Supporting Treatment Outcomes Among PWID

Korábbi kezelés

• 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.
• Currently on HCV treatment.
• Prior history of DAA-based HCV treatment

Más betegség

• Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
• Evidence of decompensated liver disease on clinical exam.
• Evidence of active tuberculosis.
• Evidence of chronic hepatitis B infection (HBsAg positive).
• Confirmed active SARS CoV-2 infection or suspected active SARS CoV-2 infection at enrollment.

Egyéb

• Psychologically unfit to provide written informed consent.
• Planning to migrate within the next six months.
• Currently nursing (breastfeeding).

• 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.
  • 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.