emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
Standard DoseOne tablet once daily without regard to food for adults and children weighing at least 77 pounds. In children weighing 37–76 pounds, Truvada is dosed based on body weight. See package insert for weight-based dosing. Truvada tablets are available in the following emtricitabine/tenofovir DF dosages: 100/150 mg tablets, 133/200 mg tablets, 167/250 mg tablets, and 200/300 mg tablets. Tablets can disintegrate in water, grape juice, or orange juice with minor stirring and pressure from a spoon; however, no studies have been performed to evaluate the pharmacokinetics (PK) or stability of crushed vs. intact tablets. Must be taken in combination with another antiretroviral(s) which does not contain the medications in this drug or medication from the same drug class.
Take a missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose. The dosing frequency needs to be adjusted for people with decreased kidney function. The dose of Truvada should be adjusted if CrCl is less than 50 mL/min and Truvada should not be used if CrCl is less than 30mL/min or if you are on dialysis.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445–3235)
Approved as generic; generic not yet commercially available
Potential Side Effects and Toxicity
Overall, it is well tolerated, but some may experience nausea, headache, gas, stomach pain, or weight loss. Rare skin discoloration on palms and soles may also occur. The TDF in Truvada is associated with long-term decreases in bone mineral density (BMD). BMD monitoring should be considered in people who have a history of bone fracture due to disease or are at risk for osteopenia or osteoporosis. While calcium and vitamin D levels can be checked to assess the need for these supplements, talk with your provider before starting on your own. Truvada can cause kidney toxicities. Tell your provider about any pain in extremities, persistent or worsening bone pain and fractures, with or without muscular pain or weakness, as well as any concerning changes in urinary habits, as these could be signs of kidney problems. Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild kidney impairment. If you have HIV and HBV, guidelines recommend treatment for both viruses. Truvada can be used to treat HIV and HBV simultaneously. If you are co-infected with HBV and HIV, you should not stop Truvada without medical supervision because it can cause your HBV to flare and cause you to experience signs and symptoms of acute hepatitis. HBV should be closely monitored by your provider. Truvada is associated with lower lipid levels than Ziagen or tenofovir AF (TAF) due to tenofovir DF’s favorable effect on cholesterol. Truvada contains lactose, which can cause some abdominal discomfort, especially in patients sensitive to lactose.
See the individual drugs contained in Truvada: Viread and Emtriva.
See package insert for more complete information on potential side effects and interactions.
Potential Drug Interactions
Do not take with Epivir-HBV, Hepsera, or Vemlidy (TAF), used for the treatment of hepatitis B. Tenofovir decreases the concentration levels of Reyataz, therefore when Reyataz is taken with Truvada or Viread, it is recommended that Reyataz 300 mg is taken with Norvir 100 mg or Tybost 150 mg (all as a single daily dose with food). In addition, Reyataz/Norvir, Prezista/Norvir, and Kaletra increase tenofovir concentrations. It is recommended that patients taking Reyataz/Norvir, Prezista/Norvir, or Kaletra with Truvada should be monitored for Truvada-associated adverse events, particularly decreases in kidney function. Avoid taking Truvada with drugs that negatively affect the kidneys, including chronic use or high doses of anti-inflammatory drugs for pain like Advil or Motrin (ibuprofen) and Aleve (naproxen). Truvada may be used with hepatitis C drugs such as Daklinza, Harvoni, Olysio, Sovaldi, Viekira Pak, or Zepatier, depending on the third drug in the HIV regimen. Monitor for tenofovir toxicities if used with Epclusa. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug ineractions not listed here.
Current DHHS HIV treatment guidelines recommend Truvada (or Descovy) over Epzicom as the preferred NRTI component for initial therapy (unless Epzicom is paired with Tivicay). The newer version of Truvada, called Descovy, was approved in 2016. The ACTG A5202 study reported that while both Epzicom and Truvada reduced viral load, for those people who started treatment with a viral load of more than 100,000 copies/mL, the times to virologic failure and the first adverse event were both significantly shorter in patients taking Epzicom compared to Truvada. In studies using Tivicay in the regimen, however, Truvada and Epzicom were equally effective regardless of baseline viral load. Kidney function must be monitored before and during treatment with Truvada and it may not be a good option for patients with underlying kidney problems. Fewer kidney and bone issues were seen with the TAF formulation compared to TDF in clinical trials. Approved in 2012 for HIV prevention (pre-exposure prophylaxis, or PrEP) in confirmed HIV-negative adults; see Truvada for PrEP page. Truvada is recommended by DHHS as one of the preferred NRTI combination components of an ART regimen in pregnancy
Dr. David Hardy says:
Truvada was approved in 2004 (on the same day as Epzicom, see that page) as a two-drugs-in-one-pill, two-nuke combination “backbone” to which a third drug is added to create a three-drug combination or “cocktail” ART regimen. Truvada was the most commonly prescribed antiretroviral for the majority of PLWH from the late 2000s until Descovy was approved in 2016. This was due to Truvada’s solid track record as a potent, well-tolerated, and durable two-nuke combination, data showing its higher potency over Epzicom, and concerns (still controversial) about Epzicom’s cardiovascular side effects. Truvada’s use has steadily declined since the approval of three TAF-containing medications (Genvoya, Odefsey, and Descovy) due to less long-term side effects (kidney and bone strength). Truvada became the first, and still only, medication approved for pre-exposure prevention (PrEP) of HIV, in 2012. In mid-December 2017, a generic form of Truvada was approved in the U.S. With the availability of TAF-containing medications, the use of generic Truvada, while probably less expensive, has yet to be seen.
Activist Moisés Agosto-Rosario says:
Truvada is the brand name of a fixed-dose combination containing emtricitabine and tenofovir disoproxil fumarate. Both drugs have a long half-life and when combined can be taken once a day. Truvada is the most prescribed NRTI fixed-dose combination with other antiretrovirals. It may cause damage to the kidneys and loss of bone density. It is important to monitor kidney function and bone density. Besides that, it is well tolerated and potent.