Complera
rilpivirine / emtricitabine / tenofovir, or RPV / FTC / TDF
STR: Single-tablet regimen | NNRTI and NRTIs
image of drug

MANUFACTURER:
Gilead Sciences, Inc. gilead.com
(800) GILEAD-5 (445–3235)

AWP:
$2,463.37 / month

Standard Dose:

One tablet (25 mg rilpivirine / 200 mg emtricitabine / 300 mg tenofovir) once daily, with a meal such as a slice of pizza; two slices of whole wheat toast with peanut butter and fresh fruit; a roast beef sandwich on a hard roll with mayo; pasta and meat sauce with salad; or tortilla with chicken, rice, and beans. Complera must be taken with a meal including some fat. Nutritional drinks, even high-calorie protein shakes or products like Ensure, are not enough for proper absorption, and do not constitute a meal. Taken with a protein shake, Edurant levels were still half of what they are with a meal.

Take 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 doses in this single-tablet regimen cannot be adjusted for people with kidney function of less than 50 mL/min—therefore, it should be used with caution in individuals with kidney problems.

Potential side effects and toxicity

See the individual drugs contained in Complera—Edurant and Truvada. Moderate to severe side effects are uncommon: insomnia, headache, and depressive disorders (depression, negative thoughts, suicidal thoughts or actions) were each seen in 2% of study participants.

Check for potential drug class side effects.

Potential drug interactions

Do not take this drug with Atripla, Combivir, Edurant, Emtriva, Epivir, Epivir-HBV, Epzicom, Hepsera, Intelence, Rescriptor, Stribild, Sustiva, Trizivir, Truvada, Viramune, or Viread, since Complera contains these medications or has equivalent medication. Tell your provider or pharmacist about all medications, herbal products, and supplements you are taking or thinking of taking, prescribed or not, as there are many other drug interactions which are not listed here. Proton pump inhibitors (PPIs, stomach acid drugs like Nexium, Prevacid, Prilosec, etc.) can’t be taken with Complera. Antacids can be taken two hours before or four hours after a Complera dose. Acid reducing drugs like Pepcid, Tagamet, and Zantac, can be taken 12 hours before or four hours after a Complera dose. Do not take Complera with Tegretol (carbamazepine), oxcarbazepine, phenobarbital, or Dilantin (phenytoin); rifampin, or Priftin; or the herb St. John’s wort (other herbs have not been studied with Complera, but use caution if planning to take any herbs). Rifabutin must be taken with an extra Edurant tablet. Do not take with more than one dose of the injectable steroid dexamethasone. Use caution if used with Diflucan, Sporanox, Nizoral, Noxafil, and Vfend. Use azithromycin when possible instead of the antibiotics clarithromycin (Biaxin), erythromycin, or Ketek, because these agents increase Edurant (rilpivirine) levels, which can increase the risk for side effects. Reduced methadone levels can be seen and while dose adjustments are not necessary, it is recommended to monitor for withdrawal. Early data shows that Complera may be taken with Incivek, Olysio, Sovaldi, and Victrelis without any dose adjustments.

More information

Complera can be difficult to take because of its food requirement and drug interactions, and so excellent adherence is critical. Moreover, the risk of virologic failure (not achieving undetectable viral load) and developing resistance and a greater number of drug resistance mutations is greater with Complera than with Atripla in people starting with viral loads greater than 100,000 copies/mL or with a CD4 count less than 200 cells/mm3. Those with a viral load of 500,000 or more in the STaR study had a greater risk of virologic failure. See Edurant for more information. Accordingly, Complera is FDA approved for people starting therapy for the first time who have viral loads of 100,000 copies/mL or less and for treatment-experienced patients with undetectable viral loads (less than 50 copies per mL) who are switching from another regimen. In the STaR study, Complera was more tolerable than Atripla and did not have the same cholesterol elevations. Nervous system and psychiatric events were the most common side effects but higher in the Atripla group. Concerns about switching from Atripla to Complera were eased when decreases in Complera levels were only seen in the first few weeks of a 12-week study (when Atripla levels were still high enough to be effective against HIV), and participants maintained their undetectable viral loads. All the drugs in Complera have long half-lives (the time it takes a drug in the body to be reduced by half), making them a great combination. Complera pills are smaller in size than Atripla. Check for hepatitis B before starting therapy (see Emtriva). Some government programs may not pay for Complera but require that patients take its components separately. Kudos to Janssen Therapeutics, developer of Edurant, and Gilead for collaborating on Complera. See package insert for more complete information on potential side effects and drug interactions.

Doctor’s comments

Complera is the second single-tablet regimen. A head-to-head comparison of Atripla and Complera is in progress, since the original Edurant studies didn’t use the single-tablet regimen. Well-tolerated Complera is a good choice for people who have trouble with Atripla, Sustiva, or boosted PIs, but be careful about switching directly from Atripla to Complera if your viral load isn’t undetectable yet. Sustiva lowers Edurant levels, and we don’t know whether early switches are safe.
—JOEL GALLANT, MD, MPH

Activist’s comments

The second single-tablet regimen to hit the market has not had quite the same launch into the stratosphere as Atripla, perhaps because once someone starts a regimen they are in no hurry to change. The calmer, nicer side effect profile of Edurant may catch on once the side effect profile of the Sustiva in Atripla gets tiresome.
—DAWN AVERITT