Strategies for HIV-1 genotyping resistance testing accessibility in a developing country
G. Hijar1, P. Caballero2,3, C. Yabar4, M. Acuña4, J.L. Sebastian5, G. Rosell5, J. Arevalo6, R. Grant7
1Instituto Nacional de Salud, Centro Nacional de Salud Publica, Lima, Peru, 2Instituto Nacional de Salud, Oficina Ejecutiva de Investigacion, Lima, Peru, 3Universidad Nacional Mayor de San Marcos, Facultad de Medicina Humana - Departamento de Microbiologia Medica, Lima, Peru, 4Instituto Nacional de Salud, Centro Nacional de Salud Publica, Lima, Peru, 5Ministerio de Salud, Estrategia Sanitaria Nacional de Control de ITS VIH SIDA, Lima, Peru, 6Ministerio de Salud Hospital Dos de Mayo, Lima, Peru, 7University of California San Francisco (UCSF), Gladstone Institute of Virology, San Francisco, United States
Issues: Before 2008, changes in ARV drugs were defined by the National Expert Committee (Ministry of Health), based on clinical experience and the patient´s pharmacological background, without the evidence of genotyping resistance tests (GRT). High costs, lack of supplies, facilities and training were main problems. The aim was to standardize and validate an in-house genotyping assay and make it accessible to health care providers and patients.
Description: The standardization and validation phase included sequencing with the in-house GRT of 20 stored plasma samples (first panel) previously sequenced in an international reference laboratory. The reproducibility and repeatability phase included a blind comparative evaluation of a second panel with 33 plasma samples, and allowed the quality performance assessment between our two operators. The GRT sequenced the entire protease and 410 codons of reverse transcriptase in the pol gene. The performance on drug resistance interpretation was evaluated against the Trugene Genotyping System and the HIV-1 drug resistance-related mutations detected by the two systems were compared. Samples were successfully amplified by both systems and showed identical drug resistance-related mutations patterns in 99%. Concordance between laboratories was 99% and operator's performance was 100%. Test`s costs are 50% of market price. First guidelines with clinical criteria were approved establishing virological failure to second line drugs as mandatory for GRT. Requests and laboratory results are sent using internet, with opportunity and confidentiality (www.netlab.ins.gob.pe).
Lessons learned: In-site training with international mentors and our own facilities was the best decision. A well standardized and validated in-house GRT provided comparable results to those of the commercial kits, with an affordable price and allowing sustainability. Use of guidelines is important in order to apply rationality beside clinical criteria to request GRT. Accessibility of GRT into a public health system can be improved with informatics tools.
Next steps: Cost-effectiveness studies, guidelines review and early warning indicators.
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