Complera - HIV Antiretroviral Drug Information

Fixed Dose Combination Drugs Offers Once-Daily, Single-Pill Therapy

Photo courtesy Gilead Sciences

Classification

Complera  is a single-tablet, fixed dose combination drug used in the treatment of HIV, which is comprised of three different antiretroviral agents:

Complera was approved by the U.S. Food and Drug Administration (FDA) on August 10, 2011 for use in both adults and children over the age of 12 who have never been on HIV therapy, who have a viral load of 100,000 cells/m or under, and weigh 77 pounds (35kg) or more.

Complera can also be used to replace a current therapy if the patient has had an undetectable viral load (<50 cells/mL) for at least six months, has no history of treatment failure, and has no known resistance to any of the component drugs in Complera.

Formulation

Complera is a pink, capsule-shaped, film-coated tablet, comprised of 25mg of rilpivirine, 200mg of emtricitabine and 300mg of TDF. It is embossed with "GSI" on one side and is plain on the other.

Dosage

One tablet daily taken with food. Complera should not be taken with any other antiretroviral drug used to treat HIV.

Side Effects

A number of drug side effects have been noted in clinical trial patients taking Complera, the most common of which were:

  • Nausea
  • Headache
  • Insomnia
  • Depression

Side effects were generally transient, with few patients discontinuing as a result of treatment intolerance.

Contraindications

Complera should not be taken with the following drugs or supplements:

  • Anti-convulsive medication: Tegretol, Trilepta, phenobarbital, phenytoin
  • Anti-tuberculosis medication: Mycobutin, Rifater, Rifamate, Rimactane, Rifadin, Priftin
  • Proton pump inhibitors (PPIs): Nexium, Kapidex, Dexilant, Prevacid, Losec, Prilosec, Protonix, Aciphex or any other PPI
  • Steroid medication: dexamethasone (although it may be administered in a single dose if medically indicated)
  • St. John's Wort

Always inform your doctor of any drug or supplement, prescribed or non-prescribed, that you may be taking before starting any antiretroviral therapy.

Other Considerations

Complera is not recommended for patients with kidney impairment (defined as having an estimated creatinine clearance of less than 30mL per minute). Please advise your doctor if you have been or are being treated for any kidney disorder by another physician.

Complera is not recommended for patients with liver impairment or for those with chronic hepatitis B (HBV) infection as it can severely exacerbate liver problems. It is advised that persons with HIV be screened for HBV before prescribing Complera. Please advise your doctor if you have any liver problems and/or a history of hepatitis.

The rilpivirine component of Complera may cause a hypersensitivity reaction in a small number of patients, often in the form of a rash, eye inflammation ("pink eye"), facial swelling, fever, or other allergic responses. Typically, hypersensitivity reactions present 1-6 weeks after the commencement of therapy.

Advise your doctor immediately of any such symptoms appears. In severe cases, therapy will likely need to be discontinued.

Treatment Update

A newer formulation of Complera was approved by the FDA on March 1, 2016, marketed under the name Odefsey. This newer formulation replaces the TDF component with a drug called tenofovir alafenamide (TAF), the latter of which is classified as a pro-drug.

Unlike TDF, TAF has no active drug but rather uses the body's own metabolism to convert it into its active form. As such, the drug is delivered more effectively to cells at far lower doses, as well as with far lower drug toxicity (particularly in regards to kidney impairment associated with TDF use).

Sources:

U.S. Food and Drug Administration (FDA_. "Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination." Silver Srping, Maryland; issued August 10, 2011.

Gilead Sciences. "Complera - Highlights of Prescribing Information." Foster City, California; accessed March 18, 2016.

Reuters. "BRIEF - Gilead Sciences Says U.S. FDA Approves Odefsey" Released March 1, 2015.

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