Truvada (tenofovir + emtricitabine) - HIV Drug Information

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Photo Credit: Jeffrey Beall

Classification:

Truvada is single-pill, fixed dose combination drug comprised of two antiretroviral agents, tenofovir, and emtricitabine, both classified as nucleotide reverse transcriptase inhibitors. The two drug components are independently marketed as Viread (tenofovir) and Emtriva (emtricitabine, FTC).

Truvada was approved by the U.S. Food and Drug Administration (FDA) in August 2004 for use in the treatment of HIV, specifically for adults and children over the age of 12 who weigh 77 pounds (35kg) or more.

Truvada was later granted FDA approval in July 2012 for use in the prevention of HIV acquisition in high-risk individuals in a strategy called pre-exposure prophylaxis (PrEP).

Formulation:

A co-formulated tablet comprised of 300mg tenofovir diisopropyl fumarate and 200mg emtricitabine. The blue, oblong tablet is film coated and embossed on one side with the number "701" and the other with the manufacturer's name "GILEAD."

Dosage:

  • For patients with HIV: one tablet daily, taken orally with or without food.
  • For use as PrEP: one tablet daily, taken orally with or without food.
  • For patients with renal (kidney) impairment: one tablet is taken every 48 hours if creatinine clearance is between 30-49mL/minute. If below 30mL/minute or on hemodialysis, do not use.

Instructions:

For patients with HIV, Truvada must be taken in combination therapy with other antiretroviral agents.

When used as PrEP, Truvada is taken on its own as part of a comprehensive HIV prevention strategy, which includes condoms and other safer sex practices.

Common Side Effects:

The most common side effects associated with Truvada use (occurring in 5% or less of cases) include:

  • Nausea
  • Diarrhea
  • Fatigue
  • Sinusitis
  • Headache
  • Dizziness
  • Depression
  • Rash

Drug Contraindications:

As a rule, any fixed dose combination drug containing tenofovir, emtricitabine or lamivudine (another NRTI drug similar to emtricitabine) should not be taken with Truvada.

  • HIV antiretroviral drugs: Atripla (tenofovir + emtricitabine + efavirenz), Combivir (Retrovir + lamivudine), Complera (tenofovir + emtricitabine + rilpivirine), Emtriva (emtricitabine, FTC), Epivir (lamivudine, 3TC), Epzicom (abacavir + lamivudine), Stribild (tenofovir + emtricitabine + elvitegravir + cobicistat), Triumeq (abacavir + lamivudine + dolutegravir), Trizivir (Retrovir + abacavir + lamivudine), Viread (tenofovir)
  • Hepatitis B medication: Hepsera (adefovir)

Drug-Drug Interactions:

Advise your doctor if you are taking any of the following:

  • Anticoagulants: Lixiana (edoxaban), Pradaxa (dabigatran)
  • Non-small-cell lung cancer medication: Ofev/Vargatef (nintedanib)

Treatment Considerations:

Truvada should be used with care in patients with a history of renal (kidney) impairment. Always assess estimated creatinine clearance before initiating treatment. In patients with a risk of renal dysfunction, include estimated creatinine clearance, serum phosphorus, urine glucose and urine protein when monitoring.

Care should be taken when co-administering Truvada with the HIV antiretroviral drug Videx (didanosine). While the mechanisms for interaction are unknown, studies have shown that co-administration may increase the serum concentration of Videx and increase the likelihood of adverse events (e.g., pancreatic, neuropathy). It is recommended that Videx is reduced to 250mg in patients weighing 132 pounds (60kg) or more.

Available human and animal data suggests that Truvada does not increase the risk of birth defects during pregnancy. However, because the effects of tenofovir and emtricitabine on an infant are still unknown, mothers are advised not to breastfeed if taking Truvada.

Sources:

U.S. Food and Drug Administration (FDA). "FDA Approves Two Fixed-Dose Combination Drug Products For the Treatment of HIV-1 Infection." Silver Spring, Maryland; press release issued August 2, 2004.

FDA. "FDA approves first drug for reducing the risk of acquired HIV infection." Silver Spring, Maryland; press release issued July 16, 2012.

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