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The Case for Pre-Emptive Pharmacogenetic Screening in South Africa.

ABSTRACT: Lack of equitable representation of global genetic diversity has hampered the implementation of genomic medicine in under-represented populations, including those on the African continent. Data from the multi-national Pre-emptive Pharmacogenomic Testing for Preventing Adverse Drug Reactions (PREPARE) study suggest that genotype guidance for prescriptions reduced the incidence of clinically relevant adverse drug reactions (ADRs) by 30%. In this study, hospital dispensary trends from a tertiary South African (SA) hospital (Steve Biko Academic Hospital; SBAH) were compared with the drugs monitored in the PREPARE study. Dispensary data on 29 drugs from the PREPARE study accounted for ~10% of total prescriptions and ~9% of the total expenditure at SBAH. VigiLyze data from the South African Health Products Regulatory Authority were interrogated for local ADRs related to these drugs; 27 were listed as being suspected, concomitant, or interacting in ADR reports. Furthermore, a comparison of pharmacogene allele frequencies between African and European populations was used to frame the potential impact of pre-emptive pharmacogenetic screening in SA. Enumerating the benefit of pre-emptive pharmacogenetic screening in SA will only be possible once we initiate its full application. However, regional genomic diversity, disease burden, and first-line treatment options could be harnessed to target stratified PGx today.

SUBMITTER: Hurrell T

PROVIDER: S-EPMC10817273 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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The Case for Pre-Emptive Pharmacogenetic Screening in South Africa.

Hurrell Tracey T Naidoo Jerolen J Masimirembwa Collen C Scholefield Janine J

Journal of personalized medicine 20240119 1

Lack of equitable representation of global genetic diversity has hampered the implementation of genomic medicine in under-represented populations, including those on the African continent. Data from the multi-national Pre-emptive Pharmacogenomic Testing for Preventing Adverse Drug Reactions (PREPARE) study suggest that genotype guidance for prescriptions reduced the incidence of clinically relevant adverse drug reactions (ADRs) by 30%. In this study, hospital dispensary trends from a tertiary So ...[more]

PMID: 38276236

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Project description:Since the introduction of oral pre-exposure prophylaxis (PrEP) in 2016, countries have successfully scaled-up PrEP to populations at risk of HIV acquisition, including key populations, serodiscordant couples and pregnant women. Between 2016 and 2023, there were over 5.6 million oral PrEP initiations globally. Of these, over 1.2 million occurred in South Africa, with nearly 700,000 implemented through USAID/South Africa's PEPFAR program. This case study uses WHO's Building Blocks for Health Systems Strengthening to describe USAID's oral PrEP program in South Africa, reporting experiences and lessons learned in 14 districts across 7 provinces. Key lessons include: (i) Substantial donor financial investment was critical for expanding oral PrEP in South Africa, but sustained leadership and investment from government stakeholders, such as the Department of Health and the National Treasury, have been essential for sustainability. Despite fluctuations in USAID funding, annual PrEP initiations have continued to increase in USAID-supported districts largely due to local leadership. (ii) Health information and supply chain systems required agility to monitor oral PrEP introduction and scale-up. When systems lacked agility, temporary solutions like the development of interim reporting tools were necessary. (iii) Integrating community-based and facility-based service delivery supported client-centered care. Nurses and lay health workers contributed to over 80% of the full-time equivalents supporting PrEP under USAID's human resources for health portfolio. (iv) Integrating sexual and reproductive health services with oral PrEP service delivery provided clients with comprehensive, client-centered care. (v) Other client-centered care included differentiated service delivery options, such as mobile and gazebo modalities, and expanded PrEP choice through implementation science activities for new PrEP products. (vi) USAID-supported PrEP initiations have been highest among females of reproductive age in the general population and men who have sex with men among key populations, priority populations in South Africa. As done in this case study, sharing best practices and lessons learned from USAID/South Africa's oral PrEP program can strengthen the implementation evidence base and inform more efficient PrEP service delivery, particularly as new PrEP products become available.

Project description:BackgroundChest X-ray offers high sensitivity and acceptable specificity as a tuberculosis screening tool, but in areas with a high burden of tuberculosis, there is often a lack of radiological expertise to interpret chest X-ray. Computer-aided detection systems based on artificial intelligence are therefore increasingly used to screen for tuberculosis-related abnormalities on digital chest radiographies. The CAD4TB software has previously been shown to demonstrate high sensitivity for chest X-ray tuberculosis-related abnormalities, but it is not yet calibrated for the detection of non-tuberculosis abnormalities. When screening for tuberculosis, users of computer-aided detection need to be aware that other chest pathologies are likely to be as prevalent as, or more prevalent than, active tuberculosis. However, non--tuberculosis chest X-ray abnormalities detected during chest X-ray screening for tuberculosis remain poorly characterized in the sub-Saharan African setting, with only minimal literature.Case presentationIn this case series, we report on four cases with non-tuberculosis abnormalities detected on CXR in TB TRIAGE + ACCURACY (ClinicalTrials.gov Identifier: NCT04666311), a study in adult presumptive tuberculosis cases at health facilities in Lesotho and South Africa to determine the diagnostic accuracy of two potential tuberculosis triage tests: computer-aided detection (CAD4TB v7, Delft, the Netherlands) and C-reactive protein (Alere Afinion, USA). The four Black African participants presented with the following chest X-ray abnormalities: a 59-year-old woman with pulmonary arteriovenous malformation, a 28-year-old man with pneumothorax, a 20-year-old man with massive bronchiectasis, and a 47-year-old woman with aspergilloma.ConclusionsSolely using chest X-ray computer-aided detection systems based on artificial intelligence as a tuberculosis screening strategy in sub-Saharan Africa comes with benefits, but also risks. Due to the limitation of CAD4TB for non-tuberculosis-abnormality identification, the computer-aided detection software may miss significant chest X-ray abnormalities that require treatment, as exemplified in our four cases. Increased data collection, characterization of non-tuberculosis anomalies and research on the implications of these diseases for individuals and health systems in sub-Saharan Africa is needed to help improve existing artificial intelligence software programs and their use in countries with high tuberculosis burden.

Dataset Information

The Case for Pre-Emptive Pharmacogenetic Screening in South Africa.

Publications

The Case for Pre-Emptive Pharmacogenetic Screening in South Africa.

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