CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

980 Intimate Partner Violence Is AssociatedWith Low PrEP Adherence in AfricanWomen Sarah T. Roberts 1 ; Connie Celum 1 ; Nelly Mugo 3 ; Jessica Haberer 2 ; Craig R. Cohen 4 ; Elizabeth Irungu 5 ; James N. Kiarie 6 ; EdwinWere 7 ; Jared Baeten 1 On behalf of the Partners PrEP StudyTeam 1 University of Washington, Seattle, WA, US; 2 Massachusetts General Hospital, Harvard Medical School, Boston, MA, US; 3 Kenya Medical Research Institute, Nairobi, Kenya; 4 University of California San Francisco, San Francisco, CA, US; 5 Kenyatta National Hospital, Nairobi, Kenya; 6 University of Nairobi, Nairobi, Kenya; 7 Moi University, Eldoret, Kenya Background: Intimate partner violence (IPV) has been associated with increased risk for HIV acquisition. Women who experience IPV are thus a potential target population for pre-exposure prophylaxis (PrEP) to prevent HIV infection. However, high adherence levels are required for PrEP efficacy, and IPV exposure is associated with lower adherence to other medication regimens. Studies have not evaluated whether IPV is associated with low PrEP adherence. Methods: We evaluated the association between IPV exposure and PrEP adherence among HIV-uninfected women enrolled in the Partners PrEP Study, a randomized, placebo- controlled trial of oral, daily PrEP in African HIV serodiscordant couples. Exposure to IPV was assessed at monthly study visits by asking whether the participant had been verbally, physically, or economically abused by her partner since the last visit, or in the last 3 months at enrollment. At each visit, women were categorized as “recently IPV-exposed” (IPV reported in the last 3 months), “previously IPV-exposed” (IPV reported more than 3 months ago) or “IPV-unexposed” (no report of IPV to date). Adherence to PrEP was measured monthly by clinic-based pill count and was dichotomized a priori as low (<80%) or high ( ≥ 80%). Adherence was measured for each scheduled study visit at which the participant was eligible to receive PrEP. Missed visits were assigned 0% adherence. Results: Among 1,785 HIV-uninfected women, 288 (16.1%) reported IPV at 437 study visits over 12-48 months of follow-up. Reported IPV included verbal abuse at 371 visits (84.9%), physical abuse at 228 visits (52.2%), and economic abuse at 163 visits (37.3%). Mean PrEP adherence was 95.3% (SD 19.9%). Women had low adherence at 88 (8.0%) of 1100 recently IPV-exposed visits and 433 (7.9%) of 5,471 previously IPV-exposed visits, compared to 2,962 (6.8%) of 43,562 IPV-unexposed visits. After adjusting for age, years of education, study site, any additional sex partners, and time on study, recently IPV-exposed women had a 52% higher likelihood of low PrEP adherence (adjusted OR 1.52, 95% CI 1.16-1.99, p=0.002). Previous IPV exposure was not associated with adherence (p=0.77). Conclusions: Among HIV-uninfected women in the Partners PrEP Study, adherence to PrEP was very high overall. Women who reported IPV in the past 3 months were at increased risk of low PrEP adherence. If PrEP is targeted towards women exposed to IPV, the risk of low adherence should be recognized and strategies to promote high PrEP adherence should be evaluated.

WEDNESDAY, FEBRUARY 25, 2015 Session P-V5 Poster Session

Poster Hall

2:30 pm– 4:00 pm PrEP: Evaluating Potential Harm

981 Reversibility of Kidney Function Decline in HIV-1 – Uninfected Men andWomen Using Preexposure Prophylaxis Kenneth K. Mugwanya 1 ; ChristinaWyatt 2 ; Connie Celum 1 ; Deborah Donnell 3 ; Nelly Mugo 4 ; James N. Kiarie 5 ; Allan Ronald 6 ; Jared Baeten 1 On behalf of the Partners PrEP StudyTeam 1 University of Washington, Seattle, WA, US; 2 Mount Sinai School of Medicine, New York, NY, US; 3 Fred Hutchinson Cancer Research Center, Seattle, WA, US; 4 Kenya Medical Research Institute, Nairobi, Kenya; 5 University of Nairobi, Nairobi, Kenya; 6 University of Manitoba, Winnipeg, Canada Background: Tenofovir disoproxil fumarate pre-exposure prophylaxis (PrEP) use is associated with a small but statistically significant decline in estimated glomerular filtration rate (eGFR). We investigated the occurrence and reversibility of eGFR decline among HIV-1 uninfected adults discontinuing PrEP. Methods: Data are from the Partners PrEP Study, a trial of daily oral tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC)/TDF PrEP among 4747 African HIV-1 uninfected men and women who had normal baseline renal parameters. Renal function was assessed at baseline, month 1, and then quarterly while on study medication and up to 2 monthly visits in the post-study drug follow-up phase. eGFR was calculated using the Chronic Kidney Disease Epidemiolgy Collaboration Equation. Results: A total of 3944 individuals had a post-study drug visit within 12 weeks of drug discontinuation (1277 in TDF group, 1309 in FTC-TDF group, and 1358 for placebo); 64% were male, median age was 34 (range 18–64) years, and mean eGFR was similar at baseline (p>0.05). Median time on study drug was 33 (IQR 25–36) months. Compared to placebo (Figure 1), mean eGFR for PrEP was slightly but statistically significantly lower at the last on-treatment visit (128 mL/min/173m 2 for TDF and FTC-TDF vs 130 mL/min/173m 2 for placebo; p ≤ 0.01). This difference reversed to within baseline levels by 4 weeks after PrEP discontinuation (130 mL/min/173m 2 for TDF, 129 mL/min/173m 2 for FTC-TDF vs 130 mL/ min/173m 2 for placebo eGFR; p>0.2 for all). Consistent patterns were observed for serum phosphorus.

Poster Abstracts

Figure 1. Change in mean eGFR after discontinuation of TDF-based PrEP

581

CROI 2015