ATLANTA — Preliminary data presented here at the 2013 Conference on Retroviruses and Opportunistic Infections show that combination telaprevir treatment may be effective in black null responder patients with chronic genotype 1 hepatitis C.
Researchers from Northwestern University and Vertex Pharmaceuticals are conducting the OUTLOOK study, which is a single-arm, open-label, phase 4 study that includes black patients who were previously treated for chronic genotype 1 HCV. None of the 34 patients had achieved a sustained virologic response after treatment with pegylated interferon and ribavirin. For this study, all patients received pegylated interferon and ribavirin for 48 weeks and telaprevir (Incivek, Vertex) for 12 weeks.
At week 4, nine of the patients (26%) had achieved a rapid virologic response. At week 12, 20 of the patients (59%) had achieved a complete early virologic response. Eight patients had an extended rapid virologic response at both weeks 4 and 12.
The researchers also conducted a subgroup analysis by IL28B subtype: 21 patients were TT subtype, 11 patients were CT subtype and two were CC subtype. At week 4, 19% of subtype TT patients and 45% of subtype CT patients achieved rapid virologic response. At week 12, 52% of subtype TT patients, 64% of subtype CT patients and 100% of subtype CC patients had a complete early virologic response. Only 19% of subtype TT patients, 36% of subtype CT patients and no subtype CC patients had an extended rapid virologic response.
Patients without cirrhosis had better responses compared with patients with cirrhosis. Fatigue, anemia, pruritus and rash were the most common adverse events.
For more information:
Flamm S. #678. Presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta.
Disclosure: The researchers report financial relationships with Abbott, Achillion, Bristol-Myers Squibb, Eisai, Genentech-Roche, Gilead, GlaxoSmithKline, Janssen, Merck, Onyx, Pfizer, Salix and Vertex.