Biotech Values

[DewDiligence]

Telaprevir PROVE-1/2 Results Made Simple

The PROVE-1 and PROVE-2 trials had almost mind-boggling complexity because there were so many treatment arms and protocols (#msg-11248731, #msg-28746843). To sift through this complexity, I’ve condensed the data into a form that is simple to understand yet accurate enough for investment purposes.

• The starting point for the calculations below is the set of all PROVE-1/PROVE-2 patients who were treated with 12 weeks of Telaprevir followed by 12 weeks of SoC.

• Deduct the 17% of patients who discontinued treatment due to adverse events or were lost to follow-up, leaving 83% of the initial patients.

• From the above, deduct the 10% of patients who never achieved undetectable virus, leaving 75% of the original patients.

• From the above, deduct the 2% of patents who experienced a viral breakthrough on treatment, leaving 73% of the original patients. These are the patients who had undetectable virus at the end of 24 weeks of treatment.

• From the above, deduct the 11% of patients who relapsed after stopping treatment, leaving 65% of the original patients who had an SVR. This was an improvement of 20 percentage points vs the 45% SVR rate in the PROVE-1/2 SoC 48-week control arms.

(Patients in PROVE-1/2 who did not achieve an RVR [undetectable virus at week 4] stopped Telaprevir and completed a total of 48 weeks of treatment with the remainder of the 48 weeks on SoC. Although a small number of these patients achieved an SVR after 48 weeks of treatment, they are not included in the 65% figure above.)