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

Primary Purpose

Chronic Hepatitis C Virus Infection

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

SOF plus (OBV/PTV/r) plus RBV

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Virus Infection focused on measuring Sofosbuvir, Ombitasvir, Paritaprevir, Ribavirin, Ritonavir, HCV GT 4, Experienced Egyptian Patients, Cirrhotic, Non-Cirrhotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Beni-Suef University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Cirrhotic Participants

Non-cirrhotic Participants

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Percentage of Participants With Viral relapse

Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.

Full Information

NCT ID

NCT04391985

First Posted

May 13, 2020

Last Updated

May 13, 2020

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT04391985

Brief Title

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

Official Title

Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

October 31, 2017 (Actual)

Study Completion Date

October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C Virus Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cirrhotic Participants

Arm Type

Active Comparator

Arm Description

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

Arm Title

Non-cirrhotic Participants

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SOF plus (OBV/PTV/r) plus RBV

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 weeks after last dose

Title

Number of Participants With Adverse Events in Each Treatment Arm

Description

Time Frame

Screening up to 12 weeks after last dose]

Secondary Outcome Measure Information:

Title

Percentage of Participants With Viral relapse

Description

Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.

Time Frame

Up to 12 weeks after last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Beni-Suef University

City

Beni-Suef

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29546644

Citation

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.

Results Reference

result

Links:

URL

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

Description

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.

Learn more about this trial

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

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