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Response-guided regimen reduced treatment duration by half in HCV
Sherman KE. N Engl J Med. 2011;365:1014-1024.
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Nearly two-thirds of patients with chronic hepatitis C infection that was not previously treated achieved viral cure with 12-week telaprevir and 24-week peginterferon/ribavirin therapy, according to Kenneth E. Sherman, MD, PhD.
“Not surprisingly, shorter therapy was associated with better tolerability and decreased side effects compared with those who were randomized to receive 48 weeks of treatment,” Sherman, of the University of Cincinnati College of Medicine, told Infectious Disease News.
In the multinational, randomized, phase 3 study, Sherman and colleagues assessed the noninferiority of a 24-week vs. a 48-week regimen of response-guided therapy of telaprevir (Incivek, Vertex Pharmaceuticals), peginterferon alfa-2a and ribavirin in patients with chronic HCV genotype-1 infection who were not previously treated (n=540).
Treatment consisted of 750 mg telaprevir every 8 hours, 180 mcg weekly peginterferon alfa-2a and 1,000 mg to 1,200 mg daily ribavirin for 12 weeks, followed by peginterferon/ribavirin.
After week 20, those with undetectable HCV RNA levels at weeks 4 and 12 (extended rapid virologic response) were randomly assigned to either 4 weeks or 28 additional weeks of treatment. The remainder of patients was assigned to 12 weeks of telaprevir and 48 weeks of peginterferon/ribavirin.
Overall rate of sustained virologic response was 72%; and 65% of all patients had an extended rapid virologic response. Of those with an extended rapid virologic response, 92% of those in the 12-week telaprevir and 24-weeks peginterferon–ribavirin group and 88% of those in the 12-week telaprevir and 48-week peginterferon/ribavirin group achieved a sustained virologic response with an absolute difference of 4% (95% CI, -2 to 11).
Adverse events included rash (37% of patients; severe in 5%) and anemia (39% of patients; severe in 6%).
“The treatment regimen was highly effective in patients with a historically poor treatment response, including blacks, patients with bridging fibrosis or cirrhosis and patients with high HCV RNA levels,” the researchers wrote. “Response-guided therapy also resulted in decreased rates of adverse events and treatment discontinuation among patients who received treatment for a shorter period.”
Disclosure: This research was funded by Vertex Pharmaceuticals and Tibotec; ILLUMINATE ClinicalTrials.gov number, NCT00758043.
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