Dataset Information

Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa : An Unblinded Randomized Controlled Trial.

ABSTRACT:

Background

Virologic failure in HIV predicts the development of drug resistance and mortality. Genotypic resistance testing (GRT), which is the standard of care after virologic failure in high-income settings, is rarely implemented in sub-Saharan Africa.

Objective

To estimate the effectiveness of GRT for improving virologic suppression rates among people with HIV in sub-Saharan Africa for whom first-line therapy fails.

Design

Pragmatic, unblinded, randomized controlled trial. (ClinicalTrials.gov: NCT02787499).

Setting

Ambulatory HIV clinics in the public sector in Uganda and South Africa.

Patients

Adults receiving first-line antiretroviral therapy with a recent HIV RNA viral load of 1000 copies/mL or higher.

Intervention

Participants were randomly assigned to receive standard of care (SOC), including adherence counseling sessions and repeated viral load testing, or immediate GRT.

Measurements

The primary outcome of interest was achievement of an HIV RNA viral load below 200 copies/mL 9 months after enrollment.

Results

The trial enrolled 840 persons, divided equally between countries. Approximately half (51%) were women. Most (72%) were receiving a regimen of tenofovir, emtricitabine, and efavirenz at enrollment. The rate of virologic suppression did not differ 9 months after enrollment between the GRT group (63% [263 of 417]) and SOC group (61% [256 of 423]; odds ratio [OR], 1.11 [95% CI, 0.83 to 1.49]; P = 0.46). Among participants with persistent failure (HIV RNA viral load ≥1000 copies/mL) at 9 months, the prevalence of drug resistance was higher in the SOC group (76% [78 of 103] vs. 59% [48 of 82]; OR, 2.30 [CI, 1.22 to 4.35]; P = 0.014). Other secondary outcomes, including 9-month survival and retention in care, were similar between groups.

Limitation

Participants were receiving nonnucleoside reverse transcriptase inhibitor-based therapy at enrollment, limiting the generalizability of the findings.

Conclusion

The addition of GRT to routine care after first-line virologic failure in Uganda and South Africa did not improve rates of resuppression.

Primary funding source

The President's Emergency Plan for AIDS Relief and the National Institute of Allergy and Infectious Diseases.

SUBMITTER: Siedner MJ

PROVIDER: S-EPMC8688215 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa : An Unblinded Randomized Controlled Trial.

Siedner Mark J MJ Moosa Mahomed-Yunus S MS McCluskey Suzanne S Gilbert Rebecca F RF Pillay Selvan S Aturinda Isaac I Ard Kevin K Muyindike Winnie W Musinguzi Nicholas N Masette Godfrey G Pillay Melendhran M Moodley Pravikrishnen P Brijkumar Jaysingh J Rautenberg Tamlyn T George Gavin G Gandhi Rajesh T RT Johnson Brent A BA Sunpath Henry H Bwana Mwebesa B MB Marconi Vincent C VC

Annals of internal medicine 20211026 12

<h4>Background</h4>Virologic failure in HIV predicts the development of drug resistance and mortality. Genotypic resistance testing (GRT), which is the standard of care after virologic failure in high-income settings, is rarely implemented in sub-Saharan Africa.<h4>Objective</h4>To estimate the effectiveness of GRT for improving virologic suppression rates among people with HIV in sub-Saharan Africa for whom first-line therapy fails.<h4>Design</h4>Pragmatic, unblinded, randomized controlled tria ...[more]

PMID: 34698502

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Dataset Information

Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa : An Unblinded Randomized Controlled Trial.

Background

Objective

Design

Setting

Patients

Intervention

Measurements

Results

Limitation

Conclusion

Primary funding source

Publications

Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa : An Unblinded Randomized Controlled Trial.

Similar Datasets

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