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Observational Study
. 2020 Apr;35(4):1011-1020.
doi: 10.1007/s11606-019-05394-9. Epub 2019 Oct 28.

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

Marina Serper  1 , Donna M Evon  2 , Paul W Stewart  3 , Anna S Lok  4 , Jipcy Amador  3 , Bryce B Reeve  5 , Carol E Golin  6 , Michael W Fried  7 , K Rajender Reddy  1 , Richard K Sterling  8 , Souvik Sarkar  9 , Adrian M Di Bisceglie  10 , Joseph K Lim  11 , David R Nelson  12 , Nancy Reau  13
Affiliations
Observational Study

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

Marina Serper et al. J Gen Intern Med. 2020 Apr.

Abstract

Background: The prevalence and risk factors for non-adherence 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 non-adherence, 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 non-adherence 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.

Keywords: adherence; alcohol use; liver disease; substance use.

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Conflict of interest statement

Donna M. Evon receives research funding from Gilead and Merck (paid to UNC). Michael Fried has received research funding from and served as a consultant for AbbVie, BMS, Gilead, Merck, and TARGET PharmaSolutions. Stock in TARGET PharmaSolutions is held in an independently managed trust. Anna S. Lok has received research support from BMS, Gilead, TARGET PharmaSolutions, AbbVie, and Merck, and served as an advisor for Gilead. Richard K. Sterling has received research support from AbbVie, BMS, Gilead, Merck, and Roche, and served as a consultant for Merck, Bayer, Sa2lix, AbbVie, Gilead, Jansen, ViiV, Baxter, and Pfizer. Joseph K. Lim has received research support (paid to Yale University) and served as a consultant for Bristol-Myers Squibb and Gilead. Nancy Reau has received research funding (paid to Rush) from AbbVie and Intercept and has served as a consultant for Merck, AbbVie, Abbott, and Gilead. Souvik Sarkar served on a Gilead and AbbVie Advisory Board. David R. Nelson has received research grant support from AbbVie, BMS, Gilead, Janssen, and Merck and owns stock in TARGET PharmaSolutions. K. Rajender Reddy is an Ad-Hoc Advisor to Gilead, BMS, Janssen, Merck, and AbbVie and has received research support from Gilead, BMS, Janssen, Merck, and AbbVie (paid to the University of Pennsylvania). Adrian M. Di Bisceglie has received research support from AbbVie, BMS, and Gilead and has served on advisory boards for AbbVie, BMS, Gilead, and Merck. He serves as Chair of the Steering Committee for TARGET HCC, a registry study funded by TARGET PharmaSolutions. Paul Stewart has served as a consultant to TARGET PharmaSolutions. Jipcy Amador served as a biostatistics intern at TARGET PharmaSolutions in 2017. Carol E. Golin, Marina Serper, and Bryce Reeve declare that they have no conflict of interests to disclose.

Figures

Figure 1
Figure 1
a Proportion of patients who were non-adherent by mental health condition, alcohol use, and substance use at T2 and T3. The 95% confidence intervals were computed using the Wilson score confidence limits. Superscript letter “a”: Among the 1513 patients with medication adherence data at T2, 65 (4%) were non-adherent, and among the 1476 patients with medication adherence data at T3, 119 (8%) were non-adherent. b Proportion of patients who were non-adherent: subgroups defined by sociodemographics, treatment cohort, symptoms burden, and medical comorbidities at T2 and T3. The 95% confidence intervals were computed using the Wilson score confidence limits. Superscript letter “a”: Among the 1513 patients with medication adherence data at T2, 65 (4%) were non-adherent, and among the 1476 patients with medication adherence data at T3, 119 (8%) were non-adherent. Superscript letter “b”: For the total cohort (n = 1562), other race includes 22% American Indian, Alaskan Native, Pacific Islander; 30% multiracial/biracial; 4% Asian; and 44% not reported or unknown. DAA direct-acting antiviral; SOF/LED sofosbuvir/ledipasvir’ SOF/VEL sofosbuvir/velpatasvir; GRZ/ELB grazoprevir/elbasvir; OBV/PTV/r + DSV ombitasvir/paritaprevir/ritonavir + dasabuvir; SOF/DAC sofosbuvir/daclatasvir; TMSAS total score for the Memorial Symptom Assessment Scale; CI confidence interval.
Figure 2
Figure 2
Reasons for non-adherence to DAA therapy. “n” is the number of responses for non-adherence reasons at T2 and T3.
See this image and copyright information in PMC

Comment in

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