Telaprevir achieves SVR in over 60% of HCV-1 patients

At the 58th annual meeting of the American Association for the Study of Liver Diseases, held in Boston, Massachusetts, the USA's Vertex Pharmaceuticals reported strong results from interim analyses of PROVE 1 and PROVE 2, two large Phase IIb trials evaluating the hepatitis C protease inhibitor telaprevir (VX-950), dosed in combination with pegylated interferon and ribavirin. In 24-week telaprevir-based regimens, genotype-1 treatment-naive HCV patients achieved sustained viral response rates of 61% and 65% in PROVE 1 (SVR 12 and SVR 24) and PROVE 2 (SVR 12), respectively. In addition, clinical researchers reported a correlation between achieving rapid viral response and SVR with telaprevir, Vertex noted.

Interim analyses of telaprevir safety from PROVE 1 and PROVE 2 appear consistent with prior analyses, with the most common adverse events, regardless of treatment assignment, being fatigue, rash, headache and nausea, the firm stated. Gastrointestinal disorders, skin adverse events and anemia were higher in the telaprevir arms compared to the control group over the dosing period. Vertex is developing telaprevir in collaboration with Ireland's Tibotec. "The SVR data from the PROVE studies are promising as the expectation today is that 40% to 50% of people with genotype-1 hepatitis C who undergo 48-week treatment regimens with currently-available therapies achieve SVR. In this Phase II study, we saw 24-week telaprevir regimens result in SVR of greater than 60% in patients with genotype 1 hepatitis C," said John McHutchison, lead investigator of PROVE 1.