Truvada
Combo Drug
Common Name: emtricitabine and tenofovir DF
Brand Name: Truvada
Class: fixed dose combination—nucleoside/nucleotide analogs (also called nucleoside reverse transcriptase inhibitors, NRTIs, or nukes)
Standard dose: One tablet (300 mg Viread and 200 mg Emtriva) once a day, with or without food, and no food restrictions. Dosing frequency needs to be adjusted for people with decreased kidney function. Take missed dose as soon as possible, unless it is almost time for your next dose. Do not double up on your next dose.
AWP: $1,118 / month
Manufacturer contact: Gilead Sciences, Inc.
www.gilead.com, 1 (800) GILEAD5 (445–3235)
Potential side effects and toxicity: See the drugs contained in Truvada—Viread and Emtriva. Overall, fairly well tolerated, however, individuals may experience nausea, headache, dizziness, diarrhea, rash, vomiting, abdominal distension/pain, and gas. Skin discoloration may also occur.
Potential drug interactions: See the drugs contained in Truvada—Viread and Emtriva. Do not take with Emtriva, Viread, Atripla, Epivir, Epivir-HBV, Combivir, Epzicom, or Trizivir, since all or part of these medications are already in Truvada or have equivalent medications. The levels of Videx EC and Videx (didanosine, ddI) are increased by 44–60% when taken at the same time as Viread, which is in Truvada. Therefore, a dose reduction to 250 mg for Videx EC is recommended for people who weigh more than 132 pounds and 200 mg for those who weigh less than this. Higher Videx (ddI) concentrations could increase the risk of ddI-associated adverse events, including neuropathy. See tips. Viread decreases the concentration levels of Reyataz. In addition, Reyataz and Kaletra increase Viread concentrations. The reason for these interactions is unknown. The FDA suggests that patients receiving Reyataz and Truvada should be monitored for Truvada-associated adverse events. When taken with Truvada, it is recommended that Reyataz 300 mg is taken with Norvir 100 mg (all as a single daily dose with food). Reyataz without Norvir should not be taken with Truvada.
Tips: Remember, Truvada is two medicines in one pill, so see the pages for those medications, Emtriva and Viread. Currently, U.S. DHHS HIV treatment guidelines recommend Truvada over Epzicom as the only preferred medication for the NRTI component of an HIV regimen. With publication last year of results from study of 2,000 participants, ACTG 5202, Truvada has won the battle against its main competitor, Epzicom. The study team reported that while both medications reduced viral load, for those people who started treatment with a viral load of more than 100,000, Epzicom was “significantly less effective at controlling HIV” in the regimens tested. Moreover, time to a serious adverse event was sooner in the people taking Epzicom. Remember, however, that Truvada has its own side effect and drug interaction issues, although it’s famed for its tolerability. 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. Truvada combines with Sustiva to form Atripla, a very popular HIV regimen. Now there’s another triple regimen in one pill in the works. Last year Gilead announced an agreement to combine Truvada with another non-nucleoside (the same drug class as Sustiva), the experimental TMC 278 (rilpivirine) from Tibotec Therapeutics, maker of Prezista and Intelence. Please see package insert for more complete potential side effects and interactions.
Doctor
Truvada (fixed dose tenofovir/emtricitabine) was approved for once-daily dosing in the treatment of HIV infection in 2004. This fixed dose combination is at the top of the list in all HIV treatment guidelines and is among the most commonly used treatments. Both of these antivirals are active against both HIV and the hep B virus, making this drug an important choice in co-infected patients. FTC or emtricitabine is a drug with few issues and these details are reviewed in that drug’s summary. While this drug combination is uniformly recommended for an initial treatment regimen, there are a few issues to be aware of with the use of tenofovir. As tenofovir is cleared by the kidneys, it is important when starting on this drug to have regular monitoring of kidney function with standard lab tests—about 1 or 2% of people starting tenofovir experience important declines in kidney function that are reversed when promptly stopping this drug. Also, in someone with markedly reduced renal function, Truvada must be dose reduced. In addition, when tenofovir is used with Reyataz, Norvir must be added to the HAART regimen to compensate for the effect that tenofovir has on lowering blood levels of Reyataz. Finally, there is a 1% difference of more bone loss in some, but not all, measures during the first year on tenofovir versus what’s seen with some other antivirals—after one year this difference stabilizes. The clinical relevance of this 1% difference is still not clear. —Cal Cohen, MD
Activist
The most popular fixed dose combination in use now, this combination of Viread and Emtriva has proven durable and long-lasting—earning it a place on the treatment guidelines preferred regimen backbones. And like the other combos, combining the drugs extends their patent life for the company—an added incentive beyond the convenience of single-pill dosing for patients. The same caveats about possible kidney toxicities and hepatitis B apply because of its Viread component. —Jeff Taylor
