N/A
N=3,000
Supporting Treatment Outcomes Among PWID
Hepatitis C · HIV Coinfection
Bottom Line
View on ClinicalTrials.gov: NCT04652804 ↗Enrolled (actual)
3,000
Serious AEs
1.7%
Results posted
Apr 2025
Primary outcome: Primary: Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) — 638; 416; 233; 76 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low intensity HCV treatment adherence support (Behavioral); Medium intensity HCV treatment adherence support (Behavioral); High intensity HCV treatment adherence support (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) |
638; 416; 233; 76; 145; 241 | — |
| SECONDARY HCV Treatment Completion |
969; 660; 311; 138; 291; 413 | — |
| SECONDARY Adherence >90% (Self-report) |
860; 595; 284; 105; 239; 372 | — |
| SECONDARY Adherence >90% (Medication Records) |
755; 541; 234; 99; 233; 305 | — |
| SECONDARY Adherence Level (Self-report) |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Adherence Level (Medication Records) |
96.5; 96.6; 95.2; 93.3; 95.5; 92.9 | — |
| SECONDARY HCV Reinfection |
— | — |
| SECONDARY HIV Viral Suppression Among HIV/HCV Coinfected Participants |
— | — |
Summary
The goal of this study is to improve HCV care continuum outcomes for people who inject drugs (PWID), reduce potential onward transmission to others and improve HIV outcomes among those who are HIV/HCV coinfected. The study will evaluate whether HCV treatment outcomes (sustained virologic response, treatment completion, adherence) and post treatment outcomes (HCV reinfection, HIV viral suppression) in HCV mono- and HIV/HCV co-infected PWID can be optimized by tailoring treatment support in 7 PWID-focused integrated HIV/HCV prevention and treatment centers in India.
Eligibility Criteria
Inclusion Criteria
- Registered for care at an Integrated Care Center (ICC) in one of the 7 field sites.
- Active HCV infection confirmed by a detectable HCV RNA by polymerase chain reaction (PCR) (HCV RNA ≥ 30 copies/ml) within 90 days prior to study entry.
- Liver disease stage defined as non-cirrhotic or compensated cirrhotic (metric/diagnostic criteria used for fibrosis staging) within 90 days prior to study entry.
i. Albumin >3.0 g/L. ii. Hemoglobin >8.0 g/dL for women; >9.0 g/dL for men. iii. Platelet count >50,000/mm3. iv. Calculated creatinine clearance (CrCl) using Cockcroft-Gault method >30 mL/min. v. Aspartate aminotransferase (AST/SGOT) <10 times the upper limit of the normal range (ULN). vi. Alanine aminotransferase (ALT/SGPT) <10 times the ULN. vii. Total bilirubin <1.5 times the ULN for participants not on atazanavir (ATV) and <3 times the ULN for participants on ATV. viii. International normalized ratio (INR) <1.5 times the ULN.
- Life expectancy greater than 1 year (as determined by study clinician)
- Willing to initiate HCV treatment
- Agree to be randomized to an adherence support strategy
- Ability and willingness to provide written informed consent
- Female participants of reproductive potential must not be pregnant
- All female participants of reproductive potential must agree not to participate in a conception process
- All female participants of reproductive potential must agree to use at least one reliable form of contraceptive while receiving protocol-specified medication, and for 6 weeks after stopping the medication.
Exclusion Criteria
- Psychologically unfit to provide written informed consent.
- Planning to migrate within the next six months.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
- In HIV positive participants, presence of active or acute AIDS-defining opportunistic infections within 30 days prior to study entry.
- Use of prohibited medications within the past 14 days prior to study entry.
- Evidence of decompensated liver disease on clinical exam.
- Evidence of active tuberculosis.
- Evidence of chronic hepatitis B infection (HBsAg positive).
- Currently on HCV treatment.
- Prior history of DAA-based HCV treatment
- Confirmed active SARS CoV-2 infection or suspected active SARS CoV-2 infection at enrollment.
- Currently nursing (breastfeeding).
Data sourced from ClinicalTrials.gov (NCT04652804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.