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EXTENDED TREATMENT DURATION TO 72 Weeks IN CHRONIC HEPATITIS C GENOTYPE 1-INFECTED SLOW RESPONDERS: FINAL RESULTS OF THE SUCCESS STUDY (SUCCESS)
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EASL April 2009 Copenhagen
Reported by Jules Levin
See slides below
M. Buti1, Y. Lurie2, N.G. Zakharova3, N.P. Blokhina4, A. Horban5, C. Sarrazin6, L. Balciuniene7, R. Chen8, X. Yu8, R. Faruqi8, R. Esteban9
1Dept. of Internal Medicine - Hepatology, Vall d'Hebron Hospital General, Barcelona, Spain, 2Gastroenterology and Hepatology, Sourasky Medical Center, Tel Aviv, Israel, 3Municipal Center of Prophylactic AIDS and Other Infections, St. Petersburg Municipal Center, St. Petersburg, 4Hepatology, Clinical Infection Hospital, Moscow, Russia, 5Hospital of Infectious Diseases, Warsaw, Poland, 6Medizinische Klinik I, Klinikum der J. W. Goethe Universität Frankfur, Frankfurt, Germany, 7Department of Infection Diseases, Vilnius University Hospital of Tuberculosis and Infection Diseases, Vilnius, Lithuania, 8Schering-Plough Corporation, Kenilworth, NJ, USA, 9Internal Medicine and Hepatology, Vall d'Hebron Hospital General, Barcelona, Spain
ABSTRACT
Background and aim: Previous studies have shown that extending duration of treatment with pegylated interferon (PEG-IFN) and ribavirin to 72 weeks in genotype 1-infected patients who have slow responses to therapy (Detectable HCV RNA with ≥2 log viral reduction at TW 12;undetectable HCV RNA at TW 24) is associated with an increase in sustained virologic response (SVR). The aim was to evaluate the effect of extending treatment duration among G1 slow responders in a large, prospective, randomized, multinational, multicenter clinical trial-the Study To Assess Treatment With Peg-Intron® And Rebetol® In Naive Patients With Genotype 1 Chronic Hepatitis C and Slow Virological Response (SUCCESS).
Methods: Slow responders were randomized at week 36 of treatment to receive PEG-IFN alfa-2b (1.5 µg/kg/wk) plus weight-based dosed (WBD) ribavirin (800-1400 mg/day) for a total of 48 (A) or 72 (B) weeks. Patients with undetectable HCV RNA at week 12 received treatment for 48 weeks (C), whereas patients with < 2 log drop at TW12 were discontinued.
Results: In total, 1427 patients were treated. Mean age was 42 years; 61% were males, and 95% were white. HCV RNA was >800,000 IU/mL in 80% of patients. HCV RNA became undetectable at week 12 in 816 (57%) patients. At week 24, 159 (11%) patients were identified as slow responders. These patients were randomized to 48- or 72-week treatment. In an intent-to-treat analysis, SVR rates were 43% (A), 48% (B), and 79% (C). Patients who were 80/80/80 compliant had SVR rates of 44% (A) and 57% (B) (no 80/80/80 analysis was performed for group C). Frequency of adverse events, including anemia and depression, were similar in both treatment groups. However, therapy discontinuation was higher in patients randomized to 72 weeks.
Conclusions: This, the largest prospective study among G1 slow responders, demonstrated no statistically significant difference between 48 and 72 weeks of treatment. However, in these true slow responders, extending PEG-IFN alfa-2b/WBD ribavirin treatment is associated with better SVR and a similar incidence of adverse events. These results are in line with those observed in other WBD ribavirin trials in slow responders.
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