Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

• Status: Completed
• Trial end date: 2017-10-31
• Target enrollment: 0
• Participant gender: All

Summary

enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

• The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV).

• The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 > 3.25 (advanced fibrosis or cirrhosis), albumin < 3.5, total bilirubin > 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.

Exclusion Criteria:

• liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV

• poorly controlled diabetes (HbA1C > 8)

• participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study

• renal failure

• evidence of hepatic decompensation

• blood picture abnormalities such as anemia (hemoglobin concentration of < 10 g/dL)

• thrombocytopenia (platelets count < 50,000 cells/mm3).

• major severe illness such as congestive heart failure and respiratory failure.