CROI 2017 Abstract e-Book

Abstract eBook

Poster and Themed Discussion Abstracts

Methods: We conducted a 6-week, double-blind, parallel-arm, placebo-controlled trial comparing encapsulated, standardized AG powdered root (≥5% total ginsenoside content confirmed yearly by HPLC) 1000 and 3000mg PO QD to placebo. HIV-infected adults, on stable ART, undetectable viral load (VL), with a Fatigue Severity Score (FSS) >=4.5, and without other illness associated with fatigue, received AG or placebo for 4 wks, and were observed until wk 6. Primary endpoint was change in FSS from baseline to wk 4. Secondary outcomes assessed other measures of fatigue (sleep quality, depression, and QOL (MOS HIV)). Changes were compared between groups using nonparametric Wilcoxon tests supplemented with repeated measures mixed models to adjust for age, gender, race, baseline insomnia and depression. Results: Of the 120 planned subjects, 96 were enrolled (African-American race (91%) and male (54%) with a median age of 52.5 years and median CD4 count of 624 ul/mL); 32 were randomized to AG 1000mg, 31 to AG 3000mg, and 33 to placebo. FSS changes were not significantly different between either of the AG arms and placebo. Mean (SD) FSS decreases were: -24.7 (18.6) on AG 1000mg, -16.9 (15.0) on AG 3000mg, and -18.7 (17.4) on placebo (p=0.15 AG 1000mg vs placebo, p=0.73 AG 3000mg vs placebo). Self-reported assessment of having much or very much improvement in fatigue was not different between arms: 45% on AG 1000mg, 34% on AG 3000mg, and 39% on placebo. In a post-hoc analysis, combining the 2 AG arms confirmed that fatigue was no different than placebo in the primary endpoint, but AG showed modest improvements in fatigue on 3/4 subscales of Brief Fatigue Inventory (p = 0.01-0.03) and trends toward improvement in 4 of 10 subscales of the MOS HIV QOL questionnaire (p = 0.01-0.07) compared to placebo. Adverse events were not different between the study arms. Overall mean adherence was ≥96% for all study arms. Conclusion: AG did not reduce fatigue compared to placebo with short-term administration to HIV-infected subjects with fatigue. The clinical significance of small improvements in the AG arms in some of the secondary endpoints relative to the large placebo effect is unclear. 670 APPLES—THE AUSTRALIAN POSITIVE & PEERS LONGEVITY EVALUATION STUDY Kathy Petoumenos 1 , Robin Huang 1 , Jennifer Hoy 2 , Mark Bloch 3 , David J. Templeton 4 , David Baker 5 , Michelle Giles 6 , Matthew Law 1 , David A. Cooper 1 1 Kirby Inst, Sydney, Australia, 2 The Alfred Hosp and Monash Univ, Melbourne, Australia, 3 Holdsworth House Med Practice, Sydney, Australia, 4 RPA Sexual Hlth, Camperdown, Australia, 5 East Sydney Doctors, Darlinghurst, Australia, 6 Monash Hlth, Melbourne, Australia Background: In Australia, 50% of HIV positive (HIV+) people are now aged over 50 years and are predominately men who have sex with men (MSM). MSM engage more in behaviours that may increase the risk of age-related comorbidities, including smoking, high alcohol consumption and recreational drug use. The objective of APPLES is to compare these comorbidities and risk factors in HIV+MSM≥55 years with an appropriate control group of HIV negative (HIV-) MSM. Methods: A prospectively recruited cross-sectional sample of HIV+ and HIV- MSM>= 55 years. Detailed data collection at recruitment included clinic data, a self-completed health and lifestyle survey, and blood sample collection for biomarker assessment and storage. We report key demographic, laboratory markers, self-reported comorbidity, and biomarker results by HIV status. For selected comorbidities and biomarkers we also adjust HIV status a priori for age, smoking and body mass index (BMI). Results: Over 16 months 228 HIV+ and 218 HIV- men were recruited. Median age was 63 years (IQR: 59-67). More HIV+men reported ever having smoked (61% vs 39%), while HIV- men reported more current smoking (24% vs 19%) (p=0.029). Greater alcohol use was reported by HIV- men (p=0.002), and recreational drug use reported more often by HIV+men (p<0.001). 98% of HIV+men had a viral load below 200 copies/mL and all but three were currently on ART. Unadjusted rates for selected comorbidities, lipids and biomarkers by HIV status are shown in Table 1. Rates of diabetes (DM), heart disease (HD), thrombosis and neuropathy were elevated in HIV+men (HIV+ vs HIV-:15% vs 9%, 20% vs 12%, 10% vs 4%, 22% vs 1% respectively). After adjustment, HIV+men had significantly increased odds of DM (Adjusted Odds ratio (aOR): 2.03, p=0.030), thrombosis (aOR: 3.10, p=0.006), neuropathy (aOR: 36.8, P<0.001), and borderline increased odds for HD (aOR: 1.77, p=0.056). HIV+men had significantly higher hsCRP and cystatin-C. There was no significant difference in IL6 or D-dimer (Table 1). After adjustment cystatin-C remained significantly elevated for HIV+men (p<0.001) but not hsCRP (p=0.562). Conclusion: HIV+men have increased self-reported comorbidities and have higher risk for some comorbidities and biomarkers, even after adjustment for age, smoking and BMI. This study underscores the importance of an appropriate HIV- control group for more accurate evaluation of the risk and attribution of age-related comorbidities in HIV+ people.

Poster and Themed Discussion Abstracts

671 PATIENTS’ BELIEFS ABOUT THEIR HAART IN COMPARISON WITH THEIR CHRONIC COTREATMENTS Susan Kamal 1 , Olivier Bugnon 1 , Matthias Cavassini 1 , Marie-Paule Schneider 2 , for the Swiss HIV Cohort Study 1 Univ of Lausanne, Lausanne, Switzerland, 2 Univ of Geneva, Univ of Lausanne, Lausanne, Switzerland

Background: Thanks to the success of highly active antiretroviral therapy (HAART), HIV infected patients almost reach a normal life expectancy. This has resulted in an aging HIV population suffering from other chronic co-morbidities such as cardiovascular diseases, osteoporosis, and depression. Our hypothesis is that patients’ perceptions and attitudes towards their HAART which is perceived as crucial to their survival differ from their beliefs about their co-treatments and this may have an impact on their medication adherence. Methods: We used the Beliefs about Medicine Questionnaire (BMQ f©) to measure the perceptions of patients about their co-treatments and the BMQ-HAART© to measure their beliefs about their HAART from a representative sample (n=150) of patients enrolled in the Swiss HIV Cohort Study (SHCS) and followed at the Infectious Disease Service at the University Hospital in Lausanne, Switzerland. The BMQ-Specific comprises two sub-scores: Specific-Necessity and Specific-concerns. The sub-scores were standardized by dividing the score scale by the number of questions in the scale resulting in a range of responses between 1 (low) and 5 (high). Self-reported medication adherence was measured using the SHCS adherence questionnaire (SHCS-AQ). Socio-demographic variables were retrieved by reviewing the SHCS database. Results: A response rate of 73% (109/150) was achieved. 105 (70%) patients were included in the analysis: median age was 56 (IQR: 51, 63) and 74 were male (70%). 87 patients (83%) were adherent to HAART and 75 (71%) were adherent to their co-treatments. The standardized mean (SD) responses of BMQ necessities sub-scores were 3.84 (0.41) and 2.79 (0.94) for HAART and co-treatments respectively (p < 0.0001). For concerns the standardized mean (SD) responses were 4.34 (0.97) for HAART and 4.06 (0.81) for co-treatments (p= 0.004). Co-treatment and HAART concerns increased as the number of co-treatments increased (p 0.03 and p 0.00003 respectively). Conclusion: Patients had higher concerns and necessities for their HAART in comparison with their co-treatments which reflected in higher adherence to HAART suggesting that it could be important to focus on patient beliefs to improve adherence to co-treatments.

CROI 2017 290