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C-SWIFT: Shortest duration of triple therapy for HCV only effective in small percentage of patients
BOSTON — Despite hopes that therapy with grazoprevir/elbasvir in combination with sofosbuvir could produce sustained virologic response with only 4 weeks of treatment, data presented at The Liver Meeting showed this was effective in only a small percentage of subjects and may not be a sufficient plan for all patients.
“There are some valuable lessons learned from this,” Eric J. Lawitz, MD, of The Texas Liver Institute, University of Texas Health Science Center, San Antonio, said during a press conference. “It teaches us what the phenotype might be for patients [who] have an opportunity to be successful with shorter duration therapy. Obviously that’s a minority of the population with hepatitis C, but it does teach us some of that. It helps us design future trials to know what populations actually have the likelihood of succeeding in a shorter duration of therapy.”
Eric J. Lawitz
In this phase 2, open-label study, Lawitz and colleagues used a fixed-dose triple therapy regimen that included grazoprevir (Merck & Co.), elbasvir (Merck & Co.) and sofosbuvir (Gilead Sciences) to treat treatment-naive patients with HCV genotype 1 infection and without cirrhosis for 6 and 4 weeks of treatment, and patients with cirrhosis for 8 and 6 weeks of treatment.
At week 4, of the 31 patients who were treatment-naive and non-cirrhotic, only 12 (38.7%) achieved SVR. That percentage jumped to 86.7% at 6 weeks.
“This is a historical data set because this is the first time there was a planned 4-week duration that ended up curing 12 patients,” Lawitz said. “Albeit there [were] a number of patients that relapsed, I think it’s important to recognize that it’s biologically plausible to cure a very select subset at 4 weeks.”
In the treatment-naive, cirrhotic group, 80% achieved SVR at 6 weeks and 94.7% achieved SVR at 8 weeks.
“It’s also encouraging to see that three-drug regimen achieved 95% SVR at 8 weeks even in the setting of these patients with cirrhosis,” Lawitz said. “It’s a valuable lesson that suggests we may be able to feasibly get to an 8-week duration for all patient types based on this small dataset.”
Lawitz said larger studies are needed to confirm that hypothesis.
For more information:
Lawitz E. Abstract LB-33. Presented at: The Liver Meeting; Nov. 7-11, 2014; Boston.
See Janice Wahl, MD, executive director of Merck Research Laboratories, discuss this study from the industry perspective.
Disclosure: This study was funded by Merck & Co. Lawitz reports advisory roles and has received grant/research support from numerous pharmaceutical companies, including Merck & Co. Please see the abstract for a complete list of disclosures.