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Title: Randomized study of danoprevir/ritonavir-based therapy for HCV genotype 1 patients with prior partial or null responses to peginterferon/ribavirin
Author: Feld, J.J.
Jacobson, I.M.
Jensen, D.M.
Foster, G.R.
Pol, S.
Tam, E.
Jablkowski, M.
Berak, H.
Vierling, J.M.
Yoshida, E.M.
Perez-Gomez, H.R.
Scalori, A.
Hooper, G.J.
Tavel, J.A.
Navarro, M.T.
Shahdad, S.
Kulkarni, R.
Pogam, S.L.
Najera, I.
Eng, S.
Lim, C.Y.
Shulman, N.S.
Yetzer, E.S.
Issue Date: 2014
Abstract: Background & Aims: Chronic hepatitis C treatment for prior non-responders to peginterferon (PegIFN)/ribavirin remains suboptimal. The MATTERHORN study evaluated regimens containing ritonavir-boosted danoprevir (danoprevir/r) in prior PegIFN alfa/ribavirin non-responders. Methods: Prior partial responders (N = 152) were randomized to 24. weeks of twice-daily danoprevir/r 100/100. mg, mericitabine 1000. mg and ribavirin 1000/1200. mg (IFN-free); danoprevir/r plus PegIFN alfa-2a/ribavirin (triple); or danoprevir/r, mericitabine and PegIFN alfa-2a/ribavirin (Quad). Prior null responders (N = 229) were randomized to 24. weeks of IFN-free therapy, or quad alone (Quad 24) or quad plus 24-weeks of PegIFN alfa-2a/ribavirin (Quad 48). The primary endpoint was sustained virological response (HCV RNA <25. IU/ml) 24. weeks after end-of-treatment (SVR24). Due to high relapse rates, genotype (G) 1a patients in IFN-free arms were offered additional PegIFN alfa-2a/ribavirin. Results: Among prior partial responders, SVR24 rates were 46.2%, 51.0%, and 86.0%, in the IFN-free, Triple and Quad arms, respectively; among prior null responders, SVR24 rates were 45.5%, 80.5%, and 83.8% respectively. Relapse rates were lower and SVR24 rates higher in G1b-infected than G1a-infected patients. SVR24 rates in G1a and G1b patients randomized to Quad were 75.0% and 96.2%, respectively, in the partial Quad arm, and 68.1% and 100%, respectively, in the null Quad 24 arm. Treatment failure was associated with resistance to danoprevir, but not to mericitabine, and was more common in G1a infected patients. Treatment was well-tolerated. Conclusions: Danoprevir/r, mericitabine plus PegIFN alfa-2a/ribavirin was well-tolerated and produced high overall SVR24 rates in prior partial and null responders to PegIFN alfa/ribavirin. In contrast, IFN-free regimens were associated with unacceptably high relapse rates. © 2014 European Association for the Study of the Liver.
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