[7] FINAL 12-MONTH RESULTS FROM THE COMBINE STUDY: A RANDOMIZED, OPEN, MULTICENTER TRIAL COMPARING COMBIVIR PLUS NELFINAVIR OR NEVIRAPINE IN NAIVE PATIENTS

1st International AIDS Society Conference on HIV Pathogenesis and Treatment

Buenos Aires, Argentina - July 8-11, 2001

[TITLE:] FINAL 12-MONTH RESULTS FROM THE COMBINE STUDY: A RANDOMIZED, OPEN, MULTICENTER TRIAL COMPARING COMBIVIR PLUS NELFINAVIR OR NEVIRAPINE IN NAIVE PATIENTS

[AUTHOR(S):] Podzamczer D, Ferrer E, Consiglio E, Gatell J, Perez P, Perez J, Luna E, González A, Pedrol E, Lozano L
Hospital De Bellvtge Hospitalet De Llobregat, Barcelona, Spain

IAS Conf HIV Pathog Treat 2001 Jul 8-11;1st: Abstract No. 7

[ABSTRACT:] Background: 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.

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