New PMTCT protocol

(to start in mid september 2010)

Background
Elimination of vertical transmission (GOAL) Possibility of New standard of quality care

and interventions for low and middle income countries Avoid high child mortality rate after 6months. Protection of children through breastfeeding

What is currently done

What is new

Advantages of the new protocol on Infant feeding

Chance for the child to continue benefiting

from breastfeeding(breast milk),No need to stop breastfeeding early. Increase mother-baby contact (affection) Avoid infant mortality rate due to malnutrition especially after 6 month when mothers was told to stop breastfeeding. Protected breastfeeding with ARVs.

Comparison of the current and the new protocols for non eligible women
Current
Mono therapy (AZT) Short period (3

New
Triple therapy (TDF

month) Starting period : 28 weeks Non protected breastfeeding

based) Long period (2 years) Starting period : 14 weeks Protected breastfeeding

I.PMTCT Protocol
1. HIV + pregnant women eligibles to ART for their

own health.
All women with CD4 <350 without considering

WHO clinical stage and alll women in stage 3 and 4 without considering their CD4 count are eligible to ART. This treatment must start as soon as possible without considering gestational age.

I. PMTCT Protocol(cont)
The regimen :
Tenofovir 300mg + Lamivudine 300mg + Nevirapine 200mg ( TDF + 3TC + NVP)

Women with renal failure will

receive:
Abacavir 300mg+ Lamivudine 150 mg + Nevirapine200mg: (ABC+ 3TC + NVP) NB: The treatment is for life.

I. PMTCT Protocol(cont)
2.

HIV +pregnant women with CD4 between 350 and 500 (RWANDA)

All these women should be considered

as eligible to ART for life. Start

tripletherapy at 14 weeks of pregnancy.

(this is to avoid the discontinuation of ART for women who will be eligible sooner and who should get pregnant again and restart ARV.) The regimen:
Tenofovir 300mg + Lamivudine 300mg + Efavirenz 600mg :

I.PMTCT Protocol(cont)
3.

HIV + pregnant women not eligible to ART.

All women with CD4 >500 are not

eligibles to ART. Start tripletherapy at 14 weeks of pregnancy up to the weaning time. The recommended period of breastfeeding is 18 months . The regimen:
Tenofovir 300mg + Lamivudine 300mg et Efavirenz 600mg :
(TDF + 3TC + EFV )

I. PMTCT Protocol(cont)
4. HIV+ pregnant women previously exposed to single dose of NVP will receive :
Tenofovir 300mg + Lamivudine 300mg

+Lopinavir/Ritonavir (Kaletra) 250mg

(TDF + 3TC + Lop/r)

NB: ARV prophylaxis will be stopped one week after weaning.

5.HIV + pregnant women with renal failure. Regimen: Abacavir 300mg+ Lamivudine 150 mg + Efavirenz 600mg:
(ABC+ 3TC + EFV)

I.PMTCT Protocol(cont)
Women with renal failure and who had

been previously exposed to Sd NVP will receive: Abacavir 300mg+ Lamivudine 150 mg +Lopinavir/Ritonavir (Kaletra)
250mg (ABC+ 3TC + Kaletra) NB:

Follow up of the renal funtion is

very important. ARV prophylaxis will stop one week after weaning.

I.PMTCT Protocol(cont)
6.HIV + pregnant women coming late for ANC: above 34 weeks of pregnancy Start TDF + 3TC + EFV after renal function test (Creatinine) without waiting for CD4 count result. After CD4 count result: CD4 <500 /mm3:eligible to ART for life . CD4 > 500/mm3: continue the same regimen up to the weaning time (one week after weaning).

I. PMTCT Protocol(cont)
. HIV - pregnant women in discordant couple . HIV testing after every 3 months and
7

during labor.
If still

Sd TDF+3TC+EFV then continue TDF+3TC during one week after delivery.

HIV negative ,she will receive during labor:

If HIV positive: CFR to above section (Care

and treatment for HIV+ pregnant women)

Children from discordant couples would take

daily NVP up to weaning time (one week after weaning). If the women turns POSITIVE during breastfeeding period, she should start ARV tripletherapy and the child should continue daily Nevirapine(NVP) for 6 weeks

I.PMTCT Protocol(cont)
Prophylaxis to HIV exposed infants Breasfeeding and non-

breastfeeding children. Daily Nevirapine (NVP) syrup for 6 weeks.

New protocol SUMMARY

SCENARIOS CD4<350 CD4 between 350-500 CD4>500 Coming >34 weeks of pregnancy-labor

REGIMENS MOTHERS TDF+3TC+NVP TDF+3TC+EFV TDF+3TC+EFV TDF+3TC+EFV

DURATION For life From 14 weeks of pregnancy - for life From 14 weeks of pregnancy - weaning Start immediately then adjust the TTT after CD4 count result. Depends on the CD4 count.

Previously exposed to Sd TDF+3TC+Lop/r(Kaletra) NVP HIV negative in discordant Testing every 3 months couple and at labor. If still HIV -:Sd TDF+3TC+EFV then TDF+3TC for 1 week If turns HIV +:triple therapy according to CD4 count results CHILDREN Born to HIV + mother Daily NVP

Birth6 weeks of life

Follow up of HIV +woman on ARV prophylaxis.

After initiation of ARV prophylaxis: Control of liver (ALAT) and renal (Creatinine) function tests at1month (M1), 3 months (M3) and at 6 months (M6) for women on tripletherapy. In case of toxicity to NVP or suspicion : transfer for medical advise. In case of toxicity to NVP in 1st term of pregnancy replace with kaletra and at 2nd term replace with EFV. CD4 count control will be done every 6months for allwomen on tripletherapy

II.Follow-up of HIV exposed infants.

Biological
PCR at 6 weeks Serology at 9 and18 months.

Growth monitoring and nutrition

status

18months:Weigh,height,neurological evaluation,infection. Nutritional status. Medical Cotrimoxazole : start at 6 weeks up to definitive HIV negative status. If the child turns HIV positive: transfert to pediatric care and treatment.

Monthly up to

PCR 6 semaines.
Si la PCR 1 est ngative, continuer le suivi et faire

une srologie 9 mois. Si la PCR 1 est positive, confirmer par une 2me PCR mais en mme temps dbuter la PEC en donnant les ARVS chez lenfant en attendant la PCR de confirmation (car le rsultat de la PCR de confirmation peut trainer).
Si la PCR de confirmation revient ngative, refaire une

3me PCR pour reconfirmer: Si la 3 me PCR de reconfirmation revient ngative: donc erreur de la PCR1, stopper la PEC pdiatrique dj initie et faire la srologie 9 mois. Si la 3 me PCR de reconfirmation revient positive, continuer la PEC pdiatrique dj initie et rfrer dans le service de PEC ARV pdiatrique. Si la PCR de confirmation revient positive, continuer la PEC pdiatrique dj initie et rfrer dans le service de PEC ARV pdiatrique.

Srologie 9 mois
Tout enfant avec une PCR 1 ngative ou si la PCR na pas t disponible le test de srologie sera fait comme suit et selon lalgorithme national:Le test de srologie 9 mois. Si la srologie est positive, confirmer par une PCR (car possibilit de la prsence des anticorps maternels), si la PCR de confirmation est positive rfrer en PEC (pdiatrique). Si la srologie 9 mois est ngative, continuer la prise en charge en cours et refaire une dernire srologie 18 mois.

Srologie 18 mois
Si la srologie est positive, confirmer par

une PCR. Si la PCR est galement positive, lenfant est dclar positif et est transfr en prise en charge (pdiatrique) Si la srologie 18 mois est ngative et que lenfant ne tte plus, il est directement dclare ngatif et sort du programme. NB: Pour les enfants qui sont allaits au del de 16 mois, la srologie sera faite un mois et demi aprs larrt complet de lallaitement.

Medical Follow up.

Le Cotrimoxazole doit tre donn

systmatiquement chaque enfant n de mre sropositive partir de 6 semaines de vie. Cest ce mme moment que lenfant doit aussi bnficier de la 1re PCR (DBS) et de la 2me vaccination. La dure du traitement dpendra de la confirmation du rsultat ngatif de la PCR ou de la srologique VIH chez lenfant. Et si le rsultat est confirm positif, lenfant sera rfr dans le service de prise en charge pdiatrique.

III.Family plannig.
Start counseling on FP during

pregnancy. Integration of FP and HIV(especially PMTCT)services. Avail and provide FP methodes :especially long term methods. Promote and encourage dual protection.

Questions & Answers

(1)
Duration of BF maximal or minimal (for

Rwanda PMTCT program)

R/18 months is the recommended maximum

duration of breastfeeding but mothers can wean their infants even before this period if the AFASS conditions are met. All this breastfeeding period is protected by ARVs.

Procedures of weaning : R/ The mother should stop breastfeeding gradually; this should take a period of 1 month. She will start the gradually process from 17 month maximum. Counseling will be provided to the mother to make sure that she had completely stop breastfeeding. She need to understand that after declaring that she had stopped breastfeeding she will no longer receive the treatment for protection of her child.

(2)
Time to test the children:
R/ Ideal is to do PCR/DBS at 6 weeks but if

not done PCR will be done at the first visit between 6 weeks and 9 months or in case of clinical indication. Serology at 9 months. Serology at 18months for all the children weaned up to 16 months but for children weaned after 16 months, the serology will be done 6 weeks after complet weaning.
When to stop ARVs prophylaxis for

mothers?
R/ ARVs will be stoped ONE WEEK after

Follow up of women: where?

and how?

R/ Where: For full package HF: i twill be done in PMTCT/C&T services. For PMTCT stand aloneit will be done in PMTCT services. R/How: Entry point for PMTCT is ANC, dossier is done lab

tests taken, drugs refilling every month, clinical assessment and ANC visits.

Criteria of readiness of sites to

implement new protocol:

R/Trained staff (task shifting/decentralized

training) Refresher training (with the support of partners and district Hospitals) Drug requisition tools available on site and

If a woman is already on current

protocol, what will be done when the new one starts?

R/ For the non eligible woman, shift to

tripletherapy after assessing the liver and the renal functions. For the eligible already on tripletherapie: dont change the regimen unless this is side effect. The women has to continue the same regimen.

THANK YOU