Study Design: Renally Impaired Adults

Study 112: Study design and baseline characteristics1-3

Study 112: Phase 3, open-label, multicenter, single-arm study1

Primary endpoint1,2
Change from baseline in eGFR at Week 24

Selected secondary endpoints1,2
Change from baseline in eGFR at Week 48
Efficacy (HIV-1 RNA <50 copies/mL), safety, and tolerability observed at Week 24 and Week 48

  • Stable virologic suppression for at least 6 months, no known resistance to any component of the FTC/TAF backbone + EVG/COBI,* and stable renal function were required for study inclusion3

Warnings and precautions

  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Study 112: Selected baseline characteristics1,2
Switched to
Median age, years (range) 58 (24-82)
Age ≥65 years, n (%) 63 (26)
Male (%) 79
Female (%) 21
White (%) 63
Black or African descent (%) 18
Asian (%) 14
Hispanic/Latino ethnicity (%) 13
Median CD4+ cell count, cells/µL (range) 632 (126-1813)
Pre-switch TDF use (%) 65
Hypertension (%) 39
Diabetes (%) 14
Median eGFR, mL/min 56
eGFR <50 mL/min (n) 80
eGFR ≥50 mL/min (n) 162
Dipstick proteinuria (Grade 1 or 2) (%) 33
Significant proteinuria (UPCR >200 mg/g) (%) 42
Significant albuminuria (UACR ≥30 mg/g) (%) 49

Important Safety Information


  • DESCOVY® is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of DESCOVY have not been established in patients coinfected with HIV-1 and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue DESCOVY. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Warnings and precautions

  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of FTC and tenofovir alafenamide with elvitegravir and cobicistat, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate DESCOVY in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue DESCOVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
    Renal monitoring: In all patients, monitor CrCl, urine glucose, and urine protein prior to initiating and during therapy. In patients with chronic kidney disease, additionally monitor serum phosphorus.
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue DESCOVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

  • Most common adverse reaction (incidence ≥10%; all grades) in clinical studies was nausea (10%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for DESCOVY for more information on potentially significant drug interactions, including clinical comments.
  • Metabolism: Drugs that inhibit P-gp can increase the concentrations of components of DESCOVY. Drugs that induce P-gp can decrease the concentrations of components of DESCOVY, which may lead to loss of efficacy and development of resistance.
  • Drugs affecting renal function: Coadministration of DESCOVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir and the risk of adverse reactions.

Dosage and administration

  • Dosage: Patients who weigh ≥35 kg: 1 tablet taken orally once daily with or without food.
  • Renal impairment: Not recommended in patients with CrCl <30 mL/min.
  • Testing prior to initiation: Test patients for HBV infection and assess CrCl, urine glucose and urine protein.

Pregnancy and lactation

  • Pregnancy: There is insufficient human data on the use of DESCOVY during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established; available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.


DESCOVY® is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients weighing at least 35 kg.

*Administered as an STR.

eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); TDF, tenofovir disoproxil fumarate; UACR, urine albumin to creatinine ratio; UPCR, urine protein to creatinine ratio.


  1. Pozniak A, Arribas JR, Gathe J, et al; GS-US-292-0112 Study Team. Switching to tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment: 48-week results from a single-arm, multicenter, open-label phase 3 study. J Acquir Immune Defic Syndr. 2016;71(5):530-537.
  2. GENVOYA® [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017.
  3. Data on file. Gilead Sciences, Inc.