Phase IIb R7128

[Trish77]

Sorry if this has been posted already - didn't see it so thought I would.

Pharmasset Announces Continuation of Phase 2b Trial of HCV Polymerase
Inhibitor RG7128

"Princeton, JN -- November 23, 2009 -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that the enrollment of Cohort 2, led by its partner Roche (SWX: ROG.VX; RO.S, OTCQX: RHHBY), will continue for the remaining 300 genotype 1 and 4 patients in the ongoing phase 2b trial of RG7128, a first-in-class nucleoside analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The decision was reached after a scheduled review by an independent Data Monitoring Committee (DMC) of all available safety data from the first cohort of approximately 100 patients completing 8 or 12 weeks of RG7128 or matching placebo in combination with pegylated interferon and ribavirin. "


About the RG7128 Phase 2b Trial

The Phase 2b trial is anticipated to enroll a total of about 400 HCV-infected patients with genotypes 1 or 4 who have never received HCV treatment. The trial is evaluating the dose and duration of treatment with RG7128 in combination with Pegasys [pegylated interferon alfa-2a] plus Copegus (ribavirin). The primary efficacy endpoint of the trial is the proportion of patients achieving an SVR, defined as serum HCV RNA below the limit of detection as measured by the Roche TaqMan assay 24 weeks after completion of treatment. Patients are equally randomized into one of 5 arms:
24 weeks of total treatment, with RG7128 500 mg BID [twice daily] in combination with Pegasys and ribavirin for 12 weeks, followed by 12 weeks of Pegasys and ribavirin ("12+12")
24 weeks of total treatment, with RG7128 1000 mg BID in combination with Pegasys and ribavirin for 12 weeks, followed by 12 weeks of Pegasys and ribavirin ("12+12")
24 weeks of total treatment, with RG7128 1000 mg BID in combination with Pegasys and ribavirin for 8 weeks, followed by a further 16 weeks of Pegasys and ribavirin ("8+16")
48 weeks of total treatment, with RG7128 1000 mg BID in combination with Pegasys and ribavirin for 12 weeks, followed by a further 36 weeks of Pegasys and ribavirin ("12+36")
A control arm with Pegasys and ribavirin for 48 weeks.

Patients randomized to the 24-week regimen will discontinue all treatment at week 24 if they have achieved a rapid virological response, defined as serum HCV RNA below the limit of detection at week 4, a strategy known as "RVR-guided" treatment. Patients who do not achieve an RVR will continue on the standard of care therapy (Pegasys and ribavirin) until week 48.

"RG7128 is also being studied in conjunction with the HCV protease
inhibitor RG7227 (also known as ITMN-191) in the INFORM trials -- the
first experimental combination regimen without interferon."

Article here:
http://www.hivandhepatitis.com/hep_c/news/2009/120409_b.html

[newleaf09]

You're very kind to post trial information.  I know there are lots of forum people searching for potential trials.  This one offers the possibility to stop at 24 weeks; that's 4 weeks less than the Boceprevir and Teleprevir response-guided trials.  Thanks, Trish.