FDA News

FDA updates Mavyret label for new safety, efficacy data

The FDA recently approved safety and efficacy revisions to the Mavyret label based on data from a hepatitis C/HIV-1 collection study and a liver and renal transplant study.

Ongoing studies from the past year have shown Mavyret (glecaprevir/pibrentasvir, AbbVie) to be a pangenotypic treatment that is highly effective over an 8-week course for most patients.

According to the released revisions, the FDA recommends a 12-week course of glecaprevir/pibrentasvir for liver or kidney transplant recipients. The FDA also recommends a 16-week course for patients with genotype 1 and NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor, and for patients with genotype 3 who are treatment-experienced with Sovaldi (sofosbuvir, Gilead Sciences) and ribavirin.

Regarding adverse reactions, results of two studies of patients with HCV/HIV-1 coinfection and genotypes 1, 2, 3, 4 or 6 showed a similar safety profile compared with HCV mono-infected patients. The FDA announced similar results from a study of patients treated post- liver and kidney transplant with genotypes 1, 2, 3, 4 or 6.

Among patients without cirrhosis or with compensated cirrhosis, both patients from the HCV/HIV-1 collection study and patients from the liver and renal transplant study demonstrated an overall sustained virologic response rate of 98%.

Reference: www.fda.gov

The FDA recently approved safety and efficacy revisions to the Mavyret label based on data from a hepatitis C/HIV-1 collection study and a liver and renal transplant study.

Ongoing studies from the past year have shown Mavyret (glecaprevir/pibrentasvir, AbbVie) to be a pangenotypic treatment that is highly effective over an 8-week course for most patients.

According to the released revisions, the FDA recommends a 12-week course of glecaprevir/pibrentasvir for liver or kidney transplant recipients. The FDA also recommends a 16-week course for patients with genotype 1 and NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor, and for patients with genotype 3 who are treatment-experienced with Sovaldi (sofosbuvir, Gilead Sciences) and ribavirin.

Regarding adverse reactions, results of two studies of patients with HCV/HIV-1 coinfection and genotypes 1, 2, 3, 4 or 6 showed a similar safety profile compared with HCV mono-infected patients. The FDA announced similar results from a study of patients treated post- liver and kidney transplant with genotypes 1, 2, 3, 4 or 6.

Among patients without cirrhosis or with compensated cirrhosis, both patients from the HCV/HIV-1 collection study and patients from the liver and renal transplant study demonstrated an overall sustained virologic response rate of 98%.

Reference: www.fda.gov