Abstract Body

Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir alafenamide (E/C/F/TAF) is approved for use in HIV-1 infected individuals with mild to moderate chronic kidney disease (estimated glomerular filtration [eGFR] 30-69 mL/min). Current HIV treatment for individuals with renal failure on hemodialysis (HD) requires complex regimens with multiple pills. This is the first study to evaluate safety, efficacy, and pharmacokinetics (PK) of a daily single-tablet regimen (STR) in HIV-infected adults with end stage renal disease (ESRD) on chronic HD.

HIV‑1 infected, virologically suppressed adults with ESRD (eGFR <15mL/min) on chronic HD for ≥6 months were switched to open-label E/C/F/TAF 150/150/200/10 mg once daily for 48 weeks (W). Efficacy was assessed as the proportion of participants with HIV‑1 RNA <50 copies (c)/mL (Snapshot algorithm). Maintenance of virologic suppression (<50 c/mL), safety, and patient satisfaction (Treatment Satisfaction Questionnaire) were assessed throughout the study. A PK substudy was done at or between W2 and 4. W24 data are presented here and W48 data will be available for the conference.

We enrolled 55 participants; median age 51yrs (range 23-64), 24% female, 82% Black, median time on HD 6yrs (range 1-17), median CD4 count 515 cells/L (IQR 387, 672), and 22% Hepatitis C Ab positive, and 27% history of diabetes. At W24, 87% (48/55) had HIV-1 RNA <50 c/mL. The other 7 participants discontinued due to lack of efficacy (n=1), AE (n=2), or other reasons not related to efficacy (n=4). EVG, COBI, and TAF PK were consistent with exposures in normal renal function. As expected, exposures of FTC and TFV (metabolite of TAF), which are renally eliminated, were higher v. historical data in normal renal function (Table). 16 (29%) participants had Grade (G) 3 or 4 AEs unrelated to study drug; 6 (11%) participants experienced study drug related AEs (all were G1-2, including nausea in 4). Two participants discontinued E/C/F/TAF due to AEs (allergic pruritis, related; staphylococcal endocarditis, unrelated). The participant with endocarditis died from heart failure after entering hospice. 24 (44%) participants had G3-4 laboratory abnormalities, all of which were present at baseline. 79% of participants felt ‘much more satisfied’ with the STR convenience compared to baseline.

Switching to E/C/F/TAF STR maintained virologic suppression at W24, was well tolerated, and more convenient for adults with ESRD on HD.