Taken literally, these guidelines would support a regimen of ABC\/3TC and twice-daily DRV\/r for a pregnant woman — something we’d never prescribe a non pregnant treatment-naive patient for several obvious reasons.<\/p>\n Additionally, there is only one integrase inhibitor-based regimen — TDF\/FTC, raltegravir — while INSTI-based regimens dominate the general recommendations for HIV treatment. There just aren’t enough data yet on the use dolutegravir in pregnancy, though we did see some encouraging information<\/a> during the IAS meeting this summer. And information on tenofovir alafenamide are scant.<\/p>\n Now, potentially making HIV treatment during pregnancy even more<\/em> divergent from standard-of-care, non-pregnancy treatment, comes a surprising new set of recommendations from the British Medical Journal. <\/em><\/a><\/p>\n Entitled\u00a0Antiretroviral therapy in pregnant women living with HIV: a clinical practice guideline,\u00a0<\/em>the paper recommends using zidovudine\/lamivudine over tenofovir DF\/emtricitabine during pregnancy:<\/p>\n Here’s their stated reason for this surprising recommendation:<\/p>\n Tenofovir and emtricitabine probably increase the risk of early neonatal death and preterm delivery <34 weeks compared with zidovudine and lamivudine; this is more certain when they are combined with lopinavir\/ritonavir.<\/p><\/blockquote>\n Importantly, most of the data they cite in support of this recommendation come from the PROMISE study<\/a>, which did show higher rates of very preterm delivery before 34 weeks and early infant death with TDF\/FTC compared with ZDV (a.k.a. AZT)\/3TC. But an important caveat is that the drugs were given with LPV\/r at high dose, a regimen we rarely use today, and which substantially increases tenofovir levels.<\/p>\n The authors of the PROMISE study themselves responded to the BMJ\u00a0<\/em>piece, stating that they do not agree with the recommendation to use ZDV\/3TC over TDF\/FTC for several reasons. While I encourage people interested in this topic to read their full comment, they cite\u00a0important observational data on the use of TDF\/FTC\/EFV:<\/a><\/p>\n Compared with a regimen of TDF-emtricitabine (FTC)-EFV, all other regimens, including AZT-based ART, were associated with higher risk of adverse outcome; increased risk of preterm birth, very preterm birth and neonatal death were observed for infants exposed to AZT-lamivudine (3TC)-lopinavir-ritonavir.<\/p><\/blockquote>\n Plus, we can add to these reassuring data a new paper<\/a>, just published in the Journal of Infectious Diseases.\u00a0<\/em>In a prospective evaluation of 422 pregnancies, the researchers found that TDF was not associated with adverse perinatal outcomes, and that preterm birth occurred less frequently among pregnancies exposed to TDF.<\/p>\n My take? We know from thirty years<\/em> (yep, it’s been that long) of experience that ZDV has considerable toxicity — subjective side effects such as nausea and headache, and additional problems related to mitochondrial toxicity, including bone marrow suppression, lipoatrophy, and lactic acidosis.<\/p>\n As a result, it’s very hard to imagine prescribing zidovudine again under any circumstances, including during pregnancy. Today, the most commonly used initial regimen at our hospital during pregnancy is TDF\/FTC and raltegravir; if patients are on a successful treatment and become pregnant, we generally continue that, almost regardless of what it is.<\/p>\n And we eagerly await the results of a\u00a0three-arm study in pregnant women<\/a>, led by my colleague Shahin Lockman, which is just getting started. It compares TAF\/FTC plus dolutegravir, TDF\/FTC plus dolutegravir, and TDF\/FTC\/EFV.<\/p>\n This, we hope, will move treatment of pregnant women with HIV closer to the treatment we offer non-pregnant adults.<\/p>\n <\/p>\n![\"\"](\"https:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2017\/10\/Table_6__What_to_Start__Initial_Combination_Regimens_for_Antiretroviral-Naive_Pregnant_Women___Perinatal___AIDSinfo.jpg\")
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