Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin

Abstract

Therapy of acute hepatitis C (AHC)has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 lg/kg/week) for 24 or 12 weeks (arm 1, n 5 44 and arm 2, n 5 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n 5 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P 5 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated. Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration. (HEPATOLOGY 2014;59:2101-2109 E ven though acute hepatitis C (AHC) incidence is gradually declining over the years in developed countries, 1 new infections continue to occur. The current major risk factors for hepatitis C virus (HCV) transmission are intravenous (IV) drug use, viral exposure during invasive diagnostic or therapeutic procedures, and sexual contacts. 1,2 Whereas the clinical course is normally mild, AHC has a high rate of progression to chronic HCV infection, ranging between 50% and 80%. 3 Treatment of AHC has been shown to be effective in reducing risk of progression to chronic HCV

Current Treatment Approach in Acute Hepatitis C Infection

“…They reported SVR at the rates of 67.6%, 82.4% and 91.2% with 8, 12 and 24 weeks of peg-IFN treatment, respectively. Age, gender and HCV genotype were found not to be associated with SVR, while rapid virologic response was reported to play an important role in achieving SVR (21).…”

Response to treatment following recently acquired hepatitis C virus infection in a multicentre collaborative cohort

“…Several variables of clinical interest relating to injecting drug use, substance use and behaviour were differentially collected across sites, precluding their use in the analysis. Similarities in treatment length (95% received 24 weeks PEG‐IFN) limit our ability to comment on differences treatment duration, although recent randomized trial data indicate equivalent response at 12 and 24 weeks in acute HCV mono‐infection . While there was no apparent additional benefit of RBV to PEG‐IFN in HCV mono‐infection, the small numbers receiving combination therapy ( n = 36) limits power to detect small differences.…”

Symptomatic Acute Hepatitis C Infection Following a Single Episode of Unprotected Sexual Intercourse

“…Until recently interferon-based regimens have been used, with pegylated interferon- α monotherapy for 24 weeks leading to SVR in >90% of cases [3]. The addition of ribavirin to pegylated interferon- α may further improve SVR rates, particularly in the treatment of HCV genotype 1a [11, 12] and in patients with other predictors of treatment failure, such as slow viral response or HIV coinfection [3]. Our patient received pegylated interferon and ribavirin combination therapy due to the presence of genotype 1a and suspected rather than proven acute HCV infection.…”