Another once-daily pill is on-track for approval by the U.S. Food and Drug Administration (FDA) for the treatment of hepatitis C, adding to the growing number of treatment options for this life-threatening disease. This time, it’s a combination of Sovaldi® (sofosbuvir) with a new NS5A inhibitor called velpatasvir from Gilead Sciences.
The sofosbuvir-velpatasvir combination is currently undergoing a priority review of the New Drug Application at the FDA and a decision on that could come as early as June 28, 2016. This drug combo, which would be used to treat chronic genotype 1-6 hepatitis C infections, came to the FDA with impressive data from four clinical trials showing excellent safety and efficacy during 12-week treatment courses. Two of these studies indicated a 97-100% cure rate (measured by sustained virologic response) in patients with genotypes 1a, 1b, 2, 4, 5, or 6.
Similarly positive results have been seen in patients who failed previous treatment, as well as in patients with compensated cirrhosis. Patients with the difficult-to-treat genotype 3 reached 95% sustained virologic response. In addition, patients with cirrhosis or previous treatment failure were documented to have cures of 89-91%. In all patients, few serious adverse effects were noted (16-19%).
As soon as this summer, it seems likely that there will be yet another option for fighting hepatitis C – an option that may prove to be easy, safe, and highly effective for all genotypes.
Stephen C. Vogt, Pharm.D.
President and CEO
BioPlus Specialty Pharmacy
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Curry MP, O’Leary JG, Bzowej N, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med 2015;373:2618-28.
Feld JJ, Jacobson IM, Hezode C, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med 2015;373:2599-2607.
Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med 2015;373:2608-17.