Background/Aim. The era of direct-acting antiviral (DAA) regimen in the treatment of chronic hepatitis C virus (HCV) started in 2011. The aim of this study was to assess the antiviral efficacy and safety of DAA regimen, ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) + dasabuvir (DSV) + ribavirin (RBV), in patients with chronic HCV infection, genotype 1. Methods. The real-life data were collected. The study was multicentric and included seven infectious diseases and hepatology departments in Serbia. A total of 21 patients were enrolled in the OBV/PTV/r + DSV + RBV early access program, 20 of which were previously treated with pegylated interferon + RBV, while 1 was treatment-naive. All patients received the adequate doses of these antiviral drugs. RBV was not given to the patients with HCV genotype 1b infection according to the therapeutic protocol. For the majority of patient, the treatment duration lasted for 12 weeks. For the patients with liver cirrhosis, who were infected with HCV genotype 1a, the duration of treatment was 24 weeks. Viremia was assessed at four points in time: at baseline, 4 weeks after the treatment beginning (rapid viral response, RVR), 12 or 24 weeks after the treatment beginning (end of treatment response ? ETR) and 12 weeks after the end of treatment (sustained viral response ? SVR). SVR, as a confirmation of the absence of HCV was considered as endpoint of successful treatment. Results. Complete RVR, ETR and SVR were achieved in 64.71%, 85.71% and 95.24% of the patients, respectively. Only 3 patients had mild adverse effects which did not required dose reduction. Conclusion. The treatment of the patients with a chronic HCV infection with OBV/PTV/r + DSV + RBV resulted in excellent antiviral activity and tolerability.

/pdf/real-life-data-on-the-efficacy-and-safety-of-ombitasvir-au98ap6x32.pdf

Real-life data on the efficacy and safety of ombitasvir/paritaprevir/ritonavir + dasabuvir +ribavirin in the patients with genotype 1 chronic hepatitis C virus infection in Serbia

Hepatitis C infection considered to be one of the most important health problems in Egyp The treatment of chronic HCV was problematic due to lack of an effective and safe drugs. This study demonstrated that a virological response exceeding 90% in most genotypes. Aim: Study of safety and efficacy of combination between Sofosbuvir plus Simeprevir without ribavirin once daily versus combination of Sofosbuvir plus Daclatasvir without ribavirin once daily for 12 weeks in treatment of naive Egyptian patients with chronic HCV infection. Methods: this study included 60 patients divided into two groupsGroup I: Thirty patients received Sofosbuvir (SOF)400 mg plus Simeprevir(SMV) 150 mg once daily for 12 weeks. Group II: Thirty patients received Sofosbuvir 400 mg plus Daclatasvir 60 mg once daily for 12 weeks. All patients were subjected to detailed history taking and clinical examination. Assessment of liver fibrosis by FIB-4, Monitoring of treatment efficacy and endpoint at week 4, 8, 12 of treatment and a week at 12, 24 post treatment. Monitoring of treatment safety by complete liver profile, complete blood picture, creatinine each vist, and history taking about any side effects. Imaging by abdominal ultrasound. Results: There was no statistically significant difference in response rates to the combination of SOF/SMV regimen at week 4 of treatment (100%), at the end of treatment (96.7%) and post treatment at week 12(93.1%) and 24(96.2%) in comparison to the combination of SOF/DAC regimen at week 4 of treatment (100%), at the end of treatment (96.7%) and post treatment at week 12(96.5%) and 24(100%), but there was statistically significant increase in number of Relapsers who received SOF/SMV regimen (10%). There was highly statistically significant decrease in FIB-4 score in the responders of group-1 in comparison to the responders of group-2 before and post treatment (p<0.0001). The commonest adverse effects for both regimens were fatigue, headache and nausea, while with regimen SOF/SMV showed transient elevation of total bilirubin and cutaneous rash with prolonged exposure to sun. Conclusion: The oral regimen of SOF/SMV combination and SOF/DAC once daily for 12 weeks are an effective and well tolerated regimen and associated with high rate of sustained virological response (SVR) in naive patients with different stages of fibrosis. The regimen of SOF/DAC has lower relapse rate than the regimen of SOF/SMV. The Fib-4 score was significantly decreased at week 24 post treatment in patients who received the regimen SOF/SMV.

/pdf/safety-and-efficacy-of-sofosbuvir-and-simeprevir-versus-3q3haey1eg.pdf

Safety and Efficacy of Sofosbuvir and Simeprevir Versus Sofosbuvir and Daclatasvir in Treatment of Naïve Egyptian Patients with Chronic Hepatitis C Virus Infection

Introduction: With the advent of direct-acting antiviral (DAA) therapy for HCV, the cure is achieved at similar rates among HIV–HCV coinfected patients as in HCV mono-infected patients. The present study evaluates host plasma metabolites as putative indicators in predicting the treatment response in baseline HIV–HCV patients. Methods: Non-cirrhotic HIV–HCV (N = 43) coinfected patients were treated with sofosbuvir and daclatasvir for 12 weeks. Plasma metabolite profiling of pre- and post-therapy was analyzed in 20/43 patients. Of the 20 selected, 10 (50%) attained the sustained viral response [(SVR) (responders)] as defined by the absence of HCV RNA at 12 weeks after the treatment, and 10 (50%) did not attain the cure for HCV (nonresponders). Results: A total of 563 features were annotated (metabolomic/spectral databases). Before therapy, 39 metabolites differentiated (FC ±1.5, p < 0.05) nonresponders from responders. Of these, 20 upregulated and 19 downregulated were associated with tryptophan metabolism, nicotinamide metabolism, and others. Post therapy, 62 plasma metabolites (12 upregulated and 50 downregulated, FC±1.5, p < 0.05) differentiated nonresponders from responders and highlighted a significant increase in the steroid and histidine metabolism and significant decrease in tryptophan metabolism and ascorbate and pyruvate metabolism in the nonresponders. Based on random forest and multivariate linear regression analysis, the baseline level of N-acetylspermidine (FC > 2, AUC = 0.940, Bfactor = −0.267) and 2-acetolactate (FC > 2, AUC = 0.880, Bfactor = −0.713) significantly differentiated between nonresponders from responders in HIV–HCV coinfected patients and was able to predict the failure of treatment response. Conclusion: Increased baseline levels of N-acetylspermidine and 2-acetolactate levels are associated with the likeliness of failure to attain the cure for HCV in HIV–HCV coinfected patients.

Baseline Plasma Metabotype Correlates With Direct-Acting Antiviral Therapy Nonresponse for HCV in HIV–HCV Coinfected Patients

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Factors associated with success of telaprevir- and boceprevir-based triple therapy for hepatitis C virus infection

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Factors associated with success of telaprevir- and boceprevir-based triple therapy for hepatitis C virus infection