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PRACTICAL ASPECTS OF IN VIVO ANTIMALARIAL DRUG EFFICACY TESTING IN THE AMERICAS

The World Health Organization (WHO) has developed guidelines for in vivo antimalarial drug efficacy testing for Plasmodium falciparum and Plasmodium vivax in areas with low-to-moderate transmission, such as the Americas. These guidelines are used widely by ministries of health and national malaria control programs to assess the efficacy of their first-line and second-line drugs for the treatment of malaria and to provide the information necessary to update national malaria treatment policies. Following the WHO guidelines, we have conducted in vivo efficacy trials with a variety of drugs and drug combinations against P. falciparum and P. vivax at 13 sites in Peru, Bolivia, and Ecuador. Based on these experiences, we have identified several modifications that we believe should be made in the WHO recommendations to make them more suitable to the relatively low levels of P. falciparum transmission in the Americas and to the logistic challenges of carrying out such studies in sparsely populated areas, such as the Amazon Basin. These include changes in inclusion and exclusion criteria, in enrollment and follow-up procedures, and in the measurement of study outcomes.

Received April 20, 2002. Accepted for publication October 7, 2002.

Acknowledgments: We thank the many physicians, nurses, and laboratory technicians who were responsible for patient enrollment, treatment, and follow-up in these studies. We also acknowledge the support of Drs. Carlos Carrillo and Eduardo Falconí of Peru, Drs. Freddy Trujillo and Raul Veloz of Ecuador, Licenciado René Molinedo of Bolivia, and Dr. Charles Oliver of USAID, without whose help these studies would not have been possible.

Financial support: This work was supported by USAID–Government of Peru VIGIA Project: Addressing Threats of Emerging and Re-Emerging Infectious Diseases (Activity 527-0391) and the U.S. Naval Medical Research and Development Command NNMC (Work Unit No. 847705 82000 25GB B0016 GEIS Lima).

Disclaimer: The opinions and assertions contained herein are the private ones of the authors and are not to be construed as official or as reflecting the views of the U.S. Navy Department or the naval service at large.

Authors’ addresses: Trenton K. Ruebush II and Jorge Zegarra, NM-RCD, Unit 3800, APO AA 34031, USA. Wilmer Marquiño, Instituto Nacional de Salud, Calle Capac Yupanqui 1400, Jesús María 11, Lima, Peru. Daniel Neyra, Programa de Control de Malaria y Otras Enfermedades Metaxénicas, Ministerio de Salud, Avenida Salaverry, Cuadra 8 S/N, Jesús María, Lima, Peru. Rodolfo Villaroel and Juan Carlos Avila, Programa Nacional de Control de la Malaria, Ministerio de Salud y Previsión Social, Calle Capitán Ravelo 2199, La Paz, Bolivia. César Díaz and Efraín Beltrán, Servicio Nacional de Erradicación de la Malaria, Calle S/N (frente a Ciudadela Naval Norte), Guayaquil, Ecuador.

Reprint requests: Trenton K. Ruebush II, NMRCD, Unit 3800, APO AA 34031, USA, Telephone: 0051-1-561-2733, Fax: 0051-1-561-3042, E-mail: ruebush{at}namrid.sld.pe