985 - Impact of Age and Medical Comorbidities on Renal Outcomes in the DISCOVER Trial

The ePoster content is available to users who are logged in.<br><br>Please log in and then come back here to use this button.

Presenting Author(s)

Eric S. Daar

Chief, Division of HIV Medicine
Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California
Disclosure: BMS (Consultant)Gilead Sciences Inc. (Consultant, Grant/Research Support, Scientific Research Study Investigator)Janssen (Consultant)Merck (Consultant, Grant/Research Support)Teva (Consultant)Theratechnology (Consultant)Viiv Healthcare (Consultant, Grant/Research Support)

Co-Author(s)

JB

Jason Brunetta

Practicing Physician
Maple Leaf Medical Clinic
Toronto, Ontario, Canada
Disclosure: AbbVie (Consultant)Gilead Sciences Inc. (Consultant, Grant/Research Support, Scientific Research Study Investigator, Speaker's Bureau, Other Financial or Material Support, Conference attendance sponsorship)Janssen (Other Financial or Material Support, Conference attendance sponsorship)Merck (Consultant, Speaker's Bureau, Other Financial or Material Support, Conference attendance sponsorship)Viiv Healthcare (Consultant, Speaker's Bureau, Other Financial or Material Support, Conference attendance sponsorship)
EC

Eric Cua

Specialsit in Internal Medicine
Nice University Hospital
Nice, Provence-Alpes-Cote d'Azur, France
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
JF

Jason Flamm

Director, HIV Clinical Care and Research, Kaiser Permanente Medical Group, Sacramento
Kaiser Permanente Medical Group
Sacramento, California
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
DA

David Asmuth

Professor of Medicine
University of California Davis,
Sacramento, California
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
CC

Christoph C. Carter

Director, Clinical Research (MD)
Gilead Sciences
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
YS

Yongwu Shao

Assoc Director, Biostatistics
Gilead Sciences
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
PW

Pamela Wong

Associate Director of Biostatistics
Gilead Sciences Inc.
Foster City, CA
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
RE

Ramin Ebrahimi

Sr Director, Biostatistics
Gilead Sciences
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
MD

Moupali Das

MD
Gilead Sciences
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
Diana M. Brainard

SVP, Therapeutic Area Head, Virology
Gilead Sciences Inc.
Foster City, CA
Disclosure: Gilead Sciences (Employee)
AC

Amanda Clarke

Clinical lead
Brighton & Hove Sexual Health
Brighton, England, United Kingdom
Disclosure: Gilead Sciences Inc. (Consultant, Scientific Research Study Investigator, Other Financial or Material Support, Conference attendance sponsorship)Viiv Healthcare (Consultant, Other Financial or Material Support, Conference travel sponsorship)

Background: In DISCOVER, emtricitabine/tenofovir alafenamide (F/TAF) was noninferior to F/tenofovir disoproxil fumarate (TDF) for preexposure prophylaxis (PrEP) in men who have sex with men and transgender women, with a superior renal laboratory profile. The differential impact of F/TAF and F/TDF on renal parameters among older individuals and those with medical comorbidities is unknown.

Methods: DISCOVER randomized participants 1:1 to daily blinded F/TAF or F/TDF. We examined renal outcomes at week 48 including estimated glomerular filtration rate (eGFR) by Cockcroft-Gault, β2 microglobulin (M):Creatinine (Cr) and retinol binding protein (RBP):Cr ratios (markers of proximal renal tubular function), and discontinuations due to investigator reported study drug-related renal adverse events (AEs).

Results: Median age was 34 years (yrs)(range 18-76), with 12.5% vs 10.9% < 25yrs, 12.2% vs 14.4% ≥ 50yrs, and 1.1% vs 0.9% > 65yrs for F/TAF and F/TDF, respectively. The prevalence of medical comorbidities at baseline were; eGFR < 90mL/min= 9.1% vs 9.3%, diabetes= 2.9% vs 3.3%, and hypertension= 10.5 vs 11.1%, for F/TAF and F/TDF, respectively. eGFR changes by age category and medical comorbidity status are found in the Table. Forty participants had study drug-related renal AEs; 14 with F/TAF and 26 with F/TDF. Of these, 25% were > 50yrs, 20% had baseline eGFR < 90mL/min, 7.5% had history of diabetes, and 22.5% had history of hypertension. β2M:Cr and RBP:Cr changes were more favorable in participants receiving F/TAF, with greater magnitude of difference in older participants (data not shown).Table.

Conclusion: The DISCOVER trial allows for a large single variable comparison of the two tenofovir prodrugs in the absence of underlying HIV infection and in the absence of third antiretroviral agents. F/TAF was associated with favorable changes in renal biomarkers regardless of age or medical comorbidity. Participants ≥50yrs or with comorbidities were proportionately more likely to develop study drug related renal AEs, but these were present in the minority of cases.