A Single CD4 Test with 250 Cells/Mm3 Threshold Predicts Viral Suppression in HIV-Infected Adults Failing First-Line Therapy by Clinical Criteria

by Charles F. Gilks, A. Sarah Walker, Paula Munderi, Cissy Kityo, Andrew Reid, Elly Katabira, Ruth L. Goodall, Heiner Grosskurth, Peter Mugyenyi, James Hakim, Diana M. Gibb, on behalf of the DART Virology Group and Trial Team

Background

In low-income countries, viral load (VL) monitoring of antiretroviral therapy (ART) is rarely available in the public sector for HIV-infected adults or children. Using clinical failure alone to identify first-line ART failure and trigger regimen switch may result in unnecessary use of costly second-line therapy. Our objective was to identify CD4 threshold values to confirm clinically-determined ART failure when VL is unavailable.

Methods

3316 HIV-infected Ugandan/Zimbabwean adults were randomised to first-line ART with Clinically-Driven (CDM, CD4s measured but blinded) or routine Laboratory and Clinical Monitoring (LCM, 12-weekly CD4s) in the DART trial. CD4 at switch and ART failure criteria (new/recurrent WHO 4, single/multiple WHO 3 event; LCM: CD43) were reviewed in 361 LCM, 314 CDM participants who switched over median 5 years follow-up. Retrospective VLs were available in 368 (55%) participants.

Results

Overall, 265/361 (73%) LCM participants failed with CD43; only 7 (2%) switched with CD4≥250 cells/mm³, four switches triggered by WHO events. Without CD4 monitoring, 207/314 (66%) CDM participants failed with WHO 4 events, and 77(25%)/30(10%) with single/multiple WHO 3 events. Failure/switching with single WHO 3 events was more likely with CD4≥250 cells/mm³ (28/77; 36%) (p = 0.0002). CD4 monitoring reduced switching with viral suppression: 23/187 (12%) LCM versus 49/181 (27%) CDM had VL3 only 11/133 (8%) had VL3 (p Conclusion

Multiple, but not single, WHO 3 events predicted first-line ART failure. A CD4 threshold 'tiebreaker' of ≥250 cells/mm³ for clinically-monitored patients failing first-line could identify ∼80% with VL

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