High HCV cure rate seen with FDA-approved direct-acting antiviral regimens

DAA regimens currently approved by the FDA for treating HCV yield high cure rates, a recent study has found.

Researchers performed a systematic review and meta-analysis of 42 clinical trials published through Nov. 1, 2016, that involved patients with chronic HCV and evaluated at least eight weeks of therapy with an HCV regimen that was interferon-free and included two or more FDA-approved DAAs. Drugs that were studied included ribavirin along with the following DAAs: grazoprevir, paritaprevir, and simeprevir; daclatasvir, elbasvir, ledipasvir, ombitasvir, and velpatasvir; and sofosbuvir and dasabuvir. The study results were published online March 21 by Annals of Internal Medicine.

Six of the DAA regimens yielded sustained virologic response rates above 95% in patients who had HCV genotype 1 without cirrhosis, including those with HIV co-infection. Similar results were seen for the remaining HCV genotypes, although only two DAA regimens were found to be effective for HCV genotype 3, and cure rates were lower in general for patients with hepatic decompensation. Addition of ribavirin was associated with improved sustained virologic response for some DAA regimens and patient groups but was also linked to more mild or moderate adverse events, although overall rates of adverse events and treatment discontinuation were low. The study authors noted that 21 of the included trials had risk for bias and that all of the trials except one were industry-funded. However, they concluded that several available oral DAA regimens are safe, tolerable, and effective for treating HCV genotype 1 infection, especially in patients without cirrhosis.

“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,” the authors wrote. “Rapid developments in oral DAA therapies can be beneficial only if they are linked to efforts to improve rates of HCV detection, linkage to care, and access to DAA therapy.”

The authors of an accompanying editorial said the study offers hope that HCV can now be considered fully treatable but noted a few cautions, including the potential for virologic relapse in 2% to 5% of patients, problems regarding access to care and cost, and the risk for rare but severe adverse effects. They also stressed that patients in whom HCV is considered cured should continue to be followed for long-term complications, including hepatocellular carcinoma, and called for additional research on optimal methods, intervals, and duration of surveillance. “These issues are a high priority for future research in this now easily treated disease,” they wrote. “Hepatitis C is down but not out.”