TM Owner Gilead Sciences
Truvada 200 mg + 300 mg Tablet
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Indications & Clinical Uses
- Truvada 200 mg/300 mg film-coated tablets combine emtricitabine and tenofovir disoproxil fumarate, two nucleoside/nucleotide reverse transcriptase inhibitors, taken once daily by mouth.
- In the United States, Truvada is approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older, and separately, on its own, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg.
- A negative HIV-1 test immediately before starting PrEP is required, and Truvada is contraindicated for PrEP in anyone with unknown or positive HIV-1 status.
- It is manufactured by Gilead Sciences, Inc.
Side Effects
- Truvada carries a boxed warning: lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues such as Truvada, and severe acute flare-ups of hepatitis B can occur in people coinfected with HIV-1 and hepatitis B who stop taking Truvada, so liver function should be monitored closely for several months after stopping.
- The most common side effects, each affecting 10% or more of patients, are diarrhoea, nausea, fatigue, headache, dizziness, depression, trouble sleeping, abnormal dreams and rash.
- Seek urgent care for unusual muscle pain with weakness, difficulty breathing, stomach pain with nausea and vomiting (possible lactic acidosis), yellowing of the skin or eyes, or worsening liver symptoms after stopping treatment.
Precautions & Warnings
- All patients should be tested for hepatitis B before starting Truvada, since stopping it in someone with hepatitis B coinfection can trigger a severe flare; liver function should be monitored for several months after discontinuation.
- Kidney function should be checked before starting and periodically during treatment, as tenofovir disoproxil fumarate can cause new or worsening kidney impairment and has been linked to decreased bone mineral density; Truvada is not recommended with other tenofovir-containing products.
- For PrEP use, confirm a negative HIV-1 test immediately before starting and retest periodically during use, since Truvada alone is not a complete HIV treatment regimen and drug-resistant virus can emerge if used to treat undiagnosed infection.
- Truvada tablets are taken by mouth, with or without food; store at 20°C to 25°C (room temperature), excursions to 15°C to 30°C permitted, in the original container.
Avoid Interactions
- Tell your healthcare provider about all medicines you take before starting Truvada.
- Avoid taking Truvada with other medicines containing tenofovir disoproxil fumarate, tenofovir alafenamide, lamivudine, or adefovir, because of overlapping toxicity or reduced effectiveness.
- Didanosine levels increase significantly with tenofovir, so this combination is generally avoided; atazanavir requires ritonavir boosting when combined with Truvada, and lopinavir/ritonavir can raise tenofovir levels, requiring monitoring for kidney and bone side effects.
- Drugs that reduce kidney function or are cleared by the kidneys, including many nephrotoxic medicines and NSAIDs used regularly, can increase tenofovir levels and toxicity when combined with Truvada.
- Always tell any new prescriber or pharmacist that you take Truvada.
References
Frequently Asked Questions
Truvada (emtricitabine/tenofovir disoproxil fumarate) treats HIV-1 infection, combined with other HIV medicines, in adults and children 12 and over. On its own, it is also used as PrEP to reduce the risk of getting HIV-1 through sex in adults and teens weighing 35 kg or more.
Truvada is one tablet taken by mouth once daily, with or without food, at about the same time each day. For PrEP, it must be taken consistently and combined with condoms and regular HIV testing for full protection.
Common Truvada side effects include diarrhoea, nausea, headache, fatigue and trouble sleeping. Truvada carries a boxed warning for lactic acidosis and severe liver problems, and for serious hepatitis B flare-ups if you stop taking it while coinfected.
Avoid other tenofovir- or lamivudine-containing medicines while on Truvada. Didanosine, atazanavir and lopinavir/ritonavir all interact with Truvada and need dose changes or monitoring. Tell your prescriber about every medicine, including over-the-counter painkillers used regularly.
Yes. A negative HIV-1 test is required immediately before starting Truvada for PrEP, and testing is repeated regularly during use. You should also be tested for hepatitis B first, since stopping Truvada can cause a serious hepatitis B flare in coinfected people.
Take a missed Truvada dose as soon as you remember on the same day; if it is almost time for the next dose, skip the missed one and continue your normal schedule. Do not double up, and missing doses regularly for PrEP lowers protection against HIV.
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