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To RIBA or Not

New Hepatitis C Treatment Needs No Antiviral Boost

Release Date: July 1, 2015

FAST FACTS:
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.

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.”

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.
5 Responses
Avatar universal
can we assume that this article was speaking specifically about those patients with Gt1, for which the FDA approved this cocktail?

Avatar universal
I would suspect that's a reasonable assumption. Especially given the amount of folks studied.

Since Sovaldi can not be taken by itself, the recommendations will stand for S/RIBA  until another drug is approved for GT2's and 3's. However, IMO this is outstanding news and I'm encouraged they are collecting data for it. This study will set the standard for other combos for which I am very grateful of.
Avatar universal
Thanks for the info.

Another article with more details with source link.

http://hivandhepatitis.org/hcv-treatment/approved-hcv-drugs/5261-adding-ribavirin-to-harvoni-for-hepatitis-c-increases-side-effects-but-not-efficacy

Refers to GT1 and also says ribavirin may still play a role for the hardest to treat

Note FYI.    I have done it myself before by posting (copying) word for word extensively and or without source link.  My intentions were good to help others.  Have since become aware that most articles stories etc are copyrighted material and cannot be copied without permission.  In the USA there is "fair use" which allows brief direct quotes and reworded comments on the material.  Notice how the article writer presented the story and the source link.

For those who aren't aware Medhep doesn't hot link urls that are outside of Medhelp. You Have to select link text and copy and or right click and open in another browser tab.
Avatar universal
I certainly understand where RIBA continues to hold some value. But, my biggest excitement was that they are actually collecting data. This will prompt other studies. With such little data we are left to going with a docs personal instinct or opinion.

This is moving us in the right direction. Slowly but surely.

Yes, I'm aware of Fair Use. I've seen your other posts referencing it and that's a good thing. I always include the link...this one IMO covered it with its sources Plus there is a 'continue reading' so it wasn't in its entirety. Thank you for your due diligence! Good job.
Avatar universal
"While the overall SVR rates with and without ribavirin were the same in these studies -- in which a majority of participants were treatment-naive and did not have cirrhosis -- ribavirin may still have a role to play in treating the most challenging patients."

Key word is "may". I'm hoping studies like the one we posted will determine definitively yes or no. Support it one way or other so it's not a guessing game.

We're getting there. :)
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