Ledipasvir/sofosbuvir combination approved for hepatitis C treatment does not require antiviral drug

Jul 2 2015

The drug approved to treat patients infected with the hepatitis C virus needs no help from other antivirals, according to a study released online this week in the journal Hepatology.

Adding the antiviral drug ribavirin to the fixed-dose combination of viral inhibtor ledipasvir and nucleotide inhibitor sofosbuvir offered no better result than ledipasvir/sofosbuvir alone, says a study led by Saleh Alqahtani, M.D., and Mark Sulkowski, M.D., of the Johns Hopkins University School of Medicine. In fact, say the study’s authors, the ribavirin combination was associated with a higher rate of adverse events.

Analyzing data from nearly 2,000 patients taking ledipasvir/sofosbuvir to clear their systems of hepatitis C, the study’s authors compared patients who were prescribed only the ledipasvir/sofosbuvir fixed-dose tablet with patients whose physicians added ribavirin to the ledipasvir/sofosbuvir treatment regimen.

“We’re in the very early days of prescribing this medication,” says Alqahtani, director of clinical liver research at Johns Hopkins. “We learn more about it all the time. This study should put to rest the notion that ledipasvir and sofosbuvir need a boost from ribavirin.”

Both sets of patients showed 97 percent viral clearance success rates. But 71 percent of patients whose regimens included ribavirin experienced adverse events related to their treatment. While less than 1 percent of the adverse reactions were severe, the 71 percent did experience symptoms like fatigue, insomnia, irritability and a skin rash. Of the patients taking only ledipasvir/sofosbuvir, 45 percent had similar reactions. Patients taking ribavirin were also more likely to need interruptions to their medication regime to resolve their complications.

The combination of ledipasvir and sofosbuvir was approved for treatment of hepatitis C by the Food and Drug Administration only last fall. The medication is a new way to treat a viral disease that causes slow liver damage and has killed millions of people around the world.

Prior to the emergence of ledipasvir and sofosbuvir, the standard of care to treat hepatitis C was the antiviral drug ribavirin, prescribed alongside interferon. Medication regimens were long, serious side effects were nearly universal and the rates of sustained viral response varied.

“Ribavirin had a real place when we fought hepatitis C with interferon,” says Alqahtani. “But as care for patients with hepatitis C evolves, this study shows that it no longer offers a benefit.”