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.