Eight weeks Gilead Sciences’ experimental triple-drug hepatitis C virus (HCV) regimen sofosbuvir/velpatasvir/voxilaprevir failed to work as well as 12 weeks of Epclusa (sofosbuvir/velpatasvir) in a recent trial, Reuters Health reports. However, the former regimen did yield comparable results to the latter regimen for those with genotype 3 of hep C and compensated cirrhosis, the milder form of the severe liver disease.
Publishing their findings in the journal Gastroenterology, researchers analyzed results from two Phase III, open-label trials that randomized participants who were first-timers to HCV treatment to receive the three-drug combination for eight weeks or Epclusa for 12 weeks.
The POLARIS-2 trial included 941 people at 117 sites in the United States, Canada, the United Kingdom, France, Germany, Australia and New Zealand. People with all six major genotypes of HCV were included, including those with and without cirrhosis, except for people with genotype 3 and cirrhosis.
The POLARIS-3 trial included 219 people with genotype 3 and compensated cirrhosis who were not included in POLARIS-2.
In POLARIS-2, 95 percent of the 501 people who took the triple-drug regimen for eight weeks achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). This response rate was not high enough for the researchers to qualify the regimen as non-inferior, or as effective as, 12 weeks of Epclusa, which led to a 98 percent cure rate among 440 participants.
The difference in cure rates between the two regimens was mainly a result of a lower cure rate of 92 percent among those with genotype 1a who took eight weeks of the triple-drug regimen.
In POLARIS-3, both regimens yielded a 96 percent cure rate.
The most common adverse health events reported in both studies were headache, fatigue, diarrhea and nausea. Among those taking the triple-drug regimen, the latter two health events were the most common. In both of the trials, between zero and 1 percent of participants stopped treatment because of adverse health events.
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