- A study of nearly 2,000 patients showed that adding ribavirin to the combination of ledipasvir and sofosbuvir had no benefit in treating hepatitis C.
- Patients taking ribavirin along with the combination were more likely to have adverse side effects to the treatment.
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.”
In addition to Alqahtani and Sulkowski, the study’s authors are Nazam Afdal of Beth Israel Deaconess Hospital in Boston; Stefan Zeuzem of Johann Wolfgang Goethe University in Franfurt; Stuart C. Gordon of the Henry Ford Health System in Detroit; Alessandra Mangia of Casa Sollievo della Sofferenza Hospital in Italy; Paul Kwo of Indiana University, Michael Fried of the University of North Carolina; Jenny C. Yang, Xiao Ding, Phillip S. Pang and John G. McHutchinson of Gilead Sciences in California; David Pound of the Indianapolis Gastroenterology Research Foundation; K. Rajender Reddy of the University of Pennsylvania; Patrick Marcellin of the Centre Hospitalier Universitaire Beaujon in France; and Kris V. Kowdley of the Swedish Medical Center in Seattle.
Funding and drugs for the studies described in the Hepatology article were provided by Gilead Sciences. Drs. Sulkowski and Alqahtani were both paid advisory board members for Gilead Sciences. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies.