Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial.

COVID-19 is a pandemic disease caused by SARS-CoV-2, which is an RNA virus similar to the hepatitis C virus (HCV) in the replication process. Sofosbuvir/ledipasvir is an approved drug to treat HCV infection. This study investigates the efficacy of Sofosbuvir/ledipasvir as a treatment for patients with moderate COVID-19 infection. This is a single-blinded parallel-randomized controlled trial. The participants were randomized equally into the intervention group that received Sofosbuvir/ledipasvir (S.L. group), and the control group received Oseltamivir, Hydroxychloroquine, and Azithromycin (OCH group). The primary outcomes were the cure rate over time and the incidence of serious adverse events. The secondary outcomes included the laboratory findings. 250 patients were divided equally into each group. Both groups were similar regarding gender, but age was higher in the S.L. group (p=0.001). In the S.L. group, 89 (71.2%) patients were cured, while only 51 (40.8%) patients were cured in the OCH group. The cure rate was significantly higher in the S.L. group (RR=1.75, p<0.001). Kaplan-Meir plot showed a considerably higher cure over time in the S.L. group (Log-rank test, p=0.032). There were no deaths in the S.L. group, but there were six deaths (4.8%) in the OCH group (RR=0.08, p=0.013). Seven patients (5.6%) in the S.L. group and six patients (4.8%) in the OCH group were admitted to the intensive care unit (ICU) (RR=1.17, P=0.776). There were no significant differences between treatment groups regarding total leukocyte and neutrophils count, lymph, and urea. Sofosbuvir/ledipasvir is suggestive of being effective in treating patients with moderate COVID-19 infection. Further studies are needed to compare Sofosbuvir/ledipasvir with new treatment protocols.

Study of the role of insulin resistance as a risk factor in HCV related hepatocellular carcinoma.

Chronic HCV infection causes hepatic cirrhosis and approximately 10%-20% of cirrhotic patients may develop hepatocellular carcinoma within 5 years. Diabetes mellitus is associated with a 2-4-fold increase in the risk of HCC. Insulin resistance (IR) emerged as a risk factor for a variety of cancers, including endometrial and breast and various gastrointestinal cancers The role of IR in the development of HCC associated with chronic HCV infection has not, been established. This study elucidated the role of insulin resistance assessed by the homeostasis model (HOMA-IR) in development of hepatocellular carcinoma associated with chronic hepatitis C infection. The study included 3 groups: GI: 100 newly diagnosed cases of HCV related hepatocellular carcinoma GII: 60 patients with HCV related chronic liver disease. Forty healthy persons as a control group (GIII). All groups were subjected to full history taking, physical examination, laboratory investigations abdominal ultrasonography and Triphasic C.T examination. In addition to Calculation of Body mass Index, Measurement of fasting blood insulin and glucose, Calculation of insulin resistance using HOMA-IR. The results showed that fasting insulin and HOMA-IR were significantly higher among HCC group than HCV group & control group. Also, fasting insulin and HOMA-IR were significantly higher in HCV group than control group. HOMA-IR above 3.7, insulin above 9µU/L & DM were considered independent predictors of HCC.