WHO recommendations on Prevention of Mother-to …...Prevention of HIV infection in pregnant women,...

Prevention of HIV infection in pregnant women, mothers and their children 2008 Towards Universal Access

WHO recommendations on Prevention of Mother-to-Child Transmission of HIV and the

Mother-Baby Pack

Dr Tin Tin SintMedical Officer - PMTCT

HIV Department

Joint WHO/UNAIDS Informal Consultation with Pharmaceutical Companies

Geneva, 16 December 2008


Geographical distribution of HIV burden

Sub-Saharan Africa• 68% of PLHA, 76% of HIV mortality• Almost 61% of adults living with HIV in 2007 were women• 8 southern African countries contribute 1/3 all HIV incidence and mortality• 1-in-6 to 1-in-7 PLHA is South African

Presenter

Presentation Notes

Epidemiological evidence indicates that sexual HIV transmission continues to be the major mode of transmission in developing countries, leading to high prevalence of HIV infection in women of childbearing age (Schmid et al. 2004).


HIV mother-to-child transmission: countries with highest burden

• Nearly 90% of all HIV- positive children live in sub-Saharan Africa

• Well over 90% are infected through mother- to-child transmission


Source: Black et al 2003

HIV/AIDS: an important cause of mortality in children aged less than five years in sub-

Saharan AfricaWorld distribution of under-five deaths

Each dot represents

5000 deaths

Presenter

Presentation Notes

HIV/AIDS is an increasingly important cause of mortality in children aged less than five years in Africa (Dabis & Ekpini 2002; Walker et al. 2002). Before the antiretroviral therapy (ART) era, child mortality due to HIV was estimated to be 35.2% by age one year and 52.5% by two years of age among HIV-infected children in a meta-analysis, which pooled information from the African clinical trials that aimed to assess the efficacy of interventions to reduce MTCT. Mortality varied by geographical region, and was associated with maternal death, maternal CD4 cell counts <200µl, and infant HIV infection and its timing. In HIV-infected children, mortality was significantly lower for those with late infection than those with early infection (Newell et al. 2004).


Prevention-of-mother-to-child transmission of HIV: WHO guidelines


Interventions to prevent mother-infant HIV transmission, by timing

HIV testing & counsellingARV to mother

ARV to newbornAvoid episiotomy and forcepsARVs to mother

Exclusive BF for 6 months No BF

Antenatal Labour & delivery Postpartum

Primary prevention of HIV infectionPrevention of unwanted pregnancies among HIV-infected women

Before pregnancy

ARV to mother

Presenter

Presentation Notes

PMTCT programmes include testing and counseling, antiretroviral therapy for HIV-infected pregnant women who require treatment for their own health or, for those who do not yet require ART, provide highly effective antiretroviral prophylaxis. Women identified with HIV require additional services during pregnancy, labour and delivery and in the postpartum. During pregnancy HIV-infected women require either ART or ARV prophylaxis for MTCT prevention depending whether or not they have indications for ART; cotrimoxazole prophylaxis if eligible; screening for and treatment of tuberculosis infection; nutritional counselling and care; and psychosocial support.


Perinatal HIV transmission

• Background transmission risk: 15-45%– 15-30% risk during pregnancy and delivery– 10-20% additional risk postpartum via breastfeeding

• Transmission risk with interventions:– 20 - 25% No breastfeeding– 15 - 25% Short-course ARV breastfeeding – ~ 6% Short-course ARV, post partum ARV 6 mo, breastfeeding – 2 - 4 % Short-course ARV, no breastfeeding– 1% 2 or 3 ARV’s + elective C-section, no breastfeeding


Recommendations for a Public Health Approach

2006

Antiretroviral Drugs for Treating Pregnant Women and

Preventing HIV Infection in Infants in Resource-Limited

Settings

Presenter

Presentation Notes

It must however be noted that for countries/settings without capacity to provide the WHO recommended regimen, singe dose NVP will still remain an interim option while systems for delivery of more effective regimen are being put in place. All countries in Sub-Saharan Africa have adopted the WHO recommended guidelines for use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants.


Recommended first-line ARV regimens for treating pregnant women and prophylactic regimen for infants

Mother

Antepartum AZT + 3TC + NVP twice daily

Intrapartum AZT + 3TC + NVP twice daily

Postpartum AZT + 3TC + NVP twice daily

Infant AZT x 7 days*

* If the mother receives < 4 wks of ART during pregnancy, give 4 wks of infant AZT


* If the woman receives at least 4 wks of AZT during pregnancy: omission of maternal NVP dose may be considered in which case infant should receive 4 wks of AZT; and women do not require 7-day tail of AZT and 3TC. ** If the mother receives < 4 wks of AZT during pregnancy, 4 weeks of infant AZT recommended The infant NVP dose must be given immediately at birth

ARV prophylactic regimens for HIV-infected pregnant women

Ranking Time of administrationPregnancy Labour Postpartum

Maternal Infant

Recommended AZT (>28 wks)

Sd-NVP *+

AZT/3TC

AZT/3TC x 7 days*

Sd NVP +

AZT x 7 days *

Alternative AZT (>28 wks)

Sd-NVP Sd NVP + AZT x 7 days **

Minimum--

Sd-NVP + AZT/3TC

AZT/3TC x 7 days

Sd NVP

Minimum -- Sd-NVP Sd NVP

Presenter

Presentation Notes

AZT + 3TC => no risk of NVP resistance Sd NVP + AZT + 3TC => effective in breast feeding populations


Prevention of Mother To Child Transmission of HIV

Zidovudine, Nevirapine and Lamivudine: first line HIV drugs used for PMTCT Cotrimoxazole: drug to prevent opportunistic infections

or

Counseling to Mum on infant

feeding

Continued infant feeding counseling &

support to Mum

CD4-testing: to determine stage of HIV-disease and needfor treatmentPCR-testing: to determine HIV status in childrenART: Antiretroviral Treatment (only when indicated by CD4- testing or clinical assessment)

If Mum HIV- positive, CD4- testing and/or

clinical assessment

(staging) takes place and

Cotrimoxazole provided for 12

months

If no need for ART,

Mum given Zidovudine

(from 28 weeks)

Mum at labor: single

dose Nevirapine

and Zidovudine

START: Recommend HIV testing at first ANC

visit

Mum: Zidovudine + Lamivudine (7

days) and referral for HIV

care

Baby: single dose

Nevirapine + Zidovudine for

7 days

At 6 weeks:

Baby: PCR testing to

determine HIV status. If HIV

infected, refer to ART

Provide Cotrimoxazole

for up to 2 years or until HIV risk

can be excluded

ART provided to Mum if needed on

basis of CD4 result or clinical

assessment

Mum: Zidovudine + Lamivudine (7 days) and referral for HIV care

Baby: single dose Nevirapine plus Zidovudine for 4 weeks

If Mum received no or less than 4 weeks of Zidovudine

If Mum received 4 or more weeks of Zidovudine


Objectives of the Mother-Baby Pack

• Improve/increase PMTCT uptake• Reduce interruptions in access to ARVs and

Cotrimoxazole :– High incidence of first ANC visit, but sharp decrease in follow-up– Low rate (50%) of delivery in health facilities– Complexity of PMTCT regimen

• Facilitate adherence• Provide HIV Care and Treatment to both Mother and

Baby• Improve procurement, distribution and supply chain

management– Forecasting difficulties when managing products separately– Supply chain difficulties when managing products separately


The Ideal Pack

• Has all the medicines required• Is user friendly, manageable• One pack per mother/baby• Is usable outside of clinical setting• Holds incentives to encourage ANC/HIV clinic

attendance• Includes medicines that are stable, easy to use

and not bulky


Pack contents - Medicines

During pregnancy• AZT 300mg: at least 200 tablets • CTX 960mg at least 100 tablets (or 200 tablets of 480mg)

During delivery• sd NVP 200mg one tablet• sd NVP 10mg/ml + dosing syringe • AZT 300mg two tablets• 3TC 150mg at least two tablets

After Delivery• AZT/3TC 300+150mg 20 tablets • AZT 10mg/ml + dosing syringe (100 ml bottle) (1 or 4

weeks )• CTX 960mg (mother) at least 70 tablets (up to first post natal 6 weeks)• CTX 100+20mg (baby) at least 70 tablets (to be started after 6

weeks of age)


AntepartumDuring pregnancy

PostpartumAfter delivery

IntrapartumDuring delivery

Zidovudine tablets

Cotrimoxazole tablets

Zidovudine + Lamivudine tablets & Cotrimoxazole tablets (mother)

Zidovudine syrup & Cotrimoxazole (baby)

Nevirapine (single dose),Zidovudine, Lamivudine tablets (mother)

Nevirapine Single Dose syrup (baby)

Pack Content

Will also include various (visual) guides/road maps, instructions and other relevant information


Links

WHO pages: http://www.who.int/hiv/mtct/en/index.html

Guidelines on PMTCT and antiretroviral therapy: http://www.who.int/hiv/pub/guidelines/pmtctguidelines3.pdf

UNICEF:www.unicef.org/supply

http://www.unicef.org/supply


Acknowledgement

• Bianca Kamps, Contracts Manager HIV/AIDS and Malaria, UNICEF, Copenhagen

• Atieno Ojoo, Technical Officer HIV/AIDS and Malaria, UNICEF, Copenhagen


THANK YOU

WHO recommendations on Prevention of Mother-to …...Prevention of HIV infection in pregnant women,...

Documents

Transcript of WHO recommendations on Prevention of Mother-to …...Prevention of HIV infection in pregnant women,...