Tenofovir (all routes except local)


Study Exclusion reasons Rmk Reference
Le Roux, 2017 inadequate or absent control group EXCLUDED: study performed according to duration of TDF exposure. All pregnant women exposed to TDF. No adequate control group.

M le Roux AIDS 2017; 31:97-104 10.1097/QAD.0000000000001302

Brown, 2012 inadequate or absent control group EXCLUDED: no internal comparator (comparison with prevalence of MACDP, European collaborative study, UK an Ireland database).

Brown J. Hepatol. 2012; 57:953-9 10.1016/j.jhep.2012.06.031

Santosa, 2019 inadequate or absent control group EXCLUDED: No adequate control group. Almost all women treated with TDF-based regimens and analysis according to the timing of initiation (before or during pregnancy).

Santosa AIDS 2019; 33:1623-1633 10.1097/QAD.0000000000002222

le Roux, 2019 inadequate or absent control group EXCLUDED: all pregnant women exposed to tenofovir/emtricitabine/efavirenz. No control group.

le Roux Pediatr. Infect. Dis. J. 2019; 38:70-75 10.1097/INF.0000000000002193

Hitti, 2007 inadequate or absent control group EXCLUDED: Analysis of protease inhibitor versus no protease inhibitor, with tenofovir in both groups. No adequate control group.

Hitti Am. J. Obstet. Gynecol. 2007; 196:331.e1-7 10.1016/j.ajog.2006.11.037

Jao, 2016 inadequate or absent control group EXCLUDED: all pregnant women exposed to tenofovir. No adequate control group.

Jao Clin. Infect. Dis. 2016; 62:1604-1609 10.1093/cid/ciw159

Hu, 2015 inadequate or absent control group EXCLUDED: all pregnancies exposed to tenofovir. No adequate control group.

Hu World J. Gastroenterol. 2015; 21:2504-9 10.3748/wjg.v21.i8.2504

Denneman, 2016 inadequate or absent control group EXCLUDED: all pregnant women exposed to tenofovir. No adequate control group.

Denneman AIDS 2016; 30:2135-7 10.1097/QAD.0000000000001156

Gao, 2020 inadequate or absent control group EXCLUDED: In the control group, women discontinued antiviral therapy (unspecified) before (37/43; 86%) or during first trimester (6/43; 14%) at the median gestational age of 5 weeks. No adequate control group.

Gao Int J Med Sci 2020; 17:170-175 10.7150/ijms.38410

Wang, 2015 inadequate or absent control group EXCLUDED: All pregnancies exposed to tenofovir (at different stages of pregnancy). No adequate control group.

Wang Antivir. Ther. (Lond.) 2015; 20:681-7 10.3851/IMP2981

Himes, 2015 inadequate or absent control group EXCLUDED: all pregnancies exposed to tenofovir. NO adequate control group.

Himes Pediatr. Infect. Dis. J. 2015; 34:851-7 10.1097/INF.0000000000000747

Onyango-Makumbi, 2014 not about fetal exposure EXCLUDED: not related to exposure during pregnancy (analysis of HIV infected lactating women enrolled at delivery and followed up through 9 months post partum).

Onyango-Makumbi Conference on Retroviruses and Opportunistic Infections. February 2014, Boston, MA. Abs. 850

Nguyen, 2014 not relevant study design EXCLUDED: inappropriate design: outcomes assessed according to the timing of cessation of treatment in post partum and not according to treatment received during pregnancy.

Nguyen Aliment. Pharmacol. Ther. 2014; 39:1225-34 10.1111/apt.12726

Aizire, 2020 not relevant study design EXCLUDED: analysis of severe adverse pregnancy/neonatal outcome according to TFV-DP concentrations.

Aizire J. Acquir. Immune Defic. Syndr. 2020; 83:173-180 10.1097/QAI.0000000000002247

Osorio, 2017 not relevant study design EXCLUDED: outcomes of infants receiving tenofovir during labor, post-natally or during labor and post-natally reported as a whole.

Osorio Pediatr. Infect. Dis. J. 2017; 36:184-188 10.1097/INF.0000000000001386

Callahan, 2015 not relevant outcome EXCLUDED: No specific data on the pregnancy outcomes ("Of the 115 women who became pregnant during the FEM-PrEP study with available outcome data, 30 (26.1%) reported some complications with no difference observed by study arm.").

Callahan J. Acquir. Immune Defic. Syndr. 2015; 68:196-203 10.1097/QAI.0000000000000413

Mirochnick, 2011 not relevant outcome EXCLUDED: continuous outcome (birth weight in grams). Substudy of IMPAACT P1025.

Mirochnick J. Acquir. Immune Defic. Syndr. 2011; 56:412-9 10.1097/QAI.0b013e31820fd093

Siberry, 2015 not relevant outcome EXCLUDED: continuous variables (bone mineral content).

Siberry Clin. Infect. Dis. 2015; 61:996-1003 10.1093/cid/civ437

Siberry, 2016 not relevant outcome EXCLUDED: continuous variables (Bone Mineral Content).

Siberry 2016; Conference on Retroviruses and Opportunistic Infections; February 2016. Boston, MA.

Floridia, 2016 not relevant outcome EXCLUDED: for dichotomic variables: no unexposed group. An unexposed group is available for continuous variables only.

Floridia J. Antimicrob. Chemother. 2016; 71:3206-3211 10.1093/jac/dkw268

Jacobson, 2017 not relevant outcome EXCLUDED: analysis according to treatments only performed for continuous variables.

Jacobson Pediatr. Infect. Dis. J. 2017; 36:189-197 10.1097/INF.0000000000001387

Maskew, 2012 not relevant outcome EXCLUDED: not relevant outcome (incidence of pregnancy).

Maskew AIDS 2012; 26:2393-7 10.1097/QAD.0b013e328359a95c

Kourtis, 2018 not relevant outcome EXCLUDED: continuous variables (bone mineral content (BMC), bone mineral density (BMD) and whole body mass).

Kourtis Pediatr. Infect. Dis. J. 2018; 37:e264-e268 10.1097/INF.0000000000002152

Liotta, 2016 not relevant outcome EXCLUDED: continuous variables (growth).

Liotta AIDS 2016; 30:525-7 10.1097/QAD.0000000000000944

Gingelmaier, 2009 not relevant outcome EXCLUDED: continuous variables and there is no group with all pregnancies exposed to tenofovir (studied group: lamivudine or tenofovir/emtricitabine).

Gingelmaier Antivir. Ther. (Lond.) 2009; 14:331-8

Nozyce, 2014 not relevant outcome EXCLUDED: continuous outcomes (mean results to the WPPSI-III, WASI and WIAT-II-A tests).

Nozyce Pediatr. Infect. Dis. J. 2014; 33:1128-33 10.1097/INF.0000000000000410

Wang, 2016 not relevant outcome EXCLUDED: analysis of HBV Viremia at Delivery and CD4, which are more efficacy related outcomes than safety ones.

Wang J. Infect. Dis. 2016; 214:1695-1699 10.1093/infdis/jiw439

Sirois, 2013 not relevant outcome EXCLUDED: continuous outcome (mean score to the Bayley assessment).

Sirois Pediatr. Infect. Dis. J. 2013; 32:648-55 10.1097/INF.0b013e318284129a

Chetty, 2016 not relevant outcome EXCLUDED: analysis of adherence to antiretroviral therapy and disease progression, without on fetal/neonatal/maternal safety data.

Chetty BMJ Open 2016; 6:e012088 10.1136/bmjopen-2016-012088

Mora, 2012 not relevant outcome EXCLUDED: continuous variables (weight, length, tibial speed of sound, bone specific alkaline phosphatase...).

Mora Bone 2012; 50:255-8 10.1016/j.bone.2011.10.030

Fernandez Ibieta, 2009 repeat population groups, duplicate reports (most recent study included) EXCLUDED: an update of these data (cohort that includes 8 public hospitals from Madrid) was published by Pietro 2014 on a longer period (2000-2009) and with more pregnancies.

Fernandez Ibieta An Pediatr (Barc) 2009; 70:253-64 10.1016/j.anpedi.2008.10.021

Jourdain, 2018 same data already obtained by other studies EXCLUDED: same study that Jourdain 2018 (New England Journal of Medicine).

Jourdain, G. Obstetrical and Gynecological Survey 2018; 73:443-. 10.1097/OGX.0000000000000592

Malaba, 2018 same data already obtained by other studies EXCLUDED: there is an overlapping between this study Malaba 2018 and Malaba 2017. Only Malaba 2018 was kept because more pregnancies were included.

Malaba Ann Epidemiol 2018; 28:893-900 10.1016/j.annepidem.2018.08.011

Sebikari, 2019 same data already obtained by other studies EXCLUDED: secondary analysis of data published by Fowler 2016.

Sebikari Journal of Acquired Immune Deficiency Syndromes 2019; 81:521-532.

Venkatesh, 2019 same data already obtained by other studies EXCLUDED: subset of PROMISE trial women for neonates with both methods for measuring preterm: New Ballard Score and ultrasound.

Venkatesh AIDS 2019; 33:2403-2413.

Morrison, 2015 same data already obtained by other studies EXCLUDED: The subanalysis published by Morrison 2015 (specifically related to seroconverter women) are probably included in the study published by Pintye 2017 and/or Heffron 2018.

Morrison PLoS ONE 2015; 10:e0140773 10.1371/journal.pone.0140773

Mhlanga, 2018 no specific data EXCLUDED: article of the feasibility to establish a pregnancy registry. No data on fetal/neonatal/maternal safety outcomes.

Mhlanga HIV Clin Trials 2018; 19:8-14 10.1080/15284336.2017.1411419

d'Arminio, 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of naive versus ART-experienced women, without distinction between treatments.

d'Arminio Monforte J. Acquir. Immune Defic. Syndr. 2014; 67:258-67 10.1097/QAI.0000000000000297

Hofer, 2016 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to antiretroviral drugs (ARVs) as a whole, without distinction between treatments, excepted for WAZ, LAZ and WLZ (3 continuous variables).

Hofer Pediatr. Infect. Dis. J. 2016; 35:71-7 10.1097/INF.0000000000000926

Hoffman, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to antiretroviral therapy (ART) as a whole, without distinction between treatments.

Hoffman Clin. Infect. Dis. 2019; 68:273-279 10.1093/cid/ciy471

Liu, 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to country, without analysis according to treatment.

Liu AIDS 2014; 28:2259-68 10.1097/QAD.0000000000000394

Baroncelli, 2009 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: for pregnancy outcomes: analysis for Antiretroviral treatment as a whole, without distinction between treatments.

Baroncelli AIDS Patient Care STDS 2009; 23:513-20 10.1089/apc.2008.0263

Gill, 2017 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to antiretroviral therapy as a whole, without distinction between treatments.

Gill Medicine (Baltimore) 2017; 96:e9445 10.1097/MD.0000000000009445

Stringer, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to group of antiretroviral therapy (NNRTI-based ART, PI-based ART or n NRTI-based ART) without distinction between treatments.

Stringer PLoS ONE 2018; 13:e0199555 10.1371/journal.pone.0199555

Hleyhel, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: cancers in infants reported according to antiretroviral regimens, but the number of pregnancies exposed to each antiretroviral regimen was not reported.

Hleyhel Environ. Mol. Mutagen. 2019; 60:404-409 10.1002/em.22162

Pinnetti, 2011 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of zidovudine-based HAART versus zidovudine-free regimens, without distinction between individual treatments in this latter.

Pinnetti J. Infect. 2011; 63:144-50 10.1016/j.jinf.2011.06.001

Favarato, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis performed for antiretroviral therapy class as a whole. OR also provided for the most frequently used antenatal antiretroviral regimens, but Tenofovir used as control group and raw data not provided.

Favarato AIDS 2018; 32:243-252 10.1097/QAD.0000000000001694

Tekin Koruk, 2015 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of tenofovir or lamivudine or telbivudine as a whole, without distinction between treatments.

Tekin Koruk J. Obstet. Gynaecol. Res. 2015; 41:1870-6 10.1111/jog.12821

Prieto, 2017 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analysis of outcomes of HIV-1 infected pregnant women, as a whole without distinction between treatments (details on treatment provided for only some patients).

Prieto PLoS ONE 2017; 12:e0183558 10.1371/journal.pone.0183558

Jena, 2017 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of cirrhotic versus non cirrhotic pregnant women, without distinction between treatments.

Jena J Obstet Gynaecol India 2017; 67:263-269 10.1007/s13224-016-0959-y

Campbell, 2012 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: no distinction in pregnancy outcomes of the 42 pregnancies exposed to EFV/FTC/TDF or EFV/3TC-ZDV.

Campbell PLoS Med. 2012; 9:e1001290 10.1371/journal.pmed.1001290

Reitter, 2013 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: fetal/neonatal/maternal outcomes provided according to antiretroviral regimens, but the number of pregnancies exposed for each antiretroviral regimen not mentionned.

Reitter Infect Dis Obstet Gynecol 2013; 2013:208482 10.1155/2013/208482

Livingston, 2007 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of Protease Inhibitors versus Nonprotease Inhibitors, without distinction between treatments.

Livingston Obstet Gynecol 2007; 110:391-7 10.1097/01.AOG.0000271210.79340.4c

Ategeka, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: no analysis according to antiretroviral treatments.

Ategeka PLoS ONE 2019; 14:e0215058 10.1371/journal.pone.0215058

Radhika, 2017 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of Prevention of Parent To Child Transmission (PPTCT) and pregnancy outcomes according to years but not according to treatments.

Radhika, A.G. Journal of Clinical and Diagnostic Research 2017; 11:QC04-. 10.7860/JCDR/2017/26432.10423

Salazar-Austin, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to maternal disease status, without distinction between treatments.

Salazar-Austin Clin. Infect. Dis. 2018; 66:921-929 10.1093/cid/cix851

Patel, 2009 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of Antiretroviral therapy as a whole, without distinction between treatments.

Patel AIDS 2009; 23:1893-901 10.1097/QAD.0b013e32832dc041

Msukwa, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to the timing of initiation of maternal combination antiretroviral therapy, without distinction between treatments.

Msukwa Trop. Med. Int. Health 2019; 24:727-735 10.1111/tmi.13233

Patel, 2010 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of antiretroviral therapy (with versus without PI) as a whole, without distinction between treatments.

Patel J. Infect. Dis. 2010; 201:1035-44 10.1086/651232

Chaudhury, 2017 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to in-utero exposure to HIV and associated ARVs, without distinction between treatments.

Chaudhury Pediatrics 2017; 140: 10.1542/peds.2017-0988

El Agheb, 2015 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of pregnancies as a whole, without distinction between treatments (tenofovir or lamivudine).

El Agheb Pan Afr Med J 2015; 20:316 10.11604/pamj.2015.20.316.6193

Goetghebuer, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of (NRTI/PI), (NRTI/NNRTI) and (NRTI only) as a whole, without distinction between treatments.

Goetghebuer Clin. Infect. Dis. 2019; 68:1193-1203 10.1093/cid/ciy673

Garcia-Otero, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to HIV status without distinction between treatments.

Garcia-Otero PLoS ONE 2019; 14:e0213279 10.1371/journal.pone.0213279

Daver, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to antiretroviral therapy as a whole, without distinction between treatments.

Daver, R.G. Journal of SAFOG 2019; 11:50-. 10.5005/jp-journals-10006-1649

Lussiana, 2012 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of antiretroviral therapy as a whole, without distinction between treatments.

Lussiana PLoS ONE 2012; 7:e36381 10.1371/journal.pone.0036381

Boivin, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of triple antiretroviral prophylaxis without distinction between the 2 regimens (lopinavir–ritonavir plus either lamivudine and zidovudine or emtricitabine and tenofovir).

Boivin Lancet HIV 2019; 6:e518-e530 10.1016/S2352-3018(19)30083-9

Benhammou, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to illness statut, without analysis according to treatments.

Benhammou J. Acquir. Immune Defic. Syndr. 2018; 77:439-450 10.1097/QAI.0000000000001618

Moren, 2015 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of HIV-infected mothers and HIV-exposed infants as a whole, without distinction between treatments.

Moren AIDS 2015; 29:5-12 10.1097/QAD.0000000000000486

Fouché, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to antiretroviral therapy as a whole, without distinction between treatments.

Fouché J. Trop. Pediatr. 2018; 64:255-261 10.1093/tropej/fmx056

Slogrove, 2017 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of HIV-exposed but uninfected (HEU) infants and HIV-unexposed (HU) infants, without analysis according to prenatal treatments.

Slogrove Pediatr. Infect. Dis. J. 2017; 36:e38-e44 10.1097/INF.0000000000001391

Springer, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis on neurodevelopmental outcome according to zidovudine antiretroviral exposure or combination antiretroviral therapy (cART), without distinction between individual treatments.

Springer Trop. Med. Int. Health 2018; 23:69-78 10.1111/tmi.13006

Massad, 2004 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of antiretroviral therapy as a whole, without distinction between treatments.

Massad AIDS 2004; 18:281-6 10.1097/00002030-200401230-00018

Wedderburn, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of antiretrovirals as a whole, without distinction between treatments.

Wedderburn Lancet Child Adolesc Health 2019; 3:803-813 10.1016/S2352-4642(19)30250-0

Fan, 2014 pattern of exposure EXCLUDED: analysis of prescription pattern, without data on fetal/neonatal/maternal safety outcomes.

Fan Infect Dis Obstet Gynecol 2014; 2014:546165 10.1155/2014/546165

Floridia, 2012 pattern of exposure EXCLUDED: data on pattern of exposure, without fetal/neonatal/maternal safety data.

Floridia AIDS Patient Care STDS 2012; 26:439-43 10.1089/apc.2012.0116

Griner, 2011 pattern of exposure EXCLUDED: analysis of maternal use of ARVs during pregnancy, without fetal/neonatal/maternal safety outcomes.

Griner AIDS Patient Care STDS 2011; 25:385-94 10.1089/apc.2011.0068