A Randomized Controlled Trial of Cash Incentives or Peer Support to Increase HCV Treatment for Persons With HIV Who Use Drugs: The CHAMPS Study

Kathleen M Ward, Oluwaseun Falade-Nwulia, Juhi Moon, Catherine G Sutcliffe, Sherilyn Brinkley, Taryn Haselhuhn, Stephanie Katz, Kayla Herne, Lilian Arteaga, Shruti H Mehta, Carl Latkin, Robert K Brooner, Mark S Sulkowski, Kathleen M Ward, Oluwaseun Falade-Nwulia, Juhi Moon, Catherine G Sutcliffe, Sherilyn Brinkley, Taryn Haselhuhn, Stephanie Katz, Kayla Herne, Lilian Arteaga, Shruti H Mehta, Carl Latkin, Robert K Brooner, Mark S Sulkowski

Abstract

Background: Despite access to direct-acting antivirals, barriers to a hepatitis C virus (HCV) cure persist, especially among persons living with human immunodeficiency virus (HIV) (PLWH) who use drugs. Interventions such as peer mentors or cash incentives may improve the care continuum.

Methods: The CHAMPS (Chronic HepAtitis C Management to ImProve OutcomeS) study randomized 144 PLWH, recruited from an outpatient clinic, with substance use disorders into three treatment groups: usual care (UC) (n = 36), UC plus cash incentives (n = 54), and UC plus peer mentors (n = 54) to evaluate HCV treatment uptake and cure. All participants received 12-weeks of ledipasvir/sofosbuvir (LDV/SOF). Trained peer mentors had well-controlled HIV and HCV. Cash incentives were contingent on visit attendance (maximum $220). The primary endpoint was HCV treatment initiation; secondary endpoints included sustained virologic response (SVR) and HCV reinfection.

Results: The majority of participants were male (61%), Black (93%), and unemployed (85%). Depression and active drug and alcohol use were common. Overall, 110 of 144 (76%) participants initiated LDV/SOF. Although treatment initiation rates were higher in PLWH randomized to peers (83%, 45 of 54) or cash (76%, 41 of 54) compared to UC (67%, 24 of 36), these differences were not statistically significant (P = .11). Most PLWH who initiated treatment achieved SVR (100 of 110, 91%). LDV/SOF was well tolerated; peers and cash had no effect on drug and alcohol use during therapy. One individual from the cash cohort experienced HCV reinfection.

Conclusion: After removal of system barriers, one-third of PLWH in UC did not initiate HCV treatment. Among those who initiated, SVR rates were high. Research involving PLWH who use drugs should focus on overcoming barriers to treatment initiation.

Clinical trial information: The registration data for the trial are in the ClinicalTrials.gov database, number NCT02402218.

Keywords: cash incentives; hepatitis C virus; human immunodeficiency virus; peer mentor; substance use disorders.

Figures

Figure 1.
Figure 1.
CONSORT Flow Diagram. Abbreviations: CONSORT, consolidated standards of reporting trials; LDV/SOF, ledipasvir/sofosbuvir; SVR, sustained virologic response; UC, usual care. *Participant failed to initiate treatment within 8 or 12 weeks of randomization (12 weeks if changes in antiretroviral therapy were required prior to direct-acting antivirals). **Three participants discontinued treatment due to adverse events (nausea, peer; tinnitus, peer; insomnia, incentive). One participant from each group (3 total) discontinued treatment early due to non-adherence to pharmacy visits. ***Sustained virologic response defined as an undetectable HCV RNA level at 12 or more weeks after stopping ledipasvir/sofosbuvir. No participants were lost to follow-up.
Figure 2.
Figure 2.
HCV Treatment Initiation and SVR by Intervention Group and Employment Status. (A) HCV Treatment Initiation and SVR Among All Participants Randomized by Intervention Group. (B) Post-Hoc Analysis of Employment Status as a Predictor of HCV Treatment Initiation and SVR. Abbreviations: HCV, hepatitis C virus; SVR, sustained virologic response. *Reference group for relative risk: usual care.
Figure 3.
Figure 3.
HCV Treatment Initiation and SVR Overall and by Treatment Initiation Status. (A) HCV Treatment Initiation Across Intervention Groups (Primary Endpoint). (B) SVR Among Participants who Initiated HCV Treatment (Secondary Endpoint). (C) SVR Among All Participants Randomized (Secondary Endpoint). Abbreviations: HCV, hepatitis C virus; SVR, sustained virologic response. (A)*Primary non-SVR includes participants that failed to initiate treatment within 8 or 12 weeks of randomization (12 weeks if changes in antiretroviral therapy were required prior to direct-acting antivirals). (B)*Secondary non-SVR includes 10 participants without SVR, 1 participant (usual care) died during follow-up (last HCV RNA not detected), 2 participants (1 peer mentor and 1 cash incentive) had post-treatment HCV relapse, 1 participant (cash incentive) with HCV genotype 1b at entry was reinfected with HCV genotype 1a between post-treatment weeks 4 and 12 in the setting of injection drug use, and 6 participants stopped LDV/SOF after less than 7 weeks (1 usual care, 3 peer mentor, and 2 cash incentive).

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