Gilead Sciences’ newly approved Epclusa (sofosbuvir/velpatasvir) cured genotypes 1 through 4 of hepatitis C virus (HCV) at high rates among those coinfected with HIV in a recent trial, aidsmap reports. Results from the ASTRAL-5 trial were presented at the 21st International AIDS Conference in Durban, South Africa (AIDS 2016).
The trial included 106 HCV/HIV-coinfected individuals in the United States. Sixty-two percent had hep C genotype 1a, 11 percent had genotype 1b, 10 percent had genotype 2, 11 percent had genotype 3, and 5 percent had genotype 4. Epclusa is approved to treat genotypes 1 through 6 of hep C, however, there were no participants in this trial with genotypes 5 or 6, which are rare in the United States.
Nearly one third of the participants had been treated for hep C before. Eighteen percent had compensated cirrhosis.
At the start of the study, the participants had been on HIV treatment for at least eight weeks with an undetectable viral load. They had an average CD4 count of about 600.
The participants were treated with Epclusa for 12 weeks.
A total of 101 out of 106 of the participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), for an overall cure rate of 95 percent. This rate was similar to those seen in HIV-negative participants of the ASTRAL-1 through -4 trials.
Cure rates broken down by genotype and sub-genotype were: genotypes 1b and 3, 92 percent, a result of one person in each group dropping out of the study; genotype 1a, 95 percent, because of two people experiencing a viral relapse and one person dropping out; genotypes 2 and 4, 100 percent.
The cure rates did not differ significantly based on whether participants had cirrhosis, had been treated for hep C before or had drug resistance to NS5A inhibitors (the velpatasvir component of Epclusa falls into that drug class).
The treatment was generally safe and well tolerated. The most common side effects were fatigue, reported by 25 percent of the participants, and headache, reported by 13 percent. None of the participants experienced hep C viral rebound while taking Epclusa.
To read the aidsmap article, click here.
To read the conference abstract, click here.
To download slides of the conference presentation, click here.