Clinical studies of FTC/TAF-based regimens

Studies 104/111 pooled: Study design and baseline characteristics1

Studies 104/111 pooled: Phase 3, randomized, double-blind, multicenter, international, active-controlled studies*

Primary endpoint1

Proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 as defined by FDA snapshot algorithm with a prespecified noninferiority margin of 12%

Selected secondary endpoints1

Serum creatinine, proteinuria, and spine and hip BMD at Week 48


Warnings and precautions

  • Fat redistribution or accumulation has been observed in patients receiving antiretroviral therapy.

Studies 104/111 pooled: Selected baseline patient characteristics1,2

FTC/TAF
+ EVG/COBI
(n=866)
FTC/TDF
+ EVG/COBI
(n=867)
Median age, years 33 35
Sex
Males (%) 85 85
Females (%) 15 15
Race/Ethnicity
White (%) 56 57
Black or African descent (%) 26 25
Hispanic/Latino ethnicity (%) 19 19
Asian (%) 11 10
Median HIV-1 RNA, log10 copies/mL (range) 4.58 (4.04-4.95) 4.58 (4.15-4.96)
HIV-1 RNA >100,000 copies/mL (%) 23 22
Median CD4+ cell count, cells/µL (range) 404 (283-550) 406 (291-542)
CD4+ cell count <200 cells/µL (%) 13 13
Median eGFRCG 117 114
Dipstick proteinuria (any grade) (%) 10 10

Important Safety Information

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs in combination with other antiretrovirals.
  • 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 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

  • Fat redistribution or accumulation has been observed in patients receiving antiretroviral therapy.
  • 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 emtricitabine 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.
  • Bone loss and mineralization defects: Decreases in bone mineral density (BMD) have been reported with the use of tenofovir prodrugs. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss. Mineralization defects, including osteomalacia associated with PRT, have been reported with the use of TDF-containing products.

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 12 years and older (≥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 are insufficient data on the use of DESCOVY during pregnancy. In animal studies, no adverse developmental effects were observed with the components of DESCOVY. An Antiretroviral Pregnancy Registry has been established.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

Indication

DESCOVY® is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients 12 years and older.

Limitations of Use:
DESCOVY is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection.

*Studies were combined for a prespecified pooled safety and efficacy analysis.
Administered as an STR.

BMD, bone mineral density; eGFRCG, estimated glomerular filtration rate (Cockcroft-Gault); QD, once daily.

References:

  1. Sax PE, Wohl D, Yin MT, et al; for GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials [supplementary appendix]. Lancet. 2015;385(9987):2606-2615.
  2. DeJesus E, Sax P, Yin M, et al. Renal and bone safety of tenofovir alafenamide vs tenofovir disoproxil fumarate. Poster presented at: HIV Drug Therapy in the Americas; April 16-18, 2015; Mexico City, Mexico. Poster P030.

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