[TuOrB1187] Comparative study of efavirenz or protease inhibitor-based HAART in HIV-infected, antiretroviral naïve patients with <100 CD4 cel/mu;L and opportunistic diseases (EFAVIP-2 study)

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Comparative study of efavirenz or protease inhibitor-based HAART in HIV-infected, antiretroviral naïve patients with <100 CD4 cel/mu;L and opportunistic diseases (EFAVIP-2 study)

[AUTHOR(S):] F. Pulido, A. Costa, R. Rubio, C. Cepeda, M. Torralba¹, J.R. Arribas, J.M. Pena, J. Gonzalez, A. Lorenzo², J.M. Miro, M. Lonca, J.M. Gatell³, EFAVIP Cohort Study Group⁴

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. TuOrB1187

BACKGROUND: We compare the virological,immunological and clinical outcomes of EFV vs PI-based HAART for the treatment of severely immunossupressed patients with a high rate of AIDS-defining conditions.

METHODS: HIV-infected patients, naïve, with <100 CD4 cell/μL in 3 Spanish HIV clinics who started treatment with EFV (all patients) or PI-based HAART (analyis of a random sample including more than one third of the total population). For ITT analysis, missing or switch not due to PI simplification were considered as failure.

RESULTS: 214 patients: 92 EFV, 122 PIs (47 IND, 47 NFV, 25 RTV, 3 IND/RTV, 3 SAQ/RTV). At baseline there were no differences between EFV/PI in gender, age or % of patients symptomatic (83/81%). There were more IVDU in the PI group (36/50%; p=0.03). At baseline median CD4 and viral load and % of patients with AIDS were 34 (IQR 13-62)/39 (IQR 13-67) cell/μL, 351,000 (IQR 145,000-500,000)/222.600 (IQR 87,300-500,000) cop/mL and 61/52% for EFV/PI (NS). Median CD4 increase after 3, 6 and 12 months were 80/97, 115/121 and 173/175 with EFV/PI (NS). There were no diferences in patients reaching CD4 counts >100 cell/μL after 3, 6 or 12 months: 51/59, 64/57, 70/58% with EFV/PI (ITT). Use of EFV was associated with higher percent of patients with <400 cop/mL at 12 months: 78 vs 55.4%(ITT), but not at 3 or 6 months. After adjusting by baseline CD4, viral load, year of therapy, nucleosides, AIDS, IVDU and hospital, use of EFV or PI was not associated with different immunological (>100 CD4; RR 0.55 [CI95% 0.2-1.5]) or virological (<400 cop/mL; RR 2 [CI95% 0.7-5.8]) outcome after 12 months of therapy. During the first year, EFV was discontinued in 13 patients (14%) and PIs in 30 (24%) p=0,09; 1 (EFV) and 4 (PIs) patients due to virological failure. There were 7 deaths (EFV: 3/PIs: 4, p=1).

CONCLUSIONS: We found no differences between EFV or PI-based HAART for the treatment of severely immunossupressed patients.

Presenting author: Federico Pulido

1Hospital 12 Octubre, Madrid, Spain

2Hospital La Paz, Unidad VIH, Hospital 12 de Octubre, Ctra Andalucia Km 5.4, 28041-Madrid, Spain

3Hospital Clinic, Barcelona, Spain

4Spain

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TuOrB1187