Newsletter GRANDIR | La lettre d’information sur le VIH pédiatrique en Afrique

Fixed dose combinations (FDCs) simplify adherence to ARV therapy because several medicines are combined in a single pill. Over a year ago, Growing Up Info announced that pediatric FDCs would soon be available. What has happened since then?

The most common first-line FDC (d4T+3TC+NVP) is now available in pediatric formulations manufactured by two Indian pharmaceutical companies. Doses differ slightly among the versions depending on the manufacturer:

• Cipla manufactures Triomune-Baby (d4T 6mg + 3TC 30mg + NVP 50mg) and Triomune-Junior (d4T 12mg + 3TC 60mg + NVP 100mg) ;
• Ranbaxy manufactures Triviro-LNS-Kid (d4T 5mg + 3TC 20mg + NVP 35mg) and Triviro-LNS-Kid-DS (d4T 10mg + 3TC 40mg + NVP 70mg).

Both medications are currently in the process of being pre-qualified by the WHO.

All these products are dispersible. The manufacturers have paid particular attention to their taste. UNITAID and the Clinton Foundation negotiated a price reduction to $60 per year in 34 resource-limited countries. UNITAID and the Clinton Foundation, with support of the WHO, have come up with simplified and standardized doses based on weight from 3kg to 35 kg (see dosage chart). Cipla's Triomune Baby can be taken by children weighing as little as 3kg but Triviro-Kid manufactured by Ranbaxy is recommended for children who weigh at least 7kg. It is worth noting that Cipla has also developed a version of its combination without Nevirapine, and that Ranbaxy will soon follow suit. This pediatric combination of d4T+3TC will be particularly helpful during the 14 day initiation of ART, when a reduced dose of NVP is recommended to prevent risks of rashes.

These two pediatric FDCs represent an important development. However, according to the WHO, the ratios of elements in the medicines that Cipla and Ranbaxy sell are not completely optimal. The ideal combination would be: d4T 7mg + 3TC 30mg + NVP 55mg. Until this ideal combination is developed, Triomune-Baby and Triviro-Kid are recommended for use.

Finally, it is important to remember that in 2006, the WHO endorsed pediatric usage of adult FDCs, including the combination d4T 30mg + 3TC 150mg + NVP 200mg (Triomune-30 from Cipla / Triviro-LNS-30 from Ranbaxy) in treating children who weigh more than 10kg. Scored tablets are preferable so as to facilitate the division into half quantities.

Triomune-Baby and Triviro-Kid are undoubtedly a real advance for children living with HIV. What is important now is to make sure that these products are made available locally. Those involved in care and treatment of children living with HIV/AIDS should encourage their central medicine stores to obtain these products as soon as possible, including in countries not involved in the UNITAID program.

As far as research is concerned, it is crucial that more FDCs are developed that include other molecules. The WHO has just compiled a priority list.

Yassinmé Elysée Somasse, from Médecins du Monde's program in Benin, provided the most complete answer to the case study quiz that we published in issue 11 of Growing Up Info ! Here is his answer :

«1) Edward (4-months-old) should be presumed to be HIV+ because this HIV-exposed infant (his mother is HIV+) shows clinical signs which point to stage 3 of the WHO classification of paediatric HIV infection. In addition he has severe immunodeficiency : CD4<20%. The single doses of Nevirapine, that both Edward and his mother received, don't rule out that HIV could have been transmitted from the mother to the child. Without access to lab data, these elements together should be enough to establish HIV infection until the contrary is proven.

2) Antiretroviral therapy should be prescribed for Edward because at this age (less than 2 years old), HIV-related infant mortality remains high. Additionally, this child has developed a severe form of HIV infection (probable transmission in utero).

3) Presuming that Edward is HIV+, we will advise his mother to continue breastfeeding until he is one year old and even beyond that, if necessary. This does not exclude diversifying his feeding at the age of 6 months. The child should continue to be given cotrimoxazole. Finally, it is important to set up a treatment and follow-up schedule for Edward and his mother.»

Bravo Yassinmé Elysée Somassé ! We agree that there is enough evidence to presume HIV infection in Edward's case. His level of immunosuppression argues for the commencement of ART, even without a confirmation by a biological exam. However, it is necessary to confirm the diagnosis as soon as possible (HIV-PCR as soon as possible or HIV-antibody screening at 18 months). It is also necessary to exclude TBinfection (case finding among family members is recommended). Breastfeeding should be continued : a study in Zambia showed that the survival rate of HIV+ children who continued to breastfeed beyond four months was higher than the survival rate of HIV+ children who were weaned at four months and received replacement feeding. Data from other cohorts show similar results. Exclusive breastfeeding should be continued until 6 months according to WHO current recommendations, then diversification should be started at 6 months.

A case study : Trésor, 14.

Trésor is 14 year old. He is living with HIV. Since his parents died, he has been taken in by his aunt. A few months ago his aunt told her children and the neighborhood children that Trésor is HIV positive. Since then Trésor has been shunned by his cousins and neighbors who are afraid that he will contaminate them if they come near him.
Trésor is very upset by the situation and has decided not to live with his aunt anymore. He has stopped taking his ARV medication that he has been taking for three years. He sees no way out of his predicament and is contemplating suicide.
Trésor confided in his social worker and explained the decisions he had taken. What propositions can the social worker offer to help Trésor?

Send your answers to grandir@sidaction.org and win a book on HIV/AIDS!
This case study was given to us by Julien Makaya, general secretary of the Congolese NGO Serment Merveil (Brazzaville, Congo)

Many of you deal with various aspects of prevention and treatment of children infected by HIV in your daily practice. In the literature that is currently available, it is not always easy to find clear and concrete answers to the problems that you face. That is why we decided to develop fact sheets to help you deal easily and quickly with various issues : diagnosis and testing, comprehensive care and follow up, counseling/psychosocial support, ARV therapy, nutrition, and mother to child transmission. Each fact sheet introduces a specific theme with a real or fictional case study and a possible solution.
Check out the fact sheets already on line at our new Growing Up Website. For the moment they are only available in French, but they will be translated into English by the end of June.

1 : Index of fact sheets: introduction, goals, intended audience
2a : HIV disclosure: why is this important?
2b : HIV disclosure to children: by whom, when, and how?
3 : Cotrimoxazole as prophylaxis: for all HIV-exposed infants?

New fact sheets will be regularly published in French and in English in the next few months.