Prolonged treatment with pegylated interferon α 2b plus ribavirin improves sustained virological response in chronic hepatitis C genotype 1 patients with late response in a clinical real‐life setting in Japan

Aim: This study was conducted to clarify the factors related to sustained virological response (SVR) to pegylated interferon α 2b (PEG‐IFN) plus ribavirin (RBV) combination therapy administered for 48 weeks in patients with chronic hepatitis C virus (CHCV) and to evaluate the usefulness of prolonged treatment in patients with late virological response (LVR). Methods: Of 2257 patients registered at 68 institutions, those with genotype 1 and high viral load were selected to participate in two studies. Study 1 (standard 48‐week group, n = 1480) investigated SVR‐determining factors in patients who received the treatment for ≤52 weeks, whereas study 2 compared SVR rates between patients with LVR who received treatment for either 36–52 weeks (48‐week group, n = 223) or 60–76 weeks (72‐week group, n = 73). Results: In study 1, SVR rate was 44.9%; that in male subjects (50.4%) was significantly (P < 0.0001) higher than in female subjects (36.4%). SVR rate significantly (P < 0.0001) decreased with 10‐year age increments in both sexes. Multivariate logistic regression analysis revealed that age, F score, platelet count, and HCV load were SVR‐related factors. In study 2, SVR rate in the 72‐week group (67.1%) was significantly (P = 0.0020) higher than in the 48‐week group (46.2%). Conclusions: Patients with CHCV genotype 1 infection should be treated with PEG‐IFN plus ribavirin combination therapy as early as possible, and 72 weeks' treatment is recommended in patients with LVR regardless of age.     

A multicenter survey of re‐treatment with pegylated interferon plus ribavirin combination therapy for patients with chronic hepatitis C in Japan

Aim: This study aimed to clarify the factors associated the efficacy of re‐treatment with pegylated interferon (PEG IFN) plus ribavirin combination therapy for patients with chronic hepatitis C who had failed to respond to previous treatment. Methods: One hundred and forty‐three patients who had previously shown relapse (n = 79), non‐response (n = 34) or intolerance (n = 30) to PEG IFN plus ribavirin were re‐treated with PEG IFN plus ribavirin. Results: Twenty‐five patients with intolerance to previous treatment completed re‐treatment and the sustained virological response (SVR) rates were 55% and 80% for hepatitis C virus (HCV) genotype 1 and 2, respectively. On re‐treatment of the 113 patients who completed the previous treatment, the SVR rates were 48% and 63% for genotype 1 and 2, respectively. Relapse after previous treatment and a low baseline HCV RNA level on re‐treatment were associated with SVR in genotype 1 (P < 0.001). Patients with the interleukin‐28B major genotype responded significantly better and earlier to re‐treatment, but the difference in the SVR rate did not reach a significant level between the major and minor genotypes (P = 0.09). Extended treatment of 72 weeks raised the SVR rate among the patients who attained complete early virological response but not rapid virological response with re‐treatment (72 weeks, 73%, 16/22, vs 48 weeks, 38%, 5/13, P < 0.05). Conclusion: Relapse after previous treatment and a low baseline HCV RNA level have predictive values for a favorable response of PEG IFN plus ribavirin re‐treatment for HCV genotype 1 patients. Re‐treatment for 72 weeks may lead to clinical improvement for genotype 1 patients with complete early virological response and without rapid virological response on re‐treatment.     

Ribavirin dose reduction raises relapse rate dose-dependently in genotype 1 patients with hepatitis C responding to pegylated interferon alpha-2b plus ribavirin

Summary.  The impact of ribavirin exposure on virologic relapse remains controversial in combination therapy with pegylated interferon (Peg-IFN) and ribavirin for patients with chronic hepatitis C (CH-C) genotype 1. The present study was conducted to investigate this. Nine hundred and eighty-four patients with CH-C genotype 1 were enrolled. The drug exposure of each medication was calculated by averaging the dose actually taken. For the 472 patients who were HCV RNA negative at week 24 and week 48, multivariate logistic regression analysis showed that the degree of fibrosis ( P  =   0.002), the timing of HCV RNA negativiation ( P  <   0.001) and the mean doses of ribavirin ( P  <   0.001) were significantly associated with relapse, but those of Peg-IFN were not. Stepwise reduction of the ribavirin dose was associated with a stepwise increase in relapse rate from 11% to 60%. For patients with complete early virologic response (c-EVR) defined as HCV RNA negativity at week 12, only 4% relapse was found in patients given ≥12 mg/kg/day of ribavirin and ribavirin exposure affected the relapse even after treatment week 12, while Peg-IFN could be reduced to 0.6 μg/kg/week after week 12 without the increase of relapse rate. Ribavirin showed dose-dependent correlation with the relapse. Maintaining as high a ribavirin dose as possible (≥12 mg/kg/day) during the full treatment period can lead to suppression of the relapse in HCV genotype 1 patients responding to Peg-IFN alpha-2b plus ribavirin, especially in c-EVR patients.     

Antiviral therapy (pegylated interferon and ribavirin) of hepatitis C in dialysis patients: meta‐analysis of clinical studies

Information on the antiviral treatment (pegylated interferon plus ribavirin) of chronic infection by hepatitis C virus (HCV) in patients on long‐term dialysis is extremely limited. We evaluated the efficacy and safety of combination antiviral therapy (pegylated interferon plus ribavirin) in patients on long‐term dialysis with chronic hepatitis C by performing a systematic review of the literature with a meta‐analysis of clinical studies. The primary outcome was sustained virological response (SVR) (as a measure of efficacy); the secondary outcome was dropout rate (as a measure of tolerability). We used the random‐effects model of DerSimonian and Laird, with heterogeneity and sensitivity analyses. We identified eleven clinical studies (287 unique patients), two of them being controlled clinical trials. The summary estimate for SVR and dropout rate was 0.60 (95% Confidence Intervals, 0.47; 0.71) and 0.18 (95% CI, 0.08; 0.35), respectively; studies being heterogeneous with regard to both the outcomes. Stratified analysis reported a higher SVR rate in controlled trials, 0.86 (95% CI, 0.27; 0.99). The most common sources of dropout were anaemia (11/46 = 23%) and infections (6/46 = 13%). Meta‐regression analysis showed a detrimental impact of HCV genotype 1 (P = 0.036) and dropout (P = 0.0001) rate upon the frequency of SVR. Antiviral therapy based on pegylated interferon plus ribavirin for HCV gives encouraging results in terms of efficacy and safety among patients on long‐term dialysis; such approach should be considered the current standard of care for HCV‐infected individuals on regular dialysis.     

Therapeutic effects of pegylated interferon plus ribavirin in chronic hepatitis C patients with occult hepatitis B virus dual infection

Background and Aim: Occult hepatitis B virus (HBV) infection is defined by the detectable serum HBV–DNA in HBV surface antigen‐negative patients. This retrospective study aims to evaluate the therapeutic effects of combined pegylated interferon (PEG–IFN) plus ribavirin (RBV) in patients with concurrent occult HBV/hepatitis C virus (HCV) dual infection. Methods: In total, 126 consecutive chronic hepatitis C (CHC) patients who received combined PEG–IFN and RBV therapy were included. Patients were divided into the occult HBV/HCV dual infection group or the HCV‐monoinfected group according to whether or not they had the detectable serum HBV–DNA. The biochemical and virological responses to combined therapy were compared between these two groups. Serum HCV‐RNA and HBV–DNA were checked before treatment, at the end of treatment as well as at 6‐ and 12‐months' follow up in the occult HBV/HCV group. Result: Six patients were seropositive for HBV–DNA and were included in the occult HBV/HCV dual infection group. There were no statistical differences in the biochemical and virological responses to combined therapy between these two groups. Undetectable serum HBV–DNA was noted at the end of the treatment and the 6‐ and 12‐months' follow up in patients with occult HBV/HCV dual infection. Conclusion: Occult HBV infection in CHC patients is rare. The biochemical and virological responses to combined PEG–IFN and RBV therapy might be similar in CHC patients with or without occult HBV infection. The serum HBV–DNA level was low in patients with occult HBV/HCV dual infection who responded to combined therapy.     

Effect of vitamin D supplementation on pegylated interferon/ribavirin therapy for chronic hepatitis C genotype 1b: a randomized controlled trial

Chronic HCV–infected patients tend to have vitamin D deficiency, suggesting that vitamin D supplementation may enhance the efficacy of treatment with pegylated interferon (PEG‐IFN) and ribavirin (RBV). We therefore assessed the effects of vitamin D supplementation on viral response to PEG‐IFN/RBV. Eighty‐four patients with HCV genotype 1b were randomized, 42 to oral vitamin D supplementation (1000 IU/day) and 42 to nonsupplementation (control), from week 8 to the end of PEG‐IFN/RBV therapy. The primary end point was undetectable HCV RNA at week 24 (viral response [VR]). VR rate at week 24 was significantly higher in the vitamin D than in the control group (78.6% vs 54.8% P = 0.037). Adverse events were similar in both groups. When patients were subdivided by IL28B SNP rs8099917 genotype, those with the TT genotype group showed a significantly higher VR rate at week 24 with than without vitamin D supplementation (86.2% vs 63.3% vs P = 0.044). Although patients with the TG/GG genotype, who were relatively resistant to PEG‐IFN treatment, had similar VR rates at week 24 with and without vitamin D supplementation, the decline in viral load from week 8 to week 24 was significantly greater with than without vitamin D supplementation. Multivariate analysis showed that rs8099917 genotype and vitamin D supplementation contributed significantly to VR at week 24. SVR rates were similar in the vitamin D and control groups [64.3% (27/42) vs 50% (21/42), P = 0.19]. Vitamin D supplementation may enhance the effects of PEG‐IFN/RBV in HCV genotype 1b–infected patients.     

Short-term prolongation of pegylated interferon and ribavirin therapy for genotype 1b chronic hepatitis C patients with early viral response

Aim:  We tailored extended treatments using pegylated interferon (PEG IFN) and ribavirin (RBV) to viral responses after initiation of therapy and investigated the efficacy and safety of its therapy for chronic hepatitis C (CHC) patients.
Methods:  Eighty-two genotype 1b CHC patients were enrolled in the present study. All patients received PEG IFN-α-2b and weight-based RBV therapy. We defined a viral response in which serum HCV-RNA is undetectable at week 4 as rapid viral response (RVR), detectable at week 4 and undetectable by week 12 as early viral response (EVR), and detectable at week 12 and undetectable by week 24 as late viral response (LVR). We set the treatment duration depending on viral response; 48 weeks for RVR patients and 72 weeks for LVR. Furthermore, EVR patients received a short-term extension of treatment duration to 52–60 weeks. We prospectively investigated sustained viral response (SVR) rates of these groups.
Results:  Overall SVR rate for the total patient group was 57.3%. SVR rates of the RVR, EVR and LVR patients were 100%, 80.5% and 40.0%, respectively. Nine patients could not complete this treatment protocol. Baseline platelet count and mutation in the interferon sensitivity-determining region of NS5A were significant independent predictors of SVR, and amino acid substitution of the core region was a significant independent predictor of non-viral response by multivariate logistic regression analyses.
Conclusion:  The results indicate that short-treatment extension of PEG IFN plus RBV treatment protocols in EVR patients can improve overall SVR rates.     

聚乙二醇干扰素加利巴韦林治疗慢性丙型肝炎疗效影响因素分析

目的研究聚乙二醇干扰素α-2a联合利巴韦林治疗慢性丙型肝炎（丙肝）疗效的影响因素。方法101例慢性丙肝患者均给予聚乙二醇干扰素α-2a 180μg／周联合利巴韦林10．6～15．0mg／（kg·d）,疗程48周,分析性别、体重指数（body mass index,BMI）、初始HCVRNA定量、ALT及GLU等对持续病毒学应答（sustainedvirologicresponse,SVR）的影响。结果聚乙二醇干扰素α-2a联合利巴韦林治疗慢性丙肝总的SVR率为50％,其中获得快速病毒学应答（rapid virologic response．RVR）和早期病毒学应答（early virologic response,EVR）患者实现SVR达100％,未获得RVR和EVR患者实现SVR为19．35％;高BMI值、发生脂肪肝的患者不容易达到SVR,而糖化血红蛋白、初始HCVRNA载量高、GLU、ALT及性别对SVR无影响。结论RVR、EVR可以预测SVR;BMI、是否合并脂肪肝是聚乙二醇干扰素α-2a联合利巴韦林治疗慢性丙肝获得SVR的影响因素。     

Chronic hepatitis C genotype 6 responds better to pegylated interferon and ribavirin combination therapy than genotype 1

Background and Aims: Chronic hepatitis C genotype 6 is common in Hong Kong, especially among i.v. drug abusers. Responses of these patients to combination of pegylated interferon and ribavirin treatment were inconsistent and the numbers of patients involved in previous studies were small. We performed a retrospective study to compare the therapeutic responses of this regimen in patients infected with genotype 6 and genotype 1. Methods: Seventy patients with either genotype 6 or genotype 1 were recruited. Both groups received 800–1200 mg of ribavirin daily plus either 180 mg of pegylated α‐interferon‐2a or 1.5 mg/kg pegylated α‐interferon‐2b weekly for 48 weeks. Their responses to treatments were compared. Results: The early virological response to combination therapy of patients with genotype 6 was significantly better than that of genotype 1 (88.6% vs 74.3%, P = 0.03). Significant difference was also identified in the end of treatment response of the two genotypes (60% vs 81.4% for genotype 1 and 6, respectively; P = 0.005). The sustained virological response (SVR) to treatment in patients with genotype 6 was also significantly superior to that of patients with genotype 1 (75.7% vs 57.1%, P = 0.02). Multiple logistic regression analysis demonstrated that age of 55 years or less, genotypes of hepatitis C virus, liver biopsy staging and baseline hepatitis C virus RNA of 200 000 IU/mL or less were independent predictors for better SVR in this cohort. Conclusion: Patients with chronic hepatitis C genotype 6 respond better to pegylated interferon and ribavirin combination treatment than patients with genotype 1.     

Adjuvant epoetin‐β with peginterferon‐α and ribavirin in Japanese ribavirin‐intolerant relapsed patients with chronic hepatitis C genotype 2

Erythropoietin is widely used in the USA and some other Western countries to maintain doses of ribavirin during peginterferon/ribavirin‐based treatment for chronic hepatitis C virus (HCV) infection. However, the impact of erythropoietin on sustained virological response (SVR) is unclear. Here, we report the cases of three Japanese ribavirin‐intolerant relapsed patients with HCV genotype 2 who achieved SVR from retreatment by adding erythropoietin. Three women aged 50, 64 and 68 years with chronic HCV genotype 2 received retreatment with peginterferon‐α and ribavirin. During their prior therapy, HCV RNA became negative according to real‐time polymerase chain reaction at weeks 4–8 in all three patients; however, the total dose of ribavirin was 18.1–30.6% lower than the planned dose, and HCV RNA relapsed post‐treatment. At present, epoetin‐β 24 000 IU was introduced at weeks 2 or 3 of dual‐combination therapy, resulting in a less than 4.2% reduction in the total dose of ribavirin. HCV RNA became negative at weeks 4–8, and all patients achieved SVR. Until the next‐generation antiviral treatments for HCV genotype 2 become available, the addition of erythropoietin to dual therapy can be a treatment of choice for ribavirin‐intolerant relapsed patients.     

Impact of early viral kinetics on pegylated interferon alpha 2b plus ribavirin therapy in Japanese patients with genotype 2 chronic hepatitis C

Summary. The recommended therapy for genotype‐2 chronic hepatitis C is a regimen of pegylated interferon alpha (peginterferon) plus ribavirin. This study was conducted to determine the value of early viral kinetics as a predictive factor for sustained virologic responder (SVR). Peginterferon alpha 2b (1.5 μg/kg/week) plus weight‐based ribavirin (600–1000 mg/day) was administered to 51 patients with chronic HCV genotype 2 for 24 weeks. The HCV‐RNA loads were measured at the baseline, hour 24, and week 1. The rebound index (RI, an index obtained from the viral load of week 1 divided by that of hour 24) was calculated. Compared with the baseline, the viral load at hour 24 for SVR was reduced by more than 1‐log: it continued to decline thereafter, and at week 1 it was significantly lower than at hour 24 (P < 0.05). The viral load for non‐SVR increased again between hour 24 and week 1. The SVR of patients with RI ≤1.0 was 100% (39/39). The SVR conversion for rapid virologic responders was 92% (35/38). The RI (≤1.0) was the only significant independent factor for SVR by multiple logistic regression analysis and is the first predictive factor in 24‐week peginterferon plus ribavirin therapy for patients infected with genotype 2.     

Enhanced efficacy of pegylated interferon alpha‐2a over pegylated interferon and ribavirin in chronic hepatitis C genotype 4A randomized trial and quality of life analysis

Aim: The therapy of chronic hepatitis C genotype 4 (HCV‐4) has not been optimized yet. This randomized, prospective, parallel‐group clinical trial compared the efficacy and safety of pegylated interferon α‐2a (PEG‐IFN α‐2a) plus ribavirin and PEG‐IFN α‐2b plus ribavirin and assessed the health‐related quality of life (HRQOL) in patients with chronic HCV‐4. Methods: Eligible patients with proven chronic HCV‐4 were randomized to receive either a weekly dose of PEG‐IFN α‐2a (180 μg) or PEG‐IFN α‐2b (1.5 μg/kg) and a daily dose of ribavirin (1000–1200 mg) for 48 weeks with 24 weeks post‐treatment follow‐up. The primary end point was sustained virological response (SVR) defined by undetectable HCV RNA 24 weeks after treatment. The Short form‐36 Health Survey version 2 (SF‐36v2) and the Chronic Liver Disease questionnaires (CLDQ) were assessed before, during and after therapy. Results: The overall SVR rate of the entire cohort was 59.9%. The SVR rates were significantly higher in patients treated with PEG‐IFN α‐2a and ribavirin (Group A; n=109) compared with those treated with PEG‐IFN α‐2b and ribavirin (Group B; n=108, 70.6 vs. 54.6%, respectively; P=0.017). The relapse rates were 5.1% for PEG‐IFN α‐2a and 15.7% for PEG‐IFN α‐2b (P=0.0019). The SF‐36v2 and CLDQ were low during therapy and improved significantly after therapy successful therapy. Conclusion: Pegylated interferon α‐2a plus ribavirin was significantly more effective than PEG‐IFN α‐2b and ribavirin therapy in the treatment of chronic HCV‐4 patients. The tolerability and adverse events were comparable between the two regimens. The HRQOL improved significantly after successful PEG‐IFN α‐2a plus ribavirin therapy.     

Low dose erythropoietin‐beta improves anemia and maintains ribavirin dose in chronic hepatitis C patients receiving combination therapy with ribavirin plus pegylated interferon Alfa‐2b

Aim: Anemia during combination therapy with pegylated interferon alfa‐2b plus ribavirin (RBV) for chronic hepatitis C virus (HCV) patients usually leads to RBV dose reduction or discontinuation. This study evaluated the effect of erythropoietin‐beta (EPO‐β) to maintain RBV dose and hemoglobin (Hb) level in chronic HCV patients treated with antiviral combination therapy. Methods: Eighty‐eight chronic HCV patients who developed anemia during therapy were enrolled into this retrospective study: 55 in the EPO‐β group and 33 in the untreated group. The study endpoints were to assess the RBV maintenance and the changes in Hb. Results: A higher percentage of patients with RBV maintenance was observed in the EPO‐β group compared with the untreated group (nadir Hb level <10.5 g/dL; 70% vs. 38%, P = 0.020; nadir Hb < 10 g/dL; 62% vs. 27%, P = 0.046). The mean Hb change from week 12 to week 20 was higher in the EPO‐β group when compared with the untreated group, especially for patients receiving a total EPO‐β dose of more than 16 000 U (+0.70 g/dL vs. ?0.32 g/dL, P = 0.023) and of 10 000 U‐14 000 U (+0.60 g/dL vs. ?0.32 g/dL, P = 0.023). Conclusions: Low‐dose EPO‐β can maintain RBV dose and increase Hb levels in anemic chronic HCV patients receiving combination therapy.     

Dose comparison study of pegylated interferon-α-2b plus ribavirin in naïve Japanese patients with hepatitis C virus genotype 2: A randomized clinical trial

Background and Aim:  To compare the efficacy and safety of pegylated interferon (PEG-I) at 1 and 1.5 µg/kg, and in combination with ribavirin (RBV) for 24 weeks in naïve Japanese patients infected with hepatitis C virus genotype 2.
Methods:  The present study was an open-label, randomized trial of 55 patients receiving PEG-I (1 or 1.5 µg/kg body weight [BW], subcutaneously, once a week) and RBV for 24 weeks. The patients were followed up for 24 weeks without treatment.
Results:  The intention-to-treat analyses showed that the proportion of patients with a sustained virological response (SVR) in the 1-µg/kg PEG-I–RBV group (38.5%, 10/26) was lower than that of the 1.5-µg/kg PEG-I–RBV group (74.1%, 20/27; P  = 0.013). The PEG-I dose was reduced in two of the 26 patients of the 1-µg/kg PEG-I–RBV group (one because of thrombocytopenia at 2 weeks, and one because of generalized fatigue at 20 weeks), and four of the 27 patients of the 1.5-µg/kg PEG-I–RBV group (one because of neutropenia at 20 weeks, and three because of generalized fatigue at 1, 5, and 8 weeks). The multivariate analysis identified age (< 60 years) and dose of PEG-I (1.5 µg/kg) as significant determinants of SVR.
Conclusion:  The dose of PEG-I to be used at the start of therapy should be 1.5-µg/kg BW in naïve Japanese patients infected with hepatitis C virus genotype 2.     

Association between the treatment length and cumulative dose of pegylated interferon alpha-2b plus ribavirin and their effectiveness as a combination treatment for Japanese chronic hepatitis C patients: Project of the Kyushu University Liver Disease Study Group

Aim:  The aim of the present study was to investigate the association between the length of the treatment period and the cumulative dose of pegylated interferon alpha-2b (peg-IFN alpha-2b) plus ribavirin (RBV) and their effectiveness in the treatment of chronic hepatitis C.
Methods:  Seven hundred and fifteen patients received peg-IFN alpha-2b plus RBV treatment for 48 weeks and 24 weeks for genotypes 1 ( n  = 586) and 2 ( n  = 129), respectively.
Results:  Sustained virological responses (SVR), defined as serum hepatitis C virus (HCV)-RNA undetectable at 24 weeks after the end of treatment, were 42.4% and 74.4% in genotypes 1 and 2, respectively, on an intention-to-treat analysis. SVR significantly increased with treatment length (4.7%, 36.4%, and 51.8% for < 24 weeks, 24–47 weeks, and 48 weeks, respectively, for genotype 1; and 28.6%, 57.1%, 78.3% for < 12 weeks, 12–23 weeks, and 24 weeks, respectively, for genotype 2). SVR significantly increased with total cumulative treatment dose (21.1%, 36.5%, and 52.9% with < 60%, 60–79%, and ≥ 80% in peg-IFN dose; 29.6%, 51.1%, and 59.2% with < 60%, 60–79%, and ≥ 80% in RBV dose) in genotype 1, although it did not differ significantly for genotype 2.
Conclusions:  In peg-IFN alpha-2b plus RBV treatment for chronic hepatitis C, it is important to complete the target length of treatment and to continue the target dosage to achieve SVR, especially for genotype 1 patients.     

Comparison of low-dose pegylated interferon versus standard high-dose pegylated interferon in combination with ribavirin in patients with chronic hepatitis C with genotype 3: an Indian experience

Background and Aims: In chronic hepatitis C virus (HCV) infection with genotype 3, therapy with pegylated interferon (peg‐IFN) alfa‐2b in a dose of 1.5 μg/kg/week and ribavirin (800–1000 mg/day) is recommended for 24 weeks. Reduced doses of peg‐IFN may increase compliance and decrease cost and adverse events. This study aimed to assess the safety and efficacy of two different regimens of peg‐IFN alfa‐2b, in combination with ribavirin, in genotype 3 patients. Methods: A total of 103 liver biopsy–proven chronic HCV patients with genotype 3, having alanine aminotransferase levels >1.2 × ULN and positive HCV‐RNA were randomized into two groups: group I (n = 76; age, 43.1 ± 11.4 years; male/female, 67/9) received peg‐IFN 1.0 μg/kg/week + ribavirin 10.6 mg/kg/day, while group II (n = 27; age, 37.3 ± 11.6 years; male/female, 21/6) received peg‐IFN 1.5 μg/kg/week + ribavirin 10.6 mg/kg/day. Patients in both groups were treated for 24 weeks. End of treatment viral response (ETVR) and sustained viral response (SVR) after a 6‐month follow‐up period were assessed. Results: In both groups I and II, one patient was lost to follow‐up, while one patient in group II withdrew due to side‐effects. ETVR was seen in 72/76 (94.7%) of patients in the low dose group and 24/27 (88.9%) of patients in the high dose group (P = 0.375). SVR was seen in 60/76 (78.9%) of patients in the low dose group and 25/27 (92.6%) of patients in the high dose group (P = 0.145). Age (Pearson correlation coefficient = 0.263; P = 0.008) and fibrosis (correlation coefficient, 0.263; P = 0.008) showed a significant correlation with the SVR. Conclusion: In patients with genotype 3, peg‐IFN at 1.0 μg/kg/week with ribavirin is as effective as peg‐IFN at 1.5 μg/kg/week with ribavirin.     

Pegylated alpha-interferon-2a plus ribavirin compared with pegylated alpha-interferon-2b plus ribavirin for initial treatment of chronic hepatitis C virus: prospective, non-randomized study

Background and Aim:  We assessed whether the two regimens of pegylated α-interferon-2b (PEG-IFN-α2b) plus ribavirin and pegylated α-interferon-2a (PEG-IFN-α2a) plus ribavirin showed differences in terms of sustained virological response, withdrawal due to side-effects and dose adjustment requirements in the treatment of naive chronic hepatitis C virus (HCV) patients.
Methods:  A prospective non-randomized, open-label comparison was made of naive HCV-infected patients undergoing standard 24- or 48-week treatment with two PEG-IFN combined with weight-based dosing regimen of ribavirin (PEG-IFN-α2a/ribavirin, n  = 91; PEG-IFN-α2b/ribavirin, n  = 92).
Results:  Sustained virological response was similar in PEG-IFN-α2a and PEG-IFN-α2b (65.9% vs 62%, P  = 0.64), without differences according to genotype. In 117 patients with HCV genotype 1, the corresponding rates were 50.8% versus 46.6% ( P  = 0.713). Rapid virological response at 4 weeks, early virological response at 12 weeks and transient virological response were also similar. In the multivariate analysis, HCV genotype (odds ratio [OR] = 0.076, 95% confidence interval [CI] 0.029–0.198, P  = 0.000) and presence of steatosis in the liver biopsy (OR = 2.799, 95% CI 1.362–5.755, P  = 0.005) were significantly associated with response to antiviral therapy. The rate of withdrawals due to treatment-related adverse events was 13.2% in the group of PEG-IFN-α2a and 10.9% in the group of PEG-IFN-α2b. Dose modification of PEG-IFN was necessary in eight patients given PEG-IFN-α2a and in seven given PEG-IFN-α2b.
Conclusion:  The two PEG-IFN plus ribavirin have comparable anti-HCV activity as shown by similar percentages of patients with sustained virological response.