Kate Mason1, Zoë Dodd1, Mary Guyton2, Paula Tookey1, Bernadette Lettner1, John Matelski3, Sanjeev Sockalingam4, Jason Altenberg1, Jeff Powis5. 1. South Riverdale Community Health Centre, Canada. 2. Sherbourne Health Centre, Canada. 3. Biostatistics Research Unit, University Health Network, Canada. 4. Centre for Mental Health, University Health Network, Department of Psychiatry, University of Toronto, Canada. 5. Michael Garron Hospital, 825 Coxwell Avenue, D306, Toronto, Ontario M4C 3E7, Canada. Electronic address: jpowi@tegh.on.ca.
Abstract
BACKGROUND: Direct acting antiviral (DAA) treatments for Hepatitis C (HCV) are now widely available with sustained virologic response (SVR) rates of >90%. A major predictor of response to DAAs is adherence, yet few real-world studies evaluating adherence among marginalized people who use drugs and/or alcohol exist. This study evaluates patterns and factors associated with non-adherence among marginalized people with a history of drug use who were receiving care through a primary care, community-based HCV treatment program where opiate substitution is not offered on-site. METHODS: Prospective evaluation of chronic HCV patients initiating DAA treatment. Self-report medication adherence questionnaires were completed weekly. Pre/post treatment questionnaires examined socio-demographics, program engagement and substance use. Missing adherence data was counted as a missed dose. RESULTS: Of the 74 participants, who initiated treatment, 76% were male, the average age was 54 years, 69% reported income from disability benefits, 30% did not have stable housing and only 24% received opiate substitution therapy. Substance use was common in the month prior to treatment initiation with, 11% reported injection drug use, 30% reported non-injection drug use and 18% moderate to heavy alcohol use. The majority (85%) were treatment naïve, with 76% receiving sofosbuvir/ledipasvir (8-24 weeks) and 22% Sofosbuvir/Ribarvin (12-24 weeks). The intention to treat proportion with SVR12 was 87% (60/69). In a modified ITT analysis (excluding those with undetectable RNA at end of treatment), 91% (60/66) achieved SVR12. Overall, 89% of treatment weeks had no missed doses. 41% of participants had at least one missed dose. In multivariate analysis the only factor independently associated with weeks with missed doses was moderate to heavy alcohol use (p=0.05). CONCLUSION: This study demonstrates that strong adherence and SVR with DAAs is achievable, with appropriate supports, even in the context of substance use, and complex health/social issues.
BACKGROUND: Direct acting antiviral (DAA) treatments for Hepatitis C (HCV) are now widely available with sustained virologic response (SVR) rates of >90%. A major predictor of response to DAAs is adherence, yet few real-world studies evaluating adherence among marginalized people who use drugs and/or alcohol exist. This study evaluates patterns and factors associated with non-adherence among marginalized people with a history of drug use who were receiving care through a primary care, community-based HCV treatment program where opiate substitution is not offered on-site. METHODS: Prospective evaluation of chronic HCV patients initiating DAA treatment. Self-report medication adherence questionnaires were completed weekly. Pre/post treatment questionnaires examined socio-demographics, program engagement and substance use. Missing adherence data was counted as a missed dose. RESULTS: Of the 74 participants, who initiated treatment, 76% were male, the average age was 54 years, 69% reported income from disability benefits, 30% did not have stable housing and only 24% received opiate substitution therapy. Substance use was common in the month prior to treatment initiation with, 11% reported injection drug use, 30% reported non-injection drug use and 18% moderate to heavy alcohol use. The majority (85%) were treatment naïve, with 76% receiving sofosbuvir/ledipasvir (8-24 weeks) and 22% Sofosbuvir/Ribarvin (12-24 weeks). The intention to treat proportion with SVR12 was 87% (60/69). In a modified ITT analysis (excluding those with undetectable RNA at end of treatment), 91% (60/66) achieved SVR12. Overall, 89% of treatment weeks had no missed doses. 41% of participants had at least one missed dose. In multivariate analysis the only factor independently associated with weeks with missed doses was moderate to heavy alcohol use (p=0.05). CONCLUSION: This study demonstrates that strong adherence and SVR with DAAs is achievable, with appropriate supports, even in the context of substance use, and complex health/social issues.
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