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- Title
Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa : An Unblinded Randomized Controlled Trial.
- Authors
Siedner, Mark J.; Moosa, Mahomed-Yunus S.; McCluskey, Suzanne; Gilbert, Rebecca F.; Pillay, Selvan; Aturinda, Isaac; Ard, Kevin; Muyindike, Winnie; Musinguzi, Nicholas; Masette, Godfrey; Pillay, Melendhran; Moodley, Pravikrishnen; Brijkumar, Jaysingh; Rautenberg, Tamlyn; George, Gavin; Gandhi, Rajesh T.; Johnson, Brent A.; Sunpath, Henry; Bwana, Mwebesa B.; Marconi, Vincent C.
- Abstract
<bold>Background: </bold>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.<bold>Objective: </bold>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.<bold>Design: </bold>Pragmatic, unblinded, randomized controlled trial. (ClinicalTrials.gov: NCT02787499).<bold>Setting: </bold>Ambulatory HIV clinics in the public sector in Uganda and South Africa.<bold>Patients: </bold>Adults receiving first-line antiretroviral therapy with a recent HIV RNA viral load of 1000 copies/mL or higher.<bold>Intervention: </bold>Participants were randomly assigned to receive standard of care (SOC), including adherence counseling sessions and repeated viral load testing, or immediate GRT.<bold>Measurements: </bold>The primary outcome of interest was achievement of an HIV RNA viral load below 200 copies/mL 9 months after enrollment.<bold>Results: </bold>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.<bold>Limitation: </bold>Participants were receiving nonnucleoside reverse transcriptase inhibitor-based therapy at enrollment, limiting the generalizability of the findings.<bold>Conclusion: </bold>The addition of GRT to routine care after first-line virologic failure in Uganda and South Africa did not improve rates of resuppression.<bold>Primary Funding Source: </bold>The President's Emergency Plan for AIDS Relief and the National Institute of Allergy and Infectious Diseases.
- Subjects
SUB-Saharan Africa; UGANDA; SOUTH Africa; HIV; VIRAL load; REVERSE transcriptase; ANTIRETROVIRAL agents; DRUG resistance; DIRECTLY observed therapy; HIV infections; RESEARCH; HETEROCYCLIC compounds; RESEARCH methodology; EVALUATION research; HIGHLY active antiretroviral therapy; HYDROCARBONS; COMPARATIVE studies; RANDOMIZED controlled trials; RESEARCH funding; DRUG resistance in microorganisms
- Publication
Annals of Internal Medicine, 2021, Vol 174, Issue 12, p1683
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/M21-2229