In a couple of weeks, the FDA is expected to rule on Merck’s new hepatitis C treatment for genotypes 1,4, and 6. Zepatier is a single pill formulated with two drugs: grazoprevir and elbasvir. In a phase 3 clinical trials, the sustained virologic response (SVR) rate was 95 percent. Fatigue, headache, nausea, and diarrhea were the most common adverse events.
However, it looks like Zepatier has a couple of shortcomings: 1) the formation of resistant-associated variants (RAVs) means that some people will relapse with potentially difficult-to-treat strains of hep C, and 2) Zepatier will only treat genotypes 1,4, and 6. This may be problematic for Merck, but not for patients who can wait until the end of June. That’s because there will be a new drug combo: Gilead’s sofosbuvir/velpatasvir (SOF/VEL).
Assuming it will get approved (it was fast-tracked by the FDA), SOF/VEL treats all genotypes with an overall SVR rate of 99 percent. The most common adverse events were fatigue, nausea, and headache.
2016 will be an awesome year, assuming these new treatments are priced more fairly than current hep C medications are. Everything rests on that,,,