Biotech Values

[gofishmarko]

>>> 23% of patients who failed first-line SoC
treatment with Pegasys had an SVR on Peg-Intron
+ ribavirin, which is impressive, IMO. <<<

That does sound pretty good , but it's too bad there was no Pegasys/riba arm to compare to. The study had 24% relapsers and another 12% who were not categorized , which could mean even more relapsers. Relapsers can respond almost as well as tx-naive patients , depending on how they're defined , so it makes interpretation of these studies difficult based on the PR results. Maybe the full dataset will make things more clear.

Here's another study , using amantadine/pegifn/riba triple therapy , that got up to 32% SVR , in which only true nonresponders were used but they were drawn from patients treated with non-peg ifn plus riba , so not really comparable to the above :

1: World J Gastroenterol. 2006 Sep 7;12(33):5293-300

Triple antiviral therapy in HCV positive patients who failed prior combination therapy.

Fargion S, Borzio M, Maraschi A, Cargnel A; Gruppo Epatologico Lombardo.

Fondazione Policlinico Mangiagalli e Regina Elena, Dipartimento di Medicina Interna Pad. Granelli, via F. Sforza 35, Milano 20121, Italy. [e-mail]

AIM: To assess the efficacy of triple therapy (peginte-rferon or high dose standard interferon, plus ribavirin and amantadine) in nonresponders to prior combination therapy. METHODS: A total of 196 patients were enrolled in a multicenter, open, randomized study. Patients were given 180 mug/wk of peginterferon-alpha-2a (40 kDa) plus ribavirin (800-1000 mg/d) and amantadine (200 mg/d) for 48 wk (group A) or interferon-alpha-2a (6 MU/d for 4 wk, 3 MU/d for 20 wk, and 3 MU tiw for 24 wk) plus ribavirin (800-1000 mg/d) and amantadine (200 mg/d) for 48 wk (group B). RESULTS: Overall sustained virologic response (SVR) was 26.6% (32.1% and 19.5% in group A and B, P = 0.057). Baseline ALT > 120 UI/L (OR 2.4; 95% CI: 1.11 to 5.20; P = 0.026) and HCV RNA negativity after 12 wk (OR 8.7; 95% CI: 3.87 to 19.74; P < 0.0001) were independently associated with SVR. Therapy discontinuation occurred less frequently in patients treated with peginterferon than standard interferon (P = 0.036). CONCLUSION: More than 25% of nonresponders to combination therapy can eradicate HCV infection when retreated with triple therapy, especially if they have a high baseline ALT and are treated with pegylated interferon.

PMID: 16981257 [PubMed - in process]

Full-text link :

http://www.wjgnet.com/1007-9327/12/5293.asp