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Abstract
FINAL 12-MONTH RESULTS FROM THE COMBINE STUDY: A RANDOMIZED, OPEN, MULTICENTER TRIAL COMPARING COMBIVIR PLUS NELFINAVIR OR NEVIRAPINE IN NAIVE PATIENTS.
PODZAMCZER D, FERRER E, CONSIGLIO E, GATELL J, PEREZ P, PEREZ J, LUNA E, GONZÁLEZ A, PEDROL E, LOZANO L
Objective: To evaluate the efficacy and safety of two HAART regimens in HIV+ naive pts.
Methods: Randomized, open, multicenter study comparing combivir (ZDV 300mg/3TC 150 mg bid) associated to nelfinavir 1250 mg bid (CNf) or nevirapine 200 mg bid (CNr) in 142 HIV-infected naive pts. recruited between Nov. 1998 and August 1999 from 12 hospitals Efficacy was assessed by intent-to-treat (ITT) (missing =failure) and on-treatment (OT) analysis.
Results: Baseline mean CD4 count was 359 (range 10--908) cells/uL, and mean viral load (VL, by PCR test) was 5.15 (3.2--6.2) log10 (median 4.78). One third of pts had VL > 5 logs and 20% CD4 <200/uL (no differences between arms). In ITT at 12 months, 60.0% (90%CI 49-70) (CNf) and 75.0% (90%CI 65-83) (CNr) had VL <200 c/ml (p = 0.056), while in OT 80.5% vs. 91.7% had VL <200 c/ml, respectively (p = 0.12). 50.0% (90%CI 40-60) (CNf) vs. 65.2% (90%CI 55-75) (CNr) had VL <20 c/ml by ITT (p = 0.065) and 70.7% vs. 79.6% had VL <20 c/ml by OT respectively (p = 0.35). No differences were observed when comparing efficacy rates in the subgroup of pts with baseline VL > 5 logs. An ITT “exposed” analysis (excluding 10 randomized pts (8 CNf, 2 CNr) who did not return to follow-up visits, did not show statistical differences when comparing VL <200 and < 20 c/ml. A gain of +173 (CNf) and +162 (CNr) CD4 cells/mL respectively, was observed (NS). Only 1 pt had a CDC C event and none has died during follow-up. About 20% of pts switched initial therapy due to adverse effects (being gastrointestinal symptoms (12 (17.1%) vs. 1 (1.4%), p=0.01) in CNf pts and hepatitis/ transaminitis (1 (1.4%) vs. 7 (9.7%), p=0.03) in CNr pts, the most frequent adverse events found.
Conclusions: Our results suggest that CNr has at least similar efficacy than a protease inhibitor-containing regimen of CNf. Both regimens have an acceptable tolerance. A simple 4-pill CNr regimen may be an excellent option for HIV-infected pts who initiate antiretroviral therapy
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
7
Suggested Citation
"PODZAMCZERD, et al.
FINAL 12-MONTH RESULTS FROM THE COMBINE STUDY: A RANDOMIZED, OPEN, MULTICENTER TRIAL COMPARING COMBIVIR PLUS NELFINAVIR OR NEVIRAPINE IN NAIVE PATIENTS..
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
7"
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