Combination treatment with the experimental direct-acting antiviral (DAA) coblopasvir plus Sovaldi (sofosbuvir) cured hepatitis C virus (HCV) at a high rate among Chinese study participants and proved well tolerated.
Coblopasvir is an NS5A inhibitor, while Sovaldi, which hit the market in 2013 and is a component of the approved regimens Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir), is a nucleotide polymerase inhibitor.
Lai Wei, MD, of the Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease at Peking University in Beijing, and colleagues conducted a randomized Phase II study of 12 weeks of coblopasvir plus Sovaldi among Chinese participants who had genotypes 1, 2, 3 or 6 of HCV. The study ran from January to November 2017. HCV genotypes 4 and 5 are rare in China.
The participants were all first-timers to HCV treatment and either did not have cirrhosis or had compensated cirrhosis, the less severe form of the advanced liver disease. None had hepatitis B virus or HIV coinfection or a history of liver disease driven by causes other than HCV.
The study enrolled 110 people, 12 (11%) of whom had cirrhosis. The participants without cirrhosis were randomized on a one-to-two basis to receive 12 weeks of daily treatment with 400 milligrams of Sovaldi plus 30 mg or 60 mg of coblopasvir. All those with cirrhosis received 400 mg of Sovaldi plus 60 mg of coblopasvir. Thirty-three people received the regimen with the lower dose of coblopasvir.
The participants had an average age of 46. Sixty-three percent had genotype 1, 25.0% had genotype 2, 6.4% had genotype 3 and 6.4% had genotype 6.
One hundred eight (98.2%) of the participants achieved a sustained virologic response 12 weeks after completing therapy, considered a cure. Among those without cirrhosis, the cure rate was 100% among those who received the lower dose of coblopasvir and 98.5% among those who received the higher dose. A total of 91.7% of those with cirrhosis were cured.
All of those with genotype 1 were cured, as were 96.3% of those with genotype 2, 100% of those with genotype 3 and 85.7% of those with genotype 6. One genotype 6 patient with cirrhosis experienced virologic relapse. One genotype 2 patient without cirrhosis did not complete follow-up and quit the study.
The treatment was well tolerated. The most common adverse health events that occurred in at least 5% of the participants were upper respiratory tract infection, headache, toothache and urinary tract infection. There were no serious adverse health events considered related to treatment.
The study authors speculated that 60 mg of coblopasvir had stronger antiviral effects than 30 mg of the drug and could be more effective against HCV with resistance mutations.
To read the study abstract, click here.