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Treatment of Primary HIV Infection with DDI, d4T, Nevirapine, and Hydroxyurea—A Pilot Study C. HICKS*1, J. ERON2, J. LENNOX3, C. PILCHER2, S. FISCUS2, J. OTTINGER1, R. BAYDO1, D. SHUGARS2, J. GINER1, P. MENEZES2, and B. DEAN3. 1Duke Univ. Med. Ctr., Durham, NC; 2Univ. of North Carolina at Chapel Hill; and 3Emory Univ., Atlanta, GA The treatment of primary HIV infection (PHI) usually involves combination antiretroviral therapy including a protease inhibitor (PI). Adherence to such regimens may be difficult for PHI patients, and the use of PIs may be associated with significant long-term toxicity. We investigated the efficacy of a PI-sparing regimen of ddI, d4T, nevirapine (NVP), and hydroxyurea (HU) in a pilot study of 14 patients (12 male [7 white, 3 black, 2 other] and 2 female [both white]; median age 29 years) with symptomatic PHI. Virologic and immunologic assessments in blood (and when possible, genital secretions, CSF, oral cavity) were done. Patients initiated therapy a median of 35 days (range 8 to 70 days) after onset of PHI symptoms. Median pre-treatment viral load was 252,976 (5.40 log10) copies RNA/mL (range 27,098 to 3,950,942) and median pre-treatment CD4 count was 543 cells/mm3 (range 90 to 1161). Pre-treatment genotypic testing revealed no mutations associated with NNRTI or protease inhibitor resistance, but 2/13 isolates (both from North Carolina) had changes associated with decreased sensitivity to nucleosides (41L, 215C; 41L, 333E). At week 24, 8/9 patients had VL <400 copies RNA/mL and 6/9 had VL <50 copies (failures were 82, 135, and 1489 copies). At week 24, CD4 counts increased a median of 190 cells (median CD4% change was + 14%) from baseline. Peripheral neuropathy developed in 6/14 patients and required a change in nucleosides in 5 patients. Two patients had self-limited asymptomatic lipase elevations not requiring treatment interruption. One patient discontinued NVP due to rash. There were no treatment failures attributed to the development of resistance to any drugs in the regimen. We conclude that the treatment of PHI with d4T, ddI, NVP, and HU is efficacious but may be associated with a high incidence of treatment-limiting peripheral neuropathy. Key Words: Acute HIV Infection, NNRTI, Resistance |
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© 7th
Conference on Retroviruses and Opportunistic Infections, |