In a study sponsored by Gilead Sciences called Astral-5, researchers in the United States tested the fixed-dose combination of sofosbuvir + velpatasvir (sold as Epclusa) in 106 people who were coinfected with hepatitis C virus (HCV) and HIV. Overall, 95% of participants (99 out of 104) were cured. The combination of sofosbuvir + velpatasvir was effective against genotypes present in the study (genotypes 1 through 4). Side effects were mostly of mild-to-moderate intensity.
The average profile of participants upon entering the study was as follows:
The distribution of genotypes was as follows:
Overall, so far 95% of participants (99 out of 104) were cured (final data from two participants are pending).
Cure rates distributed by genotype are as follows:
All participants who had cirrhosis were cured.
At the start of the study before participants began taking sofosbuvir + velpatasvir, Gilead tested blood samples from 101 participants for the presence of HCV that could, in theory, have the ability to resist the effects of treatment. Technicians found that a total of 12 participants (12%) had HCV that could resist an inhibitor of NS5A. However, all 12 of these people were cured.
Although 71% of participants reported side effects, the vast majority of these were graded mild to moderate by researchers. However, 8% of participants experienced more intense side effects.
Common side effects included the following:
No one died during the study.
Nineteen people developed highly abnormal lab test results. This was most commonly elevated levels of the waste product bilirubin in the blood, which occurred in participants who were taking the anti-HIV medicines atazanavir (Reyataz) and ritonavir (Norvir).
Participants who were taking the anti-HIV drug tenofovir (Viread and in Truvada) together with a protease inhibitor or the boosting agent cobicistat experienced a modest decrease in the functioning of their kidneys. This was assessed with eGFR (estimated glomerular filtration rate).
Treatment with 12 consecutive weeks of sofosbuvir + velpatasvir resulted in a high rate of cure: 100% of participants with cirrhosis and 97% of participants whose past therapy failed were cured.
Sofosbuvir + velpatasvir was generally safe.
Wyles D, Brau N, Kottilil S, et al. Sofosbuvir and velpatasvir for 12 weeks in patients coinfected with HCV and HIV-1: the Astral-5 study. The International Liver Congress, 13-17 April 2017, Barcelona, Spain. Abstract PS-104.
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