The use of response-guided therapy, or RGT, reduces effective treatment times by up to 50% in patients with hepatitis C virus infection and could significantly cut costs for expensive direct-acting antiviral therapy, according to research presented at the Liver Meeting 2018 in San Francisco.
“Treatment currently is standardized to be given for a set period of time, usually 12 weeks, rather than being tailored to individual patients,” Scott Cotler, MD, head of Loyola Medicine’s division of hepatology and a professor at Loyola University Chicago Stritch School of Medicine, said in a news release.
In a proof-of-concept pilot study, Cotler and colleagues enrolled patients with HCV and compensated liver disease, genotypes 1 to 6, who were either treatment naive or interferon experienced. Participants were treated with one of four all-oral DAA regimens, and their viral loads were measured at baseline, day 2 and weeks 1, 2 and 4 after beginning treatment.
Cotler and colleagues used mathematical modeling-based RGT when possible at treatment weeks 2 and 4 to project a time to cure. Treatment duration was then individualized based on the projections. The primary endpoint was proportion of patients with undetectable HCV RNA at 12 weeks after treatment.
The ongoing study includes 22 patients so far (mean age, 49.8 years, 50% female). The patients’ most common genotype was G1b (59%), followed by G3 (27%). Forty-one percent received Epclusa (sofosbuvir/velpatasvir, Gilead), 31% received Zepatier (elbasvir/grazoprevir, Merck), 23% received Harvoni (sofosbuvir/ledipasvir, Gilead) and 5% received Mavyret (glecaprevir/pibrentasvir, AbbVie).
According to the findings, modeling predicted that treatment duration could be shortened to 10 weeks in one patient, 8 weeks in eight patients and 6 weeks in two patients. At the time of study presentation, 19 patients had completed therapy, with 100% experiencing an undetectable viral load when their treatment ended. Eighteen of the 19 patients (95%) were still HCV undetectable 4 weeks after treatment, Cotler and colleagues reported. Sixteen patients were assessed 12 weeks after treatment, with 83% attaining primary endpoint of undetectable HCV RNA. The only patient to relapse was a treatment-naive man with genotype 3 HCV who had been treated with sofosbuvir/velpatasvir for 6 weeks, the researchers reported.
Cotler and colleagues said the shortened treatment duration using real-time RGT did not compromise efficacy or patient safety. They noted that a larger, multicenter study was being conducted to validate the results.
In the accompanying news release, it was noted that HCV drugs have a high cure rate but can cost more than $50,000 per patient.
“There’s a potential to save up to 20% of the costs of hepatitis C drugs,” study author Harel Dahari, PhD, co-director of the Program for Experimental and Theoretical Modeling in the hepatology division of Loyola Medicine and Loyola University Chicago Stritch School of Medicine, said in the release. – by Bruce Thiel
Etzion O, et al. Abstract LB-34. Presented at: The Liver Meeting 2018; Nov. 9-13, 2018; San Francisco.
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