Despite considerable evidence of efficacy in otherwise healthy smokers, the few studies of various medication and behavioral treatments (and their combinations) thus far appear to show mixed results in PLWHA. We now briefly review published intervention studies which were retrieved via search on PUBMED (search terms: tobacco, smoking, cessation, HIV, AIDS HIV). Study design characteristics and results are summarized in .
Smoking cessation intervention trials for HIV + smokers
In a non-randomized comparison control study, HIV + smokers interested in treatment (n
=34) received nurse-delivered individual (30 minutes sessions once weekly during the first month and once monthly thereafter for 12 months) plus nicotine replacement therapy (NRT) [33
]. Self-reported smoking abstinence at 12 months was 13/34 (38 %) in the intervention group and 27/383 (7 %) in the observational control group.
Ingersol and colleagues randomized smokers to self-guided reading plus nicotine patch (n
=18) or motivational interviewing (single session) plus nicotine patch (n
]. There were no differences in 3-month cessation outcomes (rates not reported by treatment group), and overall nicotine patch use was reported to be suboptimal (37 %–63 % use on prescribed days).
Larger randomized controlled trials (RCTs) have shown modest results for behavioral treatments combined with NRT. Vidrine et al tested a cell-phone behavioral intervention plus usual care (UC; including access to NRT) vs standard care alone in 474 HIV + smokers [35
]. Participants randomized to the cell phone group were given a prepaid cell phone on which a series of 11 proactive counseling sessions were conducted spanning a 3-month period. The cell phone group had a higher rate of 30-day abstinence at the 3-month follow-up compared with the standard care group (8.9 % vs 2.9 %; P
<0.005), but this effect was diminished and no longer significant at 6-months.
A cohort of 145 PLWHA smokers was randomized to standard care to an 8 session group treatment program co-facilitated by a graduate student and an HIV-infected peer, and tailored to address the needs and concerns of HIV-infected smokers [36
]. All were offered a 3-month supply of NRT. In an intention to treat analysis, 7-day point-prevalence abstinence at 3 months was 19.2 % for the intervention vs 9.7 % for those who received standard care (P
In an RCT comparing behavioral treatment approaches, 444 HIV + smokers who received physician advice and the option of NRT were randomized to either a brief behavioral intervention (Standard Care; SC), or a more intensive motivational-counseling intervention (Motivational Enhancement; ME) [37
]. Biochemically-verified 7-day abstinence rates at 2-, 4-, and 6-month follow-ups were 12 %, 9 %, and 9 % respectively, in the ME condition, and 13 %, 10 %, and 10 % respectively, in the SC condition. Although there were no treatment group differences at any of the follow-ups, African Americans faired particularly poorly at 6-months (5 % cessation). Overall, failure to use the nicotine patch during the study was a strong predictor of smoking at 6-month follow-up (failure to use the patch=0 % abstinence) [38
]. The need to improve adherence to cessation treatment therefore is clear; even optimal treatment will have little impact if it is not used as intended.
Although promising, the safety, tolerability, and efficacy of 2 FDA-approved first line medications, bupropion and varenicline, have only been evaluated in small, uncontrolled single arm trials.
Twenty-one HIV + patients using ART were treated with bupropion, with 38 % reporting quitting for more than 1 year [39
]. No clinically significant drug interactions were noted.
In a study of 18 PLWHA smokers on ART who were treated with varenicline for 2 months, 3, and 6 month abstinence rates were 28 % and 24 %, respectively. Five patients reported nausea and 6 reported sleep disturbance but none discontinued treatment [40
]. In an open-label study, 36 HIV + smokers were treated with a standard 12-week course of varenicline [41
]. The cotinine-verified 4-week continuous abstinence rate through weeks 9–12 was 42 %. The most frequently reported adverse events (AEs) were nausea (33 %), abnormal dreams (31 %), affective lability (19 %), and insomnia (19 %). CD4 counts increased by 69 cells/mm3 (P
=0.001) at week 24. Six (17 %) patients discontinued varenicline due to AEs. Abstinence rates and the types of AEs were comparable to those observed in generally healthy HIV-negative smokers; the rates of AEs were somewhat higher, suggesting the importance of close clinical monitoring during treatment and possible overlap in AEs due to varenicline, HIV/AIDS medication treatments, and disease symptoms.
Compounding the paucity of efficacy studies in PLWHA is a failure on the part of HIV care providers to provide even the standard of care for smoking cessation [28
]. In the US HIV Medical Association registry, only 22.9 % of providers had ever received formal tobacco treatment training [42
]. While almost all providers agreed that smoking is an important issue in PLWHAs, they reported low levels of cessation-promoting activities. The relative lack of evidence for efficacy in PLWHA may contribute to providers’ perception that available cessation treatments do not work well or are not well tolerated and are therefore not likely to be recommended. Given the suboptimal cessation rates in PLWHAwith conventional treatments such as NRT and behavioral counseling, other cessation strategies are in need of rigorous evaluation.