health educator

Have any of the telaprivir studies included people who already have evidence of liver damage(cirrhosis)?

[SusieS2010]

Yes they have. People with cirrhosis do not fare as well, but many do SVR.

[Resilient_Mimi]

I have read that a gentleman was in stage 2, but there was stipluations...he had to keep his labs under a certain # to continue with the trial. He states that he was getting a good response from the medicine.

[HectorSF]

"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."

All major subgroups achieved significantly higher viral cure rates with telaprevir-based therapy compared to pegylated-interferon and ribavirin: 86% vs. 24% in prior relapsers, 57% vs. 15% in prior partial responders and 31% vs. 5% in prior null responders -

"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."

Hectorsf