|Tenofovir disoproxil||Nucleotide analogue reverse transcriptase inhibitor|
|Emtricitabine||Nucleoside reverse transcriptase inhibitor|
|Trade names||Truvada, other|
|AHFS/Drugs.com||Professional Drug Facts|
Emtricitabine/tenofovir, sold under the brand name Truvada among others, is a medication used to treat and prevent HIV/AIDS. It is a fixed-dose combination of two antiretroviral medications: tenofovir disoproxil and emtricitabine. For treatment it is used either alone or together with other antiretroviral medication. For prevention before exposure, in those who are at high risk, it is recommended with safe sex practices. It does not cure HIV/AIDS. Emtricitabine/tenofovir is taken by mouth.
Common side effects include headache, feeling tired, trouble sleeping, abdominal pain, weight loss, and rash. Serious side effects may include high blood lactate levels and enlargement of the liver. Use during pregnancy does not appear to harm the baby, but such use has not been well studied.
Emtricitabine/tenofovir was approved for medical use in the United States in 2004. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The wholesale cost in the developing world is about US$6.06 to US$7.44 per month. In the United States, as of 2016, the wholesale cost is about US$1,415.00 per month.
Emtricitabine/tenofovir is used to both treat and to prevent HIV/AIDS.
In studies, tenofovir reduced the incidence of HIV infection, especially in high-risk individuals (by 42% in MSM), but produced conflicting results in other studies (notably the FEM-PrEP study in heterosexual African women). One study estimated through mathematical modeling that daily intake of tenofovir could potentially achieve a 99% risk reduction of contracting HIV in high-risk individuals. Another study showed overall PrEP effectiveness of 50% rising to 100% when participants took the drug four or more times per week. A Cochrane review found that both tenofovir alone, as well as the tenofovir/emtricitabine combination, decreased the risk of contracting HIV by 51%.
In the US it has been approved for pre-exposure prophylaxis (PrEP) against HIV infection. The Food and Drug Administration approved it for preventive use on July 16, 2012. In the UK a large scale clinical trial has been approved.
The FDA recommends pre-exposure prophylactic (PrEP) considerations for the following high-risk groups:
- Gay or bisexual men who either have had anal sex without a condom or been diagnosed with an STD in the past 6 months
- Heterosexual men or women who do not regularly use condoms during sex with partners of unknown HIV status who are substantial risk
- Injection of drugs in the last month with sharing of equipment
- Sero-discordant heterosexual and homosexual partners where one partner is HIV-positive and the other HIV-negative
The consideration of utilizing Truvada as a reduction strategy involves discussion with a health professional who can help the patient navigate the benefits and risks. Patients who start taking Truvada see HIV reduction benefit up to 72 hours after starting, but the medicine must be taken for thirty days after a high-risk sexual event to ensure HIV transmission levels are optimally reduced.
Emtricitabine/tenofovir is a tablet taken by mouth.
In pregnancy and lactation, Truvada was shown to be secreted in breast milk.
Emtricitabine/tenofovir is generally well-tolerated. Some of its side effects include:
- Rare: lactic acidosis, liver dysfunction, worsening of hepatitis B infection
- Common: headache, abdominal pain, and decreased weight, nausea, diarrhea, decreased bone density
Fat redistribution and accumulation (lipodystrophy) has been observed in people receiving antiretroviral therapy, including fat reductions in the face, limbs, and buttocks and increases in visceral fat of the abdomen and accumulations in the upper back. When used as pre-exposure prophylaxis (PrEP) this effect may not be present. Weight changes have however been linked to the medication.
The tenofovir component of emtricitabine/tenofovir interacts with the following drugs: didanosine, atazanavir, and lopinavir/ritonavir. When tenofovir is coadministered with didanosine, the concentration of didanosine increases, and may lead to didanosine toxicity which may result in complications such as pancreatitis and neuropathy. If authorised, the dose of didanosine may be reduced or discontinued completely. The coadministration of tenofovir and atazanavir results in decreased concentrations of atazanavir and increased concentrations of tenofovir. Atazanavir may be taken with Truvada only with ritonavir and must be monitored for tenofovir toxicity. The coadministration of tenofovir and lopinavir/ritonavir increases the concentration of tenofovir and must be monitored for tenofovir toxicity.
Other drugs with adverse reactions include adefovir, dabigatran etexilate, lamivudine, and vincristine. Adefovir may reduce the therapeutic effect of tenofovir. Dabigatran etexilate used with p-glycoprotein inducers require montering of decreased levels and effects of dabigatran. Lamivudine may increase the adverse or toxic effect of emtricitabine. Vincristine used with P-glycoprotein/ABCB1 inducers can decrease the serum concentration of vincristine.
Society and culture
As of 2014[update], the median cost per tablet, in Namibia and South Africa, was US $0.20. In Canada, Truvada costs between $800 - $1,100 per month. Generic emtricitabine/tenofovir was approved by Health Canada in August 2017, with a wholesale cost of $400 per month.
In the United States, as of 2016, the wholesale cost is about US$1415.00 per month. The price of emtricitabine/tenofovir in the United States has been criticised by activists, who argued in a 2018 New York Times opinion piece that the high cost keeps the drug out of reach for millions, thus harming efforts to reduce new HIV infections.
The patent for the drug combination is owned by Gilead in some regions. The European patent EP0915894B1 was due to expire in July 2017, however a case is due before the European Court of Justice seeking to extend the patent.[needs update] An Irish court rejected an injunction request to prevent the launch of generic versions prior to the resolution of the case.
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