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Resveratrol in Hepatitis C Patients Treated with Pegylated-Interferon-α-2b and Ribavirin Reduces Sleep Disturbance.
Pennisi, M, Bertino, G, Gagliano, C, Malaguarnera, M, Bella, R, Borzì, AM, Madeddu, R, Drago, F, Malaguarnera, G
Nutrients. 2017;(8)
Abstract
BACKGROUND Hepatitis C virus infection and interferon treatment have shown to be risk factors for sleep disorder health-related quality of life. AIM: To determine whether the effects of resveratrol on sleep disorders were associated with different tests in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV. PATIENTS AND METHODS In this prospective, randomized, placebo controlled, double blind clinical trial, 30 subjects (Group A) with chronic hepatitis received Pegylated-Interferon-α2b (1.5 mg/kg per week), Ribavirin and placebo (N-acetylcysteine 600 mg and lactoferrin 23.6 g), while 30 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b, Ribavirin and association of N-acetylcysteine 600 mg, lactoferrin 23.6 g and Resveratrol 19.8 mg for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate mood and sleep disorders (General Health Questionnaire (GHQ), Profile of Mood States (POMS), Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sleepiness Scale (ESS)). RESULTS The comparison between Group A and Group B showed significant differences after six months in C-reactive protein (p < 0.0001); after 12 months in aspartate aminotransferase (AST) (p < 0.0001) Viremia (p < 0.0001), HAI (p < 0.0012) and C-reactive protein (p < 0.0001); and at follow up in AST (p < 0.0001), Viremia (p < 0.0026) and C-reactive protein (p < 0.0001). Significant differences were observed after 12 month and follow-up in General Health Questionnaire, after 1, 6, 12 and follow-up in Profile of Mood States, after 6, 12, follow-up in Pittsburgh Sleep Quality Inventory and Epworth Sleepiness Scale. CONCLUSIONS Supplementation with Resveratrol decreased General Health Questionnaire score and reduced sleep disorders in patients treated with Peg-IFN-α and RBV.
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PEG-Interferon-α ribavirin-induced HCV viral clearance: a pharmacogenetic multicenter Spanish study.
Milara, J, Outeda-Macias, M, Aumente-Rubio, MD, Más-Serrano, P, Aldaz, A, Calvo, MV, García-Simón, MS, Martin-Barbero, M, Padullés-Zamora, N, Schoenenberger, JA, et al
Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria. 2015;(1):29-43
Abstract
OBJECTIVE Dual PEGylated interferon-α (PEG-IFN) and ribavirin therapy has been the main hepatitis C virus (HCV) treatment of the last decade. Current direct-acting antiviral agents have improved the outcome of therapy but also have increased the cost and management complexity of treatment. The current study analyzes host genetics, viral and clinical predictors of sustained viral response (SVR) to dual PEG-IFN and ribavirin therapy in a representative Spanish population. METHODS Observational prospective multicentre pharmacogenetic cohort study conducted in 12 different hospitals of 12 different Spanish regions. A total of 98 patients with SVR and 106 with non-SVR in response to PEG-IFN and ribavirin therapy were included. 33 single nucleotide polymorphisms located in 24 different genes related with inflammatory, immune and virus response were selected. Clinical and viral data were also analyzed as candidate of SVR predictors. RESULTS IL-28B (rs12979860, rs7248668, rs8105790, rs8099917) and TNFRSF1B (rs1061622) genotypes, as well as TNFRSF1B/IL-10/TNFα (-308) non-TTG and TNFRSF1B/IL- 10/IL-4 non-TTC haplotypes together with lower age, lower basal HCV RNA load, higher basal serum LDL cholesterol values, VHC genotypes 2 and 3 and basal low grade fibrosis 0-2 were associated with a SVR in the univariate analysis. Independent predictors of SVR in the multivariate analysis were IL-28B rs12979860 CC, TNFRSF1B/IL-10/IL-4 non-TTC along with low baseline HCV RNA load and HCV genotypes 2 and 3. CONCLUSIONS IL-28B rs12979860 CC, TNFRSF1B/ IL-10/ IL-4 non-TTC haplotype, low baseline HCV RNA load and HCV genotypes 2 and 3 may help to predict successful outcome to PEG-IFN/ribavirin therapy in Spanish population.
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Effectiveness of triple therapy with simeprevir for chronic hepatitis C genotype 1b patients with prior telaprevir failure.
Ogawa, E, Furusyo, N, Dohmen, K, Kajiwara, E, Kawano, A, Nomura, H, Takahashi, K, Satoh, T, Azuma, K, Nakamuta, M, et al
Journal of viral hepatitis. 2015;(12):992-1001
Abstract
Favourable efficacy and safety profiles for simeprevir in combination with pegylated interferon alpha (PEG-IFNα) and ribavirin (triple therapy) have been shown in clinical trials. This study was carried out to evaluate the effectiveness of simeprevir-based triple therapy for patients with prior telaprevir treatment failure. This multicentre, observational cohort consisted of 345 consecutive Japanese patients infected with HCV genotype 1b, including 20 who had experienced telaprevir-based triple therapy. Amino acid substitutions in the NS3/4A region were identified by direct sequencing at the time of relapse or breakthrough in treatment with telaprevir and at the initiation of treatment with simeprevir. Patients were stratified according to prior response to PEG-IFNα and ribavirin. Of the 20 patients with telaprevir treatment failure, 10 (50.0%) achieved sustained virological response at week 12 after the end of treatment (SVR12). For patients treatment naïve [3/4 (75.0%)] or with prior relapse [1/1 (100%)] or partial response [5/6 (83.3%)] to PEG-IFNα and ribavirin, almost all achieved SVR12, mainly because of the improvement of treatment adherence, especially to direct-acting antiviral agent and ribavirin. However, of the nine patients with prior null response to PEG-IFNα and ribavirin, only one (11.1%) achieved SVR12, despite all having received an adequate treatment dosage, and five (55.6%) achieved rapid virological response. The treatment outcome of simeprevir-based triple therapy for HCV genotype 1b patients with prior telaprevir failure depended on the prior response to PEG-IFNα and ribavirin. For patients with prior null response to PEG-IFNα and ribavirin, retreatment with simeprevir-based triple therapy is not a useful option.
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Can zinc levels predict response to pegylated-interferon and ribavirin therapy in hepatitis C genotype 4 infected Egyptian patients?
Mohamed, AA, Abbassi, MM, Hamed, WA, EzzEl-Arab, MA, Aref, AM
Acta gastro-enterologica Belgica. 2014;(2):217-23
Abstract
BACKGROUND AND AIMS Zinc has been found to be low in chronic hepatitis patients. Its level was correlated with response to Interferon/ribavirin therapy in patients infected with hepatitis C genotype 1. In Egypt, inexpensive predictors to treatment response in Hepatitis C genotype 4 infected patients are desperately needed. We aim to explore if pretreatment zinc serum levels correlate with response to pegylated- interferon and ribavirin therapy in Egyptian patients. METHODS This is an observational prospective study where 57 treatment naive hepatitis C genotype 4 infected patients that were Hepatitis B and Human Immunodeficiency virus negative were recruited in a hospital setting. The study was performed from October 2010 till June 2012. Patients had Liver biopsy and basic biochemical profiles were performed pretreatment for all patients. Treatment consisted of 48 weeks of pegylated-interferon-alpha2a and ribavirin therapy. Blood samples were withdrawn from 21 healthy subjects to compare zinc levels and other biochemical markers. Patients were followed up to 72 weeks. RESULTS Pretreatment serum zinc levels were significantly lower in hepatitis C infected patients compared to healthy volunteers (p < 0.05). Moreover, zinc levels correlated to sustained virological response in treated patients (p = 0.00). CONCLUSION Serum zinc levels can be used as an inexpensive predictor to effective Pegylated-interferon/ribavirin therapy in Egyptian patients infected with Hepatitic C genotype 4.
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[Clinical observation of Hashimoto thyroiditis in patients with chronic hepatitis C undergoing pegylated-interferon alpha-2a and ribavirin combination therapy].
Teng, ZL, Gong, WJ, Zhang, SQ, Sun, YX, Ma, XH
Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology. 2013;(2):101-4
Abstract
OBJECTIVE To investigate the relation of thyroid function with hashimoto thyroiditis (HT, an autoimmune disease of unknown etiology also known as chronic lymphocytic thyroiditis) in patients with chronic hepatitis C (CHC) receiving treatment with pegylated-interferon-alpha (Peg-IFNa) based on the observation that HT is common among individuals undergoing IFN-based therapy. METHODS One-hundred-and-seven patients with chronic hepatitis C were enrolled for study between January 2008 and December 2010. Thyroid function was assessed by electrochemiluminescence assays to detect serum levels of anti-thyroid peroxidase (A-TPO) antibodies, thyroid stimulating hormone (TSH), and free thyroxine (FT4) prior to initiation of the IFN-based therapy. The treatment strategies (drugs, doses, schedules) were designed according to HT status (CHC with HT, or CHC without HT). Patients were monitored during the 24 weeks of treatment (including measuring serum alanine aminotransferase (ALT), TSH, and FT4 every two to four weeks, and HCV RNA every four weeks) so that the IFNa dose could be adjusted and thyroid medications (levothyroxine sodium or methimazole) added as necessary. The response rate at end of treatment (week 24) was assessed. RESULTS Twenty-one of the CHC patients were diagnosed with HT, and the incidence of thyroid dysfunction among the CHC patients with HT was 71.4% (15/21); among the CHC patients with no HT, the incidence of thyroid dysfunction was significantly lower (30.2% (26/86), X2 = 12.1995, P less than 0.01). In the CHC patients with HT, 90.5% (19/21) had serum levels of A-TPO antibodies that were more than or equal to 2-times higher than the normal value at the end of treatment. Of the 15 CHC patients with HT and thyroid dysfunction, 73.3% (11/15) continued to show thyroid dysfunction at the end of treatment. Hypothyroidism was the most common form of thyroid dysfunction observed (4/11), and all of those patients responded to levothyroxine sodium treatment. The virological response rates of the two groups (CHC with HT and CHC without HT) were not significantly different at any time point examined (treatment week 4, 12, and 24, P more than 0.05). CONCLUSION The incidence of thyroid dysfunction is significantly higher among CHC patients with HT than among CHC patients without HT. If suspected, these patients should be carefully monitored because the clinical symptoms of thyroid dysfunction are not obvious and the drug therapy should be carefully adjusted to minimize the thyroid dysfunction while maximizing the antiviral effect.