From the Guidelines
Truvada, a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, is recommended as a once-daily oral tablet for both HIV prevention and treatment, with the most recent and highest quality evidence supporting its use as preexposure prophylaxis (PrEP) for individuals at risk of HIV infection 1.
Key Recommendations for Truvada Use
- For HIV prevention (PrEP), sexually active adults should take one tablet daily, with consistent use being crucial for effectiveness.
- For HIV treatment, Truvada must be combined with at least one additional antiretroviral medication as part of a complete regimen, also taken once daily.
- The medication should be taken with food to improve absorption and reduce gastrointestinal side effects.
- For PrEP, individuals should undergo HIV testing before starting and every 3 months during use, as Truvada alone is insufficient for treating active HIV infection and could lead to resistance if used with undiagnosed infection.
- Kidney function should be monitored regularly, as tenofovir can cause renal impairment.
Important Considerations
- Truvada works by preventing HIV from replicating in the body - emtricitabine and tenofovir are nucleoside/nucleotide reverse transcriptase inhibitors that block a key enzyme HIV needs to multiply, making it effective for both prevention in uninfected individuals and treatment in those living with HIV.
- The use of Truvada as PrEP is supported by the 2020 recommendations of the International Antiviral Society-USA panel, which suggests that it is a safe and effective method for reducing the risk of HIV acquisition in individuals at high risk 1.
- Regular monitoring of kidney function and HIV status is essential for individuals taking Truvada as PrEP, as well as ongoing risk-reduction and PrEP medication adherence counseling.
Additional Guidance
- The Centers for Disease Control and Prevention (CDC) and other health organizations have issued guidelines for the use of Truvada as PrEP, including recommendations for HIV testing, kidney function monitoring, and risk-reduction counseling 1.
- Truvada is also approved for the treatment of HIV infection in combination with other antiretroviral medications, and its use in this context is supported by a range of clinical trials and observational studies 1.
From the FDA Drug Label
The recommended dosage of tenofovir disoproxil fumarate tablets in adults and pediatric patients weighing at least 35 kg is one 300 mg tablet taken orally once daily without regard to food.
The recommended dosage of tenofovir disoproxil fumarate tablet in adults and pediatric patients 2 years and older weighing at least 17 kg is 8 mg of tenofovir disoproxil fumarate (TDF) per kg of body weight (up to a maximum of 300 mg) once daily.
The recommended use and dosage of Truvada (emtricitabine and tenofovir disoproxil fumarate) for HIV prevention and treatment is:
- One 300 mg tablet taken orally once daily without regard to food for adults and pediatric patients weighing at least 35 kg.
- 8 mg of tenofovir disoproxil fumarate (TDF) per kg of body weight (up to a maximum of 300 mg) once daily for adults and pediatric patients 2 years and older weighing at least 17 kg.
Key points to consider:
- Dosage adjustment may be necessary for patients with renal impairment.
- Testing for HBV infection and HIV-1 infection is recommended prior to or when initiating tenofovir disoproxil fumarate.
- Monitoring of serum creatinine, estimated creatinine clearance, urine glucose, and urine protein is recommended in all patients.
2, 2, and 2 provide additional information on the dosage and administration of tenofovir disoproxil fumarate.
From the Research
Recommended Use of Truvada
- Truvada, a combination of emtricitabine and tenofovir disoproxil fumarate, is recommended for pre-exposure prophylaxis (PrEP) to prevent HIV infection in individuals at high risk of HIV acquisition 3, 4.
- The US Preventive Services Task Force (USPSTF) recommends offering PrEP with effective antiretroviral therapy to persons at high risk of HIV acquisition 3.
Dosage of Truvada
- The recommended dosage of Truvada for PrEP is one tablet (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) taken orally once daily 4, 5.
- Adherence to the daily dosing regimen is crucial for the efficacy of Truvada in preventing HIV infection 3, 4.
Efficacy and Safety of Truvada
- Truvada has been shown to be highly effective in preventing HIV infection, with efficacy exceeding 90% when taken daily 4.
- Truvada is generally well-tolerated, with a low rate of discontinuation due to adverse effects (<2%) 4.
- However, Truvada may be associated with small harms, including kidney and gastrointestinal adverse effects 3.
Alternative Formulations
- Emtricitabine and tenofovir alafenamide is an alternative formulation that has been shown to be non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, with more favorable effects on bone mineral density and biomarkers of renal safety 6.