Great news from DDW re. Teleprevir for non-responders

This afternoon results of a Phase II study of teleprevir on genotype 1 previous non-responders was presented at Digestive Disease Week in Chicago. The results are very exciting:

"For the first time, researchers have shown that patients with hepatitis C (HCV) genotype 1 who do not respond to standard treatment can obtain a sustained virologic response using a combination regimen of telaprevir (T) plus peginterferon-alfa-2a (P) ± ribavirin (R). About 70 percent of patients who had relapsed on previous HCV treatment experienced sustained virologic response and about 40 percent of patients who previously had not responded to treatments experienced sustained virologic response. Patients who had not responded to previous treatments needed to undergo 48 weeks of treatment with T/PR. The sustained virologic response rate was significantly higher in all treatment groups receiving T/PR regimens compared with those receiving placebo plus PR48."

"In the PROVE3 study, 453 patients were randomized to receive T/PR for12 weeks followed by PR for 12 weeks (T12/PR24); T/PR for 24 weeks followed by PR for 24 weeks (T24/PR48); T/P for 24 weeks (T24/P24); or placebo/PR for 24 weeks, then PR for 24 weeks. Of the participants, 235 (52 percent) completed their assigned treatments. Many of the patients included in the intent-to-treat analysis had baseline characteristics know to be associated with poor response to treatment, including 196 (43 percent) with cirrhosis or bridging fibrosis, 418 (92 percent) with baseline serum HCV RNA ≥ 800,000 IU/mL, and 40 (9 percent) were African American."

"The general safety profile of T12/PR24 compared with T24/PR28 was similar to that observed in treatment naïve patients. Patients in the T12/PR24 or T24/PR48 group experienced greater frequency of fatigue, nausea, headache, rash, pruritus, diarrhea, anemia, insomnia, fever, hair loss and chills thank those treated with placebo followed by PR48. Of those patients discontinuing treatment due to adverse events, 11 (10 percent) were in the T12/PR24 group, 29 (25 percent) were in the T24/PR48 group, 10 (9 percent) were in the T24/P24 and five (4 percent) were in the placebo plus RP48 group.

"We are continuing to study these treatment combinations in a phase III trial, which is currently underway," said Dr. Di Bisceglie. "We hope to identify the optimal duration of treatment of telaprevir to ensure HCV patients have the best opportunity of clearing the disease from their system to obtain a sustained virologic response."

Here's the link to the press release:

http://www.eurekalert.org/pub_releases/2009-06/aga-abm052909.php