FDA NewsPerspective

FDA approves Harvoni for HCV treatment

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

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

    Perspective
    Michael S. Saag

    Michael S. Saag

    Sofosbuvir and ledipasvir, when used together, are getting roughly about 95% success rates in genotype 1 and also work well in genotypes 3 and 4 and so the thought is, is that this combination pill will be used a lot as a ‘go-to’ regimen for a lot of people.

    The biggest barriers that we’re finding to these drugs isn’t their side effects necessarily or their efficacy, it’s really their cost. A lot of us are having to work through ways of getting payers to come forward and cover the costs of the medicines. Right now there’s a lot of back and forth and negotiation on this. To my knowledge, the actual pricing for this drug has not been released yet, but I’m sure it will be within the next couple days.

    Hopefully the drug will be priced in a way that, No. 1, will be affordable by the payers and that there will be some negotiated rates where more patients can gain access to the medicines. This is the first in a new wave of drugs. There are going to be another three drugs coming out in about another month. It’s a really exciting time and there are even more drugs in the pipeline.

    • Michael S. Saag, MD
    • Professor of medicine, Jim Straley Chair in AIDS Research, director of the Center for AIDS Research, University of Alabama at Birmingham