Pmtct A Thing Of Past

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Published on December 21, 2008

Author: drsujnanendra

Source: slideshare.net

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Mother /parent to child transmission of HIV is a real threat to the continuance of human race.We must have to fight and look forward for a HIV free world .

06/07/09 Dr.Sujnanendra Mishra Dr.Sujnanendra Mishra. M.D.(O&G) Sub Divisional Hospital. PATNAGARH. BOLANGIR. PMTCT - - - CAN IT BE A THING OF PAST ?

06/07/09 Dr.Sujnanendra Mishra Welcome you to this brain storming session on HIV. CHIEF DISTRICT MEDICAL OFFICER & ASSOCIATES BOLANGIR

06/07/09 Dr.Sujnanendra Mishra HIV in INDIA

06/07/09 Dr.Sujnanendra Mishra

06/07/09 Dr.Sujnanendra Mishra Expanding Disease Burden 1986 to 2005

Mothers are always Targeted : 06/07/09 Dr.Sujnanendra Mishra “ Men Think females Bring The Disease”

06/07/09 Dr.Sujnanendra Mishra Prevention of Parent- to- Child Transmission (“PPTCT”) ( generally known as “ PMTCT”) To be REPLACED BY

06/07/09 Dr.Sujnanendra Mishra Rationale for PPTCT in India 27 million pregnancies per year 1,89,000 infected pregnancies per year Cohort of 56,700-60,000 infected newborns per year 0.7% prevalence 30% transmission

HIV antibody Quantitative viral load Qualitative HIV DNA Absolute CD4+ cell count High risk of progression Moderate risk of progression Low risk of progression Weeks of Infection 0 1 2 3 4 5 6 7 8 9 10 11 12 14 26 SCHEMATIC OF LABORATORY FINDINGS IN PRIMARY HIV INFECTION ACUTE RETROVIRAL SYNDROME

Transmission during Pregnancy Perinatal & Breastfeeding 06/07/09 Dr.Sujnanendra Mishra 0% 20% 40% 60% 80% 100% Early Antenatal (<36 wks) Late Antenatal (36 wks to labor) Labor and Delivery Late Postpartum (6-24 months) Early Postpartum (0-6 months) Proportion of infections

The route by which children are infected with HIV In countries in which blood products are monitored, and where there is a sufficient supply of sterile syringes and needles, transmission of the pathogen from an HIV-infected mother is the main route by which children are infected with the human immuno deficiency virus (HIV). HIV can be transmitted from mother to child during pregnancy, delivery, and breastfeeding. 06/07/09 Dr.Sujnanendra Mishra

In countries in which blood products are monitored, and where there is a sufficient supply of sterile syringes and needles, transmission of the pathogen from an HIV-infected mother is the main route by which children are infected with the human immuno deficiency virus (HIV).

HIV can be transmitted from mother to child during pregnancy, delivery, and breastfeeding.

The frequency of perinatal HIV transmission In the natural course of HIV infection and in the absence of measures to prevent transmission, it is: 15–30% - in the economically developed countries 40–50% - in the countries of Africa 25–27% - in INDIA 06/07/09 Dr.Sujnanendra Mishra

In the natural course of HIV infection and in the absence of measures to prevent transmission, it is:

15–30% - in the economically developed countries

40–50% - in the countries of Africa

25–27% - in INDIA

The frequency of perinatal HIV transmission Perinatal HIV transmission is greater in countries where: the epidemic is spreading rapidly there is a low level of medical care prolonged breastfeeding of children by HIV-infected mothers is practiced 06/07/09 Dr.Sujnanendra Mishra

Perinatal HIV transmission is greater in countries where:

the epidemic is spreading rapidly

there is a low level of medical care

prolonged breastfeeding of children by HIV-infected mothers is practiced

The frequency of perinatal HIV transmission Data on the true level of perinatal HIV transmission can be distorted if early diagnosis of HIV infection in children is not established by means of the polymerase chain reaction (PCR) in a country with high infant mortality. 06/07/09 Dr.Sujnanendra Mishra

Data on the true level of perinatal HIV transmission can be distorted if early diagnosis of HIV infection in children is not established by means of the polymerase chain reaction (PCR) in a country with high infant mortality.

Perinatal HIV transmission risk factors HIV transmission take place : in 25–40% before birth in 60–75% during delivery In 7–22% during breastfeeding ; if the mother has an acute HIV infection at the time of breastfeeding , the risk of transmission is 29%. 06/07/09 Dr.Sujnanendra Mishra

HIV transmission take place :

in 25–40% before birth

in 60–75% during delivery

In 7–22% during breastfeeding ; if the mother has an acute HIV infection at the time of breastfeeding , the risk of transmission is 29%.

Routes of mother-to-child transmission of HIV in utero and during delivery Transplacental (hematogenous) Across the amniotic membranes or via the amniotic fluid Via contact of the maternal blood and the secretions of the maternal passages with the mucous membranes of the fetus During diagnostic manipulations 06/07/09 Dr.Sujnanendra Mishra

Transplacental (hematogenous)

Across the amniotic membranes or via the amniotic fluid

Via contact of the maternal blood and the secretions of the maternal passages with the mucous membranes of the fetus

During diagnostic manipulations

Perinatal HIV transmission risk factors Maternal factors : viral load degree of immunosuppression presence of other infectious diseases drug use and smoking vitamin A deficiency and poor nutrition 06/07/09 Dr.Sujnanendra Mishra

Maternal factors :

viral load

degree of immunosuppression

presence of other infectious diseases

drug use and smoking

vitamin A deficiency and poor nutrition

Perinatal HIV transmission risk factors Obstetric al factors : prolonged interval between rupture of membranes and birth (more than 4 hours) delivery through natural maternal passages invasive interventions during pregnancy and delivery 06/07/09 Dr.Sujnanendra Mishra

Obstetric al factors :

prolonged interval between rupture of membranes and birth (more than 4 hours)

delivery through natural maternal passages

invasive interventions during pregnancy and delivery

Perinatal HIV transmission risk factors Fetal (infant) factors : prematurity low birth weight first of twins matching (concordance) of maternal and fetal HLA infant's diseases in the period of breast or mixed feeding 06/07/09 Dr.Sujnanendra Mishra

Fetal (infant) factors :

prematurity

low birth weight

first of twins

matching (concordance) of maternal and fetal HLA

infant's diseases in the period of breast or mixed feeding

Core provisions of the section &quot; Prevention of Mother-to-Child Transmission of HIV &quot; of the WHO protocol for the CIS countries, March, 2004 . The campaign against HIV infection in newborns in each country is a policy obligation of the government. The following should be reduced by the end of 2010: the prevalence of HIV infection among newborns down to 1 case per 100,000 live births the rate of mother-to-child transmission of HIV - down to 2% or less. 06/07/09 Dr.Sujnanendra Mishra

The campaign against HIV infection in newborns in each country is a policy obligation of the government.

The following should be reduced by the end of 2010:

the prevalence of HIV infection among newborns down to 1 case per 100,000 live births

the rate of mother-to-child transmission of HIV - down to 2% or less.

Core provisions of the section &quot; Prevention of Mother-to-Child Transmission of HIV &quot; of the WHO protocol for the CIS countries, March, 2004. Discrimination against HIV-infected women in medical facilities and in society must be eradicated. The rights of HIV-infected women and their children must be protected Every medical document, regardless of the presence in it of information on HIV status, is an object of medical secrecy . 06/07/09 Dr.Sujnanendra Mishra

Discrimination against HIV-infected women in medical facilities and in society must be eradicated.

The rights of HIV-infected women and their children must be protected

Every medical document, regardless of the presence in it of information on HIV status, is an object of medical secrecy .

Core provisions of the section &quot; Prevention of Mother-to-Child Transmission of HIV &quot; of the WHO protocol for the CIS countries, March, 2004. The prevention of mother-to-child transmission (PMTCT) of HIV is an integral part of the comprehensive care of the HIV-infected woman and her children . PMTCT measures must be carried out by all relevant governmental and non-governmental services (centers for the prevention and control of AIDS, facilities providing care to mothers and children , psychoso cial aid services ). 06/07/09 Dr.Sujnanendra Mishra

The prevention of mother-to-child transmission (PMTCT) of HIV is an integral part of the comprehensive care of the HIV-infected woman and her children .

PMTCT measures must be carried out by all relevant governmental and non-governmental services (centers for the prevention and control of AIDS, facilities providing care to mothers and children , psychoso cial aid services ).

Core provisions of the section &quot; Prevention of Mother-to-Child Transmission of HIV &quot; of the WHO protocol for the CIS countries, March, 2004. HIV testing in women's clinics must be voluntary. The provision of complete information and help in understanding it are obligatory components of the procedure for obtaining informed consent. HIV-infected pregnant women must be afforded the opportunity to consciously decide the fate of her pregnancy , for which she must be provided full information on the risk of transmission of HIV to the infant and on the existing PMTCT measures. 06/07/09 Dr.Sujnanendra Mishra

HIV testing in women's clinics must be voluntary. The provision of complete information and help in understanding it are obligatory components of the procedure for obtaining informed consent.

HIV-infected pregnant women must be afforded the opportunity to consciously decide the fate of her pregnancy , for which she must be provided full information on the risk of transmission of HIV to the infant and on the existing PMTCT measures.

Core provisions of the section &quot; Prevention of Mother-to-Child Transmission of HIV &quot; of the WHO protocol for the CIS countries, March, 2004. It is impermissible to dispose the HIV-infected pregnant woman to the interruption of her pregnancy . Each pregnant woman must be provided antiretroviral drugs in accordance with the most effective regimen. 06/07/09 Dr.Sujnanendra Mishra

It is impermissible to dispose the HIV-infected pregnant woman to the interruption of her pregnancy .

Each pregnant woman must be provided antiretroviral drugs in accordance with the most effective regimen.

The strategy for the prevention of mother-to-child transmission of HIV . Primary prevention of HIV infection in women of child-bearing age Prevention of unwanted pregnancies in HIV-infected women Drug-based prevention of mother-to-child transmission of HIV during pregnancy and rational delivery of HIV-infected women Introduction of contemporary methods for the diagnosis of HIV infection in children and optimization of their management 06/07/09 Dr.Sujnanendra Mishra

Primary prevention of HIV infection in women of child-bearing age

Prevention of unwanted pregnancies in HIV-infected women

Drug-based prevention of mother-to-child transmission of HIV during pregnancy and rational delivery of HIV-infected women

Introduction of contemporary methods for the diagnosis of HIV infection in children and optimization of their management

Components of the prevention of mother-to-child transmission of HIV Prevention using ARV drugs Safe obstetrics, including planned cesarean section at the 38th week of pregnancy Safe feeding of the child (when possible , artificial feeding) 06/07/09 Dr.Sujnanendra Mishra

Prevention using ARV drugs

Safe obstetrics, including planned cesarean section at the 38th week of pregnancy

Safe feeding of the child (when possible , artificial feeding)

PMTCT Feasibility Study AZT: March 2000 - August 2001 Total new ANC attendance : 192,474 No. of pregnant mothers counseled : 171,471 (89.1%) No. of pregnant mothers accepted HIV tests : 103,681 (60.5%) No. of pregnant mothers detected HIV positive : 1,724 (1.7%) No. delivered with AZT : 726 (42.1%) No. of PCR samples at 48 hrs. tested : 427 No. of samples tested (+) positive : 34/427 (8.0%) No. of additional tested (+) at 2 months : 9 (adding a 2% transmission rate) No. of women who opted for breastfeeding : 22% 06/07/09 Dr.Sujnanendra Mishra

Total new ANC attendance : 192,474

No. of pregnant mothers counseled : 171,471 (89.1%)

No. of pregnant mothers accepted HIV tests : 103,681 (60.5%)

No. of pregnant mothers detected HIV positive : 1,724 (1.7%)

No. delivered with AZT : 726 (42.1%)

No. of PCR samples at 48 hrs. tested : 427

No. of samples tested (+) positive : 34/427 (8.0%)

No. of additional tested (+) at 2 months : 9

(adding a 2% transmission rate)

No. of women who opted for breastfeeding : 22%

HIV Glossary pMTCT – Prevention of Mother-to-Child Transmission BF – Breastfeeding ARV – Antiretroviral (medication) HAART – Highly Active Antiretroviral Therapy AZT – Zidovudine NVP – Nevirapine SD NVP – Single Dose Nevirapine AP – Antepartum IP – Intrapartum PP – Postpartum 06/07/09 Dr.Sujnanendra Mishra

pMTCT – Prevention of Mother-to-Child Transmission

BF – Breastfeeding

ARV – Antiretroviral (medication)

HAART – Highly Active Antiretroviral Therapy

AZT – Zidovudine

NVP – Nevirapine

SD NVP – Single Dose Nevirapine

AP – Antepartum

IP – Intrapartum

PP – Postpartum

06/07/09 Dr.Sujnanendra Mishra Four classes of ARV drugs approved

HIV REPLICATION 06/07/09 Dr.Sujnanendra Mishra

Overview of antiretroviral drugs Nucleoside reverse transcriptase inhibitors (NRTI) mode of action: Nucleoside analog (“wrong module”), requires intracellular activation 7 drugs currently approved Non- nucleoside reverse transcriptase inhibitors (NNRTI) mode of action: non-competitive inhibition of viral RT 3 drugs currently approved Protease Inhibitors (PI) mode of action: inhibition of the viral protease 7 drugs currently approved 06/07/09 Dr.Sujnanendra Mishra

Nucleoside reverse transcriptase inhibitors (NRTI)

mode of action: Nucleoside analog (“wrong module”), requires intracellular activation

7 drugs currently approved

Non- nucleoside reverse transcriptase inhibitors (NNRTI)

mode of action: non-competitive inhibition of viral RT

3 drugs currently approved

Protease Inhibitors (PI)

mode of action: inhibition of the viral protease

7 drugs currently approved

Other ARVs for pMTCT? 3TC – Lamivudine d4T – Stavudine ddI – Didanosine TNF – Tenofovir Nelfinavir Saquinavir Indinavir Lopinavir/ritonavir 06/07/09 Dr.Sujnanendra Mishra NRTIs Nucleotide RTI Protease Inhibitors

3TC – Lamivudine

d4T – Stavudine

ddI – Didanosine

TNF – Tenofovir

Nelfinavir

Saquinavir

Indinavir

Lopinavir/ritonavir

The three-part regimen of prevention of perinatal HIV transmission by zidovudine (PACTG Protocol 076 [ Pediatric AIDS Clinical Trials Group] ) Before delivery : 100 mg 5 times a day orally (or 250-300 mg 2 times a day) starting from the 14th-34th week of pregnancy. During labor/ delivery : Intravenous injection in the first hour of delivery, 2 mg/kg, then 1 mg/kg per hour until the birth of the infant. For the newborn: starting 8-12 hours after birth, as syrup orally, 2 mg/kg every 6 hours over the first 6 weeks (if oral administration of the drug is not possible, it is used intravenously, 1.5 mg/kg every 6 hours ) Thi s regimen makes it possible to reduce perinatal HIV transmission by 68% (provided that the mother does not breastfeed the baby), i.e., the rate of HIV transmission to newborns falls to 7-8%. 06/07/09 Dr.Sujnanendra Mishra

Before delivery : 100 mg 5 times a day orally (or 250-300 mg 2 times a day) starting from the 14th-34th week of pregnancy.

During labor/ delivery : Intravenous injection in the first hour of delivery, 2 mg/kg, then 1 mg/kg per hour until the birth of the infant.

For the newborn: starting 8-12 hours after birth, as syrup orally, 2 mg/kg every 6 hours over the first 6 weeks (if oral administration of the drug is not possible, it is used intravenously, 1.5 mg/kg every 6 hours )

Thi s regimen makes it possible to reduce perinatal HIV transmission by 68% (provided that the mother does not breastfeed the baby), i.e., the rate of HIV transmission to newborns falls to 7-8%.

The short-course zidovudine regimen of prevention of perinatal HIV transmission Before delivery : 100 mg 5 times a day orally (or 250-300 mg 2 times a day) starting from the 34th-36th week During labor/ delivery : orally 250-300 mg every 3 hours until the birth of the infant For the newborn: the drug is not prescribed, artificial feeding is recommended Thi s prevention regimen reduces perinatal transmission by 30 - 50% 06/07/09 Dr.Sujnanendra Mishra

Before delivery : 100 mg 5 times a day orally (or 250-300 mg 2 times a day) starting from the 34th-36th week

During labor/ delivery : orally 250-300 mg every 3 hours until the birth of the infant

For the newborn: the drug is not prescribed, artificial feeding is recommended

Thi s prevention regimen reduces perinatal transmission by 30 - 50%

The regimen of prevention of perinatal HIV transmission by nevirapine For the woman in labor/ delivery: in the initial period of labor, 200 mg orally once For the newborn: as syrup orally, 2 mg/kg in the period between 48 and 72 hours after birth Thi s prevention regimen reduces perinatal transmission by 47% 06/07/09 Dr.Sujnanendra Mishra

For the woman in labor/ delivery: in the initial period of labor, 200 mg orally once

For the newborn: as syrup orally, 2 mg/kg in the period between 48 and 72 hours after birth

Thi s prevention regimen reduces perinatal transmission by 47%

The PETRA regimen of prevention of perinatal HIV transmission Zidovudine + lamivudine: For the woman from week 36 of pregnancy + during labor/delivery + 1 week for the mother and infant after birth reduction of perinatal transmission by 50% For the woman from week 36 of pregnancy + during labor/delivery reduction of perinatal HIV transmission by 37% . 06/07/09 Dr.Sujnanendra Mishra

Zidovudine + lamivudine:

For the woman from week 36 of pregnancy + during labor/delivery + 1 week for the mother and infant after birth

reduction of perinatal transmission by 50%

For the woman from week 36 of pregnancy + during labor/delivery

reduction of perinatal HIV transmission by 37% .

Prevention regimen s using ARV drugs with a rate of perinatal transmission below 2% HAART (USA) – 0 . 9% (Rate of planned cesarean section <40%) Zidovudine + lamivudine ( France ) – 1 . 6% (Rate of planned cesarean section >60%) 06/07/09 Dr.Sujnanendra Mishra

HAART (USA) – 0 . 9%

(Rate of planned cesarean section <40%)

Zidovudine + lamivudine ( France ) – 1 . 6%

(Rate of planned cesarean section >60%)

Prevention of perinatal HIV transmission in the management of labor/delivery Planned c esarean section performed before the onset of labor and the rupture of membranes; reduces the risk of HIV infection for the fetus. Surgical delivery, performed for emergency indications, is not a measure for the prevention of perinatal HIV transmission. Hemostatic cesarean section, a modification of planned surgical delivery that prevents contact of the skin and mucous membranes of the fetus with maternal blood and cervical/vaginal secretions, most effectively reduces the risk of HIV transmission. 06/07/09 Dr.Sujnanendra Mishra

Planned c esarean section performed before the onset of labor and the rupture of membranes; reduces the risk of HIV infection for the fetus.

Surgical delivery, performed for emergency indications, is not a measure for the prevention of perinatal HIV transmission.

Hemostatic cesarean section, a modification of planned surgical delivery that prevents contact of the skin and mucous membranes of the fetus with maternal blood and cervical/vaginal secretions, most effectively reduces the risk of HIV transmission.

Prevention of perinatal HIV transmission in the management of labor/delivery Amniotomy and episiotomy should not be done during the management of delivery via the natural maternal passages; the application of obstetrical forceps and vacuum extractor should be avoided; it is not desirable to carr y out induction and stimulation of labor. It is desirable to avoid all procedures which impair the integrity of the skin of the fetus or increase the possibility of contact of the fetus with the mother's blood (invasive monitoring). 06/07/09 Dr.Sujnanendra Mishra

Amniotomy and episiotomy should not be done during the management of delivery via the natural maternal passages; the application of obstetrical forceps and vacuum extractor should be avoided; it is not desirable to carr y out induction and stimulation of labor.

It is desirable to avoid all procedures which impair the integrity of the skin of the fetus or increase the possibility of contact of the fetus with the mother's blood (invasive monitoring).

Clinical scenarios for prevention of mother-to-child transmission of HIV (WHO recommendations , March 2004) Woman does not need treatment (asymptomatic HIV infection) For the mother - starting from the 28th week of pregnancy and during l abor/delivery : 1) zidovudine + lamivudine +(saquinavir/ritonavir or nelfinavir), if these drugs are available 2) zidovudine during pregnancy and labor/delivery, 300 mg orally twice daily + nevirapine at the beginning of labor /delivery , 200 mg once. + planned cesarean section at 38 weeks For the infant : zidovudine syrup, 4 mg/kg every 12 hours for 1 week OR nevirapine , 2 mg/kg once OR both drugs. 06/07/09 Dr.Sujnanendra Mishra

Woman does not need treatment (asymptomatic HIV infection)

For the mother - starting from the 28th week of pregnancy and during l abor/delivery :

1) zidovudine + lamivudine +(saquinavir/ritonavir or nelfinavir), if these drugs are available

2) zidovudine during pregnancy and labor/delivery, 300 mg orally twice daily + nevirapine at the beginning of labor /delivery , 200 mg once.

+ planned cesarean section at 38 weeks

For the infant :

zidovudine syrup, 4 mg/kg every 12 hours for 1 week

OR nevirapine , 2 mg/kg once

OR both drugs.

Clinical scenarios for prevention of mother-to-child transmission of HIV (WHO recommendations , March 2004) Woman does not need treatment (asymptomatic HIV infection) , alternative regimens without nevirapine 1) For the woman : zidovudine from the 28th week of pregnancy and during l abor/delivery For the infant : zidovudine syrup, 4 mg/kg orally every 12 hours for 1 week (if the woman has been provided prophylaxis for less than 4 weeks - the syrup is given to the infant longer up to 4 weeks) 2) For the woman zidovudine 300 mg + lamivudine 150 mg orally 2 times a day from the 34th–36th week of pregnancy and during l abor/delivery For the infant : zidovudine syrup 4 mg/kg + lamivudine syrup 2 mg/kg every 12 hours for 1 week . 06/07/09 Dr.Sujnanendra Mishra

Woman does not need treatment (asymptomatic HIV infection) , alternative regimens without nevirapine

1) For the woman : zidovudine from the 28th week of pregnancy and during l abor/delivery

For the infant : zidovudine syrup, 4 mg/kg orally every 12 hours for 1 week (if the woman has been provided prophylaxis for less than 4 weeks - the syrup is given to the infant longer up to 4 weeks)

2) For the woman zidovudine 300 mg + lamivudine 150 mg orally 2 times a day from the 34th–36th week of pregnancy and during l abor/delivery

For the infant : zidovudine syrup 4 mg/kg + lamivudine syrup 2 mg/kg every 12 hours for 1 week .

Clinical scenarios for prevention of mother-to-child transmission of HIV (WHO recommendations , March 2004) Woman needs treatment for her health: If HAART is unavailable - the same scenarios as for the case of absence of indications for treatment If HAART is available: # For the woman: ( zidovudine or stavudine) + lamivudine + nevirapine # For the infant : zidovudine or nevirapine or both drugs 06/07/09 Dr.Sujnanendra Mishra

Woman needs treatment for her health:

If HAART is unavailable - the same scenarios as for the case of absence of indications for treatment

If HAART is available:

# For the woman: ( zidovudine or stavudine) + lamivudine + nevirapine

# For the infant : zidovudine or nevirapine or both drugs

HAART during pregnancy It is desirable to start ART at the end of trimester I of pregnancy ; if the woman is severely ill, start treatment immediately. At the beginning of pregnancy - continue prior ART regimen (exception: in trimesters II and III of pregnancy, switch from ifavirenz to nevirapine or PI [protease inhibitor]. Stavudine + didanosine are not advisable during pregnancy (the risk of lactic acidosis is increased ). They can be prescribed only if there is no other choice. Nevirapine can cause hepatic toxicity and severe rash. The risk of these side effects is higher in women with a high CD4 lymphocyte count (> 250/ µL ) . 06/07/09 Dr.Sujnanendra Mishra

It is desirable to start ART at the end of trimester I of pregnancy ; if the woman is severely ill, start treatment immediately.

At the beginning of pregnancy - continue prior ART regimen (exception: in trimesters II and III of pregnancy, switch from ifavirenz to nevirapine or PI [protease inhibitor].

Stavudine + didanosine are not advisable during pregnancy (the risk of lactic acidosis is increased ). They can be prescribed only if there is no other choice.

Nevirapine can cause hepatic toxicity and severe rash. The risk of these side effects is higher in women with a high CD4 lymphocyte count (> 250/ µL ) .

Clinical scenarios for prevention of mother-to-child transmission of HIV (WHO recommendations , March 2004) A woman has not received prophylaxis , has arrived with labor pains; the diagnosis of HIV infection is established, or a positive express test result has been obtained in the labor ward: The woman is given 200 mg nevirapine once; delivery via the natural maternal passages The infant is given zidovudine syrup, 4 mg/kg every 12 hours for 4 weeks + nevirapine 2 mg/kg 1 time 72 hours after birth. 06/07/09 Dr.Sujnanendra Mishra

A woman has not received prophylaxis , has arrived with labor pains; the diagnosis of HIV infection is established, or a positive express test result has been obtained in the labor ward:

The woman is given 200 mg nevirapine once; delivery via the natural maternal passages

The infant is given zidovudine syrup, 4 mg/kg every 12 hours for 4 weeks + nevirapine 2 mg/kg 1 time 72 hours after birth.

Prophylaxis in relation to the time of an HIV-infected woman's visit to a women's clinic or maternity hospital For pregnant women who come in before week 28 of pregnancy : Starting week 28 – zidovudine 300 mg orally twice daily up to the beginning of labor/delivery . During labor/delivery – zidovudine 300 mg orally every 3 hours until the birth of the infant. For the newborn: zidovudine as syrup orally, 4 mg/kg every 12 hours for 7 days. 06/07/09 Dr.Sujnanendra Mishra

For pregnant women who come in before week 28 of pregnancy :

Starting week 28 – zidovudine 300 mg orally twice daily up to the beginning of labor/delivery .

During labor/delivery – zidovudine 300 mg orally every 3 hours until the birth of the infant.

For the newborn: zidovudine as syrup orally, 4 mg/kg every 12 hours for 7 days.

Prophylaxis in relation to the time of an HIV-infected woman's visit to a women's clinic or maternity hospital For pregnant women who come in after week 28 of pregnancy: up to the beginning of labor/delivery : Before labor/delivery – zidovudine 300 mg orally twice daily . During labor/delivery – zidovudine 300 mg orally twice daily until the birth of the infant + nevirapine 200 mg the beginning of labor/delivery. For the newborn: zidovudine as syrup, 4 mg/kg every 12 hours for 7 days + nevirapine 2 mg/kg for the first 72 hours. 06/07/09 Dr.Sujnanendra Mishra

For pregnant women who come in after week 28 of pregnancy: up to the beginning of labor/delivery :

Before labor/delivery – zidovudine 300 mg orally twice daily .

During labor/delivery – zidovudine 300 mg orally twice daily until the birth of the infant + nevirapine 200 mg the beginning of labor/delivery.

For the newborn: zidovudine as syrup, 4 mg/kg every 12 hours for 7 days + nevirapine 2 mg/kg for the first 72 hours.

Prophylaxis in relation to the time of an HIV-infected woman's visit to a women's clinic or maternity hospital For women in labor who have not undergone PMTCT with antiretroviral drugs during pregnancy : Nevirapine 2 00 mg orally once at the beginning of labor/delivery For the newborn: nevirapine as syrup orally, 2 mg/kg once at age 72 hours + retrovir syrup 4 mg/kg every 12 hours for 4 weeks 06/07/09 Dr.Sujnanendra Mishra

For women in labor who have not undergone PMTCT with antiretroviral drugs during pregnancy :

Nevirapine 2 00 mg orally once at the beginning of labor/delivery

For the newborn: nevirapine as syrup orally, 2 mg/kg once at age 72 hours + retrovir syrup 4 mg/kg every 12 hours for 4 weeks

Prophylaxis in relation to the time of an HIV-infected woman's visit to a women's clinic or maternity hospital If labor/delivery have taken place outside of a patient care facility: Prophylaxis is not prescribed for the woman. For the newborn: nevirapine as syrup orally, 2 mg/kg once at age 72 hours + retrovir syrup 4 mg/kg every 12 hours for 4 weeks 06/07/09 Dr.Sujnanendra Mishra

If labor/delivery have taken place outside of a patient care facility:

Prophylaxis is not prescribed for the woman.

For the newborn: nevirapine as syrup orally, 2 mg/kg once at age 72 hours + retrovir syrup 4 mg/kg every 12 hours for 4 weeks

Contraindications to the prescription of perinatal HIV prevention medicines Contraindications to the prescription of r etrovir : Granulocytopenia (below 0.75 thous/L) Anemia ( hemoglobin below 75 g/L) Thrombocytopenia (below 100 thous/L) ALAT and ASAT exceed the norm by a factor of 2.5 Creatinine exceeds the norm by a factor of 1.4 Contraindications to the prescription of nevirapine : Duration of pregnancy less than 28 weeks The woman has previously received nevirapine or NNRTIs [non-nucleoside reverse transcriptase inhibitors] Hypersensitivity to the drug Impaired liver function or ALAT exceeds the norm by a factor of 10 Impossibility of providing enteral nutrition 06/07/09 Dr.Sujnanendra Mishra

Contraindications to the prescription of r etrovir :

Granulocytopenia (below 0.75 thous/L)

Anemia ( hemoglobin below 75 g/L)

Thrombocytopenia (below 100 thous/L)

ALAT and ASAT exceed the norm by a factor of 2.5

Creatinine exceeds the norm by a factor of 1.4

Contraindications to the prescription of nevirapine :

Duration of pregnancy less than 28 weeks

The woman has previously received nevirapine or NNRTIs [non-nucleoside reverse transcriptase inhibitors]

Hypersensitivity to the drug

Impaired liver function or ALAT exceeds the norm by a factor of 10

Impossibility of providing enteral nutrition

Prophylaxis in relation to the time of an HIV-infected woman's visit to a women's clinic or maternity hospital Planned (elective) cesarean section is performed as a method of PMTCT provided the pregnant woman’s viral load is greater than 1000 HIV copies in 1 mL of blood plasma at week 38 of pregnancy before the onset of labor and before the rupture of membranes. In this case, the woman receives antiretroviral drugs according to one of the prophylaxis regimens . 06/07/09 Dr.Sujnanendra Mishra

Planned (elective) cesarean section is performed as a method of PMTCT provided the pregnant woman’s viral load is greater than 1000 HIV copies in 1 mL of blood plasma at week 38 of pregnancy before the onset of labor and before the rupture of membranes.

In this case, the woman receives antiretroviral drugs according to one of the prophylaxis regimens .

Prevention of perinatal HIV transmission in newborns The umbilical cord should be treated with a solution of chlorhexidine (aqueous or alcohol) before it is cut. The contents of the oral cavity, nose, and stomach of the infant should be suctioned carefully and meticulously. The initial cleansing of the infant is done very cautiously, in order not to injure the skin and to preclude rubbing secretions of the maternal birth passages into it. The infant should be submerged in a warm soapy solution, it should be washed off, and then rinsed with warm water. When abrasions are present on the newborn‘s skin, they are treated with a 3% solution of hydrogen peroxide, then with an alcohol solution of chlorhexidine; abrasions on the mucous membranes should be treated with an aqueous solution of chlorhexidine. 06/07/09 Dr.Sujnanendra Mishra

The umbilical cord should be treated with a solution of chlorhexidine (aqueous or alcohol) before it is cut.

The contents of the oral cavity, nose, and stomach of the infant should be suctioned carefully and meticulously.

The initial cleansing of the infant is done very cautiously, in order not to injure the skin and to preclude rubbing secretions of the maternal birth passages into it. The infant should be submerged in a warm soapy solution, it should be washed off, and then rinsed with warm water.

When abrasions are present on the newborn‘s skin, they are treated with a 3% solution of hydrogen peroxide, then with an alcohol solution of chlorhexidine; abrasions on the mucous membranes should be treated with an aqueous solution of chlorhexidine.

Strategy for the prevention of transmission of HIV from nursing mother to child The strategy includes : counseling the HIV-infected woman on issues relating to infant feeding the recommendation of artificial feeding free and continuous provision of high-quality adapted milk mixtures provision of safe water for the preparation of the milk mixture . 06/07/09 Dr.Sujnanendra Mishra

The strategy includes :

counseling the HIV-infected woman on issues relating to infant feeding

the recommendation of artificial feeding

free and continuous provision of high-quality adapted milk mixtures

provision of safe water for the preparation of the milk mixture .

HIV Testing for Infants HIV antibody tests reflect maternal antibody!!! Stays positive for 12-18 months Negative antibody test at 18 months definitively rules out MTCT Don’t use cord blood: may be contaminated with maternal blood 06/07/09 Dr.Sujnanendra Mishra

HIV antibody tests reflect maternal antibody!!!

Stays positive for 12-18 months

Negative antibody test at 18 months definitively rules out MTCT

Don’t use cord blood: may be contaminated with maternal blood

HIV Testing for Infants Current recommendation: HIV proviral DNA PCR test Sens/spec are excellent Specificity close to 100% at all time points Testing recommended at: 48 hours (sens 38%) 14 days (optional for high risk patients; sens 90%) 1-2 months (sen 96%) 3-6 months (99.9% sens) 06/07/09 Dr.Sujnanendra Mishra

Current recommendation:

HIV proviral DNA PCR test

Sens/spec are excellent

Specificity close to 100% at all time points

Testing recommended at:

48 hours (sens 38%)

14 days (optional for high risk patients; sens 90%)

1-2 months (sen 96%)

3-6 months (99.9% sens)

HIV Testing for Infants To rule OUT HIV: Need two negative viral tests One at 1 month or older One at 4 months or older Confirm with negative ab test at 18 months 06/07/09 Dr.Sujnanendra Mishra

To rule OUT HIV:

Need two negative viral tests

One at 1 month or older

One at 4 months or older

Confirm with negative ab test at 18 months

HIV Testing for Infants To rule IN HIV: Confirm a positive virologic test on a second specimen ASAP HIV infection diagnosed by two positive virologic tests on separate samples drawn at any age; or HIVab+ after 18 months 06/07/09 Dr.Sujnanendra Mishra

To rule IN HIV:

Confirm a positive virologic test on a second specimen ASAP

HIV infection diagnosed by

two positive virologic tests on separate samples drawn at any age; or

HIVab+ after 18 months

Rapid Testing in Labor CDC recommends routine rapid HIV testing for women in labor without documented HIV test EIA screening test Results in < 1hr 99-100% sensitive and specific Needs confirmatory Western blot It’s not too late to intervene! 06/07/09 Dr.Sujnanendra Mishra

CDC recommends routine rapid HIV testing for women in labor without documented HIV test

EIA screening test

Results in < 1hr

99-100% sensitive and specific

Needs confirmatory Western blot

It’s not too late to intervene!

Rapid Testing in Labor Positive Tests Positive predictive value ~50% (depending on local prevalence) Act on all positive rapid tests as true positives (until confirmatory test) Initiate meds in mom ASAP Consider using expanded regimen for mom and infant Consult local perinatal HIV experts or call the Perinatal Hotline 888 448-8765 06/07/09 Dr.Sujnanendra Mishra

Positive Tests

Positive predictive value ~50% (depending on local prevalence)

Act on all positive rapid tests as true positives (until confirmatory test)

Initiate meds in mom ASAP

Consider using expanded regimen for mom and infant

Consult local perinatal HIV experts or call the Perinatal Hotline 888 448-8765

Rapid Testing in Labor Sounds great but implementation can be difficult Requires coordination of health care providers, L&D, laboratory, hospital administration, risk management etc.. 06/07/09 Dr.Sujnanendra Mishra

Sounds great but implementation can be difficult

Requires coordination of health care providers, L&D, laboratory, hospital administration, risk management etc..

The Costs SD NVP Maternal concerns NVP resistance in up to 75% women after single dose Less likely to achieve maximal response to ARV therapy But if respond to ARV therapy, long term response good May be more likely to respond if wait > 6 months Infant concerns NVP resistance up to 50% after single infant dose Resistance higher if mother also received dose But transmission in subsequent pregnancies equivalent Unknown how this impacts infant response to ARV HAART Women on HAART 5x more likely to have LBW infant even when adjusted for HIV severity 06/07/09 Dr.Sujnanendra Mishra

SD NVP

Maternal concerns

NVP resistance in up to 75% women after single dose

Less likely to achieve maximal response to ARV therapy

But if respond to ARV therapy, long term response good

May be more likely to respond if wait > 6 months

Infant concerns

NVP resistance up to 50% after single infant dose

Resistance higher if mother also received dose

But transmission in subsequent pregnancies equivalent

Unknown how this impacts infant response to ARV

HAART

Women on HAART 5x more likely to have LBW infant even when adjusted for HIV severity

Conclusions PMTCT among BF women in resource-limited Indian settings remains major challenge BF assoc. with major reductions in infant mortality But accounts for over 1/3 HIV transmissions among BF women Early weaning (@4-6 mo.) currently recommended, but some data suggesting increased: Hospitalizations for gastroenteritis Growth faltering after weaning Resistance to NVP may complicate maternal/infant care & treatment Many studies ongoing to evaluate pMTCT interventions during BF 06/07/09 Dr.Sujnanendra Mishra

PMTCT among BF women in resource-limited Indian settings remains major challenge

BF assoc. with major reductions in infant mortality

But accounts for over 1/3 HIV transmissions among BF women

Early weaning (@4-6 mo.) currently recommended, but some data suggesting increased:

Hospitalizations for gastroenteritis

Growth faltering after weaning

Resistance to NVP may complicate maternal/infant care & treatment

Many studies ongoing to evaluate pMTCT interventions during BF

06/07/09 Dr.Sujnanendra Mishra Thanks for Saving me Let The FUTURE say ;

06/07/09 Dr.Sujnanendra Mishra PPTCT HELPS PROTECT THE FUTURE

06/07/09 Dr.Sujnanendra Mishra THANK YOU

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