Hepatitis C
Conditions
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.
Interventions
Sofosbuvir is a direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5B (NS5B)
DRUGRavidasvir 200mg
Ravidasvir is an investigational direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5A (NS5A)
Sponsors
Muhammad Radzi Abu Hassan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Willing and able to provide written informed consent. 3. Men and women age ≥ 18 years and \< 70 years. 4. Body Mass Index (BMI) of 18 to 35 kg/m2. 5. Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments. 6. Women with a negative pregnancy test at screening and baseline assessment. 7. 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. 8. 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. 9. HIV/HCV co-infected patients receiving cART fulfilling the below criteria are eligible for the study: 1. Antiretroviral therapy has been initiated at least 6 months prior to screening (to avoid the possibility of Immune reconstitution inflammatory syndrome - IRIS) 2. 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. 3. HIV ARVs: agents allowed in this study should be administered per the prescribing information in the package insert 4. Screening HIV RNA \<50 copies/mL. 5. Screening CD4 cell count ≥100 cells/uL 10. HIV/HCV co-infected patients not receiving cART: Screening CD4 cell count must be ≥ 500 cells/uL
Exclusion criteria
1. Has evidence of liver cirrhosis in which, liver cirrhosis is determined by; 1. APRI score of ≥ 1.5, 2. 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 3. Current/past history of decompensation including ascites, variceal bleeding, bacterial peritonitis, or hepatic encephalopathy. 2. Additional laboratory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SVR12 | 12 weeks upon completion of treatment | 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. |
Countries
Malaysia
Outcome results
None listed