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Changes in quality of life and sexual health are associated with low-dose peginterferon therapy and disease progression in patients with chronic hepatitis C.

ABSTRACT: Primary analysis of the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) Trial showed long-term peginterferon therapy did not reduce complications in patients with chronic hepatitis C and advanced fibrosis or cirrhosis.To assess the effects of long-term peginterferon therapy and disease progression on health-related quality of life (HRQOL), symptoms and sexual health in HALT-C patients.A total of 517 HALT-C patients received peginterferon alfa-2a (90 microg/week); 532 received no additional treatment for 3.5 years. Patients were followed up for outcomes of death, hepatocellular carcinoma and hepatic decompensation. Sexual health, SF-36 scores and symptoms were serially assessed by repeated-measures analyses of covariance.Patients with cirrhosis (n = 427) reported lower general well-being and more fatigue (P < 0.001) than patients with fibrosis (n = 622). Physical scores declined significantly over time, independent of treatment, and patients with cirrhosis reported lower scores. Vitality scores were lower in those with cirrhosis, and treated patients experienced a greater decline over time than untreated patients; HRQOL rebounded after treatment ended. Patients with a clinical outcome had significantly greater declines in all SF-36 and symptom scores. Among men, Sexual Health scores were significantly worse in treated patients and in those with a clinical outcome.Clinical progression of chronic hepatitis C and maintenance peginterferon therapy led to worsening of symptoms, HRQOL and, in men, sexual health in a large patient cohort followed up over 4 years (NCT00006164).

SUBMITTER: Snow KK

PROVIDER: S-EPMC2923484 | biostudies-literature | 2010 Apr

REPOSITORIES: biostudies-literature

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Changes in quality of life and sexual health are associated with low-dose peginterferon therapy and disease progression in patients with chronic hepatitis C.

Snow K K KK Bonkovsky H L HL Fontana R J RJ Kim H-Y HY Sterling R K RK Di Bisceglie A M AM Morgan T R TR Dienstag J L JL Ghany M G MG

Alimentary pharmacology & therapeutics 20100112 7

<h4>Background</h4>Primary analysis of the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) Trial showed long-term peginterferon therapy did not reduce complications in patients with chronic hepatitis C and advanced fibrosis or cirrhosis.<h4>Aim</h4>To assess the effects of long-term peginterferon therapy and disease progression on health-related quality of life (HRQOL), symptoms and sexual health in HALT-C patients.<h4>Methods</h4>A total of 517 HALT-C patients received pegi ...[more]

PMID: 20070284

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Project description:BackgroundIn patients with chronic hepatitis C who do not have a response to antiviral treatment, the disease may progress to cirrhosis, liver failure, hepatocellular carcinoma, and death. Whether long-term antiviral therapy can prevent progressive liver disease in such patients remains uncertain.MethodsWe conducted a randomized, controlled trial of peginterferon alfa-2a at a dosage of 90 microg per week for 3.5 years, as compared with no treatment, in 1050 patients with chronic hepatitis C and advanced fibrosis who had not had a response to previous therapy with peginterferon and ribavirin. The patients, who were stratified according to stage of fibrosis (622 with noncirrhotic fibrosis and 428 with cirrhosis), were seen at 3-month intervals and underwent liver biopsy at 1.5 and 3.5 years after randomization. The primary end point was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points.ResultsWe randomly assigned the patients to receive peginterferon (517 patients) or no therapy (533 patients) for 3.5 years. The level of serum aminotransferases, the level of serum hepatitis C virus RNA, and histologic necroinflammatory scores all decreased significantly (P<0.001) with treatment, but there was no significant difference between the groups in the rate of any primary outcome (34.1% in the treatment group and 33.8% in the control group; hazard ratio, 1.01; 95% confidence interval, 0.81 to 1.27; P=0.90). The percentage of patients with at least one serious adverse event was 38.6% in the treatment group and 31.8% in the control group (P=0.07).ConclusionsLong-term therapy with peginterferon did not reduce the rate of disease progression in patients with chronic hepatitis C and advanced fibrosis, with or without cirrhosis, who had not had a response to initial treatment with peginterferon and ribavirin. (ClinicalTrials.gov number, NCT00006164.)

Project description:AIM:To evaluate addition of boceprevir to peginterferon/ribavirin (PR) in Russian patients with chronic hepatitis C virus (HCV). METHODS:Treatment-naive (TN) and treatment-experienced (TE) patients (who had failed prior treatment with PR for ? 12 wk) with chronic HCV genotype 1 infection were enrolled in this placebo-controlled, double-blind study. All patients initially received PR for 4 wk. Patients randomized to control treatment then received PR for an additional 44 wk. TN patients randomized to triple therapy received boceprevir (800 mg three times daily) plus PR for 24 wk and then further therapy according to treatment week 8 (TW8) HCV RNA levels. TE patients received boceprevir plus PR for 32 wk and then further therapy according to TW8 HCV RNA levels. Treatment was discontinued for TN patients with detectable HCV RNA at TW24 and TE patients with detectable HCV RNA at TW12 because of futility. The primary efficacy end point was sustained virologic response (SVR) defined as undetectable HCV RNA 24 wk after completing all study therapy. RESULTS:SVR was 74.8% in the boceprevir plus PR arm compared with 46.2% in the control arm, with a stratification-adjusted treatment difference of 29.2% (95%CI: 16.4-41.5; P < 0.0001). Rates of SVR were higher in the boceprevir arm in both TN and TE patient groups (TN 78.4% vs 56.3%; TE 69.4% vs 30.0%). Within TE patients, the rates of SVR were higher with boceprevir plus PR compared with PR, regardless of treatment failure type (null responder, partial responder, and relapser). Most patients receiving boceprevir plus PR in both TN (86%) and TE (71%) populations were eligible for reduced treatment duration. Anemia was increased in patients receiving boceprevir plus PR vs PR alone (47.2% vs 24.4%); there was a corresponding increase in ribavirin dose reduction and erythropoietin use. Among patients receiving boceprevir plus PR, SVR rates were similar in patients with anemia (< 10 g/dL) and those without anemia (71.2% vs 77.4%). CONCLUSION:Regulatory approval has been obtained for boceprevir plus PR in Russian patients with HCV genotype 1 infection based on the results of this study.

Project description:IntroductionEndometriosis is a benign gynecological disease with a high disease burden and significant, multifaceted impact on health-related quality of life (HRQoL) and sexual quality of life (SQoL).AimTo explore which patient- and disease-specific characteristics were independently associated with SQoL.MethodsA literature search was carried out to identify characteristics with an evidence-based or hypothesized effect on SQoL. Subsequently, data on HRQoL in women with endometriosis (n = 224), collected between 2013 and 2018 in a prospective longitudinal Dutch cohort study performed in 7 referral centers, were used to perform a cross-sectional cohort study. Data were collected using an online self-administered survey including the validated Endometriosis Health Profile-30. Inclusion criteria were recently diagnosed endometriosis patients or newly referred patients with a clinical diagnosis of endometriosis. Patients were excluded in case of incomplete answers on the SQoL questions. Univariate analyses and multiple linear regression analyses were performed.OutcomesSQoL, measured by the 5-item "sexual intercourse" dimension score of the modular Endometriosis Health Profile-30 questionnaire, was the primary outcome with scores ranging from 0 to 100 (0 indicating the best and 100 indicating the worst health status).ResultsBased on a literature search, 29 characteristics potentially associated with SQoL were selected from the survey and included in the analyses. In total, 192 women (mean age 36 years) met the inclusion criteria. The majority of women (86.5%) had had intercourse in the period before completing the survey and the study population showed a mean SQoL score of 47.5 ± 29.6, indicating moderate SQoL. Worse SQoL was independently associated with dyspareunia (P < .001), worse HRQoL (P = .001), severity of dysmenorrhea (P = .017), and unemployed work status (P = .022).ConclusionIn a cohort of women with endometriosis, worse SQoL was significantly and independently associated with the presence of dyspareunia, more severe dysmenorrhea, worse HRQoL, and unemployed work status. van Poll M, van Barneveld E, Aerts L, et al. Endometriosis and Sexual Quality of Life. Sex Med 2020;8:532-544.

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Changes in quality of life and sexual health are associated with low-dose peginterferon therapy and disease progression in patients with chronic hepatitis C.

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Changes in quality of life and sexual health are associated with low-dose peginterferon therapy and disease progression in patients with chronic hepatitis C.

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