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Researchers recommend varenicline for smoking cessation in patients with HIV
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Adding varenicline to individualized counseling was a safe and effective way for patients with HIV to quit smoking cigarettes, according to a recent randomized controlled trial in France.
Patrick Mercié, MD, professor at the Central Hospital University of Bordeaux, France, and colleagues said the results suggest that varenicline, which is marketed in the United States as Chantix (Pfizer), should be the standard of care for smoking cessation in patients with HIV — a population that is two to three times more likely to smoke tobacco compared with the general population.
“This trial shows that a combined intervention of varenicline and individualized counseling support is effective in assisting people living with HIV to achieve short-term and long-term abstinence,” the researchers wrote in The Lancet HIV. “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.”
Mercié and colleagues conducted the phase 3 ANRS 144 Inter-ACTIV trial at 30 clinical hospital sites in France from October 2009 to December 2012. The researchers randomly assigned patients with HIV who smoked at least 10 cigarettes per day for 1 year or longer to receive varenicline (n = 123) — which was approved in France in May 2007 — or placebo (n = 125) for 12 weeks and face-to-face counseling. To reduce the risk for nausea, varenicline was given in a 0.5-mg dose once daily for the first 3 days and twice daily from day 4 to day 7. Two 0.5-mg doses were then given twice daily for the remainder of the 12-week treatment period, which was followed by a 13-week period of smoking cessation counseling only. Participants in both groups who resumed smoking before week 24 were offered varenicline for another 12-week period.
The participants were followed for a total of 48 weeks. The researchers confirmed smoking status at each visit by measuring the amount of carbon monoxide in participants’ breath with a Tabataba analyzer. Primary outcomes were assessed in an intention-to-treat (ITT) analysis, which included all participants, and a modified ITT (mITT) analysis, which included all participants who received at least one dose of varenicline (n = 102) or placebo (n = 111). A safety analysis was performed only in the mITT population.
In the ITT analysis, participants who received varenicline were more than twice as likely to achieve continuous abstinence over the study period than patients who received placebo (15% vs. 6%; adjusted OR = 2.5; 95% CI, 1-6.1). Varenicline was also associated with a higher rate of abstinence in the mITT analysis (18% vs. 7%; aOR = 2.7; 95% CI, 1.1-6.5), as well as a lower incidence of depression (2.4 per 100 person-years vs. 12.4 per 100 person-years) compared with placebo. The prevalence of cardiovascular events was 6% in the varenicline group and 7% in the placebo group.
“In people living with HIV who are motivated to quit and are not codependent on other addictive drugs, varenicline with individualized counseling is a convenient and effective option that is safe and has no clinical interaction with antiretroviral drugs,” the researchers concluded.
In a related editorial, pulmonologist Philip Diaz, MD, and Amy Ferketich, PhD, professor of epidemiology at The Ohio State University, agreed that varenicline should be implemented as standard of care for tobacco cessation in patients with HIV. However, the authors noted that there are still questions regarding the appropriate duration of varenicline, the impact of novel forms of counseling and whether the agent should be combined with nicotine replacement therapy or bupropion.
“Additional research should also focus on understanding factors contributing to persistent smoking, investigating the barriers to abstinence, and identifying ways to increase motivation for quit attempts,” they added. “Redoubling efforts to address the burden of smoking in people living with HIV is a clinical, scientific and public health imperative.” – by Stephanie Viguers
Disclosures: Diaz, Ferketich and Mercié report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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