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

Beni-Suef University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis C Virus Infection

Treatments: Drug: SOF plus (OBV/PTV/r) plus RBV

Study type: Interventional

Funder types: Other

Identifiers

NCT04391985

Qu-RBV

Details and patient eligibility

About

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

Full description

Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level < 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

Cirrhotic Participants

Active Comparator group

Description:

The experienced participants(113 participants) who failed prior DAA treatments. They were allocated to cirrhotic (30 participants) and treated for 12 weeks.

Treatment:

Drug: SOF plus (OBV/PTV/r) plus RBV

Non-cirrhotic Participants

Active Comparator group

Description:

The experienced non-cirrhotic participants(83 participants) who failed prior DAA treatments. They were treated for 12 weeks.

Treatment:

Drug: SOF plus (OBV/PTV/r) plus RBV