Oral direct-acting antiviral (DAA) regimens, particularly with the addition of ribavirin, show high rates of safety, tolerability, and efficacy for treatment of hepatitis C virus (HCV) genotype 1, according to a study published in the Annals of Internal Medicine.
Oluwaseun Falade-Nwulia, MBBS, MPH, from Johns Hopkins University School of Medicine in Baltimore, and colleagues used MEDLINE and EMBASE data sources from inception to November 1, 2016, to summarize the efficacy and safety of oral DAAs for treatment of patients with chronic HCV infections. The criteria included English-language, single-group, randomized, controlled trials of adults with chronic HCV infection that evaluated at least 8 weeks of an FDA-approved interferon-free HCV regimen that included at least 2 DAAs.
The authors reviewed trials that used DAA combinations—including inhibitors of HCV NS3 protease, NS5A, and NS5B polymerase, as well as the oral antiviral ribavirin. Two investigators abstracted data on study design, patient characteristics, and virologic and safety outcomes sequentially and assessed quality independently.
Of 1796 citations evaluated, 42 studies published in 40 articles were included. A total of 23 studies had moderate risk of bias (10 were open-label single-group trials, 11 had limited information on concealment of the allocation scheme, and 5 had selective outcome reporting).
A total of 6 DAA regimens showed high SVR rates (>95%) in patients with HCV genotype 1 infection without cirrhosis, including those with HIV co-infection. Patients with hepatic decompensation, particularly those with Child-Turcotte-Pugh class C disease, had lower SVR rates (78% vs 87%) than other populations. The addition of ribavirin was associated with increased SVR rates for certain DAA regimens and patient groups. Overall rates of serious adverse events and treatment discontinuation were low (<10% in the general population). Regimens that included ribavirin had more mild or moderate adverse events than those without.
“Across multiple trials, our findings indicate that ribavirin continues to have a role in maximizing SVR rates in certain patients, including those with genotype 1a or 3 infection, cirrhosis, or prior treatment experience,” said the authors.
- Falade-Nwulia O, Suarez-Cuervo C, Nelson DR, et al. Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review. Ann Intern Med. 21 March 2017. doi: 10.7326/M16-2575