Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa: An Unblinded Randomized Controlled Trial
| Autor: | Isaac Aturinda, Henry Sunpath, Rajesh T. Gandhi, Brent A. Johnson, Nicholas Musinguzi, Vincent C. Marconi, Jaysingh Brijkumar, Suzanne M. McCluskey, Melendhran Pillay, Mark J. Siedner, Mwebesa Bwana, Tamlyn Rautenberg, Selvan Pillay, Kevin L. Ard, Mahomed-Yunus S. Moosa, Godfrey Masette, Gavin George, Winnie Muyindike, Pravikrishnen Moodley, Rebecca F Gilbert |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Cyclopropanes Male medicine.medical_specialty Efavirenz HIV Infections Emtricitabine Article law.invention South Africa chemistry.chemical_compound Randomized controlled trial Acquired immunodeficiency syndrome (AIDS) law Antiretroviral Therapy Highly Active Internal medicine Drug Resistance Viral Internal Medicine Medicine Humans Uganda Treatment Failure Tenofovir Reverse-transcriptase inhibitor business.industry General Medicine Odds ratio Middle Aged Viral Load medicine.disease Benzoxazines Regimen chemistry Alkynes Female business Viral load medicine.drug |
| Zdroj: | Ann Intern Med |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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