Prevention of Mother-to-Child Transmission of HIV-1 Through Breastfeeding by Treating Mothers With Triple Antiretroviral Therapy in Dar es Salaam, Tanzania: The Mitra Plus Study

Kilewo, Charles; Karlsson, Katarina; Ngarina, Matilda; Massawe, Augustine; Lyamuya, Eligius; Swai, A. B. M.; Lipyoga, Rosina; Mhalu, Fred; Biberfeld, Gunnel

doi:10.1097/qai.0b013e3181b323ff

Cited by 198 publications

(165 citation statements)

References 31 publications

Supporting

Mentioning

144

Contrasting

Unclassified

Order By: Relevance

“…Two studies with CD4 cut-offs of 500 29 Fourteen studies were reviewed, including a total of 2 663 participants (Table 2). 4,5,[27][28][29][30][31][32][33][34][35][36][37][38] One study was funded by the NVP manufacturer Boehringer Ingelheim. 30 The studies, mostly undertaken between 2001 and 2006, were predominantly observational with participant numbers ranging from 17 to 703.…”

Section: Resultsmentioning

confidence: 99%

“…The CD4 cut-off was 250 cells/µl for toxicity analyses in all studies, except for one (CD4 cut-off of 200 cells/ µl). 35 Mean time to toxicity ranged from 27 to 74 days. The overall frequency of NVP toxicity was 8.3%, driven mostly by hepatotoxicity.…”

Section: Resultsmentioning

confidence: 99%

“…One study 35 was excluded from analysis as it used a CD4 cut-off of 200 cells/µl; the result following exclusion was unaltered (OR 0.62; 95% CI 0.44 -0.87; I 2 12%). Severe hepatotoxicity was not significantly reduced with NVP use at CD4 <250 cells/µl (OR 0.75; 95% CI 0.48 -1.15; I 2 0%).…”

Section: Fig 1 Identification Retrieval and Exclusion/inclusion Ofmentioning

confidence: 99%

See 2 more Smart Citations

Safety of nevirapine in HIV-infected pregnant women initiating antiretroviral therapy at higher CD4 counts: A systematic review and meta-analysis

Bera

Mia

2012

S Afr Med J

View full text Add to dashboard Cite

United States (US) Food and Drug Administration (FDA) issued a public health advisory recommending against initiating nevirapine (NVP) in HIV-infected women (including pregnant women) with CD4 counts >250 cells/µl. 1 The NVP package insert was revised accordingly to warn about risks, with further revision in November 2011 to comply with FDA recommendations on product labelling safety. 2The initial warning followed a meta-analysis of hepatotoxicity in over 600 women, stratified by CD4 count (risk ratio 9.8 with a CD4 count ≥250 cells/µl).3 However, results from several subsequent studies with larger datasets demonstrated no association between CD4 count and NVP toxicity. [4][5][6] Current World Health Organization (WHO) guidelines recommend NVP as part of first-line antiretroviral therapy (ART) for pregnant women with CD4 ≤350 cells/µl, 7 based on their own analysis of 836 pregnant women, which showed no increased hepatotoxicity risk at CD4 ≥250 cells/µl (relative risk 1.04; 95% confidence interval (CI) 0.22 -4.93). 9 In contrast, the 2011 perinatal guidelines from the US Department of Health and Human Services recommend a protease inhibitor as part of the ART regimen for pregnant women with a CD4 count ≥250 cells/µl, while cautioning against starting NVP above this count. 10 The British HIV Association 2012 draft guidelines recommend either efavirenz (EFV) or NVP (with a CD4 count <250 cells/µl) or a boosted protease inhibitor as the third drug for pregnant women requiring ART for their own health. 11 The recommendation of EFV is a departure from previous guidelines discouraging its use in pregnancy. Furthermore, women who conceived on EFV-based ART need not switch to another drug in the first trimester, following analysis of recent data showing no increased risk of birth defects after first-trimester EFV exposure. 11Reports of NVP-related maternal deaths have surfaced in South Africa, generating renewed concerns about the drug's safety, notably among ART-naive pregnant women. The Eastern Cape Province recently amended its PMTCT guidelines following an analysis of 45 HIV-related maternal deaths, 6 due to liver failure and StevensJohnson Syndrome (SJS). The use of NVP in pregnancy since then has been limited to a single dose at delivery (M Shweni, personal communication).To address the uncertainty about the safety of initiating NVPbased ART in pregnancy, we aimed to determine whether ART-naive pregnant women initiating NVP at higher CD4 counts experience greater toxicity. MethodsThe Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines were followed.12 All studies except case reports were evaluated for inclusion without consideration of their results. ART-naive pregnant women initiating NVP-based ART during the index pregnancy for maternal health or infant prophylaxis were included. For studies that included both ART-naive and -experienced pregnant women, only the data of ART-naive participants were extracted. ART-experienced pregnant women were excluded, including those naive to N...

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Safety of nevirapine in HIV-infected pregnant women initiating antiretroviral therapy at higher CD4 counts: A systematic review and meta-analysis

Bera

Mia

2012

S Afr Med J

View full text Add to dashboard Cite

show abstract

“…Recently, cohort [293][294][295][296] and RCT [66,78,297] data from Africa have shown that ART can significantly reduce the risk of HIV transmission from breastfeeding. This is in settings where breastfeeding is not affordable, feasible, acceptable, sustainable and safe, and mortality from formula feeding outweighs additional mortality from HIV transmission by breastfeeding [298,299].…”

Section: Infants Born To Hiv-positive Mothers Should Follow the Routimentioning

confidence: 99%

11.0 References

2012

HIV Medicine

View full text Add to dashboard Cite

“…I en åpen kohortstudie med brysternaerte barn fra Tanzania ga lamivudin som perieksposisjonsprofylakse til barnet en smitterisiko ned mot 1 % ved seks måneders alder (19). I en helt fersk oppfølgingsstudie fra samme studiegruppe var det tilsvarende gode resultater ved bruk av HAART-behandling hos mor (20).…”

Section: Internasjonal Medisinunclassified

Hiv, amming og antiretrovirale medisiner

Engebretsen¹,

Tylleskär²

2010

Tidsskriftet

View full text Add to dashboard Cite

Prevention of Mother-to-Child Transmission of HIV-1 Through Breastfeeding by Treating Mothers With Triple Antiretroviral Therapy in Dar es Salaam, Tanzania: The Mitra Plus Study

Cited by 198 publications

References 31 publications

Safety of nevirapine in HIV-infected pregnant women initiating antiretroviral therapy at higher CD4 counts: A systematic review and meta-analysis

Safety of nevirapine in HIV-infected pregnant women initiating antiretroviral therapy at higher CD4 counts: A systematic review and meta-analysis

11.0 References

Hiv, amming og antiretrovirale medisiner

Contact Info

Product

Resources

About