Determinants of relapse after a short (12 weeks) course of antiviral therapy and re-treatment efficacy of a prolonged course in patients with chronic hepatitis C virus genotype 2 or 3 infection

✍ Scribed by Alessandra Mangia; Nicola Minerva; Donato Bacca; Raffaele Cozzolongo; Ernesto Agostinacchio; Fernando Sogari; Gaetano Scotto; Francesco Vinelli; Giovanni Luciano Ricci; Mario Romano; Vito Carretta; Daniela Petruzzellis; Angelo Andriulli

• Publisher: John Wiley and Sons
• Year: 2008
• Tongue: English
• Weight: 142 KB
• Volume: 49
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.22679

✦ Synopsis

In hepatitis C virus (HCV) genotypes 2 and 3 patients, the high rate of relapse after 12 to 16 weeks of antiviral therapy is the main concern for shortening treatment duration. This study was undertaken to delineate predictors of relapse after short treatment in patients with undetectable HCV RNA at treatment week 4 (RVR), and to report in RVR patients with relapse the sustained virological response (SVR) after a second 24-week course of therapy. RVR patients received pegylated interferon (Peg-IFN) alfa-2b (1.5 g/kg) and ribavirin (1000-1200 mg/day) for 12 weeks; those who relapsed were retreated with the same drug doses but for the extended standard duration of 24 weeks. Logistic regression analysis was applied to delineate predictors of relapse by using age, sex, route of transmission, body mass index (BMI), serum alanine aminotransferase (ALT), HCV genotypes, serum HCV RNA levels, and platelet counts as covariates. Of 718 patients with genotypes 2 and 3 who were started on therapy, 496 ( 69.1%) had undetectable HCV RNA at week 4. Of them, 409 patients (82.5%, CI 79.1-85.8) attained SVR, and 67 (14.1%, CI 10.4-16.5) relapsed. At regression analysis, only platelet count less than 140,000 mm 3 [odds ratio, 2.51; confidence interval (CI), 1.49-4.20] and BMI 30 or higher (odds ratio, 1.7; CI, 1.03-2.70) were independently associated with relapse. Forty-three of 67 patients with relapse agreed to be re-treated, and an SVR was achieved in 30 (70.0%) of them. Conclusion: We recommend 12 weeks course of therapy for patients with undetectable HCV RNA at treatment week 4, providing they present with no advanced fibrosis and low BMI. (HEPATOLOGY 2009;49:358-363.) See Editorial on Page 345

I n patients with chronic hepatitis C virus (HCV) genotype 2 and 3 infection, a combination of pegylated interferon (Peg-IFN) with ribavirin attained sustained virological response (SVR) rates of up to 88% when administered for the standard duration of 24 weeks. [1][2][3][4] In the event the infection was cleared at treatment week 4, length of treatment may be shortened to 12 to 16 weeks without compromising SVR rates. [5][6][7][8] The major concern about the implementation of short treatment in clinical practice is the relapse rate. 9 In our original investigation, in which truncated treatment was offered only to patients with rapid virological response (RVR), relapse amounted to 10%, 5 a figure not different from the 10% to 12% values reported in other studies that used short treatment duration. 6,8 At a variance, when genotype 2 and 3 infected patients were treated for 16 weeks, irrespective of the RVR status, the rate increased to 31%. 9 Defining efficacy of re-treating patients who relapse after a shortened course of therapy is of paramount relevance, but only limited information on this aspect is available: 9 of 10 relapsers after short therapy who agreed to be re-treated for 24 weeks eventually cleared the infection. 5