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The Pediatric Antiretroviral Pipeline

September 2011

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The Drugs for Neglected Diseases Initiative

As a postscript to the pediatric pipeline, it deserves a mention that the Drugs for Neglected Diseases Initiative (DNDi) recently decided to add pediatric HIV to its portfolio. DNDi is a needs-driven, nonprofit, research and development organization founded in 2003 by partners including MSF and five public-sector research institutions. As the name suggests, the DNDi develops new treatments for the most neglected patients. DNDi's focus to date has been on visceral leishmaniases, Chagas disease, sleeping sickness (human African trypansomiasis, or HAT), and malaria. With its partners DNDi has introduced the first new treatment for HAT in 25 years and two inexpensive, field-adapted treatments for malaria.

DNDi was called on by various organizations, including MSF and UNITAID, to apply its expertise to the needs of children with HIV who are under three years old, NNRTI-exposed or -unexposed, and in need of first-line therapy, regardless of prior antiretroviral exposure.

They have come up with a target product profile that includes appropriate dosage forms usable across WHO weight bands, high genetic barriers to resistance, no cold chain needed, well tolerated, no lab monitoring required, and affordable. Any treatment would ideally be compatible with TB medicines.

We welcome DNDi's involvement and hope that it will usher in a promising new antiretroviral regimen -- and at faster pace than we have become used to.


References

  1. Treatment Action Group, Pipeline Report 2010. New York: Treatment Action Group, 2010.
  2. Waning B et al. The global pediatric antiretroviral market: Analyses of product availability and utilization reveal challenges for development of pediatric formulations and HIV/AIDS treatment in children. BMC Pediatrics, 17 October 2010.
  3. UNAIDS, Report on the global AIDS epidemic. Geneva, Switzerland: UNAIDS, 2010.
  4. Clinton Health Access Initiative. Personal communication, May 2011.
  5. World Health Organization. Antiretroviral therapy for HIV infection in infants and children: Towards universal access. Recommendations for a public health approach. Geneva, Switzerland: World Health Organization, 2010.
  6. Drugs for Neglected Diseases initiative. Needs assessment for paediatric R&D. Geneva, Switzerland: Drugs for Neglected Diseases Initiative, 2011.
  7. Palumbo P et al. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med 2010;363:1510-20.
  8. Palumbo P et al. NVP- vs LPV/r-based ART among HIV+ infants in resource-limited settings: The IMPAACT P1060 trial. 18th CROI, Boston, February 2011. Oral abstract 129LB.
  9. Coovadia A et al. Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: A randomized controlled trial JAMA 2010;304:1082-90.
  10. Kuhn L et al. Long-term outcomes of switching children to NVP-based therapy after initial suppression with a PI-based regimen. 18th CROI, Boston, February 2011. Oral abstract 128.
  11. PENPACT-1 (PENTA 9/PACTG 390) Study Team. First-line antiretroviral therapy with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor and switch at higher versus low viral load in HIV-infected children: An open-label, randomised phase II/III trial. Lancet Infect Dis. 2011;11(4):273-83.
  12. Pursuing Later Treatment Options II (PLATO II) Project Team for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE). Risk of triple-class virological failure in children with HIV: A retrospective cohort study. Lancet 2011;377(9777): 1580 - 1587
  13. Medical Research Council, Clinical Trials Unit. ARROW Antiretoviral Research for Watoto.
  14. Violari A et al. Early antiretroviral therapy among HIV-infected infants. N Engl J Med 2008;359.(21)2233-44.
  15. Baylor International Pediatric AIDS Initiative. BANA II Clinical trial.
  16. Paediatric European Network for Treatment of AIDS. PENTA 11 Trial.
  17. US Food and Drug Administration. President's Emergency Plan for AIDS Relief: Approved and tentatively approved antiretrovirals in association with the President's Emergency Plan.
  18. World Health Organization. Prequalification Programme.
  19. US Food and Drug Administration. Kaletra (lopinavir/ritonavir) oral solution label changes related to toxicity in preterm neonates. February 2011.
  20. Boxwell D et al. Neonatal toxicity of Kaletra oral solution -- LPV, ethanol, or propylene glycol? 18th CROI, Boston, February 2011. Poster abstract 708.
  21. Current Controlled Trials Ltd. Children with HIV in Africa -- Pharmacokinetics and adherence of simple antiretroviral regimens (CHAPAS-2).
  22. World Health Organization. WHO model list of essential medicines for children. 3rd list. Geneva, Switzerland: World Health Organization, 2011.
  23. International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). INSIGHT Home.
  24. TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents.
  25. TMC278-TiDP38-C213 (PAINT): An Open Label Trial to Evaluate the Pharmacokinetics, Safety, Tolerability and Antiviral Efficacy of TMC278 in Antiretroviral Naive HIV-1 Infected Adolescents.
  26. Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children (Ages 2- <12).
  27. PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV) (PRINCE1).
  28. Phase IIIB Pediatric ATV Powder for Oral Use (POU) (PRINCE2).
  29. Safety of and Immune Response to GSK1349572 in HIV-1 Infected Infants, Children, and Adolescents.
  30. Safety and Effectiveness of Raltegravir (MK-0518) in Treatment-Experienced, HIV-Infected Children and Adolescents.
  31. An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children.


Additional Sources

Untangling the Web of Antiretroviral Price Reductions.

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This article was provided by Treatment Action Group and HIV i-Base. It is a part of the publication 2011 Pipeline Report.
 

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