At the end of November 2009 the WHO published a summary of its next recommendations to better prevent the transmission of HIV from mother to child. These revisions include new guidelines for using ARVs as prophylaxis as well as a different approach to infant feeding.

Earlier ART for pregant women
Like adults and adolescents pregnant women are eligible to take ARVs for their own health if they have less than 350 CD4/mm3, as opposed to 200 CD4/mm3 as recommended in earlier guidelines. If they do not need to be taking ARVs for their own health they should start ARV prophylaxis beginning in the 14th week of gestation rather than in the 28th week as it is currently recommended.

Reinforcing treatment for pregnant women and newborns
At minimum, a woman should take AZT during pregnancy and at best she should be on triple therapy.  The newborn will take prophylaxis for 6 weeks after birth (AZT or NVP).

 Safer breastfeeding practices
If the mother has been on triple therapy prophylaxis she should continue this regimen after her child is born through the final week after she has stopped breastfeeding. If triple therapy is not available, the newborn should be given NVP prophylaxis until one week after all exposure to breast milk has ended.

The end of early weaning at 6 months
While making breastfeeding safer by taking ARVs, the WHO sanctions breastfeeding for 12 months, and maintains the recommendation that infants exclusively breastfeed for the first six months. The baby’s diet can start to be diversified after 6 months. The infant can be weaned gradually over the course of a month while still taking ARVs for one week after breastfeeding has ended. If after 12 months the infant is infected with HIV the guidelines recommend that the child continue to breastfeed until s/he is at least 2 years of age.
These new recommendations are based on studies which indicated that these regimens were well-tolerated and that they were effective in reducing vertical transmission of HIV (expected to be less than 5%). They have the added advantage of simplifying infant feeding options which currently complicate the difficult choice between breastfeeding (often without the added protection of ART) and formula feeding: even if infant formula is safer it remains expensive, difficult to implement, stigmatising and associated with significant morbidity and mortality; in addition, early weaning at 6 months is often linked to malnutrition and mortality.

Local counsellors and staff will need intensive updating on these new guidelines so that they can be prepared to provide pregnant women with the information on which these new practices are based. In fact, a certain number of women have already personally experienced or seen in their communities, successful comprehensive care—in other words, babies who have been fed formula not contracting HIV. Even so, some staff still need to be convinced of the effectiveness of safer breastfeeding. 
Some worry that infants who take monotherapy as prophylaxis for several months and still become infected, will then have to be on more cumbersome medicines later. Data on drug tolerance (to which the infant will have already been exposed for several months) needs to be better understood.

We also witnessed an increasing desire to be pregnant on the part of women living with HIV and staffs are aware of and accept this desire. Some women’s pregnancies occur closer and closer together—which makes us wonder about the effect of taking ARVs on and off for prolonged periods due to successive pregnancies-- specifically the risk of developing resistance when adherence is poor-- as well as potential treatment difficulties-- when women need to be on ARVs for their own health. These factors make it clear that staffs need support to adequately implement quality comprehensive care for the mother and child, particularly when it comes to ARV adherence, as well as the necessity for drugs to be continually available on sites.

These new recommendations will have to be locally adapted and integrated in MTCT prevention protocols and national guidelines regarding HIV-exposed infants; they imply considerable changes in daily practice as well as on a functional level.  Meanwhile they allow for a simplified approach in the nutritional care of newborns.

Now that decentralizing paediatric care is imperative—with hospitals becoming overloaded—this simplification could contribute to the success of scaling up this sensitive stage of treatment.

A good way to start improving access to early diagnostics and paediatric ARVs in West and Central Africa is to document what is currently available. GROWING UP staff called on its partners in Africa who are in the best position to explain the situation locally.

Twelve organizations completed the same survey for three consecutive years (2007, 2008 and 2009), enabling us to paint a picture of access to paediatric ARVs (on-site availability and methods of purchase and distribution), early testing through PCR and ready to use therapeutic food at sites where children and their parents go for comprehensive care.

While we wait for the full results to be published in an upcoming issue (a telephone survey to consolidate and complete the information and the full analysis are underway) here are some preliminary results:

- Access to paediatric first line ARV combinations is improving (AZT or D4T + 3TC + LPV/r or NVP or EFV), but available forms (liquid) are still difficult to administer or not up to date with WHO recommendations.
In the form of fixed dose combinations (FDC), only half of the sites have access to 1st line paediatric drugs.
D4T+3TC+NVP in FDC (‘Triomune baby’ and ‘Triomune junior’) is most commonly available, and therefore most often prescribed. It is available at 10 sites out of 12, 3 of which experienced interruptions in supply (Bamako, Brazzaville and Douala). It is unavailable at the sites of Bouaké and Moundou. In 2007, it was available only at the Bamako site.
AZT+3TC+NVP in FDC, recommended over D4T-based combinations, is available at 5 sites out of 12, one of which experienced supply interruptions (Brazzaville). It is unavailable at Cotonou, Bouaké, Bobo-Dioulasso, Lomé, Moundou and Douala. In 2007 and 2008, it was available at none of the sites.

LPV/r (recommended for newborns exposed to NVP at birth), is still inaccessible at Sikasso, Moundou, Brazzaville and Douala, with an availability punctuated by interruptions in Bobo-Dioulasso.
LPV/r 80+20mg/ml in drinkable solution is available without interruption at 6 sites.
Paediatric doses of LPV/r 100+25mg in pill form are available without interruption on only 2 sites (Pointe Noire and Yaoundé).

For sites where FDCs are not available, paediatric combinations of AZT or D4T+3TC+NVP are available only in the form of three separate drugs (generally drinkable formulas and occasionally in pill form in paediatric doses).  We see frequent supply interruptions of these separate drugs in Bobo-Dioulasso, Moundou, Brazzaville and Douala.
To deal with interruptions in drug supply, site administrators try to maintain emergency recourse to provisional supplies purchased outright, substituting ARVs by other ARVs or by replacing paediatric forms with crushing or sectioning adult doses. But these « ad-hoc solutions » are not without risk for children and do not resolve everything...

- Early diagnostics of newborns exposed to HIV, equally recommended by the WHO for early initiation of ART (before the age of 6 months, if possible) where HIV infection has been detected, are available at half of the sites surveyed. Therefore half of the sites surveyed continue to rely on clinical criteria to start ART in infants.
In 2009, the results of the study show that early diagnostics with reasonable timing for return of test results (less than two months) are available at only 6 sites. In 2007, early testing was available at 4 sites out of the 8 surveyed so there has been few progress.

At 4 sites (Bobo-Dioulasso, Moundou, Douala and Brazzaville) early testing is available but with a turn-around time for results that is longer than two months, which undermines the point of doing the test. 

The test is not available at all at sites in Cotonou nor at one site in Lomé.

We conclude that despite the progress made between 2007 and 2009, the availability of first line paediatric ARVs remains inadequate. Progress in terms of accessing early testing for infants is slow and practical obstacles to availability and to reasonable turn around times for test results remain numerous.
Other critical factors such as the availability of lab tests, cotrimoxazole prophylaxis (paediatric cotrimoxazole) and nutritional care and support will be studied in 2010.

Based on this assessment GROWING UP plans to do the following, throughout 2010:
- Share this « mapping of availability of paediatric ARVs » with people working in paediatric comprehensive care in Africa (using the Growing Up newsletter and website).
- Mobilize support to address the gaps detected at Growing Up partners’ sites.
- Lobby national institutions and international organizations to improve the availability of paediatric ARVs and early testing for infants exposed to HIV in Africa.

Classification of first line paediatric ARVs in order of their availability at the 12 sites surveyed in 2009