Truvada

Nucleoside Reverse Transcriptase Inhibitor

Combo Drug

Common Name: emtricitabine and tenofovir DF

Brand Name: Truvada

Class: fixed dose combination -- nucleoside/nucleotide analogs (also called nucleoside or nucleotide reverse transcriptase inhibitors, NRTIs or nukes)

Standard dose: One tablet (300 mg Viread and 200 mg Emtriva) once a day, no food restrictions (may be taken with or without food). Dosing frequency needs to be adjusted for people with decreased kidney function. Take missed dose as soon as possible, but do not double up on your next dose.

AWP: $1,099.70 / month

Manufacturer contact: Gilead Sciences,
www.gilead.com, 1 (800) GILEAD5 (445-3235)

AIDSInfo:
1 (800) HIV-0440 (448-0440), www.aidsinfo.nih.gov

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.

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 is recommended for people who weigh more than 60 kg (132 pounds). Higher 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) increases Viread concentrations. The reasons for these interactions are not fully understood. Higher Viread concentrations could increase the risk of Viread-associated adverse events, including kidney disorders. The FDA suggests that patients receiving Reyataz and Viread should be monitored for Viread-associated adverse events. When taken with Viread, 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 Viread.

Tips: Remember, Truvada is two drugs in one pill, so see the pages for those drugs, Viread and Emtriva. Currently, U.S. HIV treatment guidelines recommend Truvada over Epzicom as the only preferred medication for the NRTI component of an HIV regimen. The combination of Viread with either Epivir or Emtriva has shown potent virologic suppression with Sustiva and was not worse than Combivir. Kidney function must be monitored before and during treatment with Truvada. And Truvada may not be a good option for patients with underlying kidney problems. 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 sales of antiretroviral agents. Truvada is the most common NRTI backbone that our clinic uses in HAART regimens. Because of Truvada's excellent tolerability profile, Combivir usage has substantially decreased. Please see tenofovir and emtricitabine for more specific comments about the component drugs in this fixed dose combination. Important issues to re-emphasize here include:

1. Using this drug in an individual with reduced kidney and/or liver function requires dose adjustment. This will necessitate stopping Truvada and taking the component drugs separately in the appropriate dose.
2. Remember there are drug interactions between tenofovir and Videx.
3. When used with Reyataz, Norvir must be added to the HAART regimen.
4. Because of the bone health issues (see tenofovir), I would be cautious with general use in young children with active growth plates.

-- Frank M. Graziano, M.D., Ph.D.

Activist

Like its fixed dosed combination predecessors Combivir and Epzicom, Truvada is a single pill combining two drugs that simplifies treatment, but appears to be less toxic. "Appears" is the operative word though -- future studies could show possible impaired kidney function and reduced bone mineral density related to the Viread component of Truvada. But, Truvada is a highly favored treatment option, both widely prescribed by docs and well tolerated by patients. Truvada is the DHHS Guidelines "preferred" dual-nuke for treatment naive patients. Overall, it is safe, it works, and is generally well tolerated. Truvada, like its Viread component, may cause gas. -- Morris Jackson

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