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Multiple oral direct-acting antiviral regimens effectively treat HCV

FDA-approved oral direct-acting agent therapy produced high rates of safety, tolerability and efficacy for treating hepatitis C virus infection, especially for patient populations considered difficult to cure, according to research published in Annals of Internal Medicine.

“Cure of this infection, defined as the absence of detectable HCV RNA in the blood at least 12 weeks after treatment completion (sustained virologic response [SVR]), is strongly associated with reduced liver-related morbidity and mortality,” Oluwaseun Falade-Nwulia, MBBS, MPH, from Johns Hopkins University School of Medicine, and colleagues wrote. “The development of drugs that directly inhibit key steps in viral replication had led to availability of several oral HCV treatment regimens.”

To assess the efficacy and safety of these treatment regimens, researchers systematically reviewed data from 42 published clinical trials of adults with chronic HCV infection that assessed at least 8 weeks of an interferon-free HCV regimen and included at least 2 FDA-approved direct-acting antivirals (DAAs). They also evaluated the effect of oral antiviral ribavirin on rates of SVR and adverse events.

The results showed that 6 DAA regimens produced high SVR rates of more than 95% in patients with HVC genotype 1 without cirrhosis, including those co-infected with HIV. The remaining genotypes of HCV showed similar cure rates, though effective treatments for HCV genotype 3 infection saw limitations. Researchers observed that patients with hepatic decompensation, especially those with Child-Turcotte-Pugh class C disease, experienced lower SVR rates (78%-87%) than other patient populations.

When the investigators reviewed the addition of ribavirin, they observed more mild or moderate adverse events compared to regimens without ribavirin, and that the drug was linked with increased SVR rates for certain DAA regimens and patient groups. Overall rates of serious adverse events and treatment discontinuation were less than 10% across all patient populations.

“Oral DAA regimens that are highly efficacious, well-tolerated and relatively short in duration are now available for all HCV genotypes and for patient populations historically considered difficult to cure,” Falade-Nwulia and colleagues wrote. “The ease of dosing, safety profile and effectiveness of these agents provide an opportunity to expand the number of patients who can be treated for HCV infection and the pool of treating providers.”

In an accompanying editorial, Jay H. Hoofnagle, MD, and Averell H. Sherker, MD, from the National Institute of Diabetes and Digestive and Kidney Diseases, caution that although these findings offer a possible solution to HCV infection, challenges still remain, including access to care, and the potential for significant adverse events in some patients. The authors recommended continued follow-up remain a priority for patients with HCV infection and cirrhosis or advanced fibrosis. “The optimal means of surveillance and the appropriate intervals and duration of monitoring are currently not clear,” they wrote. – by Savannah Demko

Disclosure: Falade-Nwulia reports no relevant financial disclosures. Please see the full work for a list of all other authors’ relevant financial disclosures. Hoofnagle and Sherker report no relevant financial disclosures.