Advertisement

This Resource Center was provided by Gilead Sciences, Inc.
Prescribing Information: DESCOVY, GENVOYA, ODEFSEY
FTC/TAF is the #1 NRTI backbone prescribed in naive and switch patients Choose a DESCOVY® (FTC/TAF)-based regimen for your patients
INDICATIONS
DESCOVY (emtricitabine 200mg/tenofovir alafenamide 25mg) is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients 12 years and older (≥35 kg).
  • Limitations of Use: DESCOVY is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection.
GENVOYA® (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg) is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years and older (≥35 kg) who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in patients who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen for ≥6 months with no history of treatment failure and no known resistance to any component of GENVOYA.
ODEFSEY® (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years and older (≥35 kg) who have no antiretroviral (ARV) treatment history with HIV-1 RNA ≤100,000 copies/mL; or to replace a stable ARV regimen in patients who are virologically-suppressed (HIV-1 RNA <50 copies/mL) for ≥6 months with no history of treatment failure and no known resistance to any component of ODEFSEY.

IMPORTANT SAFETY INFORMATION FOR DESCOVY, GENVOYA, AND ODEFSEY

BOXED WARNING

POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • DESCOVY, GENVOYA, and ODEFSEY are not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy 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, GENVOYA, or ODEFSEY. After discontinuation, 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. If appropriate, anti-hepatitis B therapy may be warranted.

Please see below for additional Important Safety Information for DESCOVY, GENVOYA, and ODEFSEY.

DESCOVY is a dual-NRTI backbone, which is an essential element of a complete HIV-1 regimen

  • DESCOVY (FTC/TAF) is included in multiple DHHS-recommended regimens for treatment-naive adults and adolescents in combination with certain other third agents1
    • FTC/TAF has been added to the DHHS Guidelines in combination with the following third agents: AI: EVG/c; AII: DTG, RAL, DRV/r; BII: RPV if HIV RNA <100,000 copies/mL and CD4 >200 cells/µL, EFV, ATV/c or ATV/r, and DRV/c*
  • DESCOVY (FTC/TAF) has been studied in a Phase 3 clinical trial program (administered as part of an STR: FTC/TAF + EVG/COBI), including treatment-naive adults and adolescents as well as virologically suppressed adults with and without renal impairment (>2,000 patients)2-5

  • Adverse reactions

    Adverse reactions for DESCOVY, GENVOYA, and ODEFSEY:

    • Common adverse reactions (incidence ≥5%; all Grades) in clinical studies of FTC/TAF in combination with other ARV agents were nausea (10%), diarrhea (7%), headache (6%), and fatigue (5%).
    Additional adverse reactions for ODEFSEY:
    • Most common adverse reactions (incidence ≥2%, Grades 2-4) in clinical studies of rilpivirine in combination with other ARV agents were depressive disorders (2%), insomnia (2%) and headache (2%).

IMPORTANT SAFETY INFORMATION FOR DESCOVY, GENVOYA, AND ODEFSEY (cont'd)

  • Contraindications
    Contraindications for DESCOVY:
    • None
    Contraindications for GENVOYA:
    • Coadministration. Do not use with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Do not use with drugs that strongly induce CYP3A as this may lead to loss of efficacy and possible resistance to GENVOYA. Do not use with alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, or St. John's wort.
    Contraindications for ODEFSEY:
    • Coadministration. Do not use with drugs that induce CYP3A or increase gastric pH as this may lead to loss of efficacy and possible resistance to ODEFSEY or the NNRTI class. Do not use with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors (e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), systemic dexamethasone (>1 dose) and St. John's wort.
  • Warnings and precautions
    Warnings and precautions for DESCOVY, GENVOYA, and ODEFSEY:
    • 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 (TAF) with elvitegravir and cobicistat, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate 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 in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
      Renal monitoring for DESCOVY and ODEFSEY: 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.
      Renal monitoring for GENVOYA: In all patients, monitor CrCl, urine glucose, urine protein, serum creatinine, and serum phosphorus prior to initiating and during therapy as clinically appropriate.
    • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
    Additional warnings and precautions for DESCOVY and ODEFSEY:
    • 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.
    Additional warnings and precautions for GENVOYA:
    • Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during GENVOYA therapy and monitor for adverse reactions.
    Additional warnings and precautions for ODEFSEY:
    • Skin and hypersensitivity reactions: Severe skin and hypersensitivity reactions have been reported with the use of rilpivirine-containing regimens, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). In rilpivirine clinical trials, most rashes were Grades 1-2 and occurred in the first 4-6 weeks of treatment; Grades 2-4 rash occurred in 1% of subjects. Discontinue ODEFSEY immediately if severe skin or hypersensitivity reactions occur, including severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis or eosinophilia. Monitor clinical status including laboratory parameters and initiate appropriate therapy.
    • Loss of virologic response due to drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during ODEFSEY therapy and monitor for adverse reactions.
    • Prolongation of QTc interval: Rilpivirine doses 3 and 12 times higher than the recommended dose can prolong the QTc interval. Consider alternatives to ODEFSEY in patients at higher risk for Torsade de Pointes or when coadministered with a drug with known risk of Torsade de Pointes.
    • Depressive disorders: Evaluate patients with severe depressive symptoms to assess if symptoms are due to ODEFSEY and if the risks of continued treatment outweigh the benefits. In rilpivirine adult clinical trials (N=686), the incidence of depressive disorders was 9%, Grades 3-4 depressive disorders was 1%, discontinuation due to depressive disorders was 1%, and suicidal ideation and suicide attempt was reported in 4 and 2 subjects, respectively. In a rilpivirine adolescent clinical trial (N=36), the incidence of depressive disorders was 19%, Grades 3-4 depressive disorders was 6%, and suicidal ideation and suicide attempt were reported in 1 subject.
    • Hepatotoxicity: Hepatic adverse events have been reported, including cases of hepatic toxicity, in patients without pre-existing hepatic disease or other identifiable risk factors. In patients with hepatic abnormalities (e.g., hepatitis, elevated liver-associated tests), order laboratory tests before starting treatment and monitor for hepatotoxicity during treatment; consider testing and monitoring in all patients.
  • Adverse reactions
    Adverse reactions for DESCOVY, GENVOYA, and ODEFSEY:
    • Common adverse reactions (incidence ≥5%; all Grades) in clinical studies of FTC/TAF in combination with other ARV agents were nausea (10%), diarrhea (7%), headache (6%), and fatigue (5%).
    Additional adverse reactions for ODEFSEY:
    • Most common adverse reactions (incidence ≥2%, Grades 2-4) in clinical studies of rilpivirine in combination with other ARV agents were depressive disorders (2%), insomnia (2%) and headache (2%).
  • Drug interactions
    Drug interactions for DESCOVY, GENVOYA, and ODEFSEY:
    • Prescribing information: Consult the full prescribing information for more information on potentially significant drug interactions, including clinical comments.
    • Drugs affecting renal function: Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.
    Additional drug interactions for DESCOVY:
    • 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.
    Additional drug interactions for GENVOYA:
    • GENVOYA can increase the concentration of drugs metabolized by CYP3A, CYP2D6, P-gp, BCRP, OATP1B1, or OATP1B3. Drugs that inhibit CYP3A, P-gp, or BCRP can increase the concentrations of components of GENVOYA. Drugs that induce CYP3A or P-gp can decrease the concentrations of components of GENVOYA.
    Additional drug interactions for ODEFSEY:
    • Drugs that induce CYP3A or P-gp and drugs that increase gastric pH can decrease the concentrations of components of ODEFSEY. Drugs that inhibit CYP3A or P-gp can increase the concentrations of components of ODEFSEY. QT prolonging drugs: Consider alternatives to ODEFSEY in patients taking a drug with known risk of Torsade de Pointes.
  • Dosage and administration
    Information for DESCOVY, GENVOYA, and ODEFSEY:
    • Dosage for patients 12 years and older who weigh ≥35 kg: 1 tablet taken orally once daily.

      — DESCOVY: take with or without food, in combination with other ARV agents.

      — GENVOYA: take with food, as a single-tablet regimen.

      — ODEFSEY: take with a meal, as a single-tablet regimen.
    • Renal impairment: Not recommended in patients with CrCl <30 mL/min.
    • Testing prior to initiation: Test patients for HBV infection.
    • Testing prior to initiation and during therapy: Assess CrCl, urine glucose, and urine protein.
    Additional information for GENVOYA:
    • Hepatic impairment: Not recommended in patients with severe hepatic impairment.
    • Testing prior to initiation and during therapy: Additionally assess serum creatinine and serum phosphorus as clinically appropriate.
    Additional information for ODEFSEY:
    • Testing after initiation: In virologically-suppressed patients, additional monitoring of HIV-1 RNA and regimen tolerability is recommended.
  • Pregnancy and lactation
    Information for DESCOVY, GENVOYA, and ODEFSEY:
    • Pregnancy: There is insufficient human data on use during pregnancy. An ARV 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.

Please click here to view full Prescribing Information for DESCOVY, GENVOYA, and ODEFSEY, including BOXED WARNINGS.

*Strength of recommendation is defined as: A = Strong recommendation for the statement; B = Moderate recommendation for the statement. Quality of evidence for recommendation is defined as: I = One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II = One or more well-designed, non-randomized trials, observational cohort studies with long-term clinical outcomes, relative bioavailability/bioequivalence studies, or regimen comparisons from randomized switch studies.1

COBI, cobicistat; EVG, elvitegravir; FTC, emtricitabine; RPV, rilpivirine; TAF, tenofovir alafenamide.

References:

  1. US Department of Health and Human Services, Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Updated July 14, 2016. Accessed November 10, 2016.
  2. 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. Lancet. 2015;385(9987):2606-2615.
  3. Pozniak A, Arribas JR, Gathe J, et al; for 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.
  4. Mills A, Arribas JR, Andrade-Villanueva J, et al; for GS-US-292-0109 Team. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016;16(1):43-52.
  5. GENVOYA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017.

GileadGilead Corporate WebsitePrivacy PolicyContact Us