Dataset Information

High Rate of Virological Response to Peginterferon ?-2a-Ribavirin Among Non-Cirrhotic Iranian Hemophilia Patients With Chronic Hepatitis C.

ABSTRACT: BACKGROUND:Hepatitis C is a major reason of morbidity and mortality among hemophilia patients. Although combination therapy with peginterferon (peg-INF) and ribavirin is considered as standard treatment for chronic hepatitis C (CHC), but more evidence of the efficacy and safety is needed. OBJECTIVES:In this study, efficacy and tolerability of combination therapy with peginterferon ?-2a-ribavirin was investigated among hemophilia HCV infected patients. PATIENTS AND MATERIALS:In a quasi-experimental, 45 naive hemophilia patients with chronic HCV received 180 mg of pegylated interferon (Pegasys) by subcutaneous injection weekly plus an oral dose of 800-1200 µg ribavirin daily according to body weight. The treatment continued 48 weeks in patients with genotype one and 24 weeks in those with genotype 3. Sustained virological response (SVR) was considered as efficacy of treatment. RESULT:Forty three patients (95.6%) reached to end of treatment response (ETR); only two (4.4%) patients did not respond and were discontinued from treatment. None of 43 patients relapsed. SVR obtained in 43 of 45 patients (95.6%), in multivariate logistic regression model, third month's treatment WBC (WBC > 2000) remained the only significant predictor of SVR. Regimen dose reduced in three patients; two of those because of ALT increasing and other one for his retinal bleeding. In repeated measurement analysis, alanine aminotransferase (ALT) and hemoglobin (Hb) decreased significantly during treatment, but reduction of platelet (PLT) was not significant. CONCLUSIONS:Results show high efficacy and safety of combination therapy of Peg-IFN-? 2a plus ribavirin among hemophiliacs with chronic hepatitis C.

SUBMITTER: Alavi Moghaddam M

PROVIDER: S-EPMC3470839 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

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High Rate of Virological Response to Peginterferon α-2a-Ribavirin Among Non-Cirrhotic Iranian Hemophilia Patients With Chronic Hepatitis C.

Alavi Moghaddam Mostafa M Zali Mohammad Reza MR Aalaei Andabili Seyed Hossein SH Derakhshan Faramarz F Miri Seyed Mohammad SM Alavian Seyed Moayed SM

Iranian Red Crescent medical journal 20120830 8

<h4>Background</h4>Hepatitis C is a major reason of morbidity and mortality among hemophilia patients. Although combination therapy with peginterferon (peg-INF) and ribavirin is considered as standard treatment for chronic hepatitis C (CHC), but more evidence of the efficacy and safety is needed.<h4>Objectives</h4>In this study, efficacy and tolerability of combination therapy with peginterferon α-2a-ribavirin was investigated among hemophilia HCV infected patients.<h4>Patients and materials</h4 ...[more]

PMID: 23105981

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Project description:This study investigates differences in depression and anxiety between patients with chronic hepatitis C who are treated with peginterferon alpha-2a (PegIFN-?-2a) plus ribavirin and those who are treated with peginterferon alpha-2b (PegIFN-?-2b) plus ribavirin.In this 24 week, non-randomized, observational, prospective study, 55 patients with chronic hepatitis C were treated with PegIFN-?-2a plus ribavirin (Group 1), and 26 patients were treated with PegIFN-?-2b plus ribavirin (Group 2). All patients underwent assessment using the Hospital Anxiety and Depression Scale (HADS) at the baseline and at weeks 4, 12 and 24. Patients with depression scores (HADS-D)???8 and anxiety scores (HADS-A)???8 were defined as having depression and anxiety, respectively. The factors that were associated with depression and anxiety during the 24 week antiviral treatment were determined.During the 24 week antiviral treatment, the proportion of patients with depression significantly increased over time in both groups (Group 1: p?=?0.048; Group 2: p?=?0.044). The proportion of patients with anxiety did not significantly change during the follow-up period in either group. Incidences of depression or anxiety did not differ significantly between Group 1 and Group 2. A history of alcohol use disorder was an independent predictor of depression at week 12 (p?<?0.001) and week 24 (p?<?0.001), and a poor virological response to treatment was associated with depression at week 24 (p?=?0.029). Patients who had more physical comorbidities were more likely to suffer from anxiety at week 12 (p?=?0.038).This study did not identify significant differences in depression or anxiety between in patients with chronic hepatitis C who underwent a 24 week antiviral treatment regimen with PegIFN-?-2a plus ribavirin and those who underwent a regiment with PegIFN-?-2b plus ribavirin. Future research with larger samples and a randomized, controlled design are required to verify the findings in this study.This clinical study has been registered at ClinicalTrials.gov. (Trial registration: NCT02943330 ).

Project description:BackgroundThis Phase 3, open-label, rollover study (NCT01323244) investigated the efficacy and safety of simeprevir plus peginterferon α-2a (PegIFNα-2a) and ribavirin (RBV) in a well-characterized population of HCV genotype 1 (GT1)-infected treatment-experienced patients.MethodsPatients who had failed PegIFNα/RBV treatment in the placebo arm of a previous Phase 2/3 simeprevir study (Phase 2/3 group, n = 125), or had been exposed to HCV direct-acting antivirals (simeprevir or other) for up to 14 days in a selected Phase 1 study (Phase 1 group, n = 16), were eligible. Phase 2/3 group patients were classified according to prior relapse, breakthrough, or non-response (null response, partial response, non-classifiable non-response) to PegIFNα/RBV. Eight patients in the Phase 1 group received short-term (≤14 days) simeprevir. Treatment comprised simeprevir 150 mg once daily (QD) plus PegIFNα-2a/RBV for 12 weeks followed by PegIFNα-2a/RBV for 12 or 36 weeks (using response-guided therapy [RGT] to determine total treatment duration in Phase 2/3 prior relapsers or breakthrough) or 36 weeks fixed (Phase 2/3 group non-responders and Phase 1 group). The primary endpoint was sustained virologic response 12 weeks after planned end of treatment (SVR12).ResultsPhase 2/3 group: SVR12 rate was 69.6% (87/125) overall; 92.7% (51/55), 60.0% (6/10), 64.3% (18/28), and 36.7% (11/30) in patients with prior relapse, viral breakthrough, partial response, or null response, respectively. SVR12 rates were similar for patients with HCV GT1a (66.0% [33/50]) and GT1b infection (72.0% [54/75]) and among HCV GT1a-infected patients with/without a baseline Q80K polymorphism (66.7% [8/12] and 65.8% [25/38], respectively). The majority of RGT-eligible patients (prior viral relapse or breakthrough) met RGT criteria (89.2% [58/65]); of these, 89.7% (52/58) achieved SVR12. Overall, 16.0% (20/125) of patients experienced on-treatment failure and 14.4% (18/125) experienced post-treatment failure (15 relapses, 3 missing data). Phase 1 group (simeprevir-naïve and -experienced patients combined): SVR12 rate was 37.5% (6/16). Safety and tolerability findings were comparable to those of the feeder studies.ConclusionsThe majority of RGT-eligible patients met criteria for shortening treatment to 24 weeks in total. Simeprevir 150 mg QD with PegIFNα-2a/RBV led to a high SVR rate among prior relapsers with HCV GT1 infection. No new safety signals were noted.Trial registrationNCT01323244 . (date of registration: March 24, 2011).

Project description:ObjectiveTo explore dynamic changes of cytokines and virological markers associated with hepatitis B surface antigen (HBsAg) loss during peginterferon alpha-2a (PEG-IFN α-2a) treatment in hepatitis B e antigen (HBeAg) positive chronic hepatitis B (CHB) patients.MethodsIt was a single-center prospective cohort study. HBeAg-positive CHB patients were prospectively and consecutively enrolled. Cytokines were detected at baseline, week 12 and 24 of PEG-IFN treatment. HBsAg disappearance rate was the primary evaluation index at 48 weeks of PEG-IFN treatment.ResultsAmong 100 patients who completed the 48-week PEG-IFN α-2a treatment, 38 patients achieved serum HBeAg disappearance, 25 patients achieved HBeAg seroconversion, 9 patients achieved functional cure, 37 patients had HBsAg decline of ≥1 log IU/ml, and 8 patients produced hepatitis B surface antibody (HBsAb). Albumin (ALB), fms-like tyrosine kinase 3 ligand (FLT3-L) and interferon-alpha2 (IFN-α2) in the clinical cure group were significantly lower than those in the non-clinical-cure group at baseline. After 12 weeks of treatment, HBsAg in the clinical cure group was significantly lower than that in the non-clinical-cure group (median 1.14 vs. 3.45 log10IU/ml, Z=-4.355, P < 0.001). The decrease of HBsAg and hepatitis B virus desoxyribose nucleic acid (HBV DNA) in the clinical cure group was significantly higher than that in non-clinical-cure group (median: HBsAg 1.96 vs. 0.33 log10IU/ml, Z=-4.703, P< 0.001; HBV DNA 4.49 vs.3.13 log10IU/ml, Z=-3.053, P=0.002). The increase of IFN-α2 in the cure group was significantly higher than that in the non-clinical-cure group (497.89 vs. 344.74, Z=-2.126, P=0.034). After 24 weeks of treatment, HBsAg, HBeAg, Flt3-L, and IL-10 in the clinical cure group were significantly lower than those in the non-clinical-cure group (median: HBsAg 0.70 vs. 3.15 log10IU/ml, Z=-4.535, P< 0.001; HBeAg 1.48 vs. 13.72 S/CO, Z = 2.512, P = 0.012; Flt3-l 0.00 vs 2.24 pg/ml, Z = 3.137, P=0.002; IL-10 0.70 vs. 2.71 pg/ml, Z=-4.067, P < 0.001). HBsAg decreased significantly in the clinical cure group compared with non-clinical-cure group (median 3.27 vs. 0.45, Z=-4.463, P < 0.001).ConclusionDynamic changes of cytokines and virology markers during early PEG IFN α-2a treatment were associated with HBsAg loss in HBeAg-positive CHB patients.

Project description:BACKGROUND:A randomized, double-blind, multinational, phase 3 study was conducted comparing the efficacy and safety of peginterferon lambda-1a (Lambda)/ribavirin (RBV)/telaprevir (TVR) vs. peginterferon alfa-2a (Alfa)/RBV/TVR in patients with chronic hepatitis C virus (HCV) genotype-1 (GT-1) infection. METHODS:Patients (treatment-naïve or relapsers on prior Alfa/RBV treatment) were randomly assigned in a 2:1 ratio to receive Lambda/RBV/TVR or Alfa/RBV/TVR. Total duration of treatment was either 24 or 48 weeks (response-guided treatment), with TVR administered for the first 12 weeks. The primary endpoint was the proportion of patients who achieved a sustained virologic response at post treatment week 12 (SVR12), which was tested for noninferiority of Lambda/RBV/TVR. RESULTS:A total of 838 patients were enrolled, and 617 were treated; 411 and 206 patients received Lambda/RBV/TVR and Alfa/RBV/TVR, respectively. The majority of patients were treatment-naïve, with HCV GT-1b and a high baseline viral load (?800,000 IU/mL). Less than 10% of patients had cirrhosis (Lambda, 7.5%; Alfa, 6.8%). Lambda/RBV/TVR did not meet the criterion for noninferiority (lower bound of the treatment difference interval was -12.3%); the SVR12 in all patients (modified intent-to-treat) was 76.2% in the Lambda arm and 82.0% in the Alfa arm. Overall, the frequency of adverse events in each arm was comparable (Lambda, 91.7%; Alfa, 97.1%). As expected based on the safety profile of the 2 interferons, there were more hepatobiliary events observed in the Lambda arm and more hematologic events in the Alfa arm. CONCLUSIONS:In this comparison of Lambda/RBV/TVR and Alfa/RBV/TVR in patients who were treatment-naïve or had relapsed on prior Alfa/RBV treatment, Lambda failed to demonstrate noninferiority based on SVR12 results. Treatment with Lambda/RBV/TVR was associated with a higher incidence of relapse. More patients discontinued Lambda/RBV/TVR treatment during the first 4 weeks of study treatment, mainly due to hepatobiliary-related events, and more Lambda patients were lost to follow-up.

Dataset Information

High Rate of Virological Response to Peginterferon ?-2a-Ribavirin Among Non-Cirrhotic Iranian Hemophilia Patients With Chronic Hepatitis C.

Publications

High Rate of Virological Response to Peginterferon α-2a-Ribavirin Among Non-Cirrhotic Iranian Hemophilia Patients With Chronic Hepatitis C.

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