Is this a treatment for HIV?

The same combination is approved both for treatment in people who have HIV and for prevention in people who do not. The doses and the required monitoring differ, and both indications are in the label above.

Why is testing before starting so important?

Because starting these two medicines with an undiagnosed infection present can produce resistance to drugs needed later. The boxed warning addresses exactly this.

It is taken during periods when it is needed, and the decision to start or stop belongs with a clinician who knows the situation. The label describes ongoing use with monitoring, not a fixed course.

Emtricitabine and tenofovir disoproxil

Pre-exposure prophylaxis: a daily tablet taken by people who do not have HIV, to prevent acquiring it. Prevention rather than treatment, with testing built into the label.

Class: Antiretroviral combination
Sold as: Sold as: Truvada; Prescription only

Boxed warning

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B

and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue TRUVADA. If appropriate, anti-hepatitis B therapy may be warranted. TRUVADA used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use.

From the approved label

Truvada

Approved uses: TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
Forms and strengths: TRUVADA tablets are available in four dose strengths. 100 mg/150 mg Tablets: 100 mg of emtricitabine (FTC) and 150 mg of tenofovir disoproxil fumarate (TDF) (equivalent to 123 mg of tenofovir...
Tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg of emtricitabine and tenofovir disoproxil fumarate, respectively.
How it is taken: Testing: Prior to or when initiating TRUVADA test for hepatitis B virus infection. Prior to initiation and during use of TRUVADA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus.
HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating TRUVADA for HIV-1 PrEP and at least once every 3 months while taking TRUVADA, and upon diagnosis of any other sexually transmitted infections (STIs).
Treatment of HIV-1 Infection Recommended dosage in adults and pediatric patients weighing at least 35 kg: One TRUVADA tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.
Recommended dosage in pediatric patients weighing at least 17 kg: One TRUVADA low-strength tablet (100 mg/150 mg, 133 mg/200 mg, or 167 mg/250 mg based on body weight) once daily taken orally with or without food.
Recommended dosage in renally impaired HIV-1 infected adult patients: Creatinine clearance (CrCl) 30−49 mL/min: 1 tablet every 48 hours.
CrCl below 30 mL/min or hemodialysis: TRUVADA is not recommended.
Must not be used when: TRUVADA for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.
Interactions: Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted.
Coadministration decreases atazanavir concentrations. When coadministered with TRUVADA, use atazanavir given with ritonavir.
Coadministration of TRUVADA with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity.
Consult Full Prescribing Information prior to and during treatment for important drug interactions.
Warnings and precautions: Comprehensive management to reduce the risk of acquiring HIV-1 when TRUVADA is used for HIV-1 PrEP: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule.
Management to reduce the risk of acquiring HIV-1 drug resistance when TRUVADA is used for HIV-1 PrEP: refer to full prescribing information for additional detail.
New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering TRUVADA with concurrent or recent use of nephrotoxic drugs.
Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment.
Decreases in bone mineral density (BMD): Consider assessment of BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss.
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue TRUVADA in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
Common side effects: most common adverse reactions (incidence greater than or equal to 10%, all grades) included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
Pregnancy: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TRUVADA during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Data on the use of TRUVADA during pregnancy from observational studies have shown no increased risk of major birth defects.
How it acts: TRUVADA is a fixed-dose combination of antiviral drugs FTC and TDF.

Label holder:: Gilead Sciences, Inc
Label version:: 16 July 2025

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.

Written by us

How it works

The two substances block the enzyme HIV uses to convert its genetic material after entering a cell. Taken before exposure, they are present in the tissue where transmission would occur, so infection does not establish itself. This is the reason the label insists on confirming HIV-negative status first: taking two drugs against a virus already present is a recipe for resistance.

Original and generic

Generic versions are widely available across Europe and are what most public programmes dispense. This is one of the clearest cases where a generic changed access completely: prophylaxis went from a private expense to something health systems could fund.

What it costs

Free or nearly free through public programmes in France, and available at low cost or through public routes elsewhere in Europe, with details differing by country. The generic price is a small fraction of what the brand cost when it was the only option.

How to get it legally

Prescription only, and this is not a case for a one-off questionnaire. The label sets out testing before starting and repeat testing during use, and any service offering it without that schedule is not following the document it dispenses under.

Questions

Is this a treatment for HIV?: The same combination is approved both for treatment in people who have HIV and for prevention in people who do not. The doses and the required monitoring differ, and both indications are in the label above.
Why is testing before starting so important?: Because starting these two medicines with an undiagnosed infection present can produce resistance to drugs needed later. The boxed warning addresses exactly this.
Is it taken forever?: It is taken during periods when it is needed, and the decision to start or stop belongs with a clinician who knows the situation. The label describes ongoing use with monitoring, not a fixed course.

Sources

Truvada: prescribing informationDailyMed, US National Library of Medicine. Label version 16 July 2025
Drugs@FDA: NDA021752US Food and Drug Administration
Truvada: EPAR product informationEuropean Medicines Agency