CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS

Recent advances in Hepatitis C Virus (HCV) treatment represent a paradigm shift for the
treatment of HCV-infected persons with Human Immunodeficiency Virus (HIV) coinfection. With
potent antiviral activity, excellent safety/tolerability, few drug interactions and once
daily, oral dosing, Sofosbuvir (SOF)/Ledipasvir (LDV) have had excellent efficacy in
randomized controlled trials and offer great promise for the treatment of hepatitis C in
HIV/HCV coinfected patients who are at high risk for progressive liver disease and
HCV-related mortality. While the availability of SOF/LDV has great promise for the treatment
of patients, the experience with antiretroviral therapy (ART) for the treatment of HIV
infection indicates that interferon-free oral therapy is necessary but not sufficient to cure
HCV in the real world. While removal of Interferon increases the proportion of coinfected
persons who use drugs (PWUD) eligible for treatment, multiple barriers will remain (e.g.,
medical/psychiatric illness, substance abuse, and social constraints). Effective ART in
coinfected PWUDs provides a strategic framework for the delivery of curative HCV treatment;
novel and effective strategies for delivering this care for HCV must be evaluated, including
incentives and peer-mentoring.

Financial incentives. One method for increasing delivery of care is the contingent
administration of monetary incentives; such reinforcements have improved health outcomes
related to drug/alcohol abstinence, smoking cessation, childhood vaccination, tuberculosis
care and HIV treatment. Contingent reinforcement has also been successfully used to link
HIV-infected patients to care and improve adherence to ART. Curative HCV treatments are given
for a finite duration (12 weeks) which offers an ideal paradigm for incentive interventions
by reducing the overall cost and removing concerns of loss of adherence if incentives are
stopped.

Peer support. A second method for improving delivery of care is the use of peers or
laypersons with the same illness. By matching on cultural competencies and establishing
trust, peers may be particularly effective in some settings. In one study, African American
veterans with poorly controlled diabetes assigned to peer-support had better glucose control
than those assigned financial incentives. Coinfected patients may benefit from peer support.

The investigators will test two innovative strategies to improve HCV treatment outcomes in
HIV/HCV coinfected patients through the delivery of SOF/LDV for 12 weeks as part of a
randomized controlled trial. HIV-infected patients will receive SOF/LDV under one of three
randomly assigned conditions: usual care (clinic-based nursing model), incentive care (IC) or
peer-mentor care (PMC).

Inclusion Criteria:

- 18 years old or greater

- Hepatitis C genotype 1 infection for at least 6 months

- No evidence of Hepatocellular Carcinoma or End-Stage Liver Disease (e.g., history of
ascites, bleeding varices, and/or encephalopathy)

- Cluster of Differentiation 4 (CD4) cell count > 100 cells/mm3 for more than 3 months

- HIV RNA < 50 copies/mL for more than 3 months

- Ability to communicate effectively with key study personnel

- Willing to give written informed consent and comply with the study requirements

- Life expectancy > 2 year

Exclusion Criteria:

- Currently receiving Hepatitis C treatment

- Renal insufficiency - estimated glomerular filtration rate, calculated by the chronic
kidney disease epidemiology collaboration formula: <30 mL/min/1.73 m2

- Antiretroviral therapy inclusive of STRIBILD or APTIVUS

- Inability or unwillingness to avoid pregnancy for woman of child-bearing potential
and/or to father children during treatment and for a period of 3 months following
completion