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NANASI 49: October 2006

In this issue of NANASI:
==========================
•    Case Study: Pregnant, HIV positive woman
•    World Health Organization 2006 PMTCT Guidelines: A summary
•    Medicine Prices: for the essential medicines in this issue of NANASI
===========================
________________________________________
Case Study: Pregnant HIV positive woman
Sharifa arrives at the labour and delivery ward 40 weeks pregnant.  She gives you her ANC card which shows she attended a PMTCT clinic. She also has a medical record sheet from an HIV clinic (CCC), which says she has been taking d4T, 3TC, and NVP for one year. She went into labour one hour ago and this is her first child. 
Do you need to test her for HIV?
What else do you want to know about this client?
Do you give her ARV prophylaxis?
Do you give ARV prophylaxis to the infant?
What procedures do you want to avoid during delivery?
What additional counselling does she need?
Discuss the case as a group, and then refer to the comments on the back page of this newsletter
________________________________________
Prevention of Mother to Child Transmission of HIV
World Health Organization (WHO) Guidelines, 2006
The goal of WHO PMTCT guidelines is the elimination of HIV infection in infants and young children to pave the way towards an HIV-free and AIDS-free generation across the globe. This will be achieved through a comprehensive strategic approach with 4 components:
1.    Primary prevention of HIV infection;
2.    Prevention of unintended pregnancies among women living with HIV;
3.    Prevention of HIV transmission from mothers to their infants;
4.    Care, treatment and support for mothers living with HIV, their children and families.
All four components must be implemented in order to maximize the effectiveness of the programs and reach the overall goal of improving maternal and child health in the context of HIV. This approach is built around the routine offer of HIV testing and counseling to all pregnant women, ARV prophylaxis for PMTCT and counseling and support for infant feeding, and priority ART initiation for all pregnant women, their children and families that are eligible.
The guidelines strongly recommend that every pregnant woman living with HIV should have her clinical stage assessed and, where available, her CD4 cell count done in order to determine her eligibility for ART. The main purpose is to address the health of the pregnant woman herself. Additional benefits of providing ART to this group of women are: 1) substantially reducing the risk of transmitting HIV to her baby, and 2) minimizing the consequences of resistance from the use of single dose nevirapine-containing prophylactic regimens for the prevention of MTCT.
You may meet the following scenarios, and these are the recommendations:
1. Women who become pregnant while receiving ARV treatment:
•    In this case continue the treatment but observe the regimens she is on.
•    For women who become pregnant while receiving an efavirenz containing regimen and are in the first trimester of pregnancy, efavirenz should be stopped and replaced with nevirapine (NVP), with close monitoring for NVP-related liver toxicity in those women who have higher CD4 cell counts. Alternatively a triple NRTI -based(1) or PI -based(2) regimen could be used.
•    Women who are receiving efavirenz and are in the second or third trimester of pregnancy can continue with their treatment.
•    For women who become pregnant while receiving a tenofovir-containing regimen, the benefits of continuing the regimen are likely to outweigh the risks of toxicity for the infant and medicine substitution is not recommended.
•    Infants born to women who are receiving antiretroviral therapy should receive zidovudine (AZT) for 7 days.
2. Pregnant women with indications for ARV treatment
•    Treatment should be offered after all considerations.
•    ARV treatment will not only address their health and well-being but also dramatically reduce the risk of MTCT, particularly for women who are at an advanced stage of AIDS.
•    The recommended regimen is AZT, lamivudine (3TC) and NVP. Their infants should be offered AZT 4mg/kg BID for 7 days, beginning immediately after delivery.
•    If the mother has received less than 4 weeks of ART during pregnancy, then the infant should be given AZT for 4 weeks instead of 1 week.
3. Pregnant women who are not yet eligible for ART
The recommended ARV regimen consists of:
•    antepartum - AZT 300mg BID from 28 weeks of pregnancy or as soon as possible thereafter;
•    intrapartum - single dose-NVP (Sd-NVP) 200mg and AZT 300 mg at onset of labor and every 3 hours until delivery (3) and 3TC 150mg at onset of labour and every 12 hours until delivery;
•    postpartum - AZT 300mg BID for 7 days and 3TC 150mg BID for 7 days for the woman.  For the infant Sd-NVP 2mg/kg (or 6mg) immediately after delivery and AZT 4mg/kg BID for 7 days.
•    If the woman receives at least 4 weeks of AZT during pregnancy: omission of the mother's Sd-NVP may be considered. If it is not given to the mother, she will not require intrapartum 3TC or postpartum AZT and 3TC (as these are given to prevent NVP resistance).  The Sd-NVP for the infant must still be given immediately at birth, but then 4 weeks instead of 7 days of AZT is recommended.
•    If the mother receives less than 4 weeks of AZT during pregnancy: 4 weeks instead of 1 week of AZT is recommended for the infant.
•    When Sd-NVP is used to prevent MTCT, either alone or in combination with AZT: the woman should be given AZT and 3TC intrapartum and for 7 days postpartum to prevent resistance to nevirapine.
•    When delivery occurs within 2 hours of a woman taking Sd-NVP: the infant should receive Sd-NVP immediately after delivery and AZT for four weeks.
4. Women living with HIV who are in labour and who have not received ARV prophylaxis
The recommended regimen is:
•    intrapartum - Sd-NVP 200mg and AZT 300 mg at onset of labor and every 3 hours until delivery (4) and 3TC 150mg at onset of labour and every 12 hours until delivery;
•    postpartum - AZT 300mg BID for 7 days and 3TC 150mg BID for 7 days for the woman.  For the infant, Sd-NVP 2mg/kg (or 6mg) immediately after delivery and then AZT 4mg/kg BID for four weeks.
•    If delivery is expected imminently: the Sd-NVP dose for the mother should be omitted, and the same recommendations apply as for infants born to women living with HIV who do not receive antenatal or intrapartum ARV prophylaxis.
•    When delivery occurs within 2 hours of the woman taking Sd-NVP: the infant should receive Sd-NVP immediately after delivery and AZT for four weeks.
5. Infants born to women living with HIV who have not received ARVs during pregnancy or labour
•    For the infant: Sd-NVP 2mg/kg immediately after delivery and AZT 4mg/kg BID for four weeks are recommended because this regimen results in a greater reduction in transmission than just Sd-NVP
•    ARV prophylaxis for infants born to women living with HIV who had not received antenatal or intrapartum ARV prophylaxis should begin immediately after delivery or at least within 12 hours.
(The full article can be found at: http://www.who.int/hiv/pub/guidelines/pmtct/en/index.html   ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS IN RESOURCE-LIMITED SETTINGS: TOWARDS UNIVERSAL ACCESS)
(1) NRTI = nucleoside reverse transcriptase inhibitor
(2) PI = protease inhibitor
(3) an alternative dose for the AZT is 600 mg at onset of labour
(4) an alternative dose for the AZT is 600 mg at onset of labour
________________________________________
Answer to the case study from page 1
You do not need to test this woman for HIV again because her cards from the PMTCT and HIV clinics mean that she has been tested and that she is HIV positive. 
Effective ARV treatment should reduce the mother's viral load so there is a lower chance that the virus will be transmitted to the infant. This assumes Sharifa is taking her medicines as directed. The first thing to check is whether Sharifa is actually taking these medicines and when she took her last dose.
Sharifa's regimen requires her to take her medicines twice a day. If she has been taking her medicines, she should keep to the same schedule during labour and delivery and will not need ARV prophylaxis. If you have evidence that she is not adhering to treatment, provide her with prophylaxis according to the national guidelines.
The baby should receive ARV prophylaxis, regardless of whether the mother is taking her medicines properly. The recommended regimen for infants born to women who are receiving ART is AZT for 7 days. (But if the mother had received less than 4 weeks of ART during pregnancy, then the infant should be given AZT for 4 weeks instead of 1 week.)
You should use standard precautions and avoid invasive obstetrical procedures like premature rupture of membranes, episiotomy, and vacuum extraction.
Additional counselling would include counselling about safer infant feeding, contraception, the need for cotrimoxazole prophylaxis, and other issues such as recognition and treatment of opportunistic infections, adherence support for ART, and diagnosis of HIV infection in the infant.

Medicine Prices for the Essential Medicines Found in this Issue*

Medicine

Strength and Formulation

Pack Size

Approximate Price (Ksh)*

AZT

300mg tablet

60

815 (generic)

AZT

50mg/5mL oral suspension

100mL

155 (generic)

3TC

150mg tablet

60

515 (generic)

AZT/3TC

300/150mg tablet

60

1575 (generic)

NVP

200mg tablet

60

563 (generic)

NVP

50mg/mL oral suspension

100mL

152 (generic)

efavirenz

600mg tablet

30

2032 (innovator brand)

d4T/3TC/NVP

30 or 40/150/200mg tablet

60

1737 (generic)

 
* average prices from MEDS (August 2006) and CHMP (May 2006)
NANASI is produced by AfriAfya, HAI Africa, and staff from Columbia University's International Center for AIDS Care and Treatment Programs.  NANASI is funded by Liverpool VCT.

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In this issue of NANASI:

==========================

  • Case Study: Pregnant, HIV positive woman
  • World Health Organization 2006 PMTCT Guidelines: A summary
  • Medicine Prices: for the essential medicines in this issue of NANASI

===========================


Case Study: Pregnant HIV positive woman

Sharifa arrives at the labour and delivery ward 40 weeks pregnant.  She gives you her ANC card which shows she attended a PMTCT clinic. She also has a medical record sheet from an HIV clinic (CCC), which says she has been taking d4T, 3TC, and NVP for one year. She went into labour one hour ago and this is her first child. 

Do you need to test her for HIV?
What else do you want to know about this client?
Do you give her ARV prophylaxis?
Do you give ARV prophylaxis to the infant?
What procedures do you want to avoid during delivery?
What additional counselling does she need?

Discuss the case as a group, and then refer to the comments on the back page of this newsletter


Prevention of Mother to Child Transmission of HIV
World Health Organization (WHO) Guidelines, 2006

The goal of WHO PMTCT guidelines is the elimination of HIV infection in infants and young children to pave the way towards an HIV-free and AIDS-free generation across the globe. This will be achieved through a comprehensive strategic approach with 4 components:

  1. Primary prevention of HIV infection;
  2. Prevention of unintended pregnancies among women living with HIV;
  3. Prevention of HIV transmission from mothers to their infants;
  4. Care, treatment and support for mothers living with HIV, their children and families.

All four components must be implemented in order to maximize the effectiveness of the programs and reach the overall goal of improving maternal and child health in the context of HIV. This approach is built around the routine offer of HIV testing and counseling to all pregnant women, ARV prophylaxis for PMTCT and counseling and support for infant feeding, and priority ART initiation for all pregnant women, their children and families that are eligible.

The guidelines strongly recommend that every pregnant woman living with HIV should have her clinical stage assessed and, where available, her CD4 cell count done in order to determine her eligibility for ART. The main purpose is to address the health of the pregnant woman herself. Additional benefits of providing ART to this group of women are: 1) substantially reducing the risk of transmitting HIV to her baby, and 2) minimizing the consequences of resistance from the use of single dose nevirapine-containing prophylactic regimens for the prevention of MTCT.

You may meet the following scenarios, and these are the recommendations:

1. Women who become pregnant while receiving ARV treatment:

  • In this case continue the treatment but observe the regimens she is on.
  • For women who become pregnant while receiving an efavirenz containing regimen and are in the first trimester of pregnancy, efavirenz should be stopped and replaced with nevirapine (NVP), with close monitoring for NVP-related liver toxicity in those women who have higher CD4 cell counts. Alternatively a triple NRTI -based(1) or PI -based(2) regimen could be used.
  • Women who are receiving efavirenz and are in the second or third trimester of pregnancy can continue with their treatment.
  • For women who become pregnant while receiving a tenofovir-containing regimen, the benefits of continuing the regimen are likely to outweigh the risks of toxicity for the infant and medicine substitution is not recommended.
  • Infants born to women who are receiving antiretroviral therapy should receive zidovudine (AZT) for 7 days.

2. Pregnant women with indications for ARV treatment

  • Treatment should be offered after all considerations.
  • ARV treatment will not only address their health and well-being but also dramatically reduce the risk of MTCT, particularly for women who are at an advanced stage of AIDS.
  • The recommended regimen is AZT, lamivudine (3TC) and NVP. Their infants should be offered AZT 4mg/kg BID for 7 days, beginning immediately after delivery.
  • If the mother has received less than 4 weeks of ART during pregnancy, then the infant should be given AZT for 4 weeks instead of 1 week.

3. Pregnant women who are not yet eligible for ART

The recommended ARV regimen consists of:

  • antepartum - AZT 300mg BID from 28 weeks of pregnancy or as soon as possible thereafter;
  • intrapartum - single dose-NVP (Sd-NVP) 200mg and AZT 300 mg at onset of labor and every 3 hours until delivery (3) and 3TC 150mg at onset of labour and every 12 hours until delivery;
  • postpartum - AZT 300mg BID for 7 days and 3TC 150mg BID for 7 days for the woman.  For the infant Sd-NVP 2mg/kg (or 6mg) immediately after delivery and AZT 4mg/kg BID for 7 days.
  • If the woman receives at least 4 weeks of AZT during pregnancy: omission of the mother's Sd-NVP may be considered. If it is not given to the mother, she will not require intrapartum 3TC or postpartum AZT and 3TC (as these are given to prevent NVP resistance).  The Sd-NVP for the infant must still be given immediately at birth, but then 4 weeks instead of 7 days of AZT is recommended.
  • If the mother receives less than 4 weeks of AZT during pregnancy: 4 weeks instead of 1 week of AZT is recommended for the infant.
  • When Sd-NVP is used to prevent MTCT, either alone or in combination with AZT: the woman should be given AZT and 3TC intrapartum and for 7 days postpartum to prevent resistance to nevirapine.
  • When delivery occurs within 2 hours of a woman taking Sd-NVP: the infant should receive Sd-NVP immediately after delivery and AZT for four weeks.

4. Women living with HIV who are in labour and who have not received ARV prophylaxis

The recommended regimen is:

  • intrapartum - Sd-NVP 200mg and AZT 300 mg at onset of labor and every 3 hours until delivery (4) and 3TC 150mg at onset of labour and every 12 hours until delivery;
  • postpartum - AZT 300mg BID for 7 days and 3TC 150mg BID for 7 days for the woman.  For the infant, Sd-NVP 2mg/kg (or 6mg) immediately after delivery and then AZT 4mg/kg BID for four weeks.
  • If delivery is expected imminently: the Sd-NVP dose for the mother should be omitted, and the same recommendations apply as for infants born to women living with HIV who do not receive antenatal or intrapartum ARV prophylaxis.
  • When delivery occurs within 2 hours of the woman taking Sd-NVP: the infant should receive Sd-NVP immediately after delivery and AZT for four weeks.

5. Infants born to women living with HIV who have not received ARVs during pregnancy or labour

  • For the infant: Sd-NVP 2mg/kg immediately after delivery and AZT 4mg/kg BID for four weeks are recommended because this regimen results in a greater reduction in transmission than just Sd-NVP
  • ARV prophylaxis for infants born to women living with HIV who had not received antenatal or intrapartum ARV prophylaxis should begin immediately after delivery or at least within 12 hours.

(The full article can be found at: http://www.who.int/hiv/pub/guidelines/pmtct/en/index.html   ANTIRETROVIRAL DRUGS FOR TREATING PREGNANT WOMEN AND PREVENTING HIV INFECTION IN INFANTS IN RESOURCE-LIMITED SETTINGS: TOWARDS UNIVERSAL ACCESS)

(1) NRTI = nucleoside reverse transcriptase inhibitor
(2) PI = protease inhibitor
(3) an alternative dose for the AZT is 600 mg at onset of labour
(4) an alternative dose for the AZT is 600 mg at onset of labour


Answer to the case study from page 1

You do not need to test this woman for HIV again because her cards from the PMTCT and HIV clinics mean that she has been tested and that she is HIV positive. 
Effective ARV treatment should reduce the mother's viral load so there is a lower chance that the virus will be transmitted to the infant. This assumes Sharifa is taking her medicines as directed. The first thing to check is whether Sharifa is actually taking these medicines and when she took her last dose.

Sharifa's regimen requires her to take her medicines twice a day. If she has been taking her medicines, she should keep to the same schedule during labour and delivery and will not need ARV prophylaxis. If you have evidence that she is not adhering to treatment, provide her with prophylaxis according to the national guidelines.

The baby should receive ARV prophylaxis, regardless of whether the mother is taking her medicines properly. The recommended regimen for infants born to women who are receiving ART is AZT for 7 days. (But if the mother had received less than 4 weeks of ART during pregnancy, then the infant should be given AZT for 4 weeks instead of 1 week.)

You should use standard precautions and avoid invasive obstetrical procedures like premature rupture of membranes, episiotomy, and vacuum extraction.
Additional counselling would include counselling about safer infant feeding, contraception, the need for cotrimoxazole prophylaxis, and other issues such as recognition and treatment of opportunistic infections, adherence support for ART, and diagnosis of HIV infection in the infant.

Medicine Prices for the Essential Medicines Found in this Issue*

Medicine

Strength and Formulation

Pack Size

Approximate Price (Ksh)*

AZT

300mg tablet

60

815 (generic)

AZT

50mg/5mL oral suspension

100mL

155 (generic)

3TC

150mg tablet

60

515 (generic)

AZT/3TC

300/150mg tablet

60

1575 (generic)

NVP

200mg tablet

60

563 (generic)

NVP

50mg/mL oral suspension

100mL

152 (generic)

efavirenz

600mg tablet

30

2032 (innovator brand)

d4T/3TC/NVP

30 or 40/150/200mg tablet

60

1737 (generic)

* average prices from MEDS (August 2006) and CHMP (May 2006)

NANASI is produced by AfriAfya, HAI Africa, and staff from Columbia University's International Center for AIDS Care and Treatment Programs.  NANASI is funded by Liverpool VCT.

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Contact Information

Health Action International (HAI) Africa Office
4th Floor, Top Plaza off Kindaruma Road Suite 4-2
P.O Box Nairobi - Kenya
Tel: +254 20 2692973 ext 108, Cell phone: + 254 0733 398654.
E-mail:info@haiafrica.org, Web:http:// www.haiafrica.org