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Complera follow up question
Oct 19, 2012

Hello Dr Young A few days ago you kindly answered my question regarding Complera compared with a Kivexa/ Isentress regimen. I have to spend a lot of time in sub Saharan Africa with work and will be taking anti Malaria tablets. I have since read that Complera interacts with anti Malaria tablets. What does this mean? Does this rule out complera for me? Also, in your answer you listed a negative with taking Kivexa as having decreased potency compared with Truvada. What do you mean by "decreased potency"? Thank you very much for your assistance and advice.

Response from Dr. Young

Hello and thanks for posting- good to hear back from you.

To clarify, there have been a couple of prominent clinical studies (but not all) that have raised the question as to whether Kivexa (Epzicom) is as potent as Truvada in persons starting treatment with high viral loads. I generally don't find this to be the only major factor in deciding which NRTI to use, but also factor in whether the person is at risk of kidney or bone toxicity from the tenofovir part of Truvada.

The US DHHS treatment guidelines offer up this language on the subject: "The ACTG 5202 study, a randomized controlled trial in more than 1,800 participants, evaluated the efficacy and safety of ABC/3TC versus TDF/FTC when used in combination with either EFV or RTV-boosted ATV. Treatment randomization was stratified on the basis of a screening HIV RNA of <100,000 copies/mL or >100,000 copies/mL. HLAB*5701 testing was not required prior to study entry, which may have influenced the results of the trial with respect to some of the safety and tolerability endpoints. A Data Safety Monitoring Board recommended early termination of the >100,000 copies/mL stratification group because of a significantly shorter time to study defined virologic failure in the ABC/3TC arm than in the TDF/FTC arm. This difference in virologic failure between arms was observed regardless of whether the third active drug was EFV or ATV/r. There was no difference between ABC/3TC and TDF/FTC in time to virologic failure for participants who had plasma HIV RNA <100,000 copies/mL at screening. TDF/FTC has a more favorable safety and tolerability profile than ABC/3TC.

In another study (HEAT), 688 participants received ABC/3TC or TDF/FTC in combination with once-daily LPV/r. A subgroup analysis according to baseline HIV RNA of <100,000 copies/mL or 100,000 copies/mL yielded similar percentages of participants with HIV RNA <50 copies/mL at 96 weeks for the two regimens (63% vs. 58% for those who had <100,000 copies/mL and 56% vs. 58% for those who had >100,000 copies/mL, respectively).71 The ASSERT study compared open label ABC/3TC with TDF/FTC in 385 HLAB*5701-negative, ART-naive patients; all study subjects also received EFV. At 48 weeks, the proportion of participants with HIV RNA <50 copies was lower among ABC/3TC-treated subjects (59%)."

As for possible drug-drug interactions, we're talking about how the presence of one medication may affect the metabolism (and blood levels of another, or multiple) medications. These interactions can increase or decrease levels; affecting potentially the effectiveness or safety of drugs. With malaria medications, much depends on which malaria prophylaxis meds you're interested in taking, but clearly a Complera regimen has a greater likelihood of having interactions than an Isentress regimen. I'd speak to your doctor or pharmacist about which malaria medications are being considered for you.

I hope that helps, BY



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