Direct-acting antivirals are safe and effective in African-American patients with chronic hepatitis C (HCV) genotype 1 infection, according to a real-world study published in the European Journal of Gastroenterology and Hepatology. The use of an all-oral treatment regimen has helped significantly reduce the burden of disease within this population.
Previous studies have reported that the prevalence of HCV infection is double that in African Americans than in white patients, yet this population is typically underrepresented in clinical trials. This retrospective study sought to evaluate the efficacy, safety, and tolerability of all-oral regimens involving 3 sofosbuvir-based direct-acting antiviral drugs in the treatment of African-American patients with chronic HCV infection.
The study included 278 patients of African-American descent with HCV genotype 1 infection who were treated with direct-acting antiviral drugs between January 2014 and January 2018. Of these, 162 patients received a ledipasvir/sofosbuvir ± ribavirin regimen, 38 received a simeprevir/sofosbuvir ± ribavirin regimen, and 38 received sofosbuvir/velpatasvir regimen.
The primary efficacy outcome was measured by a sustained virologic response reported at 12 weeks post-treatment; any adverse reactions were recorded. Demographic and clinical characteristics were assessed at baseline and analyzed for variables that could potentially impact sustained virologic response rates.
Sustained virologic response at 12 weeks post-treatment was achieved overall in 94.6% of the study participants; specifically, 93.8% in the ledipasvir/sofosbuvir group, 92.1% in the simeprevir/sofosbuvir group, and 97.4% in the sofosbuvir/velpatasvir group. Previous treatment experience (P =.905), HCV RNA levels (P =.680), and HIV infection status (P =.425) were not considered statistically significant factors in predicting sustained virologic response. Presence of compensated cirrhosis or other comorbidities did not influence efficacy outcomes in any of the treatment groups.
Although 45.9% of the study cohort reported at least 1 non-severe adverse effect (fatigue, headache, nausea, arthralgia, or rash), none of the patients decided to discontinue treatment due to adverse events.
Limitations of the study included using a retrospective design, a lack of viral resistance testing in the patient cohort, and inadequate documentation of adverse treatment events.
With a high overall sustained virologic response rate of 94.6%, sofosbuvir-based direct-acting antiviral drugs were proven safe, effective, and well tolerated in the treatment of African-American patients with chronic HCV genotype 1 infection. Direct-acting antiviral treatments remained efficacious in patients with compensated cirrhosis status or who were previously treated.
Gayam V, Tiongson B, Khalid M, et al. Sofosbuvir based regimens in the treatment of chronic hepatitis C genotype 1 infection in African-American patients: a community-based retrospective cohort study [published online August 21, 2018]. Eur J Gastroenterol Hepatol. doi: 10.1097/MEG.0000000000001233