Safety Of Sofosbuvir-based Regimens Research Articles

Efficacy and Safety of Sofosbuvir-Based Regimens in Patients with Viral Hepatitis C and Stage 4 and 5 Chronic Kidney Disease: The Cameroon Experience

Efficacy and Safety of Sofosbuvir-Based Regimens in Patients with Viral Hepatitis C and Stage 4 and 5 Chronic Kidney Disease: The Cameroon Experience

Efficacy and Safety of Sofosbuvir-based Regimens in Hepatitis C Patients With Decompensated Cirrhosis: A Systematic Review and Meta-analysis.

Decompensated cirrhotic patients with hepatitis C (HCV) are often under-represented in clinical trials. We aimed to evaluate pooled data on the efficacy and safety of sofosbuvir (SOF)-based regimens in these patients. We conducted a systemic review and meta-analysis by searching multiple databases for studies published from October 2010 to October 2020. Outcomes of interest were sustained virologic response (SVR) and safety of SOF-based regimens in decompensated HCV patients. Two reviewers independently performed the study selection and data extraction. We included 33 studies that enrolled 5,302 HCV patients. The pooled SVR rate in decompensated patients with SOF-based regimens was 85.1% (95% CI: 82.8-87.3). Patients on SOF/velpatasvir±ribavirin achieved a significantly higher SVR (91.0%, 95% CI: 87.7-93.9) than that of SOF/ledipasvir±ribavirin [(86.3%, 95% CI: 84.6-87.8); p=0.004)], or on SOF/daclatasvir±ribavirin (82.4%, 95% CI: 78.2-86.2%; p<0.001). Adding ribavirin to SOF-based regimens (pooled SVR 84.9%, 95% CI: 81.7-87.9) did not significantly increase the SVR [(83.8% (95% CI: 76.8-89.8%; p=0.76)] in decompensated patients, which was also true in subgroup analyses for each regimen within the same treatment duration. However, adding ribavirin significantly increased the frequency of adverse events from 52.9% (95% CI: 28.0-77.1) to 89.2% (95% CI: 68.1-99.9) and frequency of severe events. The pooled incidence of hepatocellular carcinoma and case-fatality of decompensated patients were 3.1% (95% CI: 1.5-5.0) and 4.6% (95% CI: 3.1-6.3), respectively. The overall heterogeneity was high. There was no publication bias. The analysis found that 12 weeks of SOF/velpatasvir without ribavirin is the preferred therapy, with a significantly higher SVR compared with other SOF-based regimens in decompensated HCV patients.

Sofosbuvir-Based Therapies Achieved Satisfactory Virological Response in Chinese Individuals with Genotypes 3 and 6 Infections: A Real-World Experience.

BackgroundPrevious studies have shown that sofosbuvir-based regimens yield high sustained virological response rates in patients with hepatitis C virus (HCV) infection except for genotype 3b complicated with cirrhosis. This real-world study aims to explore the efficacy and safety of sofosbuvir-based regimens in Chinese patients with genotypes 3 and 6 infections, especially the impact of ribavirin coadministration on sustained virological response in cirrhotic patients with genotype 3b infection.MethodsThis is a retrospective cohort study that included 101 patients initiated on sofosbuvir-based regimens. The main endpoint of treatment was sustained virological response at posttreatment week 12 (SVR12).ResultsOverall, the SVR12 rates were 95.0% (96/101); specifically, the rates were 100% in sofosbuvir, 88.2% in sofosbuvir+ribavirin, 100% in sofosbuvir+daclatasvir, 100% in sofosbuvir+daclatasvir+ribavirin, 95.0% in sofosbuvir/velpatasvir, and 97.1% in sofosbuvir/velpatasvir+ribavirin (p=0.534). The SVR12 rates were comparable in patients infected with genotypes 3 and 6 (93.2% versus 97.6%, p=0.339). The SVR12 rate was 93.9% in cirrhotic patients (31/33). Among those infected with genotype 3, the SVR12 rate was 91.7% (22/24); the rate was 95.0% in those with ribavirin coadministration regimens, which was numerically higher than the 75.0% in those without ribavirin. However, no statistical difference was found (p=0.312). In total, five patients failed to achieve SVR12, including 3 patients with genotype 3b infection treated with ribavirin coadministration regimens (one of them was cirrhotic), 1 cirrhotic patient with genotype 3k infection, and 1 noncirrhotic patient with genotype 6a infection. No severe adverse event occurred.ConclusionReal-world data show that sofosbuvir-based regimens are highly effective and safe for patients with HCV genotypes 3 and 6 infections.

Safety and Efficacy of Sofosbuvir Based Regimens in Treating Chronic ‎Hepatitis C Virus in Egyptian Patients: Real World Study: Single Center ‎Experience

Backgroundand study aims:Hepatitis C virus (HCV) is the main leading cause of liver disease in ‎Egypt. A new era of HCV treatment has been started with the evolution ‎of direct acting antiviral agents. Sofosbuvir (SOF)-based therapy was ‎introduced by the Egyptian ministry of health in 2014 in an attempt to ‎decrease disease burden. We aimed to evaluate efficacy and safety of ‎Sofosbuvir-based regimens in HCV Egyptian patients with compensated ‎liver disease‎. Patients and Method:‎This study was conducted in National Liver Institute, Menoufia‎University, Egypt. Seven hundred patients out of seven hundred fifty-‎eight chronic HCV patients with compensated liver disease who met the ‎inclusion criteria were included. According to treatment regimen patients ‎were divided to 4 groups; group 1 received Sofosbuvir (SOF), ‎Pegylated interferon (PEG-IFN) plus ribavirin (RBV), group 2 received ‎SOF plus RBV, group 3 received SOF and Simeprevir± RBV, group 4 ‎received SOF and Daclatasvir ±RBV‎.‎ Results:The overall SVR was 90.9%, 81.5%, 95% and 98% in groups 1, 2, 3, ‎and 4 respectively. SVR in patients with liver cirrhosis was 90.56, ‎‎79.16, 95 and 96% in the 4 groups respectively. In treatment ‎experienced patients, SVR was 86.8% in group 1, 78.3% in group 2, ‎‎100% in group 3 and 86.7% in group 4‎‎‎‎. Conclusion: Sofosbuvir plus daclatasvir with or without ribavirin is the safest ‎andmost effective SOF-based regimen in treatment of HCV Egyptian ‎patients with compensated liver disease‎‎‎‎.

SAT-217-Effectiveness and safety of sofosbuvir-based regimens in treatment of chronic HCV patients aged 60 years and older, Egyptian single center experience

SAT-217-Effectiveness and safety of sofosbuvir-based regimens in treatment of chronic HCV patients aged 60 years and older, Egyptian single center experience

Direct-acting Antiviral Agents in Hepatitis C Virus-infected Renal Allograft Recipients: Treatment and Outcome Experience from Single Center.

Hepatitis C virus (HCV) infection in renal allograft recipient is associated with increased morbidity and mortality. At present, only few studies related to treatment and outcomes of HCV-infected renal allograft recipients with DAAs have been published. We aimed the study to assess the efficacy and safety of sofosbuvir-based regimens in HCV-infected renal allograft recipients. We analyzed data of 22 eligible HCV-infected renal allograft recipients (14 genotype-3, 6 genotype-1, one each genotype-2 and 4) who were treated with DAAs at our institute. DAA regimen included sofosbuvir and ribavirin with or without ledipasvir or daclatasvir for 12–24 weeks. Patients were followed up for 24 weeks after completion of treatment. A rapid viral response of 91%, end of therapy response of 100%, and sustained viral response at 12 and 24 weeks of 100% with rapid normalization of liver enzymes were observed. Therapy was well tolerated except for ribavirin-related anemia. A significant decrease in tacrolimus trough levels was observed and most patients required increase in tacrolimus dose during the study. Treatment with newer DAAs is effective and safe for the treatment of HCV-infected renal allograft recipients.

Sa1515 - Integrated Analysis of Controlled Clinical Trials Evaluating Efficacy and Safety of Sofosbuvir-Based Regimens in Chronic Hepatitis C Genotype 6 (HCV GT 6)

Sa1515 - Integrated Analysis of Controlled Clinical Trials Evaluating Efficacy and Safety of Sofosbuvir-Based Regimens in Chronic Hepatitis C Genotype 6 (HCV GT 6)

Sa1527 - Efficacy and Safety of Sofosbuvir-Based Regimens in a National Cohort of Asian-American Patients with Chronic Hepatitis C

Sa1527 - Efficacy and Safety of Sofosbuvir-Based Regimens in a National Cohort of Asian-American Patients with Chronic Hepatitis C

Efficacy and safety of sofosbuvir-based regimens in chronic hepatitis C patients on dialysis.

Patients with end-stage renal disease (ESRD) have poor treatment tolerance and outcome to interferon-based regimens. Sofosbuvir-based regimens have improved treatment success in chronic hepatitis C. There is limited data in ESRD patients as sofosbuvir is excreted by the kidney. Several small studies have shown good results. Sixteen consecutive patients of ESRD (on dialysis) and chronic hepatitis C were treated with sofosbuvir-based regimens as they were prospective kidney transplantation recipients, at a tertiary care center in north India. Sofosbuvir was given 400mg on alternate days. Data is shown as number, mean (SD), and median (range). Sixteen patients (12 males) aged 45±12 years received sofosbuvir-based treatment. These patients were on hemodialysis from 10 (2-48) months. Eleven of these patients had genotype 1, four had genotype 3, and one had genotype 4 infection; baseline RNA was 7 (5-8) log. The following treatment regimens were used: sofosbuvir, ribavirin, and low dose peginterferon (n=8; 6 genotype 1 and one each had genotype 3 and 4); sofosbuvir and daclatasvir (n=7); sofosbuvir, ribavirin, and daclatasvir (n=1). Ten patients achieved end of treatment response and 8 (80%) of these achieved sustained virological response at 12weeks (SVR12); six are on treatment. Two patients with genotype one (including one with cirrhosis) had relapse. Seven patients needed blood transfusion; interferon was stopped in one due to thrombocytopenia. Fatigue was present in 4 patients. Sofosbuvir-based regimens can be used in ESRD patients on dialysis with good efficacy.

SAT-237 - Integrated analysis of controlled clinical trials evaluating efficacy and safety of sofosbuvir-based regimens in chronic hepatitis C genotype 6 (HCV GT 6)

SAT-237 - Integrated analysis of controlled clinical trials evaluating efficacy and safety of sofosbuvir-based regimens in chronic hepatitis C genotype 6 (HCV GT 6)