26/MVA plus low-dose gp140; Ad26/MVA; Ad26/high-dose gp140; and placebo. “Overall, no substantial differences in safety or tolerability of any of the seven active vaccine groups were observed,” according to Dr. Barouch and his colleagues.
In addition, the researchers vaccinated 72 Indian-origin rhesus monkeys (Macaca mulatta) using a study design that was similar to that of the human APPROACH clinical study.
The mosaic HIV-1 vaccine “induced robust humoral and cellular immune responses in both humans and rhesus monkeys,” which were similar in both species in “magnitude, durability, and phenotype,” the investigators reported. In addition, the vaccine “provided 67% protection against acquisition of six intrarectal SHIV challenges in rhesus monkeys.”
Based on these results, the mosaic Ad26/Ad26 plus gp140 HIV-1 vaccine sufficiently met “pre-established safety and immunogenicity criteria to advance into a phase 2b clinical efficacy study in sub-Saharan Africa, which is now underway (NCT03060629),” according to the authors.
“Previous HIV-1 vaccine candidates have typically been limited to specific regions of the world. Optimized mosaic antigens offer the theoretical possibility of developing a global HIV-1 vaccine,” Dr. Barouch and his colleagues concluded.
This study was funded in part by Janssen Vaccines & Prevention BV and the National Institutes of Health. Dr. Barouch has received grant funding from Janssen Vaccines & Prevention BV and is a co-inventor on HIV-1 vaccine antigen patents that have been licensed to Janssen Vaccines & Prevention.
SOURCE: Barouch DH et al., The Lancet. 2018 July 6. doi: 10.1016/S0140-6736(18)31364-3.
FROM THE LANCET
Transplanting HCV-infected kidneys in HCV-infected patients showed positive outcomes, costs
Transplanting a kidney infected with hepatitis C into individuals infected with HCV, followed by treatment, was more effective and less costly than transplanting an uninfected kidney, preceded by HCV treatment, according to Mark H. Eckman, MD, of the University of Cincinnati and his colleagues.
Largely because of the longer wait times for uninfected kidneys, a typical patient aged 58 years on hemodialysis would gain an average of 0.5 quality-adjusted life-years at a lifetime cost savings of $41,591 dollars, according to the model.
“In an era of increasing success for kidney transplants and demand that far outstrips supply, deferring antiviral therapy until after transplant of HCV-infected kidneys, when available, should be both cost saving and effective,” the researchers wrote.
The study was funded by grants from Merck Sharpe & Dohme and the National Center for Advancing Translational Science. Several of the authors reported having grants from Merck and grants and personal fees from a variety of other pharmaceutical companies.
SOURCE: Eckman MH et al. Ann Intern Med. 2018 Jul 10. doi: 10.7326/M17-3088.
Transplanting a kidney infected with hepatitis C into individuals infected with HCV, followed by treatment, was more effective and less costly than transplanting an uninfected kidney, preceded by HCV treatment, according to Mark H. Eckman, MD, of the University of Cincinnati and his colleagues.
Largely because of the longer wait times for uninfected kidneys, a typical patient aged 58 years on hemodialysis would gain an average of 0.5 quality-adjusted life-years at a lifetime cost savings of $41,591 dollars, according to the model.
“In an era of increasing success for kidney transplants and demand that far outstrips supply, deferring antiviral therapy until after transplant of HCV-infected kidneys, when available, should be both cost saving and effective,” the researchers wrote.
The study was funded by grants from Merck Sharpe & Dohme and the National Center for Advancing Translational Science. Several of the authors reported having grants from Merck and grants and personal fees from a variety of other pharmaceutical companies.
SOURCE: Eckman MH et al. Ann Intern Med. 2018 Jul 10. doi: 10.7326/M17-3088.
Transplanting a kidney infected with hepatitis C into individuals infected with HCV, followed by treatment, was more effective and less costly than transplanting an uninfected kidney, preceded by HCV treatment, according to Mark H. Eckman, MD, of the University of Cincinnati and his colleagues.
Largely because of the longer wait times for uninfected kidneys, a typical patient aged 58 years on hemodialysis would gain an average of 0.5 quality-adjusted life-years at a lifetime cost savings of $41,591 dollars, according to the model.
“In an era of increasing success for kidney transplants and demand that far outstrips supply, deferring antiviral therapy until after transplant of HCV-infected kidneys, when available, should be both cost saving and effective,” the researchers wrote.
The study was funded by grants from Merck Sharpe & Dohme and the National Center for Advancing Translational Science. Several of the authors reported having grants from Merck and grants and personal fees from a variety of other pharmaceutical companies.
SOURCE: Eckman MH et al. Ann Intern Med. 2018 Jul 10. doi: 10.7326/M17-3088.
FROM ANNALS OF INTERNAL MEDICINE
Antibodies to HCV core protein can be expressed in E. coli and silkworms
Intrabody 2H9-L, which can function as a hepatitis C virus (HCV) inhibitor in human hepatic cells, was expressed at high levels in Escherichia coli and silkworm pupae and was successfully purified in soluble form, according to a report published in Protein Expression and Purification by Tatsuya Kato, an assistant professor at Shizuoka (Japan) University, and his colleagues.
In their study, 171 mcg of purified intrabody was obtainable from 100 mL of E. coli culture, and 132 mcg could be obtained from 10 silkworm pupae.
The intrabodies were capable of binding to all HCV core protein variants tested. These purified intrabodies can be used in biochemical analyses and provide a potential pathway to developing a new type of therapy, according to the researchers.
“The structural basis of HCV core–intrabody interfaces would allow a novel strategy to design and generate chemical drugs with antiviral activities,” they stated. In addition, “to analyze the HCV core protein in detail, this intrabody can be used to keep the HCV core protein soluble, even when its concentration is high.”
No funding source or disclosures were reported in the paper.
SOURCE: Kato T et al. Protein Expression and Purification. 2018 October;150:61-6.
Intrabody 2H9-L, which can function as a hepatitis C virus (HCV) inhibitor in human hepatic cells, was expressed at high levels in Escherichia coli and silkworm pupae and was successfully purified in soluble form, according to a report published in Protein Expression and Purification by Tatsuya Kato, an assistant professor at Shizuoka (Japan) University, and his colleagues.
In their study, 171 mcg of purified intrabody was obtainable from 100 mL of E. coli culture, and 132 mcg could be obtained from 10 silkworm pupae.
The intrabodies were capable of binding to all HCV core protein variants tested. These purified intrabodies can be used in biochemical analyses and provide a potential pathway to developing a new type of therapy, according to the researchers.
“The structural basis of HCV core–intrabody interfaces would allow a novel strategy to design and generate chemical drugs with antiviral activities,” they stated. In addition, “to analyze the HCV core protein in detail, this intrabody can be used to keep the HCV core protein soluble, even when its concentration is high.”
No funding source or disclosures were reported in the paper.
SOURCE: Kato T et al. Protein Expression and Purification. 2018 October;150:61-6.
Intrabody 2H9-L, which can function as a hepatitis C virus (HCV) inhibitor in human hepatic cells, was expressed at high levels in Escherichia coli and silkworm pupae and was successfully purified in soluble form, according to a report published in Protein Expression and Purification by Tatsuya Kato, an assistant professor at Shizuoka (Japan) University, and his colleagues.
In their study, 171 mcg of purified intrabody was obtainable from 100 mL of E. coli culture, and 132 mcg could be obtained from 10 silkworm pupae.
The intrabodies were capable of binding to all HCV core protein variants tested. These purified intrabodies can be used in biochemical analyses and provide a potential pathway to developing a new type of therapy, according to the researchers.
“The structural basis of HCV core–intrabody interfaces would allow a novel strategy to design and generate chemical drugs with antiviral activities,” they stated. In addition, “to analyze the HCV core protein in detail, this intrabody can be used to keep the HCV core protein soluble, even when its concentration is high.”
No funding source or disclosures were reported in the paper.
SOURCE: Kato T et al. Protein Expression and Purification. 2018 October;150:61-6.
FROM PROTEIN EXPRESSION AND PURIFICATION
