A triple therapy regimen consisting of telaprevir (Incivek, Vertex) administered during the first 12 weeks followed by 24 weeks of peginterferon alfa and ribavirin was noninferior to the same regimen administered for 48 weeks among patients with chronic hepatitis C virus (HCV) infection.
Patients in each treatment group achieved nearly identical treatment-response rates; with 92% of patients in the 24-week group (n=149) and 88% of patients in the 48-week group (n=140) achieving a sustained virologic response, data published in the New England Journal of Medicine indicate.
Relapse rates were low (overall, 8%) and were not significantly different between the 24-week (2%) and 48-week treatment groups (3%; P=0.02).
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“The medications that we use to treat hepatitis C do have some side effects, and shortening the duration of treatment shortens a patients exposure to these side effects,” study researcher Michael W. Fried, MD, and director of the University of North Carolina Liver Center in Chapel Hill said in a press release.
Fried and colleagues enrolled 540 patients with chronic genotype 1 HCV from 74 sites in Belgium, the Netherlands and the United States, who had not been previously treated or who could not be successfully treated with standard of care combination peginterferon alfa and ribavirin.
All patients were treated with peginterferon, ribavirin and telaprevir for 12 weeks; 322 tested negative for hepatitis C and were randomly assigned to receive an additional 12 weeks (n=162) or 36 weeks (n=160) of treatment with peginterferon alfa and ribavirin. The 118 patients that did not achieve a rapid virologic response at 12 weeks were assigned to receive the same combination therapy for an additional 36 weeks.
Overall, 72% of patients achieved a sustained virologic response. Among the nearly two-thirds of patients that achieved extended rapid virologic responses, sustained response rates were uniformly high regardless of race/ethnicity or presence or absence of advanced fibrosis.
“This study supports the concept of response-guided therapy,” the researchers wrote.
Overall adverse event rates, including rash (37%) and anemia (39%) were similar to those observed in other clinical trials involving telaprevir-based therapy. Discontinuation rates due to adverse events were low and most occurred after HCV was undetectable.
