Primary Care Corner with Geoffrey Modest MD: New 1st line antiretroviral recs

DHHS panel on antiretrovirals came out with an upate on initial ART recommendations for adults and adolescents (see http://aidsinfo.nih.gov/contentfiles/upload/AdultARV_INSTIRecommendations.pdf).   these new recommendations are based on 144-week data showing that the combo pill of tenofovir/FTC/elvitegravir/cobicistat was non-inferior to atripla, and 3 studies finding that dolutegravir-based regimens (dolutegravir vs raltegravir, both with abacavir/3TC; dolutegravir plus abacavir/3TC vs atripla; dolutegravir vs ritonivir-boosted darunavir, with either abacavir/3TC or truvada) showed non-inferiority overall, and the dolutegravir regimens actually did better than darunavir and efavirenz based regimens because of more discontinuations of the latter because of adverse events. in brief, the following 4 INSTI (integrase strand transfer inhibitor)-based regimens are now recommended as first-line:

 

–raltegravir 400mg bid plus tenofivir 300/emtricitabine 200 (truvada) daily – this one was approved in last recommendations

–elvitegravir 550/cobicistat 150/ tenofovir 300/emtricitabine 200 daily (one pill)

–dolutegravir 50, abacavir 600/ lamivudine 300 daily (only if HLA B*5701 negative) –(2pills)

–dolutegravir 50 plus truvada once daily –(2pills)

 

these regimens are in addition to prior approved regimens of tenofivir/ FTC (truvada) in combination with either efavirenz, atazanavir/ritonivir, or darunavir/ritonivir

 

dolutegravir can be given once daily with or without food. really well-tolerated, with only adverse reactions of moderate to severe intensity being insomnia (3%) and headache (2%).  but, it does decrease tubular secretion of creatinine without affecting glomerular function, so can see increase of creat by 0.11 on average, but no drug-related renal adverse events (ie, the increase in creat is not clinically significant.  my only caution is that tenofovir is pretty nephrotoxic, so important to follow renal function to make sure creatinine plateaus out and doesn’t keep increasing.  also, several of the meds (eg, tenofovir, FTC, 3TC) need renal dosing if CrCl<50.  dolutegravir (as opposed to raltegravir) has low incidence of drug resistance. seems like a really good drug, but (not to shock you too much) ain’t cheap: $1400/month.

 

geoff

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