Researchers recently published their findings on a combination therapy for use in patients with hepatitis C (HCV) genotype 4 in PLoS One. According to the Belgian researchers, sofosbuvir in combination with simeprevir with or without ribarivirn was found to be safe and effective.
According to the World Health Organization, between 130 million and 150 million people around the world are infected with chronic HCV. Of those individuals, a significant amount goes on to get liver cirrhosis or liver cancer, and around 700,000 individuals die annually from liver disease associated with HCV infection. Furthermore, “there are 6 genotypes of HCV and they respond differently to treatment.” Not only this, but simultaneous infection with more than one genotype of HCV is possible.
Conducted by Delphine Degré, MD, of Université Libre de Bruxelles in Brussels, Belgium and colleagues, the study evaluated the drug combination in a real-world cohort. Far more research has focused on patients infected with HCV genotype 1 than genotype 4, which the authors said accounts for about 20% of infections worldwide. In some places, though, such as Egypt, genotype 4 is much more prevalent, accounting for as many as 90% of infections. “However, efficacy and safety data regarding interferon-free regimens in HCV genotype 4 patients are currently scarce,” the authors wrote in PLoS One. The objective of the study was to evaluate the safety and efficacy of sofosbuvir and simeprevir treatment in these patients.
The participants in this observational study were enrolled between January and September 2015 and came from 15 referral centers in Belgium. They were treated with sofosbuvir and simeprevir either with or without ribavirin. There was a total of 87 participants; 36 of them had severe fibrosis (41%) and 51 had cirrhosis (59%). All but two patients received 12 weeks of treatment and the remaining two received 24 weeks of treatment.
The sustained virologic response rate at 12 weeks (SVR12) was 87.4%. Of those patients who did not achieve SVR12, five had post treatment relapse, one did not respond during treatment, and five were lost to follow-up. The difference in SVR12 between patients treated with and without ribavirin was small: 89.9% for patients treated with ribavirin, and 87% without ribavirin. The researchers report, “An additional analysis that excluded patients who did not achieve SVR12 for reasons other than virologic failure demonstrated an SVR12 rate of 91.6%.”
Although the use of ribavirin did not appear to increase the rate of SVR12, it did seem to lead to a faster decrease in viral load. Additionally, the researchers did not observe a difference in results between patients with severe fibrosis and those with cirrhosis, but they added, “all but one patient who failed to achieve SVR12 were patients with cirrhosis and advanced disease.” This finding is consistent with previous studies.
The authors concluded that the combination of sofobuvir and simeprevir was found to be well-tolerated and efficacious in the real-world cohort of patients with HCV genotype 4 and severe fibrosis. The researchers confirmed that it is “a good therapeutic option.” However, for patients with decompensated cirrhosis, second generation interferon-free combinations would be better.