Outcomes of dual-protease inhibitor salvage therapy in human immunodeficiency virus-infected patients referred to a telephone consultation service.

Abstract

To determine the clinical outcomes of dual-protease inhibitor salvage therapy in heavily experienced patients after their providers consulted the National HIV Telephone Consultation Service (Warmline, 800-933-3413). Observational survey study. Consultation service for United States health care providers. Thirty-one human immunodeficiency virus (HIV)-infected patients who had received previous treatment with at least two protease inhibitor--or nonnucleoside reverse transcriptase inhibitor--based regimens and had a viral load of at least 1000 copies/ml. Patients whose providers consulted Warmline regarding antiretroviral salvage regimens were identified through a review of telephone calls from January-July 2001. Virologic and immunologic outcomes were determined for patients who had received a regimen containing either ritonavir and indinavir or ritonavir and amprenavir. Primary outcomes were percentages of patients with a viral load less than 500 copies/ml at 3 and 6 months and changes in log10 viral load and CD4+ cell count at 3 and 6 months compared with baseline values. By using intent-to-treat analysis, a viral load less than 500 copies/ml was achieved in 35% of the 31 patients at 3 months and in 32% of them at 6 months. By using as-treated analysis, this outcome was achieved in 48% of 23 patients who continued therapy at 3 months and in 59% of 17 patients who continued therapy at 6 months. At 3 months (23 patients) and 6 months (17 patients), respectively, changes in viral load were -1.7 log10 copies/ml (p<0.001) and -1.4 log10 copies/ml (p<0.001), and changes in CD4+ cell count were +99 cells/mm3 (p<0.001) and +95 mm3 (p=0.012), compared with baseline. Significant improvements in virologic and immunologic markers occurred in patients heavily experienced with antiretroviral therapy after starting dual-protease inhibitor treatment regimens. Salvage therapy guided by Warmline consultation appears to be beneficial for this patient population with limited treatment options.