Generic Name: tenofovir disoproxil fumarate + emtricitabine
Abbreviation: TDF + FTC
Other Market Name: N/A
Pharmaceutical Company: Gilead Sciences
Approval Status: Approved
Generic Version Available: No
Experimental Code: N/A
A component of recommended and alternative treatment regimens for antiretroviral-naive people living with HIV, as indicated by the U.S. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Visit https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/0 for the full DHHS guidelines.
Truvada is also recommended by the U.S. Centers for Disease Control and Prevention as pre-exposure prophylaxis (PrEP) for HIV-negative individuals with any of the following indications:
- Anyone who is in an ongoing sexual relationship with an HIV-infected partner.
- A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past six months, and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.
- A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV (for example, a person who injects drugs or bisexual male partners of unknown HIV status), and is not in a mutually-monogamous relationship with a partner who recently tested HIV-negative.
- Anyone who has, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.
The CDC PrEP guidelines, published in 2014, can be accessed here: http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf.
Truvada is an HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors. Truvada was approved by the U.S. Food and Drug Administration for the treatment of HIV in August 2004. Truvada was approved for use as PrEP to prevent HIV among those at high risk in July 2012.
Truvada is a coformulation of two drugs: Viread (tenofovir DF) and Emtriva (emtricitabine). Both of these drugs can still be purchased individually for use in combination with other HIV drugs
As HIV treatment, Truvada must be used in combination with other HIV drugs.
As PrEP, Truvada should be used in combination with risk-reduction counseling, correct and consistent condom use, regular HIV testing and screening for and treatment of other sexually transmitted infections.
Adult Dose: One tablet once a day. Each tablet contains 300mg tenofovir disoproxil fumarate + 200mg emtricitabine.
Pediatric Dose: Children weighing 37lbs (17kg) – 48lbs (22kg): One tablet containing 150mg tenofovir disoproxil fumarate + 100mg emtricitabine once a day.
Children weighing 48lbs (22kg) – 61lbs (28kg): One tablet containing 200mg tenofovir disoproxil fumarate + 133mg emtricitabine once a day.
Children weighing 61lbs (28kg) – 77lbs (35kg): One tablet containing 250mg tenofovir disoproxil fumarate + 167mg emtricitabine once a day.
Dosing Info: Take with or without food.
Common side effects among people using Truvada as a component of a treatment regimen include: diarrhea, nausea, tiredness, headache, dizziness, depression, problems sleeping, abnormal dreams, and rash.
Common side effects among people using Truvada as PrEP include: headache, stomach-area (abdomen) pain, and decreased weight.
Truvada may lead to new or worsening kidney problems, including kidney failure. Your healthcare provider may order creatinine clearance (CrCl) tests to check your kidneys before and during treatment with Truvada. If you develop kidney problems, your healthcare provider may adjust your medication doses or switch Truvada for other HIV medications.
Truvada may lead to bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.
If you also have hepatitis B virus (HBV) and take Truvada, your hepatitis may become worse if you stop taking Truvada. Do not stop taking Truvada without first talking to your healthcare provider.
Tenofovir disoproxil fumarate decreases Reyataz (atazanavir) concentrations in the blood; atazanavir increases tenofovir disoproxil fumarate concentrations in the blood. Atazanavir should be combined with ritonavir (Norvir) if tenofovir disoproxil fumarate is also being used. Combining Truvada with atazanavir and Norvir (ritonavir), Prezista (darunavir) and ritonavir, or Kaletra (lopinavir/ritonavir) increases tenofovir concentrations in the blood; may increase risk or severity of tenofovir side effects.
Truvada should not be combined with any HIV medications that contain any of the active ingredients in Truvada. These include: Atripla, Complera, Emtriva, Genvoya, Stribild, or Viread. Combining Truvada with HIV medications containing active ingredients similar to those in Truvada should also be avoided. These include: Combivir, Epivir, and Trizivir.
Other drug interactions are possible. Consult the Truvada package insert for more details: http://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.PDF
Before taking this medication, tell your doctor if you have kidney disease or liver disease (including hepatitis B). In addition, tell your doctor if you are pregnant or planning to become pregnant; if you are breast feeding, and all your medical conditions, including all prescription and over-the-counter medications and supplements you are taking.
Co-Pay Program Info: https://www.poz.com/basics/hiv-basics/drug-assistance-programs
Patient Assistance Program Info: https://www.poz.com/basics/hiv-basics/drug-assistance-programs
Last Revised: July 15, 2016