Yu ML, Dai CY, Huang JF, Hou NJ, Lee LP, Hsieh MY, et al. A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C. Gut 2007;56:553-559

Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Gut (Impact Factor: 14.66). 05/2007; 56(4):553-9. DOI: 10.1136/gut.2006.102558
Source: PubMed


The recommended treatment for patients infected with hepatitis C virus genotype 2 (HCV2) is pegylated interferon (peginterferon) and ribavirin for 24 weeks.
To assess whether a shorter 16-week treatment is as effective as a standard 24-week treatment.
Patients with HCV2 infection were randomised in a 1:2 ratio to either 16 weeks (n = 50) or 24 weeks (n = 100) of treatment with peginterferon alpha-2a (180 mug/week) and weight-based ribavirin 1000-1200 mg/day, with a 24-week follow-up period. A rapid virological response (RVR) was defined as seronegative for HCV RNA at 4 weeks of treatment, and the primary end point, sustained virological response (SVR), as seronegative for HCV RNA at the 24-week follow-up.
The rate of RVR and SVR was 86% (43/50, 95% confidence interval (CI) 76% to 96%) and 94% (47/50, CI 87% to 100%), respectively, in the 16-week group, which was comparable to 87% (87/100, CI 80% to 94%) and 95% (95/100, CI 91% to 99%) in the 24-week group. Patients with RVR had a significantly higher SVR rate than patients without RVR in both 16-week (100% vs 57%, p = 0.015) and 24-week groups (98% vs 77%, p = 0.002). Multivariate analysis showed that RVR and age were independent factors associated with SVR. Both treatment arms were equally well tolerated. The incidence of alopecia was significantly higher in the 24-week group (49%) than in the 16-week group (20%, p = 0.001).
16 weeks and 24 weeks of peginterferon treatment with weight-based ribavirin at a dose of 1000-1200 mg/day provided equal efficacy in patients with HCV2 who achieved RVR at 4 weeks.

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    • "Third, PBMC sampling is not included in the current routine clinical practice. Finally, approximately 85% of HCV genotype 2 or 3 patients could achieve an SVR to the current standard-of-care (Yu et al., 2007). The role of PBMC miR-125b on HCV-2/3 remains to be determined. "
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    ABSTRACT: Backgrounds Chronic hepatitis C virus (HCV) infection has been associated with induction of microRNAs (miRNAs) in peripheral blood mononuclear cells (PBMC). We aimed to evaluate the role of PBMC-miRNAs in the treatment outcome to antiviral therapy for HCV genotype 1 (HCV-1) patients. Methods Treatment-naive chronic HCV-1 patients, including 13 in screening phase and 48 in validation phase, were treated with 48 weeks of peginterferon/ribavirin. The primary end-point was the achievement of a sustained virological response (SVR, HCV RNA undetectable during 24 weeks post-treatment follow-up). Expression profiling of PBMC-miRNAs was performed by quantitative PCR-based array in typical responders and null-responders. Then candidate PBMC-miRNAs were validated by quantitative PCR in an independent validation set. Results PBMC-miR-125b was significantly predictive of an SVR, with expression levels of 5.28-fold lower in sustained responders versus null-responders (p=0.0163). In multivariate analysis, PBMC-miR-125b was significantly associated with the achievement of SVR (per 2-fold decrease, odds ratio/95% confidence interval (OR/CI): 2.07/1.14-6.31) independent of sex, age and interleukin-28B genotype. In patients who did not achieve a rapid virological response (RVR, undetectable HCV RNA at treatment week 4), PBMC-miR-125b was the only predictive factor of an SVR (per 2-fold decrease, OR/CI: 2.07/1.14-6.31). However, the circulating and hepatic miR-125b did not show significant difference between responders and non-responders. Conclusions PBMC-miR-125b expression levels were inversely related to the achievement of an SVR in HCV-1 patients, independent of interleukin-28B genotype, and was the single predictor of SVR in non-RVR patients.
    Full-text · Article · May 2014 · Antiviral research
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    • "Studies have also suggested that it is reasonable to treat some patients infected with this genotype for only 12–16 weeks. Conversely, the most prevalent genotype worldwide, genotype 1 is the least responsive [5] [6] [7]. The SVR for patients infected with genotype 1 is less than 50%. "
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    ABSTRACT: Introduction HCV is the leading cause of death throughout the world.The standard of care for the treatment of chronic hepatitis C is combination therapy with Pegylated Interferon (PEG-IFNα 2a) and Ribavirin (RBV). There currently exists no systematic explanation for these genotype-specific differences in clinical outcome. Furthermore, whether factors that govern outcome for one genotype play a similar role in other genotype remains to be fully explored. Hence, the present study was taken in consideration of the factors emphasizing their impact on the SVR against HCV genotypes. Methodology A total of 50 patients of age (Mean±SD 42.53 ± 12.6) having chronic hepatitis C genotype 3 and genotype 1 who showed positive result for HCV-RNA for more than 6 months were treated with combination therapy of PEG-IFNα 2a and RBV. All the patients were followed up for 48 weeks of post treatment and varied virological response was recorded in respect to the HCV genotypes, subtypes and biological parameters. Results In the present study, we have observed that males had a better SVR and EVR as compared to females in both the genotypes (genotype 1 and genotype 3) and among the non responders there were less males as compared to females. It was seen that there were less females who showed EVR and SVR as compared to males. Conclusion Our study has demonstrated that EVR, RVR, NR and most importantly SVR are important factors for the achievement of complete virological response against HCV genotypes and subtypes. Keywords Virological response, HCV, Pegylated Interferon-α and Ribavirin
    Full-text · Article · Jan 2014
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    • "[3] Recently, the introduction of direct antiviral agents (DAA) has greatly improved the sustained virological response (SVR) rate in patients with HCV genotype 1 (HCV-1) infection.[4] On the other hand, pegylated interferon (peginterferon)/ribavirin, which is the standard-of-care for HCV-2 patients, has provided satisfactory results with an SVR rate of 80–93%.[5]–[7] As a consequence, only a minority of HCV-2 patients fail antiviral therapy and are prone to be neglected because of the excellent treatment efficacy toward HCV-2 infection. "
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    ABSTRACT: BACKGROUNDAIMS: The impact of virological factors and interleukin-28B (IL-28B) genetic variants on retreatment of hepatitis C virus genotype 2 (HCV-2) treatment-experienced patients remains unknown. On-treatment virological responses and IL-28B rs8099917 genotype were determined in 46 HCV-2 treatment-experienced patients (42 previous relapsers; four previous non-responders) retreated with 24-week peginterferon/ribavirin. Forty (87.0%) patients carried the rs8099917 TT genotype and 6 patients (13.0%) carried the TG/GG genotype. The sustained virological response (SVR; seronegativity of HCV RNA throughout 24 weeks of the post-treatment follow-up period) rate was 71.7%. Compared with previous non-responders, previous relapsers had a significantly higher SVR rate (78.6% vs. 0%, P = 0.004) and a lower relapse rate (17.5% vs. 100%, P = 0.04). All the previous non-responders were with the rs8099917 TT genotype. As for those who relapsed, treatment responses, including the rates of rapid virological response (RVR, 80.6% vs. 66.7%, P = 0.59), early virological response (EVR, 97.2% vs. 83.3%, P = 0.27), end-of-treatment virological response (97.2% vs. 83.3%, P = 0.27) and SVR (80.6% vs. 66.7%, P = 0.59) and relapse rate (17.1% vs. 20.0%, P = 1) did not differ significantly between patients with the rs8099917 TT and those with the non-TT genotype. Multivariate analysis revealed that the most important factor predictive of an SVR in the retreatment of HCV-2 was previous relapse; the only factor predictive of an SVR for previous relapsers was the achievement of an EVR. Compared with the achievement of a RVR, the attainment of an EVR was more accurate in predicting an SVR (88% vs. 74%). Peginterferon/ribavirin is effective in the retreatment of HCV-2 relapsers, especially among those who achieved an EVR.
    Full-text · Article · Mar 2013 · PLoS ONE
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