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.
- Treatment Action Group, Pipeline Report 2010. New York: Treatment Action Group, 2010.
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- UNAIDS, Report on the global AIDS epidemic. Geneva, Switzerland: UNAIDS, 2010.
- Clinton Health Access Initiative. Personal communication, May 2011.
- 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.
- Drugs for Neglected Diseases initiative. Needs assessment for paediatric R&D. Geneva, Switzerland: Drugs for Neglected Diseases Initiative, 2011.
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- 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.
- 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.
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- Baylor International Pediatric AIDS Initiative. BANA II Clinical trial.
- Paediatric European Network for Treatment of AIDS. PENTA 11 Trial.
- 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.
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- US Food and Drug Administration. Kaletra (lopinavir/ritonavir) oral solution label changes related to toxicity in preterm neonates. February 2011.
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- Current Controlled Trials Ltd. Children with HIV in Africa -- Pharmacokinetics and adherence of simple antiretroviral regimens (CHAPAS-2).
- World Health Organization. WHO model list of essential medicines for children. 3rd list. Geneva, Switzerland: World Health Organization, 2011.
- International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). INSIGHT Home.
- TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents.
- 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.
- Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children (Ages 2- <12).
- PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV) (PRINCE1).
- Phase IIIB Pediatric ATV Powder for Oral Use (POU) (PRINCE2).
- Safety of and Immune Response to GSK1349572 in HIV-1 Infected Infants, Children, and Adolescents.
- Safety and Effectiveness of Raltegravir (MK-0518) in Treatment-Experienced, HIV-Infected Children and Adolescents.
- 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.
Untangling the Web of Antiretroviral Price Reductions.