As requested by a commenter, on our back-up site, here's the run-down on this breaking current-generation Hepatits C pegalated-interferon study result. Quoth the NEJM synopsis, then:
. . . .We conducted a randomized, controlled trial of peginterferon alfa-2a at a dosage of 90 µg per week for 3.5 years, as compared with no treatment, in 1050 patients with chronic hepatitis C and advanced fibrosis who had not had a response to previous therapy with peginterferon and ribavirin. . . . The primary end point was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points. . . .We randomly assigned the patients to receive peginterferon (517 patients) or no therapy (533 patients) for 3.5 years. . . . there was no significant difference between the groups in the rate of any primary outcome (34.1% in the treatment group and 33.8% in the control group; hazard ratio, 1.01; 95% confidence interval, 0.81 to 1.27; P=0.90). The percentage of patients with at least one serious adverse event was 38.6% in the treatment group and 31.8% in the control group (P=0.07). . . .
Long-term therapy with peginterferon did not reduce the rate of disease progression in patients with chronic hepatitis C and advanced fibrosis, with or without cirrhosis, who had not had a response to initial treatment with peginterferon and ribavirin. . . .
This plainly makes the recent Teleprevir Phase III results (acheiving very solid efficiacy for Vertex, in the same sort of non-responders) all the more impressive. Bet on Vertex to win the next generation battle, here -- over Schering's boceprevir candidate.
1 comment:
Since you brought this back to the forefront, I feel the need to comment.
This data is based on a study with Pegasys that was not very well designed -- too many cooks in the trial design. There have now been 2 PegIntron maintenance studies that show that in a subset of patients with particularly advanced liver disease, PegIntron maintenance therapy is of benefit. This data is being presented again this week at DDW.
As for Telaprevir vs Boceprevir, all signs point to both being filed at about the same time based upon where the phase 3 studies stand. The issue will be which is more difficult to overcome, a bad rash from telaprevir or the perceived higher anemia rate with boceprevir.
I think you do a very good job of presenting the business issues that SP has, but when you continually take data out of context and always spin it to put SP in the worst possible light you lose credibility.
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