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Inadequacy of clinical and immunological criteria in identifying virologic failure of 1st line ART: the Ugandan experience
Presented by Apollo Basenero, Uganda.
Basenero A.1, Castelnuovo B.1, Birabwa E.1, John L.1, MacAdam K.1, Schlech W.2, Kambugu A.1
1Infectious Diseases Institute, Kampala, Uganda, 2Dalhousie University Faculty of Medicine, Department of Medicine, Halifax, Canada
Objectives: To evaluate the use of a consensus meeting of care providers in a large urban HIV clinic to determine the need to switch patients from 1st line to 2nd line therapy.
Methods: ART outcome is monitored by clinical criteria and CD4+ count in ~ 4,200 patients at the IDI which is a referral centre for HIV care. Virologic monitoring is expensive and not routinely done. The regimens available include: 1st line therapy - stavudine/lamuvidine/nevirapine or zidovudine/lamuvidine/efavirenz and 2nd line- lopinavir/ritonavir plus 2 new NRTIs. Patients with possible clinical or immunologic failure are discussed at a weekly “Switch Meeting” by clinic staff. Three categories are established:
1: Clinical/immunological failure with good adherence by self report: - these patients are switched to lopinavir/ritonavir and a post hoc viral load (VL) is done.
2: Clinical/immunological failure with poor adherence: - patients are given intensified adherence counseling and a repeat CD4+ after 3 months.
3: Clinically stable with immunologic failure according to WHO guidelines, a VL determines the need for switching.
We report data on the first 100 patients.
Results:
Category 1: 20 patients. All switched to 2nd line. 75% had VL performed and all were >400 copies/ml.
Category 2: 26 patients. After 3 months 62% had an increased CD4+, 38% the same or decreased, the latter were switched to 2nd line.
Category 3: 54 patients. 30 (56%) had a detectable VL (median 93,686, range2611-694,993), 24 (44%) had a VL <400 copies/ml and were not switched.
Conclusions: Decisions to switch to 2nd line therapy even by an experienced HIV team based on clinical and immunologic monitoring alone may lead to unnecessary ART change in up to 35% of patients. This suggests that VL testing should be an essential part of monitoring in resource-limited setting and resources must be made available to make this possible.
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