Providing ARVs to children in resource limited settings “Current practice in Thailand” Thanyawee Puthanakit, MD Assistant Professor in Pediatrics Research Institute for Health Sciences, Chiang Mai University, Thailand

HIV/AIDS situation in Thailand Population = 65 millions No. of PLWH Adults = 700,000 Children = 30,000 HIV prevalence in pregnant women = 1.04% Perinatal transmission rate = 2 - 3%

Outline Scale-up of national program Special issues of pediatric ARV program Outcome of HAART in Thai children Challenges of national program

Scale-up of ARV Program in Thailand Components Thailand program Political will National program since 2000 Set target 50,000 by end of 2004 Universal access by 2006 Availability of drugs Generic drugs Public health approach Integrate to existing health care services Equal access Phased-approach

Model of Pediatric HIV Care Harmonize with adult program Treatment guideline, first-line regimen Supply chain of ARV Separate M&E system Multiple entry points Pediatric OPD and IPD services PMTCT program Related service; adult ARV program

Patients on ARV in national program As of May 2006 Total = 77,758 Pediatric = 5,848 Thai MOPH

Appropriate formulations d4T 5 mg/ml 3TC 10 mg/ml NVP = GPOvir 60 tab/bottle d4T (30 mg) + 3TC (150 mg)+ NVP (200 mg) 5 cm 1 cm

Caregivers & Family support

Outcome of HAART in Thai children Clinical outcomes ? Complications? Survival rate ? Hospitalization rate? CD4 Immune recovery ? HIV viral suppression ?

Baseline patient characteristics August 2002 to March 2005 Number: 192 children Age: 7.6 years (range 0.4 to 14.8) CD4 percentage 5.3% (SD 4.9) HIV RNA 5.4 log10 copies/mL (SD 0.5) ARV regimen: d4T+3TC+NVP or EFV

Before Clinical outcomes 2 mo 12 mo 18 mo

Complications after HAART Drug adverse events Nevirapine: rash 23% (8% substitute with EFV) Efavirenz: transient CNS 26%, rash 7% d4T: lipodystrophy 20-40% Immune reconstitution inflammatory syndrome Incidence 19% Common organisms: mycobacterial (non-TB,TB), herpes virus (HSV, VZV), cryptococcus Puthanakit et al. Clin Infect Dis 2005;41: 100-7 Puthanakit et al. Pediatr Infect Dis J 2006; 25:53-8

The survival curve after HAART after first 6 months of HAART Survival rate = 94.3% after first 6 months of HAART Puthanakit et al. Clin Infect Dis 2006 ( in revision)

Hospitalization rate after HAART 54 % Pneumonia, bacterial infection 29 % IRIS 10 % Opportunistic infections Puthanakit et al. Clin Infect Dis 2006 ( in revision)

Immunological outcomes after HAART Puthanakit et al. Clin Infect Dis 2005;41: 100-7

HIV viral suppression after HAART Virological success: HIV viral load < 50 copies/mL Puthanakit et al. Clin Infect Dis 2005;41: 100-7

Challenges of national program Programmatic challenges National registry of HIV-infected children Roll-out program to community hospitals Clinical management challenges Early treatment of infant < 12- 18 mo. Psychosocial & adherence esp. adolescent Second-line regimens

Conclusions Scale-up of Pediatric ARV program in developing countries are feasible The outcome of ARV therapy is similar to what observed in developed countries

Acknowledgements Dr. Virat Sirisanthana Dr. Thira Sirisanthana Dr. Penninah Oberdorfer Dr. Linda Aurpibul Dr. Noppadol Akaratham Dr. Pornphan Wannarit Dr. Suparat Kanchanavanich Dr. Sunchai Chayasombat Thai Ministry of Public Health Thai Government Pharmaceutical Organization Faculty of Medicine, Chiang Mai University Research Institute for Health Sciences, Chiang Mai University Fogarty International Center, National Institute of Health