8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C

NCT04885855 | Completed Phase 2

• 1 other identifier: MOH-8v12-SOF/RDV-01-HCV
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

This is open-label, randomized, multicentre study to compare the efficacy and safety of the 8-week versus 12-week of SOF-RVD combination treatment for non-cirrhotic chronic hepatitis C patients. All the recruited subjects will receive the treatment accordingly and be followed up for 24 weeks following the completion of treatment.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• SVR12

  Sustained Virological Response (SVR) at week-12 post treatment, as evidenced by Hepatitis C Viral (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification of 15 IU/mL.

  12 weeks upon completion of treatment

Study Arms (2)

8-week

EXPERIMENTAL

Patient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 8 weeks.

Drug: Sofosbuvir 400 MG; Drug: Ravidasvir 200mg

12-week

ACTIVE COMPARATOR

Patient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 12 weeks.

Drug: Sofosbuvir 400 MG; Drug: Ravidasvir 200mg

Interventions

Sofosbuvir 400 MG DRUG

Sofosbuvir is a direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5B (NS5B)

Also known as: Grateziano

12-week; 8-week

Ravidasvir 200mg DRUG

Ravidasvir is an investigational direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5A (NS5A)

Also known as: PPI-668

12-week; 8-week

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has evidence of chronic HCV infection, defined as:
• a. Positive anti-HCV antibody or detectable HCV RNA or HCV genotype and HCV viral load ≥104 IU/mL within 6 months prior to the time of blood collection for screening.
• Willing and able to provide written informed consent.
• Men and women age ≥ 18 years and \< 70 years.
• Body Mass Index (BMI) of 18 to 35 kg/m2.
• Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
• Women with a negative pregnancy test at screening and baseline assessment.
• Women of childbearing potential who accept effective contraception from 2 weeks prior to day 1 of study to 1 month after treatment (double contraceptive method including at least one barrier method). A woman is of non-childbearing potential if she (a) reached natural menopause determined retrospectively after 12 months of amenorrhea without any other obvious medical cause or (b) had procedures like bilateral tubal ligation or hysterectomy or bilateral oophorectomy.
• Subjects who are compliant in opioid substitution maintenance program may be included as long as there is no concern about study medications adherence and interaction or compliance to study schedules.
• HIV/HCV co-infected patients receiving cART fulfilling the below criteria are eligible for the study:
• Antiretroviral therapy has been initiated at least 6 months prior to screening (to avoid the possibility of Immune reconstitution inflammatory syndrome - IRIS)
• Patient has been on the same protocol-approved ARV regimen for ≥ 8 weeks prior to screening and is expected to continue the current ARV regimen through the end of study.
• HIV ARVs: agents allowed in this study should be administered per the prescribing information in the package insert
• Screening HIV RNA \<50 copies/mL.
• Screening CD4 cell count ≥100 cells/uL

You may not qualify if:

• Has evidence of liver cirrhosis in which, liver cirrhosis is determined by;
• APRI score of ≥ 1.5,
• In case where APRI score is \>1.0 but \<1.5,
• Perform fibroscan\* (where TE ≥12.5 kPa indicates liver cirrhosis) or
• Calculate FIB-4 index (where ≥3.25 indicates liver cirrhosis) \*Depending on availability at facility
• Current/past history of decompensation including ascites, variceal bleeding, bacterial peritonitis, or hepatic encephalopathy.
• Direct bilirubin \>3x ULN
• AST, ALT \>10x ULN
• Low neutrophil count (≤599 cells/mm3), haemoglobin (\<9.0 g/dL), platelets (\<150000 cells/mm3).
• Patients with serum creatinine \>1.5 ULN or end-stage renal disease.2
• Hepatitis B co-infection (HBsAg positive).
• Pregnancy, as documented by positive pregnancy tests at screening and baseline assessment.
• Breastfeeding.
• Subjects currently receiving or unable to stop the use for at least 1 week prior to receiving the first dose of study drug any medications or herbal supplements known to be potent inhibitors or moderate inducers of cytochrome P450 (CYP) 3A4 and potent inducers of P-glycoprotein. This includes subjects who are on amiodarone or other contraindicated drugs. Refer to www.hep\_druginteractions.org, the investigator manual and the investigator's brochure for detailed information.
• Participation in other clinical trials within 3 months.

Sponsors & Collaborators

• Muhammad Radzi Abu Hassan: lead

Study Sites (1)

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460, Malaysia

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; ravidasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Muhammad Radzi Abu Hassan, FRCP

  Hospital Sultanah Bahiyah, Ministry of Health Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: March 23, 2021
• Primary Completion: December 29, 2023
• Study Completion: March 15, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)