The 66th annual Liver Meeting begins tomorrow. Sponsored by the American Association for the Study of Liver Diseases (AASLD), it is the premier event devoted to liver health in the U.S. I am confident that the meeting will be packed with not-to-be-missed hepatitis C information. To stoke your appetite, here’s information about a much anticipated hepatitis C treatment that will likely be discussed at the meeting:
On October 28, 2015, Gilead submitted a new drug application to the FDA for a new hepatitis C treatment. If approved, the combination sofosbuvir/velpatasvir (GS 5816) would be the first all-oral, single-tablet regimen to treat all six hep C genotypes. The ability to cure all genotypes is referred to as pan-genotypic. (Note: Genotype 7 is a provisional genotype, as only one case has been isolated.)
Co-formulated into a single once-daily pill (SOF/VEL), sofosbuvir (approved as Sovaldi in December 2013) is a nucleotide analog polymerase inhibitor; velpatasvir is an investigational pan-genotypic NS5A inhibitor.
The application to the FDA is supported by data from four clinical trials:
The ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies treated 1,035 patients with SOF/VEL for 12 weeks: 98 percent achieved a sustained virologic response (SVR) following 12 weeks of completion of 12 weeks of treatment (SVR12 is the term used for virological cure.)
The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis, and reported the following results:
- SOF/VEL with ribavirin for 12 weeks: 94 percent achieved SVR12
- SOF/VEL without ribavirin for 12 weeks: 83 percent achieved SVR12
- SOF/VEL (no ribavirin) for 24 weeks: 83 percent achieved SVR12
The most common adverse events were fatigue, nausea and headache.
The FDA designated SOF/VEL as a Breakthrough Therapy, which is granted to investigational medicines that may offer major advances in treatment over existing options. Gilead plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year. My guess is that it will be available in mid-2016.
I don’t suppose it is too soon to talk about price. Shall we start sending messages to Gilead now, requesting an affordable price tag?
Stay-tuned for more information about this and other hepatitis C research. I will post regular updates to my blog at HepMag.com. I’ll also post to Twitter @LucindaPorterRN and Facebook LucindaPorterRN. Twitter users may follow the meeting at #Liver15.