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  ID Week
Oct 8-12 2014
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Switch to Complera in Clinical Practice Usually Safe and Effective
  IDWeek 2014, October 8-12, 2014, Philadelphia
Mark Mascolini
Switching from a suppressive antiretroviral regimen to Complera (rilpivirine coformulated with tenofovir/emtricitabine [TDF/FTC]) generally proved safe and effective in clinical practice, according to results of a 162-person retrospective analysis [1]. Five people had virologic failure after the switch, but 2 of them regained viral control with continued Complera.
Switching from suppressive Atripla--the once-daily single-tablet combination of efavirenz with TDF/FTC--to one-pill once-daily Complera was effective through 48 weeks in a phase 2b, open-label, multicenter study [2]. SPIRIT (http://www.natap.org/2013/ICAAC/ICAAC_50.htm), a phase 3 trial, determined that switching from a ritonavir-boosted protease inhibitor (PI) to Complera maintained virologic suppression through week 48 [3]. To determine the safety and efficacy of switching from a suppressive regimen to Complera in clinical practice, clinicians conducted this retrospective analysis [1].
The study involved HIV-positive adults at a county HIV clinic in Houston taking a stable antiretroviral regimen for at least 6 months who switched to Complera because of intolerance, side effects, or abnormal lipids, or to simplify their treatment. Everyone had a viral load below 200 copies/mL for at least 6 months, and all had pertinent lab tests approximately 6 and 24 weeks after the switch. No one had a history of resistance to nucleosides or nonnucleosides.
The 162 people eligible for analysis had a median age of 43 (interquartile range [IQR] 34 to 52). Two thirds were men, 65% white, 32% black, and 57% Hispanic. Median CD4 count measured 577 at the switch (IQR 419 to 798), and 151 people (93%) switched from their first antiretroviral regimen. Almost everyone changed to Complera from a nonnucleoside (55%) or a ritonavir-boosted PI (41%). Among people switching from a nonnucleoside, 88% were taking efavirenz. Sixty-six people stopped their current regimen because of side effects, 62 for simplification, and 47 for abnormal lipids; 29 people had multiple reasons for switching.
Sixteen people (10%) stopped Complera during the study period, including 11 who stopped by week 6 and 5 who stopped by week 24. Three people (2%) stopped because of virologic failure (viral load above 200 copies) and 13 stopped because of clinical or lab abnormalities. Seven of those 13 had a grade 3 or 4 adverse event, including liver toxicity in 3, central nervous system (CNS) side effects in 2, and acute renal failure or acute pancreatitis in 1 each. Among all adverse events, CNS problems proved the most frequent, affecting 9 people, followed by liver toxicity in 4.
Five people had a viral load above 200 copies at any time after the switch to Complera. Two dropped out of care, 2 who reported poor adherence or low calorie intake continued Complera and regained viral control, and 1 switched back to a darunavir/ritonavir regimen and regained control.
In the first 24 weeks after the switch to Complera, total cholesterol dropped an average 20 mg/dL (P < 0.0001), low-density lipoprotein cholesterol fell 8 mg/dL (P < 0.0001), high-density lipoprotein (HDL) cholesterol fell 4 mg/dL (P < 0.0001), and triglycerides dropped 34 mg/dL (P = 0.006). These changes remained consistent through week 48. The investigators did not report changes in total-to-HDL cholesterol ratio. While 31 people were taking lipid-lowering therapy at the switch, 22 were at week 24. Average Framingham cardiovascular risk score dropped from 4.57 at the switch to 4.16 after 24 weeks. Average estimated glomerular filtration rate fell from 104 mL/min at the switch to 95 mL/min at week 24, but this small decline was statistically significant (P = 0.01).
1. Monczor A, Yu X, Vigil KJ, et al. A retrospective study to evaluate the safety of switching antiretroviral therapy to rilpivirine/tenofovir disoproxil fumarate/emtricitabine STR in virologically suppressed HIV-infected patients. IDWeek 2014. October 8-12, 2014, Philadelphia. Abstract 538.
2. Mills AM, Cohen C, Dejesus E, et al. Efficacy and safety 48 weeks after switching from efavirenz to rilpivirine using emtricitabine/tenofovir disoproxil fumarate-based single-tablet regimens. HIV Clin Trials. 2013;14:216-223.
3. Fisher M, Palella F, Tebas P, et al. SPIRIT: switching to emtricitabine/rilpivirine/tenofovir DF single-tablet regimen from boosted protease inhibitor maintains HIV suppression at week 48. J Int AIDS Soc. 2012;15(Suppl 4):18275. Abstract P285. (http://www.natap.org/2013/ICAAC/ICAAC_50.htm)