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

NCT04391985 | Completed Phase 1 DMC

• 1 other identifier: Qu-RBV
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis C Virus Infection

Keywords

Sofosbuvir; Ombitasvir; Paritaprevir; Ribavirin; Ritonavir; HCV GT 4; Experienced Egyptian Patients; Cirrhotic; Non-Cirrhotic

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm

  SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/ml 12 weeks after the last dose of drugs.

  12 weeks after last dose

• Number of Participants With Adverse Events in Each Treatment Arm

  An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity

  Screening up to 12 weeks after last dose]

Secondary Outcomes (1)

• Percentage of Participants With Viral relapse

  Up to 12 weeks after last dose

Study Arms (2)

Cirrhotic Participants

ACTIVE COMPARATOR

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

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

Non-cirrhotic Participants

ACTIVE COMPARATOR

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

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

Interventions

SOF plus (OBV/PTV/r) plus RBV 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.

Also known as: 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

Cirrhotic Participants; Non-cirrhotic Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University

Banī Suwayf, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29546644 RESULT

Related Links

• 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.

MeSH Terms

Interventions

paritaprevir; ombitasvir

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: March 1, 2017
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)