# Novel virologic and pharmacologic assays to predict clinical outcomes after first-line ART failure in sub-Saharan Africa

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2020 · $768,825

## Abstract

PROJECT SUMMARY
In 2014, UNAIDS introduced the “90-90-90” targets for HIV control, including that 90% of those on ART are
virologically suppressed. In order to reach these treatment goals, additional progress will need to be made in
sub-Saharan Africa, where rates of 1st-line antiretroviral treatment (ART) failure are reportedly as high as 1 in 3
individuals and increasing rates of drug resistance are complicating efforts to effectively treat these patients.
For patients experiencing virologic failure (VF) on 1st-line ART, there is currently uncertainty over which
individuals should be maintained on their 1st-line ART regimen and who should be switched to a 2nd-line
regimen. Multiple studies have indicated that traditional Sanger-based genotypic testing might not accurately
predict clinical outcomes in these situations. VF commonly occurs in those taking regimens with a high
genotypic susceptibility scores (GSS) as determined by standard Sanger sequencing techniques, and
conversely, virologic suppression often occurs in patients on regimens with a low GSS. This study brings
together an experienced team of clinical researchers, virologists, pharmacologists, and biostatisticians from the
United States and Africa to determine the predictors of VF either with maintenance of 1st-line ART or after
switch to 2nd-line ART. This study will leverage stored samples from existing clinical trials combined with
innovative viral sequencing and pharmacologic technologies to assess the risk of VF with either approach. The
proposed studies will directly address key knowledge gaps related to drug resistance and medication
adherence, and are ultimately intended to improve the clinical management of patients with 1st-line ART failure
in sub-Saharan Africa. Optimizing treatment strategies in this population is critical for preventing drug
resistance, controlling the epidemic, and ensuring the long-term sustainability of HIV programs.

## Key facts

- **NIH application ID:** 9969050
- **Project number:** 5R01AI138801-03
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Jonathan Li
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $768,825
- **Award type:** 5
- **Project period:** 2018-07-06 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969050

## Citation

> US National Institutes of Health, RePORTER application 9969050, Novel virologic and pharmacologic assays to predict clinical outcomes after first-line ART failure in sub-Saharan Africa (5R01AI138801-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9969050. Licensed CC0.

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