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Three Postpartum Antiretrovir al Regimens to Prevent Intrapartum HIV Infection BY : Aulia Eksissi Komara Supervisor : dr. Cahyono Hadi Sp.OG (K)

Three Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV

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Three Postpartum Antiretroviral

Regimens to Prevent Intrapartum

HIV Infection

BY : Aulia Eksissi Komara

Supervisor : dr. Cahyono Hadi Sp.OG (K)

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Title : Three Postpartum Antiretroviral Regimens to Prevent

Intrapartum HIV Infection

Author : Saines KN, Watts DH, Veloso MD, Bryson YJ, Joao EC,at all.

Published : NEJM.ORG June 21, 2012

Total page : 12 pages

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BACKGROUND

• The safety of adding antiretroviral drugs on

infants of mothers with HIV Infection without

antenatal antiretroviral therapy (ART) is

unclear.

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Previous Research

Control studies of

postexposure

prophilaxis in infantsborn presenting

mother with HIV

Infection who didnot received ART in

pregnancy havebeen performed in

breast-fedpopulation

Observasionalstudies have shown

reduced

transmission whenzidovudie therapy

was initiated within

48 housrs after birth

and continued for 6

weeks in neonatesborn to untreated

mother with HIV

Type 1 infection

A Randomized

South Africa of

infants born to

untreated HIV-infection mother,

the rates ofintrapartum

transmission were

similar amongformula fed infants

receiving zidovudine

and nevirapine

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Methode – Study population

• A positif HIV of maternal in rapid test

• A mother who had not received ART before labour

• Woman who received ART before labour is exclude

• Had a gestasional ages at least 32 weeks

• Weight at least 1,5 kg and Had no life-threatening

condition

• Were able to take oral medication

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1st group

• Received

zidofudine alone

2nd group

• Received

zidovudine and

three dose of

nevirapine:

• 1. 48 hours afterbirth

• 2. 48 hours after

the first dose

• 3. 96 hours after

the second dose

3rd group

• Received

zidovudine

regimen plus

nelvinavir and

lamivudine for 2weeks

• Nelvinavir dose

was 200 mg (>3

kg), 150 (2-3kg),

100 (<2kg)• Lamivudine dose

6 mg (>2kg), 4

mg (<2kg)

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Maternal evaluation

• The obstetrical histories were obtained,

complete blood counts, plasma HIV-1 RNA, T

Cell and Veneral Disease Research Laboratory

(VDRL) titer.

• Mother were counseled not to breast-feed

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Infant evaluation

• Study visit at 4 to 7 days, 10 to 14 days, 4 to 6weeks, and 3 to 6 moth of ages.

• Medical histories were obtained and physical

examination in each visit.• Complete blood counts and hepatic

aminotransverase levels were measured in eachvisit

• The level of HIV-1 DNA was measured with use ofthe Amplicor 1.5 DNA Polymerase Chain Reaction(PCR) at all visits exept at 4 to 7 days.

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Infant evaluation

• Infants with a positive HIV-1 DNA PCR Assay

underwent repeat testing as soon as possible.

• Confirmed HIV-1 infectin was defined as two

positive results on different days.

• The infants who infected in utero is exclude of

the primary efficacy anlysis.

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Infant evaluation

• Infants with positive DNA PCR results at birth and

confirmatory positive results on repeating testing

were classified as having been infected in utero

• Intrapartum infection was defined as a negative

test result at birth with a positive result on

subsequent testing

• Once HIV-1 infection was confirmed, the studyART prophilaxis was discontinued so that infants

could begin ART treatment

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Results

• The overall trasnmission in the zidovudine-

alone group was similar rates in obesrvasional

studies in which zidovudine was initiated

within 48 hours after birth postpartum

• Intrapartum transmission were reduced by

half in the two and three drugs groups, as

compared with zidovudine alone group.

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Result

• Neutropenia was significantly more common

with the three regimen than with the other

two regiments. It’s difference is probably

related to combined suppresive effects of

zidovudine and lamivudine on bone marrow

production of blood cells.

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Result

• There has significant difference between 1stgroup – 2nd group (p = 0.046), 1st group – 3rdgroup (p = 0,046)

• The overall transmission is 140 infants with anincreased rate in zidovudine alone group (p =0,03 for the comparisons with 2nd and 3rdgroup)

• The rate of neutropenia is increased in the 3rdgroup

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Conclution

• Adding an ART drugs significantly reduces the risk

of intrapartum transmitted of HIV.

• Combination ART Regimens drug with zidovudine

is effective for prophylaxis in the infants of

mother who did not received antenatal ART.

• Ease of use, reduced toxicity, availability and low

cost suggest that zidovudine + nevirapine is anatractive option for prophylaxis in infants at high

risk for perinatal HIV-1 infection.

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CRITICAL APPRAISAL

JOURNAL 

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Critical Appraisal

• Title : Three

Postpartum

AntiretroviralRegimens to Prevent

Intrapartum HIV

Infection

 It has been

appropriate

• prevent intrapartum

HIV Infection

Primary

variable

• three Postpartum

Antiretroviral

Regimens

Secondary

variable

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Abstract

Consist of 5 paragraph

Substance of Abstract are background,

methode, result and conclutin

> 250 word

Abstract has reflected of its consist of this journal and research

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PICO Analysis

1684

infantswithmother

-HIV-1Infectionwithoutreceived ART

beforelabour

1684 infants :

566 infants zidovudine-alone group.562 infants zdovudinenevirapine556 infants zidvudine,

nelvinavir andlamivudine

To comparedefficacy andsafety orthree ART to

preventivetransmissionin infantswhosemother didnot receiveART uring

pregnancy

• adding ARV drugs

significantlyreduces the riiskof intrapartumtransmitted ofHIV

• Combination ARTregimens

effective as aprophylaxis HIV 1infectiontransmittedintrapartum

• Zidovudine andnevirapine is the

most effective asan ARV

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THANK YOU