Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03037151
• Date of registration: 27/01/2017
• Prospective Registration: Yes
• Primary sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Public title: Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV
• Scientific title: Safety and Fibrosis Improvement of Grazoprevir and Elbasvir for HCV GT1 and GT6 With or Without HIV
• Date of first enrolment: August 1, 2018
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03037151
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Anchalee Avihingsanon, MD, PhD
• Affiliation: HIV-NAT, Thai Red Cross - AIDS Research Centre

• Name: Pisit Tangkijvanich, MD
• Affiliation: Chulalongkorn University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Men and women aged 18 years or older

2. Documented chronic HCV GT1 or GT6 (positive for anti-HCV antibody and HCV RNA at least
6 months prior to screening)

3. HCV RNA of at least 10,000 IU/ml

4. Cirrhosis defined by: liver biopsy showing cirrhosis METAVIR F4; or TE showing
cirrhosis with a result of >13.0 kPa

5. Treatment-naïve individuals for chronic HCV infection

6. Treatment-experienced individuals (Previous treatment failure with PEG-IFN plus RBV)
for chronic HCV infection

7. HIV-infected participants enrolled in this study must meet following criteria:

7.1 Documented HIV infection 7.2 Naïve to treatment with any antiretroviral therapy
(ART) or on HIV ART for at least 8 weeks prior to study entry using a dual nucleoside
reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either
emtricitabine or lamivudine plus raltegravir (or dolutegravir or rilpivirine) 7.3 CD4+
T-cell count >200 cells/mm3 if on ART or >500 cell/mm3 if ART treatment naïve 7.4
Undetectable plasma HIV-RNA at least 8 weeks prior to screening if on ART or <50,000
copies/mL if ART treatment naïve

8. Agree to use two acceptable methods of birth control from at least 2 weeks prior to
Day 1 and continue until at least 6 months after last dose of study drug, or longer if
dictated by local regulations (for female subject who is of childbearing potential or
male subject with female sexual partner who is of childbearing potential).

Exclusion Criteria:

1. Evidence of decompensated liver disease (Child-Pugh Class B or C or Child-Pugh score
>6, platelets less than 75 × 10³/µL, serum albumin < 3·0 g/dL, presence of or history
of ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or
symptoms of advanced liver disease)

2. Co-infected with hepatitis B virus

3. Has cirrhosis and liver imaging within 6 months showing evidence of HCC or is under
evaluation for HCC

4. Pregnant or breast-feeding from day 1 or anytime during treatment, and 14 days after
the last dose of study medication

5. Any medical condition requiring or likely to require chronic systemic administration
of corticosteroids or other immunosuppressant drugs during the course of the study



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Compensated Cirrhosis

Intervention(s)

Drug: Grazaoprevir/Elbasavir

Drug: Grazaoprevir/Elbasavir/RBV

Primary Outcome(s)

Rate of SVR12 [Time Frame: 12 weeks post-treatment]

Secondary Outcome(s)

changes in liver stiffness [Time Frame: 5 years]

Decline of liver stiffness [Time Frame: 5 years post-treatment]

Rate of SVR24 [Time Frame: 24 weeks post-treatment]

Secondary ID(s)

HIV-NAT 245

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chulalongkorn University

Merck Sharp & Dohme Corp.