Randomised trial of interferon α2b plus ribavirin for 48 weeks or for 24 weeks versus interferon α2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus

Poynard, Thierry; Marcellin, Patrick; Lee, Samuel S.; Niederau, Christian; Minuk, Gerald; Idéo, G.; Bain, Vincent G.; Heathcote, Jenny; Zeuzem, Stefan; Trépo, C.; Albrech, Janice

doi:10.1097/00042737-199812000-00020

Cited by 644 publications

(1,100 citation statements)

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“…Depression has been a common indication for dose reduction or even discontinuation of therapy [17,31]. Discontinuation of therapy due to adverse effects was reported in 15% in this study and was similar to that reported by others [18,19,32,33].…”

Section: Discussionsupporting

confidence: 89%

Hepatitis C infection among Dutch haemophilia patients: a nationwide cross‐sectional study of prevalence and antiviral treatment

et al. 2005

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Summary. Hepatitis C is a major co‐morbidity among patients with haemophilia who received inadequately or non‐virus‐inactivated clotting factor concentrates before 1992. The objectives of this study were to investigate the prevalence of hepatitis C and the use of antiviral therapies during the last decade among patients with haemophilia in the Netherlands. We performed a cross‐sectional study and a questionnaire was sent to all 1519 patients known with haemophilia in the Netherlands between 2001 and 2002. The study population for the present study consisted of 771 patients who had received clotting factor products before 1992 of whom 638 reported their hepatitis C status. In total, 441 of the 638 (68%) patients ever had a positive test for hepatitis C virus (HCV); 344 patients (54%) had a current infection, and 97 (15%) had cleared the virus. Among 344 patients currently HCV infected, 111 (32%) had received treatment for hepatitis C, while 34% (33/97) of patients with an infection in the past had been treated for hepatitis C. In 2002 the prevalence of hepatitis C among patients with haemophilia who received clotting factor products before 1992 was 54%. The majority of patients with a current HCV infection had not been treated with antiviral therapy.

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Section: Discussionsupporting

confidence: 89%

Hepatitis C infection among Dutch haemophilia patients: a nationwide cross‐sectional study of prevalence and antiviral treatment

et al. 2005

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“…Hence, this combined treatment favors the development of systemic and organ-specific autoimmune diseases, such as autoimmune thyroid disease (ATD) and thyroid dysfunction (TD). [2][3][4] Patients infected with HCV present 40-42% of detectable antithyroid autoantibody levels; whereas in patients with hepatitis B virus, the index varies from 5 to 10%. 4 The prevalence of TD in patients under IFN-α use ranges from 1 to 35%, possibly due to the lack of standardization for the routine screening of thyroid function evaluation in several studies.…”

Section: Introductionmentioning

confidence: 99%

Virus C genotype predisposes to primary hypothyroidism during interferon-α treatment for chronic hepatitis C

Pavan¹,

Pavin²,

Gonçales³

et al. 2011

Braz J Infect Dis

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Objective: The treatment of the chronic hepatitis C (HCV) with α-interferon is associated with thyroid dysfunction (TD). The aim of this study was to evaluate thyroid function outcome among patients with chronic HCV under treatment with conventional interferon (IFN) or peguilated interferon (PEG-IFN) in association with ribavirin. Patients and Methods: We studied 293 patients with chronic HCV, submitted to drug therapy for 24 or 48 weeks. Initially, we evaluated FT4, TSH, TPOAb, TgAb, and continued to monitor FT4 and TSH every three months during therapy and six months thereafter. Results: At baseline, TD prevalence was 6.82% (n = 20); 6.14% hypothyroidism; 0.68% hyperthyroidism. TPOAb was present in 5.46% of euthyroid patients. Out of 273 euthyroid patients at baseline, 19% developed TD: 17.2% hypothyroidism; 1.8% hyperthyroidism; 5.1% destructive thyroiditis (DT). 90% of TPOAb-positive patients at baseline developed hypothyroidism vs 14.5% of TPOAb-negative patients (p < 0.001). On average, TD occurred after 25.8 ± 15.5 weeks of treatment. 87.2% of patients who developed hypothyroidism did so during the first therapeutic cycle (p = 0.004; OR = 3.52; 95% CI = 1.36-9.65). Patients infected with genotype 1 virus were 2.13 times more likely to develop hypothyroidism (p = 0.036; 95% CI = 1.04-4.38). Hypothyroid and DT patients presented higher TSH levels before-treatment than patients who had remained euthyroid (p < 0.001; p = 0.002, respectively). DT patients presented lower qALT (p = 0.012) than euthyroid patients. Conclusion: Hypothyroidism was the most frequent TD, especially during the first cycle of α-interferon. Genotype 1 virus was associated with a risk two times higher for developing the illness. There was no need to interrupt or to change HCV treatment. Therefore, approximately 34% of TD was transient.

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“…Interferon has been an important agent used in anti-HCV therapy, first as monotherapy 13,14 and more recently, in combination with ribavirin. 15,16 The addition of a polyethylene glycol moiety to interferon-a has also been developed, and may be administered alone or in combination with ribavirin. 17,18 During the first 3 months of therapy, HCV viral loads usually fall to undetectable levels in response to interferon-a.…”

Section: Introductionmentioning

confidence: 99%

Polymorphisms in interferon-induced genes and the outcome of hepatitis C virus infection: roles of MxA, OAS-1 and PKR

et al. 2003

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Interferon stimulates the expression of a number of genes encoding enzymes with antiviral activities, including myxovirus resistance-1 (MxA), 2-5-oligoadenylate synthetase 1 (OAS-1) and double-stranded RNA-dependent protein kinase (PKR). We examined whether polymorphisms in these genes influenced the outcome of hepatitis C virus (HCV) infection. We observed a lower frequency of the GG genotype at position À88 in the MxA gene promoter in self-limiting HCV infection (OR ¼ 0.56; 95% CI: 0.35-0.8; P ¼ 0.010) and in nonresponders to therapy (OR ¼ 0.49; 95% CI: 0.25-0.95; P ¼ 0.020). This genotype predominantly influenced the outcome of treatment in patients with viral genotype 1 (OR ¼ 0.22 95% CI: 0.07-0.67; P ¼ 0.002). A polymorphism in the 3 0 -untranslated region of the OAS-1 gene was associated with outcome of infection (GG genotype less frequent in self-limiting infection: OR ¼ 0.43; 95% CI: 0.21-0.86; P ¼ 0.010). A polymorphism at position À168 in the promoter region of the PKR gene was associated with self-limiting infection (CT genotype: OR ¼ 2.75; 95% CI: 1.45-5.24; P ¼ 0.002). Further associations were found with a CGG trinucleotide repeat in the 5 0 UTR region of the PKR gene. Polymorphisms in the interferon-induced genes, MxA, OAS-1 and PKR appear thus associated with HCV outcome.

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Randomised trial of interferon α2b plus ribavirin for 48 weeks or for 24 weeks versus interferon α2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus

Cited by 644 publications

References 1 publication

Hepatitis C infection among Dutch haemophilia patients: a nationwide cross‐sectional study of prevalence and antiviral treatment

Hepatitis C infection among Dutch haemophilia patients: a nationwide cross‐sectional study of prevalence and antiviral treatment

Virus C genotype predisposes to primary hypothyroidism during interferon-α treatment for chronic hepatitis C

Polymorphisms in interferon-induced genes and the outcome of hepatitis C virus infection: roles of MxA, OAS-1 and PKR

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