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

NCT ID: NCT04391985

Last Updated: 2020-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2017-10-31

Brief Summary

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

Detailed 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).

Conditions

Chronic Hepatitis C Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cirrhotic Participants

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

Group Type: ACTIVE_COMPARATOR

SOF plus (OBV/PTV/r) plus RBV

Intervention Type: DRUG

They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.

Non-cirrhotic Participants

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

Group Type: ACTIVE_COMPARATOR

SOF plus (OBV/PTV/r) plus RBV

Intervention Type: DRUG

They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.

Interventions

SOF plus (OBV/PTV/r) plus RBV

They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.

Intervention Type: DRUG

Other Intervention Names

Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease; Sovaldi is a trade name of sofosbuvir; Ombitasvir (ABT 267) is an NS5A inhibitor

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abdel-Gabbar, Ph.D

Associate Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni-Suef University

Banī Suwayf, , Egypt

Countries

Egypt

References

Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty M, Ramadan M. Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients. Dig Dis Sci. 2018 May;63(5):1341-1347. doi: 10.1007/s10620-018-5005-8. Epub 2018 Mar 15.

Reference Type: RESULT

PMID: 29546644 (View on PubMed)

Related Links

https://link.springer.com/article/10.1007/s10620-018-5005-8

This link clarify the retreatment efficacy and safety of the SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens.

Other Identifiers

Qu-RBV

Identifier Type: -

Identifier Source: org_study_id