Brand name: Complera

Generic name: rilpivirine/emtricitabine/tenofovir, or RPV/FTC/TDF

Class: NNRTI and NRTI -- single-tablet regimen (STR)

Manufacturer: Gilead Sciences,, (800) GILEAD-5 (445-3235)

AWP: $2,195.83/month; ADAP/Public Aid/Medicare Part D may not pay for Complera and you may need to take its individual components, Edurant and Truvada, instead (2 pills/once a day). Patient assistance is available for Complera for those without insurance; see the HIV Co-Pay and Patient Assistance Programs chart.

Standard Dose: One tablet (25 mg rilpivirine/200 mg emtricitabine/300 mg tenofovir) once daily, with a meal of at least 400 calories. Take missed dose as soon as possible but no later than 12 hours after your regularly scheduled dose. Do not double up on your next dose. Dose of this fixed combination pill 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 (rilpivirine /emtricitabine/tenofovir). Moderate to severe side effects are uncommon (2% or fewer of patients): insomnia, headache, nausea, dizziness, rash, abnormal dreams, and depressive disorders (depression, negative thoughts, suicidal thoughts or actions). See chart for potential drug class side effects.

Potential drug interactions: Do not take this drug with Atripla, Combivir, Emtriva, Epivir, Epivir-HBV, Epzicom, Edurant, Trizivir, Truvada, or Viread, since Complera contains these medications or their equivalents. Antacids can be taken two hours before or four hours after a Complera dose. H2 receptor antagonists, such as Pepcid, Tagamet, and Zantac, can be taken 12 hours before or four hours after a Complera dose. Proton pump inhibitors, such as Nexium, Prevacid, and Prilosec can't be taken with Complera. Do not take Complera with the anti-hepatitis B drug Hepsera; the anti-seizure medications carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the anti-TB drugs rifabutin, rifampin, and rifapentine; or the herb St. John's wort (other herbs have not been studied with Complera, but caution is advised if planning to take any herbs). Do not take with more than one dose of the injectable steroid dexamethasone. Clinically monitor drug levels of the antifungals Diflucan, Sporanox, Nizoral, Noxafil, and Vfend; no dose adjustments are needed. Use azithromycin when possible instead of the antibiotics Biaxin, erythromycin, and troleandomycin (Tao). These agents will increase rilpivirine levels, which can increase the risk for side effects. Methadone levels may be reduced and the dose of methadone may need to be adjusted to prevent withdrawal.

More information: Complera was approved by the FDA in 2011. It had been nicknamed "B-tripla" because it is a direct competitor to the first once-daily, single tablet, complete HIV regimen on the market, Atripla. There was a higher rate of virologic failure (inability to suppress viral load) in people with more than 100,000 viral load copies per mL compared to Atripla, and virologic failure was associated with a greater risk of drug resistance to the non-nuke class of medications than seen with Atripla. On the other hand, Complera was more tolerable than Atripla and did not have its cholesterol elevations. Rash was seen in 4.2% of the Complera group vs. 15.1% of the Atripla group. Head-to-head study is underway (complex dosing and multiple pills were used in previous research instead of the actual STR pills of Complera and Atripla). For proper absorption, it must be taken with a meal of at least 400 calories, including some fat. Nutritional drinks, even high-calorie protein shakes or products like Ensure, are not enough and do not constitute a meal. Taken with a protein shake, rilpivirine levels were still half of what they are with a meal. Meal examples include two slices of whole wheat toast with peanut butter, fresh fruit, and orange juice; a roast beef sandwich on a hard roll with mayo and cheese; or two cups of spaghetti with marinara sauce and a slice of bread. Concerns about switching from Atripla to Complera were eased when decreases in Complera levels were only seen in the first week of a 12-week study, and participants maintained their undetectable viral loads (less than 50 copies per mL). High doses (at least three pills) can lead to a risk of prolonged QT interval, which is a heart condition. While Sustiva (efavirenz) is associated with a risk of birth defects, Complera is Pregnancy Category B (found safe in animal studies). No trials in humans have been conducted, and Complera should be used in pregnancy only if the potential benefit justifies the potential risk. (Most HIV medications are Pregnancy Category B.) Rilpivirine, emtricitabine, and tenofovir all have long half-lives (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 Truvada). Kudos to Janssen Therapeutics, developer of Edurant, and Gilead for collaborating on Complera. When Bristol-Myers Squibb and Gilead worked together to combine their drugs Sustiva and Truvada into Atripla, it was an unheard of collaboration among makers of HIV drugs. How soon we forget. Today such collaborations are expected and Gilead has more of them in the works. See package insert for more complete information on potential side effects and drug interactions.

Doctor's Comments

Complera is the second single-tablet regimen. The advantages and disadvantages of Complera vs. Atripla are discussed elsewhere (see Edurant). A head-to-head comparison of the two regimens 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, M.D., M.P.H.

Activist's Comments

Complera is a one pill/once-a-day triple combo pack of Edurant (rilpivirine) with the powerhouse Truvada (emtricitabine/tenofovir). It offers the convenience of a single-tablet regimen (STR) without the downside of the other once-a-day agent Atripla. This drug has been an easy way to slide into taking daily medications for those just starting. As mentioned earlier, many experienced patients are moving to it because their side effects from Atripla persist after even four weeks. Since their viral loads are undetectable, doctors are switching them and experiencing pretty good results. So far all the folks I've talked to who have switched report greater quality of life with fewer side effects.

-- Joey Wynn

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