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Randomized Controlled Trial
. 2021 Jan:112:106638.
doi: 10.1016/j.addbeh.2020.106638. Epub 2020 Aug 31.

Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV

Anna-Marika Bauer  1 , Mackenzie Hosie Quinn  1 , Su Fen Lubitz  1 , Alex Flitter  1 , Rebecca L Ashare  1 , Frank T Leone  2 , Robert Gross  3 , Brian Hitsman  4 , Robert Schnoll  5
Affiliations
Randomized Controlled Trial

Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV

Anna-Marika Bauer et al. Addict Behav. 2021 Jan.

Abstract

Introduction: PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.

Methods: This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT).

Results: Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ2[1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ2[1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ2[1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ2[1] = 4.43, p = 0.04).

Conclusions: Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.

Keywords: Adherence; Anxiety; Depression; HIV; Smoking cessation; Varenicline.

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Conflict of interest statement

Conflicts of Interest

Dr. Schnoll and Dr. Hitsman receive medication and placebo free from Pfizer and has provided consultation to Pfizer. Dr. Schnoll has provided consultation to GlaxoSmithKline and CuraLeaf. Dr. Gross serves on a Data and Safety Monitoring Board for a Pfizer drug unrelated to HIV or smoking.

Figures

Fig. 1.
Fig. 1.
Rates of smoking cessation by placebo and varenicline arms overall across medication adherence (Top) and across nicotine metabolism (Bottom) groups. Note. Sample size for analyses for adherence was 179 but 131 for NMR.
See this image and copyright information in PMC

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