Biology subjects

Torrico, F.

Publications and source records attributed to Torrico, F..

2 recordsLinked to original sources

bioRxiv2018

Strengthening Bolivian Pharmacovigilance system: new therapeutic strategies to improve health of Chagas Disease and Tuberculosis patients

IntroductionChagas disease (CD) and Tuberculosis (TB) are important health problems in Bolivia. Current treatments for both infections require a long period of time, and unwanted drug-related adverse events (ADRs) are frequent.\n\nPurposeThis study aims to strengthen the Bolivian Pharmacovigilance system, focusing on CD and TB.\n\nMethodsA situational diagnosis of Pharmacovigilance in the Department of Cochabamba was performed. The use of a new Local Case Report Form (CRF) was implemented, together with the CRF established by the Unidad de Medicamentos y Tecnologia en Salud (UNIMED), in several health care centers. Training and follow-up on drug safety monitoring and ADR reporting was provided to all health professionals involved in CD and TB treatment. A comparative analysis of the reported ADRs using the CRF provided by UNIMED, the new CRF proposal, and medical records, was performed.\n\nResultsOut of the total patients starting treatment for CD, 35,35% suffered ADR according to the information collected in the medical records, and 25% of them were classified as moderate/severe (MS) types. Only 51,43% of MS ADRs were reported to UNIMED. Regarding TB treatment, 9,89% of the total patients suffered ADR, 44% of them were classified as MS, and 75% of MS ADRs were reported to UNIMED.\n\nConclusionsThe reinforcement of the Bolivian Pharmacovigilance system is an ambitious project that should take a long-term perspective and the engagement of national health workers and other stake holders at all levels. Continuity and perseverance are essential to achieve a solid ADR reporting system, improving patient safety, drug efficacy and adherence to treatment.

pharmacology and toxicology↗

bioRxiv2018

Real Time PCR for the Evaluation of Treatment Response in Clinical Trials of Adult Chronic Chagas Disease: Usefulness of Serial Blood Sampling and qPCR Replicates.

This work evaluated a serial blood sampling procedure to enhance the sensitivity of duplex real time PCR (qPCR) for baseline detection and quantification of parasitic loads and post-treatment identification of failure in the context of clinical trials for treatment of chronic Chagas disease, namely DNDi-CH-E1224-001 (NCT01489228) and MSF-DNDi PCR sampling optimization study (NCT01678599). Patients from Cochabamba (N= 294), Tarija (N = 257), and Aiquile (N= 220) were enrolled. Three serial blood samples were collected at each time-point, and qPCR triplicates were tested per sample. The first two samples were collected during the same day and the third one seven days later.\n\nA patient was considered PCR positive if at least one qPCR replicate was detectable. Cumulative results of multiple samples and qPCR replicates enhanced the proportion of pre-treatment sample positivity from 54.8 to 76.2%, 59.5 to 77.8%, and 73.5 to 90.2% in Cochabamba, Tarija, and Aiquile cohorts, respectively and increased cumulative detection of treatment failure from 72.9 to 91.7%, 77.8 to 88.9%, and 42.9 to 69.1% for E1224 low, short, and high dosage regimes, respectively; and from 4.6 to 15.9% and 9.5 to 32.1% for the benznidazole (BZN) arm in the DNDi-CH-E1224-001 and MSF-DNDi studies, respectively. The monitoring of patients treated with placebo in the DNDi-CH-E1224-001 trial revealed fluctuations in parasitic loads and occasional non-detectable results. This serial sampling strategy enhanced PCR sensitivity to detecting treatment failure during follow-up and has the potential for improving recruitment capacity in Chagas disease trials which require an initial positive qPCR result for patient admission.

microbiology↗