Vertex announces final results from Phase 3 REALIZE study against HCV

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced final results from its pivotal Phase 3 REALIZE study that evaluated people with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon and ribavirin was unsuccessful either because they relapsed, had a partial response or had a null response. Data from the study showed that people in each of these subgroups who were treated with telaprevir-based combination therapy achieved superior rates of sustained viral response (SVR, or viral cure) compared to those treated with pegylated-interferon and ribavirin alone.

REALIZE also evaluated whether viral cure rates could be further improved by delaying the start of telaprevir by four weeks, during which time patients received four weeks of pegylated-interferon and ribavirin alone (lead-in), compared to a simultaneous start. The data showed no clinical benefit to a lead-in for people treated with telaprevir-based combination therapy. Safety and tolerability results were consistent with results from the prior Phase 3 studies of telaprevir. These data were presented today at The International Liver Congress™ 2011, 46^th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany. REALIZE was conducted by Vertex's collaborator, Tibotec BVBA.

"Patients with chronic hepatitis C who undergo re-treatment with currently available medicines rarely achieve a viral cure and remain at an increased risk for advancing to more serious liver disease," said Stefan Zeuzem, M.D., Professor of Medicine and Chief of the Department of Medicine at the JW Goethe University Hospital, Frankfurt, Germany and principal investigator for REALIZE. "These data are important because they showed that viral cure rates were three to six times higher for patients treated with a telaprevir-based regimen compared to re-treatment with currently available medicines."

Among those in the simultaneous start arm of REALIZE, 83 percent (121/145) of prior relapsers, 59 percent (29/49) of prior partial responders and 29 percent (21/72) of null responders achieved viral cures compared to 24 percent (16/68), 15 percent (4/27) and 5 percent (2/37), respectively, who received pegylated-interferon and ribavirin. The viral cure rates among those in the lead-in arm were 88 percent (124/141) among prior relapsers, 54 percent (26/48) among prior partial responders and 33 percent (25/75) among prior null responders. In a combined endpoint analysis of the two telaprevir-based treatment arms, 86 percent (245/286) of prior relapsers, 57 percent (55/97) of prior partial responders and 31 percent (46/147) of prior null responders achieved viral cures.

"The REALIZE results are encouraging, especially considering people in this study had been unsuccessfully treated in the past and many already had scarring of the liver," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "Rates of viral cure among those treated with telaprevir-based regimens were similar between the simultaneous and delayed start arms of the study, supporting the conclusion that there was no clinical benefit to a lead-in strategy with telaprevir."

In this study, 48 percent (316/662) of patients overall had advanced liver fibrosis or cirrhosis (scarring of the liver) and 89 percent (586/662) of patients overall had high amounts of hepatitis C virus (high viral load; HCV RNA ≥ 800,000 IU/mL) upon study entry.