| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Bagkeris, 2015 |
Ukraine 2000 - 2012 |
Liveborn singleton babies of women with a diagnosis of HIV infection before or during pregnancy (including intrapartum) who deliver liveborn babies at seven sites. | Exposure to Tenofovir-based regimens during pregnancy (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Exposure to zidovudine or lamivudine-based regimens during pregnancy (unspecified regimens). |
124 / 2204 | Starting ART: mostly during second or third trimester of pregnancy (95%). |
| Bérard (Controls exposed to other ARV), 2017 |
Canada 1998 - 2015 |
All singleton liveborn of women between 15 and 45 years of age on the first day of gestation, continuously insured by the RAMQ drug plan for at least 6 months before the first day of gestation and during pregnancy, in the province of Quebec. | Pregnant women with prescription fillings of Tenofovir-based regimens during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women with prescription fillings of non-Tenofovir-based regimens during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
53 / 145 | Addition of cases of malformations of all regimens including Tenofovir versus all other regimens (TableS6). |
| Bérard (Controls unexposed, disease free), 2017 |
Canada 1998 - 2015 |
All singleton liveborn of women between 15 and 45 years of age on the first day of gestation, continuously insured by the RAMQ drug plan for at least 6 months before the first day of gestation and during pregnancy, in the province of Quebec. | Pregnant women with prescription fillings of Tenofovir-based regimens during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnancies without antiretroviral exposure during the first trimester. |
53 / 214042 | Among the 214 042 pregnancies unexposed to antiretrovirals during the first trimester, 169 pregnancies were HIV positive (99,9%). |
| Bérard (Controls unexposed, sick), 2017 |
Canada 1998 - 2015 |
All singleton liveborn of women between 15 and 45 years of age on the first day of gestation, continuously insured by the RAMQ drug plan for at least 6 months before the first day of gestation and during pregnancy, in the province of Quebec. | Pregnant women with prescription fillings of Tenofovir-based regimens during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant HIV positive women without antiretroviral exposure during the first trimester. |
53 / 169 | |
| Brogly, 2010 |
USA 1993 - 2000 |
Children born to HIV-infected women. | Live-born children exposed to Tenofovir during the 1st trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Live-born children unexposed to Tenofovir during the 1st trimester (included ARV unexposed children, children exposed to ARV in labor only, children unexposed to Tenofovir but to other ARV, and children exposed to Tenofovir in the 2nd and/or 3rd trimester only). |
45 / 1988 | |
| Calitri, 2014 |
Italy 2001 - 2012 |
Pregnancy in women with perinatally acquired HIV-1 infection enrolled over the years in the Italian Register for HIV Infection in Children. | Pregnancies in women that received Tenofovir-based regimens during pregnancy. |
exposed to other treatment, sick
Pregnancies in women that received non-Tenofovir-based regimens during pregnancy. |
12 / 14 | |
| Caniglia, 2018 |
Botswana 2004 - 2015 |
HIV-positive women who delivered at one of the selected hospitals at ≥24 weeks gestation. | Pregnant women with pre-conception initiation of tenofovir, emtricitabine, efavirenz (TDF/FTC/EFV) (historical comparison). |
exposed to other treatment, sick
Pregnant women with pre-conception initiation of zidovudine, lamivudine, nevirapine (ZDV/3TC/NVP) (historical comparison). |
1108 / 637 | Data reported for historical comparison ("The risks of adverse birth outcomes were similar in the contemporaneous comparison and the historical comparison.") |
| Celen, 2013 |
Turkey 2010 - 2012 |
Pregnant women, who were diagnosed with HBeAg-positive chronic hepatitis B before 12 wk of gestation between. | Pregnant women with active hepatitis B infection treated with Tenofovir 300 mg orally once a day from week 18 to 27 of gestation. |
unexposed, sick
Untreated pregnant women with active hepatitis B infection. |
21 / 24 | Maternal outcomes (Elevated creatinine kinase, Spontaneous abortion, VaginitisArrhythmia Anemia Proteinuria) not reported because most of them occurred before treatment. |
| Chang, 2019 |
Taiwan 2011 - 2016 |
Chronic HBV‐infected pregnant women aged 20‐40 years | Pregnant women that received an oral dose of 300 mg of tenofovir disoproxil fumarate daily starting at 30‐32 weeks of gestation and continuing until post‐partum week 4. |
unexposed, sick
Pregnant women that did not receive any anti‐viral therapy. |
110 / 91 | |
| Chen, 2015 |
Taiwan 2011 - 2013 |
Chronic HBV-infected pregnant women 20-40 years of age. | Pregnant women who received Tenofovir 300 mg once daily initiated from gestational week 30-32 until 1 month following delivery. |
unexposed, sick
Pregnant women who did not receive antiviral therapy. |
62 / 56 | For 2 outcomes (preterm and caesarean section), data were updated by Chang 2019 and thus not reported here. |
| Chetty, 2018 |
South Africa 2010 - 2015 |
Singleton live births of HIV-infected pregnant women attending any one of the 17 antenatal clinics in the Hlabisa HIV Treatment and Care Programme. | Singleton live births exposed to Tenofovir-(lamivudine (3TC)/emtricitabine(FTC))-efavirenz (EFV) initiated in pregnancy (TDF-3TC-EFV (30.5%); TDF-FTC-EFV (69.6%)). |
exposed to other treatment, sick
Singleton live births exposed to Zidovudine (ZDV) initiated in pregnancy |
959 / 528 | Preconception and post-conception ARV initiation were studied by authors. Only post-conception ARV initiation was reported here (more exposed pregnancies). |
| Chi, 2007 |
Zambia 2005 - 2007 |
HIV-infected pregnant women who sought care at two public-sector primary health facilities. | Pregnant women assigned to receive in labour a single oral dose of 300 mg tenofovir disoproxil fumarate with 200 mg emtricitabine under direct observation. |
unexposed, sick
Pregnant women assigned to receive any intervention above the standard of care. |
200 / 199 | |
| Colbers, 2015 |
Europe 2010 - 2013 |
HIV-infected, pregnant, at least 18 years of age at screening and treated with a cART regimen containing ATV for at least 2 weeks before the day of first PK curve evaluation (in the third trimester of pregnancy). | Pregnant patients on ritonavir-boosted atazanavir (ATV/r) 300/ 100 mg with Tenofovir (and other nucleoside reverse transcriptase inhibitors (NRTIs)). |
exposed to other treatment, sick
Pregnant patients on ritonavir-boosted atazanavir (ATV/r) 300/ 100 mg without Tenofovir (and other nucleoside reverse transcriptase inhibitors (NRTIs)). |
19 / 10 | Other NRTIs taken were: emtricitabine (n=20), lamivudine (n=10), zidovudine (n=6) and abacavir (n=4). One patient also used raltegravir. One patient started cART in the 2nd trimester, the others were on cART at conception. |
| Crain, 2011 |
USA including Puerto Rico 2007 - 2009 |
All subjects enrolled in SMARTT with at least one point of care (POC) lactate measurement reported as of October 1, 2009. | Children born to HIV-infected women receiving Tenofovir-based regimens during pregnancy (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children born to HIV-infected women receiving non-Tenofovir-based regimens during pregnancy (unspecified regimens). |
299 / 1273 | |
| Dadabhai, 2019 |
Malawi 2016 - 2017 |
Healthy HIV-infected women on antiretroviral treatment (ART) and HIV-uninfected women, enrolled at delivery. | Pregnant HIV-infected women on Tenofovir, lamivudine and efavirenz. |
unexposed, disease free
Pregnant HIV-uninfected women. |
614 / 685 | |
| Ejigu, 2019 |
Ethiopia 2010 - 2016 |
Antiretroviral treatment (ART)-exposed pregnancies to HIV-infected women attending prenatal care follow-up. | Singleton pregnancies exposed to Tenofovir (TDF)-based highly active antiretroviral therapy (HAART) (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Singleton pregnancies exposed to Zidovudine (ZDV)-based highly active antiretroviral therapy (HAART) regimens (unspecified regimens). |
1004 / 379 | |
| Favarato, 2019 |
The United Kingdom and Ireland. 2007 - 2015 |
Pregnancies in women diagnosed with HIV and their children seen for care in the United Kingdom and Ireland. | Pregnant women exposed to Tenofovir-based regimens during pregnancy. (Addition of all ARV-regimens including Tenofovir). |
exposed to other treatment, sick
Pregnant women exposed to non-Tenofovir-based regimens during pregnancy. (Addition of all ARV-regimens non including Tenofovir). |
3115 / 3837 | |
| Floridia, 2013 |
Italy 2001 - 2011 |
Pregnant women with HIV exposed to antiretroviral treatment at any time during pregnancy. | Pregnancies with first-trimester exposure to Tenofovir-based ART (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies unexposed to antiretroviral treatment during the first trimester. |
173 / 561 | |
| Floridia, 2018 |
Italy 2001 - 2017 |
Pregnant women with HIV who started treatment before gestation week 26. | Pregnant women exposed to tenofovir–emtricitabine (TDF/FTC)-based regimens. |
exposed to other treatment, sick
Pregnant women exposed to Abacavir–lamivudine-based (ABC/3TC)-based regimens. |
661 / 252 | |
| Fowler, 2016 |
India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. 2011 - 2014 |
HIV-infected women at 14 or more weeks of gestation with CD4 counts of at least 350 cells per cubic millimeter. | Pregnant HIV-infected women assigned to tenofovir-based ART (tenofovir, emtricitabine, and lopinavir–ritonavir). |
exposed to other treatment, sick
Pregnant HIV-infected women assigned to zidovudine-based ART (zidovudine, lamivudine, and lopinavir–ritonavir). |
406 / 410 | For TDF-based-ART vs ZDV-based ART, we reported data available for the period 2 only (as made by the authors). |
| Gibb, 2012 |
Uganda, Zimbabwe. 2004 - 2009 |
Pregnancies in antiretroviral-naive HIV-infected women aged <45 years with CD4 cell counts, 200 cells/mm3. | Infants with in utero exposure of tenofovir ≥90% days from the estimated start to end of pregnancy. (111 in subtudy: 94 TDF/zidovudine/lamivudine; 11 TDF/stavudine/lamivudine-based; 1 TDF/ lopinavir/ritonavir-based; 5 other TDF based). |
exposed to other treatment, sick
Infants without in utero exposure of tenofovir (62 in subtudy: 49 zidovudine/lamivudine-based; 2 stavudine/lamivudine-based; 3 lopinavir/ritonavir-based; 1 lamivudine/abacavir/nevirapine; 7 other non–TDF based). |
251 / 115 | |
| Greenup (Controls exposed to lamivudine), 2014 |
Australia 2007 - ? |
Pregnant women with chronic Hepatitis B Virus (HBV) and high viral load (VL) (>7 log /- 0.5 IU/mL) in the second trimester were recruited. | Pregnancies exposed to Tenofovir for at least two weeks (after the 2nd trimester). |
exposed to other treatment, sick
Pregnancies exposed to Lamivudine for at least two weeks (after the 2nd trimester). |
58 / 52 | |
| Greenup (Controls unexposed, sick), 2014 |
Australia 2007 - ? |
Pregnant women with chronic Hepatitis B Virus (HBV) and high viral load (VL) (>7 log /- 0.5 IU/mL) in the second trimester were recruited. | Pregnancies exposed to Tenofovir for at least two weeks (after the 2nd trimester). |
unexposed, sick
Pregnancies in mothers who chose not to take antiviral therapy. |
58 / 20 | |
| Heffron, 2018 |
Kenya and Uganda 2008 - 2016 |
HIV-negative women who became pregnant while using pre-exposure prophylaxis (PrEP) (for high risk HIV serodiscordant couples). | Pregnancies in women who choose to continue tenofovir-based pre-exposure prophylaxis (PrEP) during pregnancy. |
unexposed, sick
Pregnancies in women unexposed to pre-exposure prophylaxis (PrEP) during pregnancy (placebo arm). |
30 / 96 | |
| Jourdain a, 2018 |
Thailand 2013 - 2015 |
Hepatitis B e antigen (HBeAg)–positive pregnant women with an alanine amino- transferase level of 60 IU or less per liter enrolled at 28 weeks of gestational age. | Participants randomly assigned to receive 300 mg of Tenofovir dministered once daily from 28 weeks of gestation to 2 months post partum. |
unexposed, sick
Participants randomly assigned to receive matching placebo dministered once daily from 28 weeks of gestation to 2 months post partum. |
168 / 163 | |
| Knapp, 2012 |
International 2002 - 2007 |
Live-born children born to HIV-infected ≥ 13 years of age enrolled after the 8th week of pregnancy up to 14 days following delivery. | Children exposed in utero to Tenofovir-based antiretroviral (unspecified regimens) in 1st trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed in utero to non-Tenofovir-based antiretroviral (unspecified regimens). |
138 / 876 | Tenofovir-based antiretroviral: 97 exposures in 2nd/3rd trimester. |
| Kolgelier, 2016 |
Turkey 2010 - 2013 |
HBsAg-positive pregnant women who presented to the Infectious Diseases and Clinical Microbiology Outpatient Clinics. | Pregnant patients who began Tenofovir treatment during their pregnancy. |
exposed to other treatment, sick
Pregnant patients who began lamivudine treatment during their pregnancy. |
9 / 2 | |
| Lin, 2018 |
China 2013 - 2016 |
Pregnancies with HBsAg/HBeAg double-positive mothers with serum HBV DNA ≥ 2×106 (6.3 log10) IU/mL. | Pregnancies with Tenofovir (300 mg/day, oral) initiated at 24 weeks of gestation and continued to 4 weeks after delivery. |
unexposed, sick
Pregnancies that did not receive anti-viral treatment (routine nursing and prenatal care until the end of the study). |
59 / 52 | Abortions reported by authors occurred before treatment, thus there are not reported in Results. |
| Liu (Controls exposed to LDT), 2019 |
China 2010 - 2016 |
Chronic hepatitis B infected pregnant women with HBV DNA levels > 106IU/mL and gestational age 22‐28 weeks. | Pregnant women who started on Tenofovir 300 mg daily from gestational weeks 24‐28. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women who started on Telbivudine 600 mg daily from gestational weeks 24‐28. (This is a subgroup of exposure among the whole exposed group considered in the study). |
331 / 408 | |
| Liu (Controls unexposed, sick), 2019 |
China 2010 - 2016 |
Chronic hepatitis B infected pregnant women with HBV DNA levels > 106IU/mL and gestational age 22‐28 weeks. | Pregnant women who started on Tenofovir 300 mg daily from gestational weeks 24‐28. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnant women who refused to take medication during pregnancy. |
331 / 154 | |
| Malaba, 2017 |
South Africa 2013 - 2015 |
Consecutive HIV-infected and HIV-uninfected women seeking antenatal care (ANC). | Live births of HIV-infected pregnant women that received a first-line regimen of tenofovir/emtricitabine-based regimen (with efavirenz or nevirapine). |
unexposed, disease free
Live births of HIV-uninfected pregnant women. |
1276 / 278 | In 1554 women, 82% were HIV-infected (n=1276), 92% (n=1173) of whom received a first-line regimen of tenofovir, emtricitabine and efavirenz or nevirapine. => HIV-infected women considered as exposed to tenofovir. |
| Mehta, 2019 |
South Africa 2013 - 2014 |
All deliveries at Prince Mshiyeni Memorial Hospital (PMMH). | Exposure to tenofovir-based regiments during the entire first trimester (96%TDF/emtricitabine (FTC)/EFV). |
unexposed, disease free
HIV-negative pregnancies and HIV-positive late initiation pregnancies (more than 15 weeks after LMP). |
336 / 7532 | Control group: HIV-negative pregnancies and HIV-positive late initiation pregnancies (>15 weeks after LMP) => mainly HIV negative pregnancies. TDF exposures: addition of TDF/FTC/EFV, TDF/FTC/EFV and TDF/FTC/EFV (definitive and entire first trimester). |
| Moodley (Controls exposed to other treatments), 2016 |
South Africa 2011 - 2014 |
HIV positive women with viable pregnancies delivering a neonate greater than or equal to 500 g and whose birth outcomes were recorded in the maternity register. | Pregnant women receiving a fixed dose combination of triple ARVs [Tenofovir (TDF), Emtracitabine (FTC) and Efavirenz (EFV)]. |
exposed to other treatment, sick
Pregnant women receiving a dual ARV prophylaxis [Zidovudine from 14 weeks in pregnancy and single dose Nevirapine (NVP) in labour/delivery]. |
1666 / 974 | |
| Moodley (Controls unexposed, sick), 2016 |
South Africa 2011 - 2014 |
HIV positive women with viable pregnancies delivering a neonate greater than or equal to 500 g and whose birth outcomes were recorded in the maternity register. | Pregnant women receiving a fixed dose combination of triple ARVs [Tenofovir (TDF), Emtracitabine (FTC) and Efavirenz (EFV)]. |
unexposed, sick
Pregnant women who had a reported CD4 count < 350 cells/mm3 in pregnancy and did not receive any ARV. |
1666 / 148 | |
| Mugo, 2014 |
Kenya and Uganda 2008 - 2013 |
HIV-uninfected women who became pregnant during the trial on PrEP. | Pregnancies in women receiving daily oral tenofovir disoproxil fumarate (300 mg) (Addition of before and after July 2011). |
unexposed, sick
Pregnancies in women receiving placebo. |
174 / 96 | Study medication was discontinued in the event of pregnancy for the duration of pregnancy and breastfeeding. The study team estimated that the duration of study medication exposure in the event of pregnancy would be approximately 6 weeks or less. |
| Pan, 2016 |
China 2012 - 2013 |
Pregnant women who had chronique hepatitis B virus (HBV) infection, HBeAg negative and who had an HBV DNA level higher than 200,000 IU per milliliter. | Pregnant women assigned to receive an oral dose of 300 mg of Tenofovir daily, starting from 30 to 32 weeks of gestation until postpartum week 4. |
unexposed, sick
Pregnant women assigned to receive usual care without antiviral therapy. |
92 / 88 | |
| Phiri, 2014 |
USA 1994 - 2009 |
All infants including stillbirths born to HIV-infected women enrolled in TennCare and with at least 1 prescription dispensing from 30 days before the LMP through delivery. | Infant exposed in utero to tenofovir, i.e whose mother had at least 1 prescription dispensing from 30 days before the LMP through delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infant unexposed in utero to tenofovir in the first trimester (includes non-TDF ARV (25%) or no ARV (75%)). |
28 / 778 | Total number of infants: 806, including 221 exposed to any ARV (including 28 exposed to Tenofovir-based ARV) and 585 unexposed to any ARV. Control group: 806-28=778 (including 585 unexposed to any ARV (75%) and 193 exposed to other ARVs). |
| Pintye, 2017 |
Kenya and Uganda 2008 - 2012 |
All participants members of a mutually disclosed HIV-serodiscordant couple, ≥18 years old, and not using PrEP or ART at enrollment. | Pregnant women exposed to any Tenofovir (TDF)-containing 3-drug antiretroviral treatment (ART) during pregnancy (mainly Tenofovir/lamivudine-based regimens). |
exposed to other treatment, sick
Pregnant women exposed to non-Tenofovir (TDF)-containing 3-drug antiretroviral treatment (ART) during pregnancy (mainly Zidovudine/lamivudine-based regimens). |
208 / 214 | Exposed group: mainly Tenofovir/lamivudine-based regimens (n=205/208; 99%). Control group: mainly Zidovudine/lamivudine-based regimens (n=186/214; 87%). |
| Pintye, 2015 |
Kenya June-Dec 2013 |
All infants with PCR-confirmed HIV-negative serostatus and complete anthropometric measurements born to HIV- positive mothers with documented use of 3-drug combination ART during pregnancy. | Mothers that used Tenofovir-containing regimens during pregnancy (mainly Tenofovir, lamivudine, and nevirapine (TDF/3TC/NVP) and tenofovir, lamivudine, and efavirenz (TDF/3TC/EFV)). |
exposed to other treatment, sick
Mothers that did not use Tenofovir-containing regimens during pregnancy (mainly zidovudine, lamivudine, and nevirapine (AZT/3TC/NVP) (78%)). |
89 / 188 | Tenofovir, lamivudine, and nevirapine (TDF/3TC/NVP) and tenofovir, lamivudine, and efavirenz (TDF/3TC/EFV) were the most common regimens among mothers who used TDF-containing ART (65% and 26%, resp.). |
| Prieto (Controls exposed to other ARVs), 2014 |
Spain 2000 - 2009 |
HIV-infected pregnant women and their infants. | Pregnancies exposed to tenofovir in first or since second or third trimester (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnancies exposed to non-tenofovir-based regimens (unspecified regimens). |
80 / 755 | |
| Prieto (Controls unexposed, sick), 2014 |
Spain 2000 - 2009 |
HIV-infected pregnant women and their infants. | Pregnancies exposed to tenofovir in first or since second or third trimester (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies not exposed to antiretroviral treatment during pregnancy. |
80 / 80 | |
| Ransom, 2013 |
USA and Puerto Rico 2002 - 2011 |
Liveborn singleton infants of HIV-infected pregnant women using a combination ARV regimen (triple ARV regimen or greater) during pregnancy, enrolled between 8-14 weeks’ gestation and 14 days postpartum. | Maternal use of a combination ARV regimen (at least triple ARV regimen) with Tenofovir. (Unspecified regimens). |
exposed to other treatment, sick
Maternal use of a combination ARV regimen (at least triple ARV regimen) without Tenofovir. (Unspecified regimens). |
630 / 1395 | Infants found to be HIV-infected were excluded. The publication of Rough 2018 updated data for Preterm birth. Thus data on preterm were not reported here. |
| Rice, 2018 |
USA including Puerto Rico 2007 - 2014 |
Pre-school perinatally HIV-exposed but uninfected (HEU) infants and children. | Pregnant women exposed to a Tenofovir-combination ARV (cARV) (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women exposed to a non-Tenofovir-combination ARV (cARV) or a triple nucleoside/nucleotide analog reverse transcriptase inhibitor (NRTI) regimen (unspecified regimens). |
-9 / -9 | Classified as 'cohort' because Static Cohort was a retrospective cohort and the Dynamic Cohort was a prospective cohort. |
| Rice, 2013 |
USA including Puerto Rico 2007 - 2011 |
Infants HIV-exposed but uninfected (HEU). | Children with in utero Tenofovir-based regimens (unspecified regimens) exposure at any time during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children with in utero non-Tenofovir-combination antiretroviral (cARV) regimens (unspecified regimens) exposure at any time during pregnancy. |
-9 / -9 | Classified as 'cohort' because Static Cohort was a retrospective cohort and the Dynamic Cohort was a prospective cohort. |
| Rough, 2018 |
USA including Puerto Rico 2007-2016; 2002-2013 |
All the infants with an observed birth outcome in the SMARTT or P1025 study, when the first ART regimen that their mothers used during pregnancy was one of the three being investigated. | Infants with in utero exposure to tenofovir, emtricitabine and any protease inhibitor (TDF–FTC–ATV/r or TDF–FTC–LPV/r). |
exposed to other treatment, sick
Infants with in utero exposure to zidovudine, lamivudine and any protease inhibitor (ZDV–3TC–based). |
960 / 1593 | Supplemental Table S3 and S4. |
| Samadi Kochaksaraei, 2016 |
Canada, 2011 - 2014 |
Pregnant women with CHB were prospectively recruited from a tertiary referral centre | Pregnancies in Tenofovir-treated women with chronic hepatitis B (CHB). |
unexposed, sick
Pregnancies in untreated women with chronic hepatitis B (CHB). |
23 / 146 | "Most women were seen in the 2nd trimester and at 3–6 months post-partum." |
| Seidel, 2020 |
Germany 2008 - 2013 |
HIV-pregnant women exposed at least 28 days to a combination of antiretroviral therapy during pregnancy. | HIV-pregnant women who received combination antiretroviral therapy (cART) with Tenofovir (unspecified regimens). |
exposed to other treatment, sick
Pregnant women who received combination antiretroviral therapy (cART) without Tenofovir (mainly with zidovudine). |
106 / 126 | |
| Seo, 2018 |
Korea 2011 - 2015 |
Pregnant women with chronic hepatitis B virus (CHB). | Pregnant women with tenofovir administration once daily, starting from gestational week 28–34 until delivery. |
exposed to other treatment, sick
Pregnant women with telbivudine administration once daily, starting from gestational week 28–34 until delivery. |
11 / 30 | |
| Siberry, 2012 |
USA including Puerto Rico 2007 - 2010 |
HIV-infected mothers enrolled in SMARTT (in the Static Cohort and in the Dynamic Cohort). | Pregnant women receiving combination Tenofovir-based ART (unspecified regimens). |
exposed to other treatment, sick
Pregnant women receiving combination non-Tenofovir-based ART (unspecified regimens). |
449 / 1580 | The publication of Rough 2018 updated data for Low birth weight. Thus data on Low birth weight were not reported here. Classified as 'cohort' because Static Cohort was a retrospective cohort and the Dynamic Cohort was a prospective cohort. |
| Sibiude, 2014 |
France 1994 - 2010 |
All live births exposed to antiretroviral during pregnancy (around 70% of the HIV-infected women in metropolitan France). | Children exposed in utero to Tenofovir-based ART (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed to non–Tenofovir-based ART (unspecified regimens) . |
823 / 12043 | Exposed group: 823 first trimester TDF-based ART; 208 second/third trimester TDF- based ART (unspecified regimens). Two methods of classification for malformations: the higher OR are reported. |
| Sibiude, 2019 |
France 2005 - 2014 |
All pregnant women living with HIV (PWLH) delivering in the 90 participating centers. | Children exposed in utero to Tenofovir-based ART (unspecified regimens) at conception. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed to non–Tenofovir-based ART (unspecified regimens) at conception. |
1151 / -9 | TDF-based ART: 1151 treated at conception and 277 started during pregnancy. Here we reported results for the group with more exposed women, i.e women treated at conception. |
| The EPPICC study group, 2019 |
UK, Ireland, Belgium, Romania, Russia, Spain, Switzerland and Ukraine 2008 - 2014 |
HIV positive women with singleton pregnancies ending in a live birth conceived off treatment and in which a single combination antiretroviral therapy (cART) was initiated during pregnancy. | Pregnant women exposed to a combination of Tenofovir (with either lamivudine (3TC) or emtricitabine (FTC) and a third agent). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women exposed to a combination of Zidovudine (ZDV) - lamivudine (3TC) and a third agent. (This is a subgroup of exposure among the whole exposed group considered in the study). |
1122 / 5122 | UK, Ireland and Ukraine : 89% of included pregnancies. ART was startedat median 22.9 gestation weeks (IQR 18.9–25.7) and received for median 15.7 weeks by delivery (IQR 12.3–19.6). |
| Torre, 2016 |
USA including Puerto Rico ? - 2013 |
Pregnant women and their newborns enrolled from week 22 of gestation through 72 hours after birth (Dynamic Cohort). | Pregnant women exposed to Tenofovir during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Not clearly specified (use exact adjusted logistic regression). |
602 / -9 | The primary exposures of interest were in utero ARV exposure overall during pregnancy and within individual trimesters. |
| Vigano, 2011 |
Not specified. Not specified. |
HAART exposure at least in the third trimester of pregnancy, no breastfeeding and definitive exclusion of HIV infection based on ≥2 nega- tive virological tests, one of which was obtained at ≥1 month of age and one at ≥4 months of age, or 2 negative HIV antibody tests from separate specimens obtained at ≥6 months of age . | Children exposed in utero to protease-inhibitor-based HAART, including tenofovir (unspecified regimens). |
exposed to other treatment, sick
Children exposed in utero to protease-inhibitor-based HAART, not including tenofovir (unspecified regimens). |
33 / 35 | |
| Wakano (Controls exposed to lamivudine), 2018 |
Japan 2011 - 2015 |
Pregnant hepatitis B virus (HBV) asymptomatic carriers (seropositive for both the HBs and HBe antigen). | Pregnant women treated with tenofovir (300 mg daily) initiated from 22 to 32 weeks. |
exposed to other treatment, sick
Pregnant women treated with lamivudine (100 mg daily) initiated from 28 to 32 weeks. |
2 / 3 | |
| Wakano (Controls unexposed, sick), 2018 |
Japan 2011 - 2015 |
Pregnant hepatitis B virus (HBV) asymptomatic carriers (seropositive for both the HBs and HBe antigen). | Pregnant women treated with tenofovir (300 mg daily) initiated from 22 to 32 weeks. |
unexposed, sick
Pregnant women that declined the antepartum antiviral therapy. |
2 / 3 | |
| Watts, 2004 |
International 1989 - 2003 |
Pregnant women with prenatal exposures to any of the antiretroviral drugs (mainly in a context of HIV). | Pregnancies exposed to tenofovir-containing regimens (unspecified regimens). |
exposed to other treatment, sick
Pregnancies exposed to non-tenofovir-containing regimens (unspecified regimens). |
64 / 3519 | Control group: all exposed lived births (3583) excepted pregnancies exposed to tenofovir-containing regimens (19), i.e 3519. |
| Wilkinson, 2013 |
USA including Puerto Rico 2007 - 2009 |
HIV-exposed but uninfected (HEU) infants. | Pregnant women receiving combination Tenofovir-based ART (unspecified regimens). This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed in utero to non-tenofovir-based highly active antiretroviral therapy (HAART) (unspecified regimens). |
-9 / -9 | For tenofovir: the numbers of exposed and not exposed not provided. Classified as 'cohort' because Static Cohort was a retrospective cohort and the Dynamic Cohort was a prospective cohort. |
| Williams, 2015 |
USA including Puerto Rico 2007-2012;1995-2008 |
HIV-infected pregnant women and their children enrolled in the SMARTT study (in the Static Cohort and in the Dynamic Cohort). | Maternal use of Tenofovir-based ART (unspecified regimens) during the first trimester (<14 weeks gestation). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Maternal use of non-Tenofovir-based ART (unspecified regimens) during pregnancy. |
431 / 2086 | Classified as 'cohort' because Static Cohort was a retrospective cohort and the Dynamic Cohort was a prospective cohort. '162 unique children with at least one major CA and 13 children with two or more conditional but no major anomalies'. |
| Williams, 2020 |
USA including Puerto Rico 2007 - 2017 |
Infants of HIV-women enrolled in the static and dynamic cohorts. | Children exposed in utero to tenofovir-based regimens (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed in utero to non-tenofovir-based regimens (unspecified regimens). |
1219 / 1764 | "Microcephaly defined by Nellhaus criteria considered by authors as the primary outcome and results for microcephaly by SMARTT criteria included in the appendix (pp 7–8)." |
| Williams, 2016 |
USA and Puerto Rico 2007 - 2012 |
Infants born to HIV-infected women (enrolled between 22 weeks gestation and 1 week after delivery in Dynamic Cohort and between 1 and 12 years in the Static cohort). | Children exposed in utero to Tenofovir-based regimens (unspecified regimens). (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children unexposed in utero to the specific ARV drug class or drug being considered. |
-9 / -9 | Classified as 'cohort' because Static Cohort was a retrospective cohort and the Dynamic Cohort was a prospective cohort. |
| Zash, 2016 |
Botswana 2009 - 2014 |
HIV- infected women who initiated ARVs before 30 weeks and who delivered live-born or stillborn infants at the 2 largest public maternity wards in Botswana (almost 25% of all births in the country). | Pregnant women who initiated Tenofovir/Emtricitabine/Efavirenz during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnant women who initiated any other antiretroviral (ARV) during pregnancy. |
1461 / 2172 | |
| Zash (Controls exposed to other treatments), 2017 |
Botswana 2014 - 2016 |
All live births and stillbirths with a gestational age of at least 24 weeks in 8 geographically dispersed government hospitals throughout Botswana (approximately 45% of births nationwide). | Births among HIV-infected women who started 3-drug Tenofovir-based regimens from conception and did not switch or stop ART in pregnancy. (Addition of TDF/FTC/EFV and TDF/FTC/NVP and TDF/FTC/LPV-R). |
exposed to other treatment, sick
Births among HIV-infected women who started 3-drug Zidovudine-Lamivudine-based regimens after conception and did not switch or stop ART in pregnancy. (Addition of ZDV-3TC-NVP and ZDV-3TC–LPV-R). |
3463 / 1532 | |
| Zash (Controls unexposed, disease free), 2017 |
Botswana 2014 - 2016 |
All live births and stillbirths with a gestational age of at least 24 weeks in 8 geographically dispersed government hospitals throughout Botswana (approximately 45% of births nationwide). | Births among HIV-infected women who started 3-drug Tenofovir-based regimens from conception and did not switch or stop ART in pregnancy. (Addition of TDF/FTC/EFV and TDF/FTC/NVP and TDF/FTC/LPV-R). |
unexposed, disease free
Births among HIV unexposed with documentation of a negative maternal HIV test result during pregnancy. |
3463 / 34138 | Authors studied ART exposure started before conception and ART exposure started after conception. Only results on ART exposure started after conception are reported here (higher number of pregnancies). |
| Zash (Controls unexposed, sick), 2017 |
Botswana 2014 - 2016 |
All live births and stillbirths with a gestational age of at least 24 weeks in 8 geographically dispersed government hospitals throughout Botswana (approximately 45% of births nationwide). | Births among HIV-infected women who started 3-drug Tenofovir-based regimens from conception and did not switch or stop ART in pregnancy. (Addition of TDF/FTC/EFV and TDF/FTC/NVP and TDF/FTC/LPV-R). |
unexposed, sick
Births among HIV-infected women without antiretroviral therapy during pregnancy. |
3463 / 1059 | Authors studied ART exposure started before conception and ART exposure started after conception. Only results on ART exposure started after conception are reported here (higher number of pregnancies). |
| Zeng (Controls exposed to telbivudine), 2019 |
China 2013 - 2017 |
Hepatitis B virus (HBV)-positive pregnant women, 20 to 28 weeks gestation. | Pregnant patients who received tenofovir. |
exposed to other treatment, sick
Pregnant patients who received telbivudine. |
51 / 58 | |
| Zeng (Controls unexposed, sick), 2019 |
China 2013 - 2017 |
Hepatitis B virus (HBV)-positive pregnant women, 20 to 28 weeks gestation. | Pregnant patients who received tenofovir. |
unexposed, sick
Pregnant patients who received no antiviral treatment. |
51 / 36 |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|---|---|---|---|---|
| Garcia-Otero, 2016 |
Spain 2010 - 2014 |
Fetal cardiac hypertrophic phenotype (septal wall thickness > 4.5 mm that corresponds to the 95th centile reported in normal fetuses and the 75th centile of our cases) | Fetal cardiac nonhypertrophic phenotype (septal wall thickness < 4.5 mm). | -9 / -9 | The fetal cardiac hypertrophic was the only parameter studied according to the kind of treatment. This analysis was only performed among the HIV group (as a case-control design). |
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