Varenicline is safe and effective for smoking cessation in patients with HIV, according to a study published in the Lancet HIV.
The ANRS 144 Inter-ACTIV study was a randomized, parallel, double-blind, placebo-controlled phase 3 trial that included 30 clinical hospital sites in France. The study included participants with documented HIV infection who had smoked at least 10 cigarettes per day for 1 year or longer, were motivated to stop smoking, were not dependent on another psychoactive substance, and had no history of depression or suicide attempts. Study participants were randomly assigned to receive either 0.5 mg varenicline twice daily (n=123) or placebo twice daily (n=125) for 12 weeks, plus face to face counseling.
The researchers analyzed both the intention-to-treat (ITT) population and the modified ITT (mITT) population, which included all participants who took at least 1 tablet of their assigned study treatment. The mITT group included 102 participants from the varenicline group and 111 from the placebo group.
In the ITT population, varenicline was associated with a higher proportion of patients who achieved continuous smoking abstinence over the study period (weeks 9-48): 18 patients of 123 (15%; 95% CI, 8-21) in the varenicline group compared with 8 of 124 (6%; 95% CI, 2-11) in the placebo group, adjusted odds ratio (OR) 2.5 (95% CI, 1.0-6.1; P =.041).
In the mITT population, varenicline was also associated with a higher proportion of patients who achieved continuous smoking abstinence: 18 patients of 102 (15%; 95% CI, 10-25) compared with 8 of 111 (7%; 95% CI, 2-12) in the placebo group (adjusted OR, 2.7; 95% CI, 1.1-6.5; P =.029).
“Because smoking is the most common modifiable risk factor worldwide for cardiovascular diseases and malignancies in people living with HIV, smoking cessation interventions should systematically be offered to smokers living with HIV,” the researchers wrote.
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], Lancet HIV. doi: 10.1016/S2352-3018(18)30002-X