Background and Aims
This study aimed to assess the safety and efficacy of sofosbuvir (SOF)‐based regimens in patients with moderate to severe renal impairment; a subject which has been questioned by many investigators with conflicting results.
Methods
This is a real‐life multicentre retrospective cohort study on 4944 chronic Hepatitis C virus (HCV) patients with chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m2) who received SOF‐based therapy in specialized treatment centres affiliated to the National Committee for the Control of Viral Hepatitis in Egypt. The efficacy and safety of SOF‐based regimens was assessed.
Results
Week 12 virological response rates were 97.5%, 96.7%, 85.7% and 80% in the total cohort, patients with eGFR <30 mL/min/1.73 m2, patients with associated hepatic decompensation and patients on dialysis respectively. Various treatment regimens did not statistically affect the response rates. Treatment experience, cirrhosis and diabetes were predictors of treatment failure on multivariate analysis. Serious adverse events occurred in 0.1% of cases. Forty patients (0.8%) discontinued treatment.
Conclusion
Sofosbuvir‐based regimens are effective and safe for treating patients with chronic HCV and moderate to severe CKD, and in those with associated hepatic decompensation.
Adverse effects associated with DAAs are few, anaemia being the most common. SOF/RBV regimen showed the highest rate of side effects while SOF/DCV showed the least.
Background and Aim: Cirrhotic patients have lower response rates to DAAs with increased frequency of adverse events. This study aims to evaluate the value of HCVcAg as an early predictor of SVR to DAAs in cirrhotic patients to justify the treatment and avoid side effects.
Patients and Methods: This prospective cohort study was conducted on 85 treatment-naive HCV cirrhotic patients who had fulfilled the inclusion and exclusion criteria of the National Treatment Protocol of chronic HCV infection. HCVcAg detection was done on 10th day of treatment. Predictivity of HCVcAg for SVR was assessed in terms of specificity, sensitivity, positive predictive value (PPV), negative predictive value (NPV) and accuracy rates. ROC curve was conducted to assess predictivity of HCVcAg as well.
Results: SVR12 was (91.76%). HCVcAg was negative in 79 patients; 78 of them achieved SVR, while it was positive in 6 patients; all of whom did not achieve SVR. HCVcAg had sensitivity, specificity, PPV, NPV and accuracy rates of 100%, 98.73%, 85.71%, 100% and 98.82% respectively in prediction of SVR. With AUC of 0.929. There was a positive strong significant correlation between HCVcAg and SVR12 (r = 0.898, P = 0.015).
Conclusion: HCVcAg is a sensitive, specific, accurate, easily available, and affordable on- treatment predictor of SVR in cirrhotic patients with chronic HCV with possible future treatment regimen modification to improve efficacy and tolerability in difficult to treat cirrhotic patients.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.