title: Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study.
abstract: The prevalence of smoking in HIV-infected subjects is high. As a smoking cessation aid, varenicline (Champix(®), Pfizer, Saint-Laurent, QC, Canada or Chantix(®), Pfizer, Mission, KS) has not been previously evaluated in HIV-infected smokers. In this multicenter pilot open label study, varenicline 1.0 mg was used twice daily for 12 weeks with dose titration in the first week. Adverse events (AEs) during the treatment period were recorded. Changes from baseline in laboratory tests, vital signs, daily cigarette consumption, nicotine dependence, and withdrawal were measured through week 24. Self-reported abstinence was validated by serum cotinine at week 12. We enrolled 36 subjects with a mean of 29 pack-years of smoking and a minimum of 4 cigarettes per day. All but 1 were male, 33 (92%) were white. The most frequently reported AEs were nausea (33%), abnormal dreams (31%), affect lability (19%), and insomnia (19%). Six (17%) subjects discontinued varenicline due to AEs. No grade 3/4 laboratory abnormalities or serious AEs occurred during the study. There was no significant change in HIV viral load. CD4 counts increased by 69 cells/mm3 (p = 0.001) at week 24. Serum cotinine-verified 4-week continuous abstinence rate through weeks 9-12 was 42% (95% confidence interval [CI]: 26-58%). AEs and abstinence rates were comparable to those in published randomized controlled trials conducted in generally healthy HIV-negative smokers. Varenicline was safe and appears effective among HIV-infected smokers in this exploratory study, although AEs were common. The most common AE was nausea, with no adverse effect on HIV treatment outcome. Close monitoring of liver enzymes and blood pressure is recommended for HIV-positive smokers taking varenicline.
authors: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. cuiq2@mcmaster.ca
authors: Qu
authors: Q
authors: Cui
authors: Linda
authors: L
authors: Robinson
authors: Dawn
authors: D
authors: Elston
authors: Fiona
authors: F
authors: Smaill
authors: Jeffrey
authors: J
authors: Cohen
authors: Corinna
authors: C
authors: Quan
authors: Nancy
authors: N
authors: McFarland
authors: Lehana
authors: L
authors: Thabane
authors: Andrew
authors: A
authors: McIvor
authors: Johannes
authors: J
authors: Zeidler
authors: Marek
authors: M
authors: Smieja
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D003367:Cotinine / Q000097:blood*; D004325:Dreams / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D006679:HIV Seropositivity / Q000150:complications* / Q000453:epidemiology; D006801:Humans; D007202:Indicators and Reagents; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D018722:Nicotinic Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D009864:Ontario / Q000453:epidemiology; D010865:Pilot Projects; D015995:Prevalence; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use*; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced / Q000453:epidemiology; D012907:Smoking / Q000009:adverse effects / Q000188:drug therapy* / Q000453:epidemiology; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D007202:Indicators and Reagents; D018722:Nicotinic Agonists; D011810:Quinoxalines; D003367:Cotinine; D000068580:Varenicline