2011 HIV Drug guide Truvada brand name:
Truvada
emtricitabine and tenofovir DF Nucleoside/nucleotide analog reverse transcriptase inhibitor (nucleoside/nucleotide analog, NRTI, or nuke)—fixed dose combination manufacturer: Gilead Sciences, Inc. | www.gilead.com, (800) GILEAD5 (445–3235) common name: class:
Standard dose: One tablet (300 mg Viread and 200 mg Emtriva) once a day, with or without food, with no dietary 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: $1,195.15 / month
Potential side effects and toxicity See the drugs contained in Truvada—Viread (page 29) and Emtriva (page 22). Overall, fairly well tolerated, however, individuals may experience nausea, fatigue, headache, dizziness, diarrhea, depression, insomnia, abnormal dreams, rash, vomiting, abdominal distension/pain, and gas. Skin discoloration may also occur. The Viread in Truvada is associated with decreases in bone mineral density (BMD). BMD monitoring should be considered in people who have a history of pathologic bone fracture or are at risk for osteopenia or osteoporosis. Potential drug interactions See the drugs contained in Truvada—Viread (page 29) and Emtriva (page 22). Do not take with Atripla, Combivir, Emtriva, Epivir, EpivirHBV, Epzicom, rilpivirine/Truvada, Trizivir, Truvada, or Viread, 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 More Information. 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 taking 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
P o s i t i v e lyAwa r e . c o m
100 mg (all as a single daily dose with food). Reyataz without Norvir should not be taken with Truvada. More information Truvada is two medicines in one pill, so see the pages for those medications, Emtriva (page 22) and Viread (page 29). Currently, U.S. DHHS HIV treatment guidelines recommend Truvada over Epzicom as the only preferred medication for the NRTI component of an HIV regimen. Study ACTG 5202 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. After years of being used off-label (not an FDA approved use) for HIV prevention, one of the biggest HIV news reports last year was from the international iPrEx study, showing Truvada reduced rates of HIV infection in men who have sex with men (MSM) and transgender women born men who have sex with men, with a success rate between 44 and 73% (depending on adherence). Research continues in the quest for answers to several important questions, such as the development of drug resistance. Truvada combines with Sustiva to form Atripla, a very popular HIV regimen. There’s another triple regimen in one pill in the works. Gilead entered into an agreement to combine Truvada with the experimental
rilpivirine from Tibotec Therapeutics, maker of Prezista and Intelence (see rilpivirine/Truvada, page 38). Truvada is also in advanced Phase 3 study in a quadruple formula with two of Gilead’s experimental drugs: elvitegravir, an integrase inhibitor (same class as Isentress) and the drug booster cobicistat (GS-9350). Although the effect of supplementation with calcium and vitamin D has not been studied, such supplementation may be beneficial for all patients, according to the FDA. See package insert for more information on potential side effects and interactions. Doctor’s COMMENTS Truvada is now the preferred nucleoside backbone for initial regimens according to DHHS and IAS-USA guidelines, based on studies showing that it’s more effective and safer than Combivir, and more effective at high viral loads than Epzicom. When combined with Sustiva, it can be used in the form of Atripla, currently the only approved single-pill regimen, but other co-formulated pills containing tenofovir and FTC are being developed. People taking Truvada need to be monitored for kidney toxicity (see Viread, page 29), and those who already have kidney disease may need to take Truvada less frequently than once a day, or better yet, avoid it altogether. The bone issues seen with tenofovir (see Viread, page 29) also apply to Truvada. —Joel Gallant, MD, MPH ACTIVIST’S COMMENTS This combination of Gilead’s Viread and Emtriva is the most widely used combination today—thanks to its proven efficacy and durability, and relatively few side effects. It doesn’t hurt that combining two drugs extends the patent life in addition to providing dosing convenience. Its only downside is that there are no comparable alternatives for those who need to avoid the possibility of kidney toxicity and possible bone loss from the Viread component. —Jeff Taylor
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