Home            Past Issues            About IP            About IAP           Author Information            Subscription            Advertisement              Search  

   
Correspondence

Indian Pediatr 2016;53: 932-933

Non-availability of Pediatric Formulations of Antiretroviral Drugs

 

Ira Shah

Pediatric HIV Clinic, BJ Wadia Hospital for Children, Mumbai, India.
Email: [email protected]

 


In September 2015, World Health Organization (WHO) released a guideline whereby it was recommended that all HIV-infected children should be put on life-long anti-retroviral therapy (ART) irrespective of age, clinical manifestations and CD4 counts [1]. Tenofovir (TDF) is now recommended for use in children, and older molecules like stavudine are being phased out [1]. As part of Prevention of mother-to-child transmission (PMTCT) of HIV, pregnant women are now put on life-long triple drug ART and their babies after birth are started on daily nevirapine (NVP) or zidovudine (AZT) for 4-6 weeks while their mothers breastfeed them. This was labelled as option B+ [2].

National AIDS Control Organization (NACO) in India adopted the option B+ PMTCT guidelines recommended by WHO for public sector in India in 2013 [3]. However, India has the largest private healthcare system in the world with over 80-85% physicians practising in the private sector [4]. Thus, to achieve the goal of eliminating pediatric HIV, it is important that the private sector is also involved in management of HIV-infected women and children.

The antiretroviral drugs are currently are procured by NACO from the pharmaceutical companies based on the bid process [5]. However, physicians in private sector prescribe the medication that is then dispensed by the chemist. Unfortunately, in the last few months, the pharmaceutical companies have gradually stopped manu-facturing the pediatric formulations. Initially, syrup formulations of AZT, lamivudine (3TC), nevirapine (NVP) and lopinavir/ritonavir (LPVr) were available in India and fixed drug combinations (FDC) of stavudine (d4T) and 3TC were available. However, currently, no liquid formulation of AZT, 3TC and NVP or the FDC are available in the private sector. The other NRTI like TDF and abacavir (ABC) are available only as adult formulations. Moreover, as part of PMTCT, if a baby has to be prescribed AZT or NVP, we are back to good old days of pulverising the adult tablet of NVP (200 mg) into 6 mg sachet and dispensing to the newborn. Thus, currently we are left with no pediatric formulation of antiretrovirals except for LPVr. This has created an immense problem in treating HIV-exposed and infected children. This had led to even delay in starting the NVP prophylaxis in HIV-exposed infants while the parents search for the pediatric formulation.

Thus, in order to achieve the goal of "Getting to zero", it is imperative that pediatric formulations are available for all. We seem to be heading towards the initial days of HIV epidemic – where drugs were just not available. With this grim scenario as the ground reality, it would not be unusual to expect a rise in pediatric HIV in the near future.

References

1. World Health Organization (WHO). Guideline on When to Start Antiretroviral Therapy and on Pre-exposure Prophylaxis for HIV. September 2015, Geneva. Available from: http://apps.who.int/iris/bitstream/10665/186275/1/9789241509565_eng.pdf?ua=1. Accessed June 2, 2016.

2. World Health Organization (WHO). Use of Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants. April 2012, Geneva. Available from: http://apps.who.int/iris/bitstream/10665/70892/2/WHO_HIV_2012.6_eng.pdf. Accessed June 2, 2016.

3. National Aids Control Organization (NACO). Prevention of Parent to Child Transmission (PPTCT) of HIV using Multi Drug Anti-retroviral Regimen in India. December 2013, New Delhi. Available from: http://naco.gov.in/upload/NACP%20-%20IV/18022014%20BSD/National_Guidelines_for_PPTCT.pdf. Accessed June 2, 2016.

4. Loh LC, Ugarte-Gil C, Darko K. Private sector contributions and their effect on physician emigration in the developing world. Bull WHO. 2013;91:227-23.

5. National Aids Control Organization (NACO). Available from: http://www.naco.gov.in/upload/2015%20MSLNS/Minutes_of_the_Pre-bid_meeting_ARV_Paediatric-08-2015.pdf. Accessed June 2, 2016.

 

Copyright © 1999-2016 Indian Pediatrics