Using the breakthrough therapy designation, the FDA approved the first combination pill for treatment of chronic hepatitis C virus genotype 1 that does not require interferon or ribavirin for administration, according to an agency release.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”
The combination pill, which will be marketed by Gilead Sciences as Harvoni, combines ledipasvir (Gilead) and sofosbuvir (Sovaldi, Gilead) and has be evaluated in three clinical trials.
The trials included 1,518 participants who were treatment-naive or had not responded to previous treatment. The participants were randomly assigned the combination pill with or without ribavirin and monitored until 12 weeks after treatment to determine whether the infection was eliminated.
Treatment-naive participants showed a 94% sustained virologic response rate after 8 weeks of treatment and a 96% SVR rate after 12 weeks. Treatment-naive patients with and without cirrhosis showed a 99% SVR rate after 12 weeks. Among treatment-experienced participants with and without cirrhosis, ribavirin did not improve response rates in any of the trials.
According to the release, the most common adverse effects reported were fatigue and headache.
For more information:
FDA approves first combination pill to treat hepatitis C