Classes
DEA Class; Rx
Common Brand Names; Descovy
- HIV, ART Combos
Description
Combination product containing 2 nucleoside analog reverse transcriptase inhibitors (NRTIs)
Used as part of a combination regimen to treat HIV-1 in adults and pediatric patients who weigh at least 14 kg and in combination with safe sex practices for HIV pre-exposure prophylaxis in adults and adolescents without HIV who weigh at least 35 kg
Black Box Warning regarding acute exacerbations of hepatitis B in patients with HBV after drug discontinuation
Indications
Indicated in combination with other antiretroviral agents (ARTs) for treatment of HIV-1 infection in adults
Indicated for at-risk patients to reduce risk of HIV-1 infection from sex, excluding those at risk from receptive vaginal sex
Contraindications
Use for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status
Adverse Effects
Adults
Nausea (10%)
Bone mineral density (BMD) decline spine ≥5% (10%)
BMD decline femoral neck ≥7% (7%)
Diarrhea (5%)
Headache (2%)
Fatigue (2%)
Abdominal pain (2%)
Warnings
All individuals should be tested for the presence of chronic HBV infection before initiating ART therapy or PrEP; emtricitabine/tenofovir AF is not approved for treatment of chronic HBV infection, and safety and efficacy are not established in patients coinfected with HIV-1 and HBV (see Black Box Warnings)
Use for HIV-1 PrEP to reduce the risk of HIV-1 infection is part of a comprehensive prevention strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs); the time from initiation of emtricitabine/tenofovir AF for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown
Before initiating for PrEP, individuals must be confirmed to be HIV-1 negative; HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only emtricitabine/tenofovir AF, which alone does not constitute a complete HIV-1 treatment regimen; while using for PrEP, testing should be repeated at least every 3 months, and upon diagnosis or any other STD
Immune reconstitution syndrome reported with combination ART therapy, including emtricitabine; during initial phase of combination ART treatment, patients whose immune system responds may develop inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment; autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barré syndrome) may also emerge
New-onset or worsening renal impairment reported with tenofovir, including cases of acute renal failure and Fanconi syndrome
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with the use of nucleoside analogs, alone or in combination with other ARTs; suspend treatment with clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
Pregnancy and Lactation
Pregnancy exposure registry monitors pregnancy outcomes in women exposed to drug during pregnancy
FTC has been shown to be present in human breast milk; not known if TAF is present in human breast milk; tenofovir has been shown to be present in milk of lactating rats and rhesus monkeys after administration of TDF; not known if TAF is present in animal milk
Maximum Dosage
200 mg emtricitabine; 25 mg tenofovir alafenamide (1 tablet) per day PO.
200 mg emtricitabine; 25 mg tenofovir alafenamide (1 tablet) per day PO.
200 mg emtricitabine; 25 mg tenofovir alafenamide (1 tablet) per day PO.
weight 25 kg or more: 200 mg emtricitabine; 25 mg tenofovir alafenamide (1 tablet) per day PO.
weight 14 to 24 kg: 120 mg emtricitabine; 15 mg tenofovir alafenamide (1 tablet) per day PO.
weight less than 14 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Emtricitabine/tenofovir alafenamide (AF)
tablet
- 200mg/25mg
