PMID- 31381233
OWN - NLM
STAT- MEDLINE
DCOM- 20200601
LR  - 20201210
IS  - 1365-3156 (Electronic)
IS  - 1360-2276 (Linking)
VI  - 24
IP  - 10
DP  - 2019 Oct
TI  - 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.
PG  - 1221-1228
LID - 10.1111/tmi.13296 [doi]
AB  - 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/mul (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.
CI  - (c) 2019 John Wiley & Sons Ltd.
FAU - Harrington, Bryna J
AU  - Harrington BJ
AD  - Department of Epidemiology, The University of North Carolina at Chapel Hill, 
      Chapel Hill, NC, USA.
FAU - DiPrete, Bethany L
AU  - DiPrete BL
AD  - Department of Epidemiology, The University of North Carolina at Chapel Hill, 
      Chapel Hill, NC, USA.
FAU - Jumbe, Allan N
AU  - Jumbe AN
AD  - UNC Project-Malawi, Kamuzu Central Hospital, Lilongwe, Malawi.
FAU - Ngongondo, McNeil
AU  - Ngongondo M
AD  - UNC Project-Malawi, Kamuzu Central Hospital, Lilongwe, Malawi.
FAU - Limarzi, Laura
AU  - Limarzi L
AD  - UNC Project-Malawi, Kamuzu Central Hospital, Lilongwe, Malawi.
FAU - Wallie, Shaphil D
AU  - Wallie SD
AD  - UNC Project-Malawi, Kamuzu Central Hospital, Lilongwe, Malawi.
FAU - Chagomerana, Maganizo B
AU  - Chagomerana MB
AD  - UNC Project-Malawi, Kamuzu Central Hospital, Lilongwe, Malawi.
FAU - Hosseinipour, Mina C
AU  - Hosseinipour MC
AD  - UNC Project-Malawi, Kamuzu Central Hospital, Lilongwe, Malawi.
AD  - Department of Medicine, The University of North Carolina at Chapel Hill, Chapel 
      Hill, NC, USA.
CN  - S4 Study Team
LA  - eng
GR  - R01HD080485/NH/NIH HHS/United States
GR  - T32AI007001/NH/NIH HHS/United States
GR  - T32GM008719/NH/NIH HHS/United States
GR  - F30MH111370/NH/NIH HHS/United States
GR  - D43TW010060/NH/NIH HHS/United States
GR  - P30AI50410/NH/NIH HHS/United States
GR  - R25TW009340/NH/NIH HHS/United States
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, N.I.H., Extramural
DEP - 20190819
PL  - England
TA  - Trop Med Int Health
JT  - Tropical medicine & international health : TM & IH
JID - 9610576
RN  - 0 (Alkynes)
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Anti-Retroviral Agents)
RN  - 0 (Benzoxazines)
RN  - 0 (Cyclopropanes)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 99YXE507IL (Tenofovir)
RN  - JE6H2O27P8 (efavirenz)
SB  - IM
MH  - Adult
MH  - Alkynes
MH  - Anti-HIV Agents/*therapeutic use
MH  - Anti-Retroviral Agents/*therapeutic use
MH  - Benzoxazines/*therapeutic use
MH  - Cohort Studies
MH  - Cyclopropanes
MH  - Drug Therapy, Combination
MH  - Female
MH  - HIV Infections/*drug therapy
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Infectious Disease Transmission, Vertical/prevention & control
MH  - Lamivudine/*therapeutic use
MH  - Malawi
MH  - Pregnancy
MH  - Pregnancy Complications, Infectious/*drug therapy
MH  - Tenofovir/*therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - HIV infection
OT  - Malawi
OT  - Option B+
OT  - grossesse
OT  - infection par le VIH
OT  - pregnancy
OT  - prevention of mother to child transmission
OT  - prevention de la transmission mere-enfant
OT  - safety and efficacy
OT  - securite et efficacite
EDAT- 2019/08/06 06:00
MHDA- 2020/06/02 06:00
CRDT- 2019/08/06 06:00
PHST- 2019/08/06 06:00 [pubmed]
PHST- 2020/06/02 06:00 [medline]
PHST- 2019/08/06 06:00 [entrez]
AID - 10.1111/tmi.13296 [doi]
PST - ppublish
SO  - Trop Med Int Health. 2019 Oct;24(10):1221-1228. doi: 10.1111/tmi.13296. Epub 2019 
      Aug 19.