Duration of peginterferon therapy in acute hepatitis C: A randomized trial.
Duration of peginterferon therapy in acute hepatitis C: A randomized trial.
Kamal SM, Moustafa KN, Chen J, Fehr J, Moneim AA, Khalifa KE, El Gohary LA, Ramy
AH, Madwar MA, Rasenack J, Afdhal NH.
Department of Gastroenterology and Liver Disease Center, Beth Israel Deaconess
Medical Center, Harvard Medical School, Boston, MA.
Spontaneous resolution of acute hepatitis C virus infection cannot be predicted,
and chronic evolution of the disease occurs in a majority of cases. To assess
the efficacy and safety of peginterferon alpha-2b administered for 8, 12, or 24
weeks in patients with acute hepatitis C virus infection a total of 161 patients
were identified with acute hepatitis C virus infection. Of these, 30 patients
refused treatment but were retained in the study as a nonrandomized comparison
group. Of the 131 patients who consented to treatment, 29 patients spontaneously
resolved, leaving 102 patients randomly assigned to peginterferon alpha-2b (1.5
mug/kg) for 8 weeks (group A; n = 34), 12 weeks (group B; n = 34), and 24 weeks
(group C; n = 34). The primary end point was sustained virologic response. An
intent-to-treat analysis was used for efficacy and safety end points. Sustained
virologic response was achieved in 23/34 (67.6%), 28/34 (82.4%), and 31/34
(91.2%) of patients in groups A, B, and C, respectively; all had undetectable
hepatitis C virus RNA 48 weeks after the end of therapy. Treatment for 8 or 12
weeks was effective in genotypes 2, 3, and 4, whereas genotype 1 required 24
weeks of therapy. The 8- and 12-week regimens were associated with fewer adverse
events compared with the 24-week regimen. In conclusion, peginterferon alpha-2b
effectively induces high sustained virologic response rates in patients with
acute hepatitis C virus infection, thus preventing development of chronic
hepatitis C. Duration of treatment should be further optimized based on genotype
and rapid virologic response at week 4. (HEPATOLOGY 2006;43:923-931.).
PMID: 16628640 [PubMed - as supplied by publisher]
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