908. Stable caloric intake and continued virologic suppression for HIV positive antiretroviral treatment (ART) experienced women after switching to fixed dose combination (FDC) of Emtricitabine (FTC), Tenofovir (TDF) and Rilpivirine (RPV)
Session: Poster Abstract Session: Clinical Trials
Friday, October 9, 2015
Room: Poster Hall
Background:

Choosing ART for HIV+ women is influenced by pregnancy safety, potential interactions with contraceptives, pill burden, adherence and tolerability. RPV in a FDC presents one option, yet the ability to comply with the caloric requirement has not been studied.  The absorption of RPV is influenced by food intake and lower absorption may decrease viral efficacy.  We conducted a 48 week study to assess compliance with caloric intake, virologic suppression and adherence. Here we present the week 4 analysis.

Methods:

HIV+ women on ART with viral load <50 c/mL for 6 months prior to study entry and no known resistance to FTC, TDF or RPV were enrolled and switched to RPV FDC.  Caloric intake (>400 kcal) compliance and concurrency with oral RPV FDC was evaluated with a 3-day food diary recorded at baseline, week 1 and 3. The food diary was validated by obtaining participant’s caloric consumption through phone calls on randomly chosen dates. For each 3-day food diary, the median value was computed for each nutrition measure. As carbohydrates from sugar sweetened beverages (SSB) increase gastric transit time, we compared consumption of all calories vs. all calories minus SSB.  Medication adherence was measured using a visual analog scale (VAS). Nutrition information was summarized using Food Processor 10.13.1 software. Statistical analyses were conducted in SAS 9.3.

Results:

HIV+ women (n=31) with median age 46yrs were enrolled; 71% were African American; median years since diagnosis was 13; 58% were obese and 29% overweight.  At Week 4, 29 women had HIV RNA measured, and all were <50 c/mL. Most women (89% food diary; 93% random call) consumed > 400 kcal at week 4.  Median calorie intake did not change significantly from baseline (684 kcal; IQR 512- 939) to week 4 (697 kcal (IQR 596-944); median change 55 kcal, Wilcoxon signed-rank p=0.46. Median macronutrient intake from baseline to week 4 appeared stable (p>0.05). While 13% of total calories came from SSB, median caloric intake minus SSB was 623 kcal (IQR 495-753) at week 4. Using the VAS, 97% reported perfect medication adherence at baseline, and 89% at week 4.

Conclusion:

This population of women was able to adhere to a 400+ calorie meal without changing either calorie or macronutrient intake. HIV RNA suppression was maintained at week 4.

Prema Menezes, Ph D1, Katie Mollan, MS2, Erin Hoffman, BS2, Parker Xie, BS2, Jennifer Wills, RDN3, Cheryl Marcus, MSN2, John Rublein, pharm d4, Michael G. Hudgens, PhD5 and Joseph Eron, MD2, (1)Medical University of South Carolina, Charleston, SC, (2)UNC-Chapel Hill, Chapel Hill, NC, (3)Nutrition, UNC-Chapel Hill, Chapel Hill, NC, (4)Gilead Sciences, Durham, NC, (5)Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC

Disclosures:

P. Menezes, Gilead Sciences: Grant Investigator , Grant recipient

K. Mollan, None

E. Hoffman, None

P. Xie, None

J. Wills, None

C. Marcus, None

J. Rublein, Gilead Sciences, Inc.: Employee and Shareholder , Salary

M. G. Hudgens, None

J. Eron, Janssen: Consultant , Consulting fee and Research grant
Gilead: Consultant , Consulting fee

See more of: Clinical Trials
See more of: Poster Abstract Session

Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.