Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir 400 MG | Drug | Sofosbuvir is a direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5B (NS5B) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
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:
HIV/HCV co-infected patients not receiving cART: Screening CD4 cell count must be ≥ 500 cells/uL
Exclusion Criteria:
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,
Current/past history of decompensation including ascites, variceal bleeding, bacterial peritonitis, or hepatic encephalopathy.
Additional laboratory exclusion criteria:
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 [blocked], the investigator manual and the investigator's brochure for detailed information.
Participation in other clinical trials within 3 months.
Any clinically significant findings or unstable condition during the screening, medical history or physical examination that, in the investigator's opinion, would compromise participation in this study. This could include patients with poorly controlled hypertension, asthma, diabetes, or other life-threatening conditions.
Current or history of use within the preceding 6 months of immunosuppressive or immune-modulating agents. Corticosteroid used to treat any medical condition are allowed if systemic for not more than 2 weeks or if topical.
History of solid organ or bone marrow transplantation.
Any prior DAA use or NS5A inhibitors therapy.
Patients with significant cardiovascular conditions including myocardial infarction within the previous 6 months or heart failure NYHA class III or IV; history of Torsade de pointes
HIV/HCV co-infected patients who are yet to receive stable antiretroviral therapy or for whom ART treatment initiation maybe scheduled during the study period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Radzi Abu Hassan, FRCP | Hospital Sultanah Bahiyah, Ministry of Health Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultanah Bahiyah | Alor Star | Kedah | 05460 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42277657 | Derived | Muhamad NA, Mohd Dali NS, Maamor NH, Rosli IA, Leman FN, Awaluddin SM, Chan HK, Mohd Zin R, Abu Hassan MR. Time to viral load suppression with 8-week versus 12-week ravidasvir/sofosbuvir regimens among chronic hepatitis C patients in Malaysia: a non-inferiority, randomized clinical trial. BMC Infect Dis. 2026 Jun 11. doi: 10.1186/s12879-026-13741-5. Online ahead of print. | |
| 42140479 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C000621711 | ravidasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ravidasvir 200mg | Drug | Ravidasvir is an investigational direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5A (NS5A) |
|
|
| Derived |
| Abu Hassan MR, Muhamad NA, Mohammed NS, Mohd Suan MA, Zulkifli Supramaniam DN, Jogulu SR, Md Salleh MF, Soelar SA, Rosli IA, Leman FN, Mohd Dali NS, Maamor NH, Ngah NF, Chan HK; EASE Trial Group. A Multicenter, open-label, randomized, non-inferiority trial of 8 versus 12 weeks of sofosbuvir/ravidasvir treatment in non-cirrhotic patients with chronic hepatitis C virus infection (EASE trial). Int J Infect Dis. 2026 Aug;169:108788. doi: 10.1016/j.ijid.2026.108788. Epub 2026 May 14. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |