Background We hypothesized that in patients with hepatitis Cvirus (HCV) genotype 2 or 3 in whom HCV RNA is not detectableafter 4 weeks of therapy, 12 weeks of treatment is as effectiveas 24 weeks.
Methods A total of 283 patients were randomly assigned to astandard 24-week regimen of peginterferon alfa-2b at a doseof 1.0 µg per kilogram weekly plus ribavirin at a doseof 1000 mg or 1200 mg daily, on the basis of body weight. Ofthese, 70 patients were assigned to the 24-week regimen (standard-durationgroup) and 213 patients to a variable regimen (variable-durationgroup) of 12 or 24 weeks, depending on whether tests for HCVRNA were negative or positive at week 4. The primary end pointwas HCV that was not detectable by polymerase-chain-reaction(PCR) assay 24 weeks after the completion of therapy.
Results In the standard-duration group, 45 (64 percent) patientshad HCV that was not detectable by PCR assay at week 4, as comparedwith 133 (62 percent) in the variable-duration group (difference[the rate in the standard-duration group minus that in the variable-durationgroup], 2 percent; 95 percent confidence interval, –11to 15 percent). Fifty-three patients (76 percent) in the standard-durationgroup and 164 patients (77 percent) in the variable-durationgroup had a sustained virologic response (difference, –1percent; 95 percent confidence interval, –13 to 10 percent).Fewer patients in the variable-duration group receiving the12-week regimen had adverse events and withdrew than in thegroup receiving the 24-week regimen (P=0.045). The rate of relapse(defined as HCV not detectable at the end of treatment but detectableat the end of follow-up) was 3.6 percent in the standard-durationgroup and 8.9 percent in the variable-duration group (P=0.16).Overall, the rate of sustained virologic response was 80 percentamong patients with HCV genotype 2 and 66 percent among thosewith genotype 3 (P<0.001).
Conclusions A shorter course of therapy over 12 weeks with peginterferonalfa-2b and ribavirin is as effective as a 24-week course forpatients with HCV genotype 2 or 3 who have a response to treatmentat 4 weeks.
Source Information
From the Gastroenterology Unit, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo (A.M., R.S., F. Spirito, A.A.); the Department of Internal Medicine, Hospital Canosa, Canosa (N.M.); the Department of Internal Medicine, University La Sapienza, Rome (G.L.R.); the Department of Internal Medicine, Hospital Venosa, Venosa (V.C.); the Department of Internal Medicine, Federico II University, Naples (M.P.); the Department of Gastroenterology, Ospedali Riuniti, Foggia (F.V.); the Department of Infectious Disease, University of Foggia, Foggia (G.S.); the Department of Internal Medicine, Hospital Casarano, Casarano (D.B.); the Department of Internal Medicine, Hospital Policoro, Policoro (M.A.); the Department of Internal Medicine, Sant'Andrea Hospital, Rome (M.R.); the Liver Unit, Sovrano Ordine di Malta, Rome (F.Z.); and the Department of Internal Medicine, Santissima Annunziata Hospital, Taranto (F. Sogari) — all in Italy.
Address reprint requests to Dr. Mangia at the Gastroenterology Unit, Casa Sollievo della Sofferenza Hospital IRCCS, 71013 San Giovanni Rotondo, Italy, or at a.mangia{at}tin.it.
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