A combination of Sovaldi (sofosbuvir) plus the experimental NS5A inhibitor ravidasvir, which together could cost low- and middle-income nations $300 or less per 12-week treatment, cured hepatitis C virus (HCV) in nearly all those with a range of genotypes of the virus in a Southeast Asian study, aidsmap reports.
Sovaldi is manufactured by Gilead Sciences. Ravidasvir was developed by Presidio Pharmaceuticals and licensed to Pharco Pharmaceuticals for development and marketing in poorer nations.
The STORM-C1 study recruited 300 people with a range of genotypes of hep C in Malaysia and Thailand between October 2016 and June 2017. Those without cirrhosis received 12 weeks of Sovaldi and ravidasvir; those with compensated cirrhosis (the milder form of the advanced liver disease) were treated for 12 weeks.
Findings were presented at the 52nd International Liver Congress in Paris.
A total of 158 participants had genotype 3 of hep C, 97 had genotype 1a, 27 had genotype 1b, two had genotype 2, and 16 had genotype 6. Twenty-seven percent had compensated cirrhosis, and 30 percent were coinfected with HIV. One third had previously been treated for hep C with interferon-based therapy.
Ninety-seven percent of participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), including 99 percent of those with genotype 1a, 100 percent of those with genotypes 1b and 2, 97 percent of those with genotype 3, and 81 percent of those with genotype 6.
There was no significant difference in the cure rate based on whether participants had cirrhosis or HIV or were previously treated with interferon. There was no evidence of harmful drug-drug interactions with antiretrovirals used to treat HIV.
Sixty-four percent of the participants reported an adverse health event. Seventy-two percent of these events were mild, most frequently fever, cough and headache. Eight percent reported serious adverse health events.
To read the aidsmap article, click here.