AEGiS-15IAC: The Confort study: A randomised and controlled open trial of efficacy and safety of switching protease inhibitor to nevirapine in patients with undetectable viral load.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

The Confort study: A randomised and controlled open trial of efficacy and safety of switching protease inhibitor to nevirapine in patients with undetectable viral load.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrB1287)

Gorgolas M, Bernaldo de Quiros JC, Arranz A, Santos I, Estrada V, Sanz J
Infectious Diseases Division/Fundacion Jimenez Diaz/Universidad Autonoma de Madrid, Madrid, Spain

Objectives: To evaluate the effectiveness of switching protease inhibitor (PI) to nevirapine (NVP) in maintaining viral control and limiting undesirable side-effects in HIV infected patients with undetectable viral load.

METHODS: Randomized, multicenter, open label trial in naïve patients on HAART including a PI and two NRTIs with undetectable viral load for at least 6 months, who were assigned to continue with the PI or change to NVP. Patients were stratified by baseline viral load before HAART below or above 100.000 cop/ml. The follow up period was 48 weeks.

RESULTS: A hundred and sixty patients were included. The proportion of patients with undetectable VL at 48 weeks in the NVP and PI arms was: 61,7% vs 65,8% (ITT, p = 0,590) and 92,6 vs 96,3% (OT, p = 0,400) respectively. The increase in CD4 cell count throughout the study was significant in both arms (p< 0,00001) but the average CD4 cell count at 48 weeks was slightly higher in the NVP arm (596 vs 569, p = 0,1588). Patients with >100.000 RNA cop/ml before HAART had higher rates of viral rebound (8,7% vs 6,7%), with similar proportions in both arms (5p in the NVP arm vs 3p PI arm). The number of patients with severe hypertriglyceridemia (>400 mg/dl) after 48 weeks of treatment decreased in the NVP arm (from 11 to 6); however, it increased in the PI arm (from 4 to 11) and led to treatment discontinuation in two patients. Patient self-reported body shape changes increased in 15% of patients in the PI arm but decreased in 4% of patients in the NVP arm. Finally, patients reported a significantly lower ef fort to keep on treatment in the NVP arm.

CONCLUSIONS: Switching PI to NVP is as effective as continuing with PI for maintaining viral control, even in patients with baseline viral load above 100.000 RNA cop/ml. In addition, a reduction of hypertriglyceridemia, self-reported body-shape changes and effort to keep on treatment is observed.

Keywords: AEGIS, Nevirapine, Viral Load, Protease Inhibitors, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Safety, Humans

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WeOrB1287