Is Varenicline Safe for Smokers With HIV?
Varenicline is a safe and effective option for smoking cessation in patients living with human immunodeficiency virus (HIV), a new study found.
In the randomized, phase 3 ANRS 144 Inter-ACTIV trial, the researchers evaluated 303 eligible (of whom 248 were randomized) French patients with HIV who had smoked at least 10 cigarettes per day for 1 year or more. All patients in the study wished to stop smoking, were not dependent on another psychoactive substance, and had no history of depression or suicide attempts.
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Each patient was randomly assigned to receive either twice-daily 0.5 mg varenicline (n = 123) or placebo (n = 125) for 12 weeks, along with face-to-face counseling. Patients who were not abstinent from smoking by week 24 were offered open-label varenicline for 12 more weeks.
A total of 102 patients taking varenicline and 111 patients taking placebo were included in the modified intention-to-treat analysis. Findings showed that a higher proportion of patients taking varenicline had achieved continuous abstinence throughout the study period vs placebo (18 patients vs 8 patients; adjusted odds ratio [OR] 2.5). Additionally, varenicline use was associated with higher continuous abstinence vs placebo (18 of 102 patients vs 8 of 111 patients).
The researchers found the incidence of depression to be 2.4 per 100 person-years in varenicline participants compared with 12.4 per 100 person-years in placebo participants. A total of 14 of 213 participants had 18 cardiovascular events (6 of 102 patients taking varenicline vs 8 of 111 patients taking placebo).
“Varenicline is safe and efficacious for smoking cessation in people living with HIV and should be recommended as the standard of care,” the researchers concluded.
—Christina Vogt
Reference:
Mercié P, Arsandaux J, Katlama C, et al. Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial [Published online January 9, 2018]. The Lancet HIV. http://dx.doi.org/10.1016/S2352-3018(18)30002-X.