User login
The Food and Drug Administration has approved the four-drug combination package Viekira Pak for the treatment of hepatitis C virus genotype 1 infection with or without cirrhosis, the agency announced December 19.
Viekira Pak is a combination of three new drugs, ombitasvir, paritaprevir, and dasabuvir; and the previously approved drug ritonavir. It can be taken with or without ribavirin but is not recommended for those with decompensated cirrhosis, the FDA said in a statement.
The FDA studied the drug combination’s efficacy in six clinical trials with 2,308 HCV patients, with or without cirrhosis. Patients were randomized to receive either Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12-24 weeks. Results showed that 91%-100% of participants who received the drug combination achieved sustained virologic response at least 12 weeks after treatment, the FDA said.
The most common side effects in trial participants were tiredness, itching, lack of energy, weakness, nausea, and trouble sleeping.
Viekira Pak is the fourth treatment approved for chronic hepatitis C virus in the past year. Simeprevir (Olysio); sofosbuvir (Sovaldi); and ledipasvir and sofosbuvir (Harvoni) were approved in November 2013, December 2013, and October 2014, respectively.
The recommended dosage for Viekira Pak is two ombitasvir, paritaprevir, and ritonavir tablets once per day at 12.5 mg, 75 mg, and 50 mg, respectively; and one 250-mg dasabuvir tablet twice per day.
The treatment was reviewed via FDA’s priority review program, which allows for expedited review of especially effective treatments for serious conditions.
Viekira Pak is marketed by AbbVie.
The Food and Drug Administration has approved the four-drug combination package Viekira Pak for the treatment of hepatitis C virus genotype 1 infection with or without cirrhosis, the agency announced December 19.
Viekira Pak is a combination of three new drugs, ombitasvir, paritaprevir, and dasabuvir; and the previously approved drug ritonavir. It can be taken with or without ribavirin but is not recommended for those with decompensated cirrhosis, the FDA said in a statement.
The FDA studied the drug combination’s efficacy in six clinical trials with 2,308 HCV patients, with or without cirrhosis. Patients were randomized to receive either Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12-24 weeks. Results showed that 91%-100% of participants who received the drug combination achieved sustained virologic response at least 12 weeks after treatment, the FDA said.
The most common side effects in trial participants were tiredness, itching, lack of energy, weakness, nausea, and trouble sleeping.
Viekira Pak is the fourth treatment approved for chronic hepatitis C virus in the past year. Simeprevir (Olysio); sofosbuvir (Sovaldi); and ledipasvir and sofosbuvir (Harvoni) were approved in November 2013, December 2013, and October 2014, respectively.
The recommended dosage for Viekira Pak is two ombitasvir, paritaprevir, and ritonavir tablets once per day at 12.5 mg, 75 mg, and 50 mg, respectively; and one 250-mg dasabuvir tablet twice per day.
The treatment was reviewed via FDA’s priority review program, which allows for expedited review of especially effective treatments for serious conditions.
Viekira Pak is marketed by AbbVie.
The Food and Drug Administration has approved the four-drug combination package Viekira Pak for the treatment of hepatitis C virus genotype 1 infection with or without cirrhosis, the agency announced December 19.
Viekira Pak is a combination of three new drugs, ombitasvir, paritaprevir, and dasabuvir; and the previously approved drug ritonavir. It can be taken with or without ribavirin but is not recommended for those with decompensated cirrhosis, the FDA said in a statement.
The FDA studied the drug combination’s efficacy in six clinical trials with 2,308 HCV patients, with or without cirrhosis. Patients were randomized to receive either Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12-24 weeks. Results showed that 91%-100% of participants who received the drug combination achieved sustained virologic response at least 12 weeks after treatment, the FDA said.
The most common side effects in trial participants were tiredness, itching, lack of energy, weakness, nausea, and trouble sleeping.
Viekira Pak is the fourth treatment approved for chronic hepatitis C virus in the past year. Simeprevir (Olysio); sofosbuvir (Sovaldi); and ledipasvir and sofosbuvir (Harvoni) were approved in November 2013, December 2013, and October 2014, respectively.
The recommended dosage for Viekira Pak is two ombitasvir, paritaprevir, and ritonavir tablets once per day at 12.5 mg, 75 mg, and 50 mg, respectively; and one 250-mg dasabuvir tablet twice per day.
The treatment was reviewed via FDA’s priority review program, which allows for expedited review of especially effective treatments for serious conditions.
Viekira Pak is marketed by AbbVie.
