FTC/TDF emtricitabine/tenofovir disoproxil fumarate
Standard DoseOne tablet once daily without regard to food for adults and children weighing at least 77 pounds (35 kg). In children weighing 37–76 pounds (17–34 kg), Truvada is dosed based on body weight. See package insert for weight-based dosing. Truvada tablets are available in the following emtricitabine/tenofovir DF (TDF) dosages: 100/150 mg tablets, 133/200 mg tablets, 167/250 mg tablets, and 200/300 mg tablets. Tablets can dissolve 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. When used for HIV treatment, Truvada must be taken in combination with another antiretroviral(s) that does not contain the medications in this drug combination.
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 who have 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 30 mL/min (less than 60 mL/min if used for PrEP) or if you are on dialysis. Truvada was approved for HIV prevention (pre-exposure prophylaxis, or PrEP) in 2012; see “Truvada for PrEP” page.
- See the individual drugs contained in Truvada: Viread and Emtriva.
- See package insert for more complete information on potential side effects and interactions.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445–3235)
Potential Side Effects and Toxicity
Overall, Truvada is well tolerated, but some people may experience nausea, headache, bloating, 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 for 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 bone or 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. Prior to initiation, people should be tested for hepatitis B virus (HBV) infection. Severe exacerbations of hepatitis B have been reported in people co-infected with hepatitis B who have discontinued Truvada (due to elimination of both emtricitabine and TDF, which also treat HBV). Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon Truvada discontinuation. Call your health care provider right away if you develop any of the following signs or symptoms of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs. Truvada is associated with lower lipid levels than Ziagen or TAF due to TDF’s favorable effect on LDL (bad) cholesterol (although it also lowers levels of HDL, or good cholesterol). The ratio of total cholesterol to HDL remains the same as that of TAF. Truvada contains lactose, which can cause some abdominal discomfort, especially in patients sensitive to lactose. See weight discussion in the online version of this page.
Weight gain is becoming more widely recognized as a potential side effect. GO TO positivelyaware.com/articles/weighty-concerns and positivelyaware.com/articles/fatty-tissues. In the community, enlargement of the stomach and waist area can be distressing. According to DHHS HIV treatment guidelines, “Weight gain has been associated with initiation of ART [antiretroviral therapy] and subsequent viral suppression. The increase appears to be greater with INSTIs than with other drug classes. Greater weight increase has also been reported with TAF than with TDF, and greater with DOR than EFV.” Other factors have been associated with weight gain in addition to medication used, including race, sex, and previous overweight status. There is no word yet on reversibility, but the race is on to find more answers.
Potential Drug Interactions
Do not take with Cimduo or Temixys, Descovy, Emtriva, Epivir-HBV, Hepsera, Vemlidy, or Viread, all used for the treatment of hepatitis B. Tenofovir DF decreases the concentration levels of Reyataz, therefore when Reyataz is taken with Truvada or Viread, it is recommended that Reyataz 300 mg be 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 DF concentrations. It is recommended that people 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 such as Advil or Motrin (ibuprofen) and Aleve (naproxen). Truvada may be used with hepatitis C drugs Harvoni 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 interactions not listed here.
Don’t believe the lawsuit advertisers: Truvada is a safe medication to take. As with any drug therapy, some people will experience side effects. Adverse events are rare and usually reversible. See “Truvada Safety” in the September+October 2019 issue of Positively Aware (positivelyaware.com/articles/truvada-safety). 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 ACTG A5202 study reported that while both Epzicom and Truvada reduced viral load, for 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 among 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 people who have underlying kidney problems or are at higher risk for them. Fewer kidney and bone issues were observed with the TAF formulation compared to TDF in clinical trials. Truvada is approved for HIV prevention; see Truvada for PrEP page. Truvada is recommended by DHHS as one of the preferred NRTI combination components of an ART regimen in pregnancy. Truvada generic became available in the U.S. in October 2020. See discussion of the generic’s pricing in the January+February 2021 issue.
Dr. Melanie Thompson:
Coformulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) is a potent and durable backbone that can be used with all INSTIs, NNRTIs, and boosted PIs for treatment and, as a standalone, for prevention. (See Truvada for PrEP.)
Both TDF and FTC have activity against hepatitis B and stopping the drug can cause a flair of hepatitis B.
TDF can cause kidney dysfunction as well as decreases in bone density over time. This is especially of concern for older people, or people who have other conditions such as diabetes or hypertension that can affect kidney function. Likewise, it could be of concern for menopausal women in whom bone density commonly declines. However, TDF/FTC remains a good choice for younger people without a lot of other medical conditions who have good kidney function (and probably bone density) before starting TDF/FTC.
Because ritonavir and cobicistat boosters also raise blood levels of TDF, the “bystander” toxicity of TDF to kidneys and bone appear to be worse with boosters, and this should be considered for people who already have kidney or bone problems or who are at high risk.
Generic TDF/FTC is made by Teva but the cost is disappointingly high, at $48.51 per tablet. Do not ever think that generic is synonymous with inexpensive, as once was the case. Teva offers a co-pay card to offset $600/month of out-of-pocket costs.
Activist Bridgette Picou:
In recent years Truvada became better known for its use as PrEP (see Truvada for PrEP) than as part of an HIV therapy, but it is used for both. Both can affect bone health and the kidneys. You should be monitored regularly for these if you are prescribed Truvada.