Medication Non-adherence in a Prospective, Multi-center Cohort Treated with Hepatitis C Direct-Acting Antivirals

Abstract

BACKGROUND: The prevalence and risk factors for nonadherence to direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) in clinical practice settings are under-studied. OBJECTIVES: (1) To quantify DAA non-adherence in the total cohort and among subgroups with and without mental health conditions, alcohol use, and substance use, and (2) to investigate patient-and treatment-level risk factor non-adherence. DESIGN: Prospective, observational cohort study. PARTICIPANTS: A total of 1562 patients receiving DAAs between January 2016 and October 2017 at 11 US medical centers including academic and community practices. MAIN MEASURES: Self-reported medication nonadherence, defined as any missed doses in the past 7 days, surveyed early (T2: at 4 ± 2 weeks) and late in treatment (T3: 2-3 weeks prior to end of treatment). Non-adherence to post-treatment follow-up visits was defined as absence of lab results after DAA therapy completion. KEY RESULTS: Of 1447 patients, 162 (11%) reported non-adherence at T2 or T3. Medical records indicated 262 (17%) of the 1562 participants had not returned for post-treatment visits. At baseline, 37% of patients reported mental health conditions, 15% reported alcohol use, and 23% reported using substances in the previous year. Baseline characteristics associated with DAA nonadherence included alcohol use (OR 1.96), younger age (< 35 years vs. > 55 years: OR 3.40), non-white race (OR > 2.26), and DAA treatment cohort, but not substance use or mental health condition. Non-adherence to follow-up exhibited association with younger age and a higher baseline overall symptom burden. Among 1287 patients with evaluable sustained virologic response (SVR) data, 53 patients (4%) did not achieve SVR. The bivariate correlation between adherence and SVR was negligible (r = 0.01). CONCLUSIONS: DAA non-adherence was low and SVR rates were high. Mental health conditions, substance use, and alcohol use should not disqualify patients from DAA therapy. Patients with alcohol use disorder before DAA therapy initiation may benefit from targeted on-treatment support.

Patient‐reported outcomes 12 months after hepatitis C treatment with direct‐acting antivirals: Results from the PROP UP study

“…This suggests that patients with psychosocial comorbidities benefit substantially from viral cure. A previous study by our group showed high SVR and DAA adherence rates among patients with drug use and mental health conditions 27 ; thus coupled with this study's findings strongly suggest universal access to DAA therapy irrespective of age and psychosocial comorbidities. Older patients with HCV may not have obtained as robust PRO improvements compared to adults aged 35 to 55 given the presence of a higher number of other comorbidities that continue to cause symptoms unrelated to HCV.…”

The use of all-oral direct-acting antivirals in hepatitis C virus-infected patients with substance use disorders

“…23,26 On the other The low treatment initiation in the SUD population may be due to factors such as patients' refusal, physicians' concerns, and payer's rejection/rigid eligibility criteria which appears to be most relevant to those who was similar to other recent studies which also showed that among those with SUDs those that started treatment were highly likely to complete treatment and to obtain a cure. 25,33,34 We found that those whose treatment regimens included RBV were almost four times as likely to discontinue therapy regardless of their SUD status as those who did not have RBV as part of their therapy. This finding partially explains why those with cirrhosis, regardless of their SUD status, were almost three times as likely to discontinue treatment.…”

Rates of perfect self‐reported adherence to direct‐acting antiviral therapy and its correlates among people who inject drugs on medications for opioid use disorder: The PREVAIL study

“…Another important finding was that being Black, Latino or Other race than White was associated with non‐perfect self‐reported adherence. Non‐White or Black race has been shown to be associated with poor self‐reported adherence to DAA medication among HCV‐infected individuals with recent drug use in the past year 15 . Our finding is novel in the context that our study included PWID with active drug use and receiving MOUD.…”