R7128 85% response

hi,

check this out about hep c

http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=284920

[copyman]

a few months back i was offered a trial with that drug at the university of penn in philadelphia. i declined. the trial nurse/cordinater was very nice and had told me they had really good results with the first trial, this must have been what she was talking about. as matter of fact she had posted here asking if anyone was interested in participating in it.

[denzelbrown]

Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
- 85% of patients achieve undetectable HCV RNA levels following 4 weeks of treatment with R7128 1500mg and Pegasys(R) plus Copegus(R) with safety and tolerability comparable to placebo - - Conference Call Scheduled for 4:00PM ET Today -

PRINCETON, N.J., Jan 07, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces the preliminary results of a 4-week Phase 1 clinical trial to evaluate two oral dose levels of R7128 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in 50 treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1. In this study, R7128 demonstrated potent short-term antiviral activity and was generally safe and well-tolerated. Eighty-five (85%) of patients receiving R7128 1500mg and Pegasys plus Copegus achieved undetectable HCV RNA levels following 4 weeks of treatment with safety and tolerability comparable to placebo. R7128 is a prodrug of PSI-6130, a cytidine nucleoside analogue polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche.

Dr. Michelle Berrey, Pharmasset's Chief Medical Officer, stated "R7128, in combination with Pegasys plus Copegus, has shown that nucleoside polymerase inhibitors can demonstrate Rapid Virologic Response (RVR) percentages that are similar to protease inhibitors with an acceptable short-term clinical safety profile. This study also suggests that there appear to be certain synergies between nucleoside polymerase inhibitors and the standard of care that is not found with other classes of HCV inhibitors. The addition of R7128 at both dose levels to the current standard of care has demonstrated a greater percentage of RVR compared to the standard of care alone, which could translate into improved clinical outcomes with longer treatment periods. In addition, the level of antiviral activity from 500mg to 1500mg provides flexibility in selecting doses for future clinical studies."

R7128 Phase 1 Combination Study Overview

The Phase 1 combination clinical trial was a multiple center, observer- blinded, randomized and placebo-controlled study that was conducted in 50 treatment-naive patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability and pharmacokinetics of R7128 in combination with Pegasys plus Copegus. The secondary objective was to evaluate the change in HCV RNA after 4 weeks of treatment.

The study investigated two oral dose levels of R7128, 500mg and 1500mg, each administered twice-daily (BID) with once-weekly injections of Pegasys plus Copegus. Each cohort of 25 patients was comprised of 20 patients receiving active R7128 and 5 patients receiving placebo with Pegasys plus Copegus (standard of care). The initial evaluation period reported is 4 weeks.

[merryBe]

that's really great info, and since you are treatment naive, you may be able to do the phase 3...you are close enough I hope???

The thing I'd be careful of, is make sure they will tell you by week 40 (the cut off for treatment) whether you are on the drug or just SOC...by law they have to show you your records if it might effect your health...so insist.

the reason is, if you are genotype 1 and you only got SOC then you are putting yourself at a slightly higher risk stopping even 8 weeks early. Just a cautionary.

thee are really great numbers though!! 85 % wow.  and did you notice, the anemia went down by half, from 10 to 5 percent? also good news.
Hope you get tx soon denzel.
maryB

[denzelbrown]

hi,

i am actually going to wait till these drugs come out in market, and approved by FDA, so far i have minimal damage and i am hoping one of these inhibitors really kick the virus ***,
thanks anyways