Vertex study data

[Proactive]

http://biz.yahoo.com/bw/071102/20071101006689.html?.v=1
I just don't see this as blockbuster data?
I suspect the discontinuation data will be a problem for the fda.

In PROVE 1, the overall discontinuation rate through 12 weeks was 18% across all telaprevir treatment arms and 3% in the control arm. This includes discontinuations due to adverse events, withdrawal of consent and patients lost to follow-up. The incidence of treatment discontinuations through week 12 due to adverse events was 13% and 2% in the telaprevir and control arms, respectively. The most common reason for discontinuation was rash, with 7% of patients discontinued for this reason in the telaprevir arms during the first 12 weeks of treatment. After week 12, discontinuations due to adverse events were 8% each in the telaprevir and control arms. Over the full course of the treatment period, the incidence of severe adverse events was 27% in the telaprevir arms and 24% in the control arm.

In PROVE 2, the overall discontinuation rate through 12 weeks was 14% across all telaprevir treatment arms and 6% in the control arm. This includes discontinuations due to adverse events, withdrawal of consent and patients lost to follow-up. The incidence of treatment discontinuations through week 12 due to adverse events were 10% and 3% in the telaprevir and control arms, respectively. As with PROVE 1, the most common reason for discontinuation was rash, with 7% of patients discontinued due to rash in the telaprevir arms, compared to less than one percent in the control arm during the first 12 weeks of treatment. Through to week 12, the time of the interim safety analysis being reported, the incidence of severe adverse events was 17% in the telaprevir arms and 10% in the control arm.

[drofi]

Hi, yes my quoting is correct: http://biz.yahoo.com/bw/071102/20071101006689.html?.v=1 and search vor n=79

This would probably mean a lower rate of ETR from Triple Therapy with telaprevir than from SOC. Or did I miss something?

regards, Drofi

[orleans]

I"n the 48-week telaprevir treatment arm (12+36; n=79) of PROVE 1, 65% had undetectable HCV RNA (<10 IU/mL) at end of treatment."
Hey, I've not seen these #s before. Are you sure you are quoting them correctly? Seems like SOC gets 80% eot und, then comes relaspe.  jerry

[glucklich]

I felt the same way after I quit Telaprevir , after 6 days it was like I was clean of it and saw everything more clearly and energetically. I could listen to people talk and not fall apart inside my head.

[Andiamo1]

I certainly felt a general malaise that I could not describe easily that disappeared once I stopped Telaprevir and continued with SOC drugs.  I don't know how much that increased the dropout rate.

Anyone else in Prove 3 experience this?

[moahunter]

If RVR SOC.

[moahunter]

"I thought that 91% SVR for RVR was true for soc too? I'm new to tx, so i'm just trying to wrap my mind around all these numbers and statistics"

You are correct, but that is for 48 weeks of SOC.  This is for 24 weeks.  And lots more people get RVR on the new drug.

My understanding is that it is possible to stop SOC at 24 weeks now with similar, almost 90% SVR. I hope this drug helps more people succeed though, and that the side effects are tolerable, given it seems to be another poision in the mix (as any new drug will be).