Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention

Fowler, Mary Glen; Qin, Mei; Fiscus, Susan A.; Currier, Judith S.; Flynn, Patricia M.; Chipato, Tsungai; McIntyre, James; Gnanashanmugam, Devasena; Siberry, George K.; Coletti, Anne; Taha, Taha E.; Klingman, Karin L.; Martinson, Francis; Owor, Maxensia; Violari, Avy; Moodley, Dhayendre; Theron, G.B.; Bhosale, Ramesh; Bobat, Raziya; Chi, Biing-Tzong; Strehlau, Renate; Mlay, Pendo; Loftis, Amy James; Browning, Renee; Fenton, Terry; Purdue, Lynette; Basar, Michael; Shapiro, David E.; Mofenson, LM

doi:10.1097/01.aoa.0000521253.11653.d9

Cited by 50 publications

(76 citation statements)

References 10 publications

(13 reference statements)

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“…Overall, infant outcomes were reassuring with regards to maternal‐to‐child transmission (MTCT) of HIV. MTCT occurred in only 2% of women enrolled in this cohort, comparable to MTCT among participants managed on this same regimen in other studies , and lower than the overall MTCT rate of >4% in Malawi . Most MTCT events in our cohort occurred in mother‐infant pairs where the mother had an unsuppressed viral load.…”

Section: Discussionsupporting

confidence: 58%

Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz

Harrington

DiPrete

Jumbe

et al. 2019

Tropical Med Int Health

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Objectives Malawi's Option B+ universal antiretroviral therapy (ART) program for pregnant and breastfeeding women does not include routine laboratory monitoring. We report safety outcomes of pregnant women who initiated ART through Option B+. Methods We analysed 12‐month data from an observational cohort study on Option B+ among women newly initiating tenofovir/lamivudine/efavirenz (TDF/3TC/EFV) at a government antenatal clinic in Lilongwe, Malawi. Proportions of women engaged in care, incidence of DAIDS grade ≥ 2 laboratory toxicity, grade ≥ 3 adverse events (AEs), viral suppression (<1000 copies/mL), birth outcomes and infant HIV infections are reported. Results At ART initiation, participants (n = 299) had a median age of 26 years (IQR 22–30), median CD4 count of 352 cells/μl (IQR 231–520) and 94% were in WHO Stage 1. We noted 76 incident DAIDS Grade ≥ 2 laboratory results among 58 women, most commonly elevated liver function tests (n = 30 events) and low haemoglobin (n = 27). No women had elevated creatinine. Clinical AEs (n = 45) were predominantly infectious diseases and Grade 3. Five participants (2%) discontinued TDF/3TC/EFV due to virologic failure (3) or toxicity (2). Twelve months after ART initiation, most women were engaged in care (89%) and had HIV RNA < 1000 copies/ml (90%). 8% of pregnancies resulted in preterm birth, 9% were low birthweight (<2500 g), and 2% resulted in infant HIV infection at 6 weeks post‐delivery. Conclusion Most women remained on ART and were virally suppressed 12 months after starting Option B+. Few infants contracted HIV perinatally. While some women experienced adverse laboratory events, clinical symptom monitoring is likely reasonable.

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Section: Discussionsupporting

confidence: 58%

Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz

Harrington

DiPrete

Jumbe

et al. 2019

Tropical Med Int Health

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“…Considerations for the backbone include side‐effect profile, frequency of dosing, interactions with the third agent, adverse outcome profiles and prior cART experience including a resistance profile where available. The writing group recommends that women are advised against the combination of tenofovir DF/emtricitabine and lopinavir/r (especially high‐dose lopinavir/r), which demonstrated an increased risk of neonatal death and prematurity in the randomised controlled PROMISE trial .…”

Section: Current Issues In the Use Of Art In Pregnancy And Pregnanmentioning

confidence: 99%

“…The PROMISE study compared the efficacy of zidovudine/single‐dose nevirapine with two combination therapy arms to prevent vertical transmission. The first combination consisted of zidovudine/lamivudine/lopinavir/r and the second comprised tenofovir DF/emtricitabine/lopinavir/r.…”

Section: Current Issues In the Use Of Art In Pregnancy And Pregnanmentioning

confidence: 99%

British HIV Association guidelines for the management of HIV in pregnancy and postpartum 2018

et al. 2019

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“…Our reported 0·5% in utero MTCT rate is lower than most studies and programmes . Our MTCT rate may be artificially low because we did not include some infants with potentially higher risk for HIV in our study, including those <35 weeks’ gestational age, <2000 g, with severe medical illness, or those with mothers who were <18 years of age.…”

Section: Discussionmentioning

confidence: 73%

Targeted HIV testing at birth supported by low and predictable mother‐to‐child transmission risk in Botswana

et al. 2018

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IntroductionMost African countries perform infant HIV testing at 6 weeks or later. The addition of targeted testing at birth may improve retention in care, treatment outcomes and survival for HIV‐infected infants.Methods HIV‐exposed infants were screened as part of the Early Infant Treatment (EIT) study in Botswana. Screened infants were ≥35 weeks gestational age and ≥2000 g at birth. Risk factors for mother‐to‐child transmission (MTCT) were assessed by maternal obstetric card or verbally. Risk factors included <8 weeks ART in pregnancy, last known CD4 <250 cells/mm3, last known HIV RNA >400 copies/mL, poor maternal ART adherence, lack of maternal zidovudine (ZDV) in labour, or lack of infant post‐exposure prophylaxis. Infants underwent dried blood spot testing by Roche Cobas Ampliprep/Cobas Taqman HIV‐1 qualitative PCR.ResultsFrom April 2015 to April 2016, 2303 HIV‐exposed infants were tested for HIV in the EIT study. Of these, 369 (16%) were identified as high risk for HIV infection by information available at birth, and 12 (0.5% overall, 3.25% of high risk) were identified as HIV positive at birth. All 12 positive infants were identified as high risk at the time of screening, and only 2 risk factors were required to identify all positive infants: either <8 weeks of maternal ART in pregnancy (75%) or lack of maternal HIV suppression at last test (25%).Conclusions In utero MTCT occurred only among infants identified as high risk at delivery, using information available from the mother or obstetric record. Birth testing that targets high‐risk infants based on maternal ART receipt is likely to identify the majority of in utero HIV transmissions, and allows early ART initiation for these infants.

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Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention

Abstract: BACKGROUND-Randomized-trial data on the risks and benefits of antiretroviral therapy (ART) as compared with zidovudine and single-dose nevirapine to prevent transmission of the human immunodeficiency virus (HIV) in HIV-infected pregnant women with high CD4 counts are lacking.

Cited by 50 publications

References 10 publications

Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz

Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir/lamivudine/efavirenz

British HIV Association guidelines for the management of HIV in pregnancy and postpartum 2018

Targeted HIV testing at birth supported by low and predictable mother‐to‐child transmission risk in Botswana

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