Women should be offered the choice to avoid treatment with tenofovir and emtricitabine during pregnancy owing to a higher risk of stillbirth and early infant death associated with these drugs, according to new recommendations published this week in the British Medical Journal (BMJ).
The authors – a panel of experts in maternal and child health, and of women living with HIV – say that women's strong preferences to avoid early infant death and have a healthy infant are not given sufficient weight in other recommendations, and that in order to reduce this risk, antiretroviral treatment during pregnancy should be based on zidovudine and lamivudine, not tenofovir and emtricitabine, especially when combined with lopinavir/ritonavir.
Women should be informed of all the potential benefits and harms of treatment options and should share in the decision-making about which drugs they should take during pregnancy, say the authors.
The recommendations recognise that guidelines that take a public health approach, such as those of the World Health Organization, will place greater emphasis on efficient use of resources, and will seek to minimise the number of different drug options used in a health system so as to simplify the delivery of treatment.
But, in an accompanying BMJ Opinion blog post, Alice Welbourn of the Salamander Trust, a long-standing activist for the rights of women living with HIV, strongly criticises the ways in which the World Health Organization and other international agencies have formulated guidance on treatment for pregnant women with HIV. In particular, she says, “Women’s intrinsic rights over our bodies should be prioritised. Women should be offered informed choices just as men are offered voluntary medical male circumcision for HIV prevention.”
In 2014 the World Health Organization adopted a policy, Option B+, which encouraged national health systems to offer antiretroviral treatment for life to all pregnant women living with HIV. In 2016, the World Health Organization recommended treatment for everyone living with HIV, regardless of CD4 cell count, preferably with a combination of tenofovir, either lamivudine or emtricitabine, and efavirenz.
The combination of zidovudine and lamivudine was recommended as an alternative option where the preferred option is contraindicated or unavailable.
Tenofovir and emtricitabine are co-formulated as part of the three-drug combinations Atripla (with efavirenz), Eviplera (with rilpivirine) and in the four-drug pill Stribild (with elvitegravir and cobicistat). Numerous generic products that contain tenofovir are also available in lower-income countries, and increasingly in Europe and the United States.
Due to lack of evidence, the guidelines panel is unable to state whether or not the findings of the systematic review apply to the new formulation of tenofovir, tenofovir alafenamide, contained in the two-drug combination pill Descovy (with emtricitabine) and in the combination pills Odefsey (with emtricitabine and rilpivirine) and Genvoya (with emtricitabine, elvitegravir and cobicistat).