The needs of children living with HIV, especially in resource poor settings, are tragically apparent - from stories from our partners on the ground to studies and reports from AIDS and children's organizations. To address the problems, we are asking pharmaceuticals to build on their existing research to make child-friendly formulations of their medicine widely available and affordable.
Our specific asks were first developed in August 2008 with information from the World Health Organization, the International Federation of Pharmaceutical Manufacturers & Associations, and Médecins Sans Frontières.
These asks will be updated as we received new information.
Abbott (USA)
Abbott produces ritonavir (brand name NORVIR®), and a combination of lopinavir and ritonavir (brand name KALETRA®). Both are protease inhibitors (PIs) and they are currently available in syrup form needing refrigeration with prices in line with adult formulation. NORVIR® is indicated for use in children above 2 years old and its pediatric formulation consists in 80mg/ml flavored oral solution x bottle of 90ml (5 bottles in one package). However, its use in children as a sole PI is limited by its high incidence of toxicity; the poor palatability of the liquid preparation; and the limited shelf-life of the oral solution. KALETRA® is indicated for use in children above 6 months. Its pediatric formulation is in oral solution with 80mg/ml (lopinavir) and 20mg/ml (ritonavir) x bottle of 60ml. These products are available in 69 countries including all African countries and low developed countries.
Abbott has said it is developing a low-dose tablet form suitable for children, but does not have a timetable for this.
We appreciate the steps Abbott has already taken, and call on it to develop a timetable that expedites development of heat stable tablets of lopinavir/ritonavir and ritonavir. We also call on Abbott to ensure their medicines are available in developing countries at an affordable price.
Boehringer Ingelheim (Germany)
Boehringer Ingelheim makes nevirapine (brand name VIRAMUNE®). Nevirapine is a non-nucleoside reverse transcriptase inhibitors and it is important in preventing mother-to-child transmission. It is indicated for use in children at birth and/or in children older than 2 years of age. The pediatric formulation is available in 50mg/ml oral suspension liquid formulation x bottle of 240 ml. The syrup is a similar price to the adult formulation. The 20 ml bottle is free of charge in DCs since July 2000.
We call on Boehringer Ingelheim to produce a low-dose pill form of nevirapine that is widely available and affordable.
Bristol-Myers Squibb (USA)
BMS makes didanosine (brand name VIDEX®), didanosine (brand name VIDEX®EC), and stavudine (brand name ZERIT®). They are NRTIs. VIDEXEC is available in capsule formulation only. BMS produces a 2g VIDEX® pediatric powder for oral solution and chewable/dispersible buffered tablets. Stavudine is available in 1mg/ml 200 mg cherry-flavored powered for oral solution x bottle 200ml. The didanosine low-dose formulation is priced in line with the adult formulation, but for stavudine it is significantly higher. The three products are available at non-profit price in low-income countries and Sub-Saharan Africa (65 countries) through BMS Access Initiative.
BMS also makes atazanavir (brand name REYATAZ®). It is a newer drug and does not have any formulation for children.
We appreciate the steps BMS has already taken and call on it to produce a low-dose pill formulation of atazanavir that is widely available and affordable. We also call on BMS to make their existing products affordable.
GlaxoSmithKline (UK)
GSK makes a pediatric formulation of lamivudine/zidovudine (brand name COMBIVIR®) for use in children of 14 Kg or above. It is a nucleoside reverse transcriptase inhibitors (NRTIs). This medicine is a scored tablet, approved by the EMEA in November 2007, but not yet available in developing countries. GSK also makes lamivudine (brand name EPIVIR®), zidovudine (brand name RETROVIR®) and abacavir (brand name ZIAGEN®). These medications are NRTIs. The pediatric formulations of these antiretroviral medicines are available at not-for-profit price in 64 countries, all low-developed countries and Sub-Saharan Africa, plus all projects fully funded by the Global Fund to fight AIDS, TB and Malaria, and through PEPFAR. EPIVIR® can be used in children above 3 months. It is available in a 19mg/ml strawberry banana-flavored syrup x 240 ml bottle, and in a scored tablet for children of 14 kg or above. RETROVIR® is indicated for use in children above 3 months old and neonates in prevention of MTCT. The pediatric formulation of zidovudine (RETROVIR®) is available in 10mg/ml strawberry-floured syrup x 200ml bottle. ZIAGEN® is suitable for children above 3 months in oral strawberry/banana flavored solution 20mg/ml x bottle of 240 ml, and in scored tablet for children of 14 kg and above. Lamivudine, zidovudine and abacavir are generally well tolerated in children. They are recommended as a first line drug as part of combination therapy for the treatment of HIV infection in children. GSK makes also a pediatric formulation of Telzir (fosamprenavir) a PI. It is indicated for use in children older than 6 years in the European Union (with low dose ritonavir), and in children older than 2 years in the United States. It is available in oral suspension of 50 mg/ml. This pediatric indication has been recently approved by the EMEA, but it is not yet available in developing countries.
We appreciate the steps GSK has already taken, and we call on GSK to produce low-dose pill formulations of abacavir, lamivudine, zidovudine, lamivudine/abacavir, lamivudine/zidovudine and abacavir/lamivudine/zidovudine, and to study the effects on children of all their medicines. We also call on GSK to make its pediatric ARVs available and affordable in all developing countries.
