RETRACTED ARTICLE: Efficacy and safety of sofosbuvir plus ribavirin for treatment of cirrhotic patients with genotype 4 hepatitis C virus in real-life clinical practice

Abstract

Egypt has the highest hepatitis C virus (HCV) prevalence in the world. Sofosbuvir is a new highly effective drug for treatment of HCV infection. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to fourfold reduced duration of therapy. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin in Egyptian patients with liver cirrhosis due to chronic HCV infection. We studied 2400 cirrhotic Egyptian patients with chronic HCV infection who were treated with dual therapy with sofosbuvir and ribavirin for 24 weeks. Efficacy was determined by assessment of serum HCV RNA. Any adverse events during treatment were recorded. Two thousand four hundred cirrhotic Egyptian patients with chronic HCV infection treated with sofosbuvir and ribavirin for 24 weeks were enrolled in the study. The mean age of the studied group (± SD) was 53.9 ± 6.5 years, 1549 (64.54%) were males, all were cirrhotic patients, 3.41% were treatment-experienced, the baseline mean HCV RNA concentration was 4.33 × 10 IU/mL, and 94.37% of the patients had completed the full course of therapy. The overall SVR12 rate was 71.2%. The most common adverse events were fatigue, myalgia, headache, insomnia, and anemia. One hundred thirty-five (5.63%) patients stopped treatment permanently due to the appearance of complications that prevented continuation of treatment. The sofosbuvir and ribavirin combination is safe and effective in treatment of HCV patients with liver cirrhosis. However, further studies are needed to establish the optimal treatment regimen for those cases.

Efficacy and safety of direct‐acting antivirals for hepatitis C in the elderly: A systematic review and meta‐analysis

“…In fact, we identified several studies that specifically focus on elderly populations while others reported age‐specific subgroup analyses. While most of the studies reported comparable efficacy of DAAs in the elderly compared to younger patients, some raised concerns that higher rates of treatment failure may specifically affect subgroups with other negative predictive factors, including cirrhosis and HCV genotypes 3 and 4 . Moreover, some studies also reported higher rates of SAEs and treatment discontinuation in the elderly .…”

“…While most of the studies reported comparable efficacy of DAAs in the elderly compared to younger patients, some raised concerns that higher rates of treatment failure may specifically affect subgroups with other negative predictive factors, including cirrhosis 24 and HCV genotypes 3 and 4. [25][26][27] Moreover, some studies also reported higher rates of SAEs and treatment discontinuation in the elderly. 18,[28][29][30] These findings have raised concerns whether a 'treat all' strategy is justified given the lack of a comprehensive risk-benefit analysis in this particular patient population.…”

Effect of cyclosporine A versus tacrolimus on the response to antiviral therapy after hepatitis C genotype‐4 recurrence post–liver transplantation: A prospective cohort trial

“…proximately 13% of all HCV infections worldwide, 1 with the highest prevalence occurring in Egypt (93% of genotype 4 worldwide and 15% of Egyptians), 2,3 where it is a leading cause of liver cirrhosis, hepatic cell carcinoma (HCC) and mortality. 4 Liver transplant (LT) has become a frequently used treatment strategy for end-stage liver disease (ESLD), HCC and acute liver failure, as it provides the only possibility of cure, long-term survival and improved quality of life.…”

“…The participants in groups II and III were between 18 and 75 years of age and had detectable HCV RNA by PCR. The patients were excluded from these groups if they were younger than 18 years or older than 75 years of age, or had one of the following criteria: total bilirubin (T.Bil) >3 mg/dL, serum albumin <2.8 mg/dL, international normalized ratio ≥1.7, platelet count <5000/mm 3…”

Safety, efficacy and cost of two direct‐acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients

“…HCV genotype 4 ( G4 ) is the common genotype in the Middle East, Northern Africa and Sub‐Saharan Africa. In Egypt, 93% of HCV patients are infected with G4 …”