Table 1

Study characteristics of comparative studies for tenofovir-containing regimens in pregnant women

Authors, year	Design	Study period	Setting	Population	Sample size	Mother age*	Comparison
Pregnant women living with HIV
Campbell, 201235	RCT	2005–2007	Brazil, Haiti, India, Malawi, Peru, South Africa, Thailand, USA, Zimbabwe	Antiretroviral-naïve, non-pregnant adults, CD4 <350 cells/μL, continued ART if pregnant	42 births	34	TDF/FTC/efavirenz versus AZT/3TC/efavirenz
Fowler et al, 2016 (PROMISE)12	RCT	2012–2014	India, Malawi, South Africa, Tanzania, Uganda, Zambia, Zimbabwe	HIV-positive women, ≥14 weeks’ gestation, CD4 ≥350 cells/mm³, 3490	694	Median 26 (IQR 22–30)	TDF/FTC/LPV/r versus AZT/3TC/LPV/r
Gibb, 201239	Obs	2003–2009	Uganda, Zimbabwe	Infants born to HIV-positive mothers on combination ART	173	NR	TDF/AZT/3TC versus ABC/AZT/3TC or NVP/AZT/3TC
Rough et al, 2017 (abstract)40	Obs	2002–2016	USA	HIV-positive women with birth outcome information in a database	1082	NR	TDF/FTC/LPV/r versus AZT/3TC/LPV/r
Wang, 201634	RCT	2012–2015	China	HIV-positive women, antiretroviral-naïve, 14–28 weeks’ gestation, hepatitis B coinfection	31	Mean 28.5 (range 19–39)	TDF/3TC/LPV/r versus AZT/3TC/LPV/r
Zash et al, 2017 (abstract)41	Obs	2014–2016	Botswana	Births >24 weeks’ gestational age to HIV-positive women in maternity wards	2584	34 (IQR 30–38)	TDF/FTC/NVP versus AZT/3TC/NVP and TDF/FTC/LPV/r versus AZT/3TC/LPV/r
At risk but HIV-negative women receiving tenofovir/FTC for PrEP and become pregnant
Mugo et al, 201415	RCT	2008–2013	Kenya, Uganda	HIV serodiscordant heterosexual couples	1785	33 (28–38)	TDF versus TDF/FTC versus placebo (discontinued when pregnancy detected)
Van Damme et al, 2012*37	RCT	2009–2011	Kenya, South Africa, Tanzania	Women at risk of for HIV acquisition	2120	Mean 24.2	TDF/FTC versus placebo (discontinued when pregnancy detected)
Bunge et al, 2015 (abstract)*36	RCT	2009–2011	South Africa, Uganda, Zimbabwe	HIV-negative women using contraceptives	428	Median 23 (IQR 21–27)	TDF versus TDF/FTC versus placebo (discontinued when pregnancy confirmed)
Women living with hepatitis B but not HIV
Pan et al, 201638	RCT	2012–2013	China	Women with active hepatitis B virus infection	197	Mean 27.1	TDF versus placebo From 32 weeks

*Excluded post hoc because of very low medication adherence.
3TC, lamivudine; ABC, abacavir; AZT, zidovudine, FTC, emtricitabine; LPV/r, lopinavir boosted with ritonavir; NR, not reprted; NVP, nevirapine; Obs, observational study; PrEP, pre-exposure prophylaxis; PROMISE, Promoting Maternal and Infant Survival Everywhere; RCT, randomised controlled trial; TDF, tenofovir.