Gilead Sciences’ Sovaldi (sofosbuvir) and PharmaCo Pharmaceuticals and Presidio Pharmaceuticals’ investigatory ravidasvir (PPI-668), given with or without ribavirin, cured almost all people with genotype 4 of hepatitis C virus (HCV) in a large trial, HIVandHepatitis.com reports. The Phase III Pyramid 1 trial included 300 people with genotype 4 of hep C in Egypt, who received Sovaldi and the NS5A inhibitor ravidasvir, with or without ribavirin, for 12 or 16 weeks. Results were presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
Half of the participants were treatment naive and half had previously taken interferon-based treatment.
The participants were divided into four groups: Group 1a included 90 treatment-naive people without cirrhosis; Group 1b included 60 treatment-naive people with cirrhosis; Group 2 included 80 treatment-experienced people without cirrhosis; and Group 3 included 70 treatment-experienced people without cirrhosis.
The individuals in groups 1a, 1b and 2 took Sovaldi and ravidasvir once daily for 12 weeks; they were randomly assigned to also take ribavirin. Those in group 3 took Sovaldi and ravidasvir, plus ribavirin, for either 12 or 16 weeks.
Among the participants who did not have cirrhosis and who were treated with just Sovaldi and ravidasvir, 100 percent of those who were treatment naive and 95 percent of those who had been treated for hep C before achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure).
Among the non-cirrhotic individuals treated with Sovaldi, ravidasvir and ribavirin, 98 percent of the treatment-naive participants and 100 percent of the treatment-experienced participants were cured.
As for the cirrhotic treatment-experienced participants, 86 percent were cured with 12 weeks of Sovaldi, ravidasvir and ribavirin, compared with 100 percent of those in this category who were treated for 16 weeks.
There was one serious adverse health issue in the study, a case of bradycardia (slow heartbeat) that the researchers considered related to treatment. (Sovaldi is a known risk factor for potentially serious bradycardia.) After eight weeks of treatment, this individual stopped hep C therapy and his bradycardia resolved.
The most common adverse health matters were headache (13 percent), abdominal discomfort (6 percent), fatigue (5 percent), itching (4 percent) and diarrhea (2 percent).
To read the HIVandHepatitis article, click here.
To read the conference abstract, click here.