| |
Factors Predictive of Durable HIV Suppression in Randomized Double-Blind Trial with Nevaripine (NVP), Zidovudine (ZDV), and Lamivudine (3TC) in Treatment-Naive (ARV-n) Patients with Advanced AIDS R. POLLARD*.
Univ. of Texas Med. Branch, Galveston
Background: In a 2256 patient international study of NVP versus
placebo (PL), plasma specimens were evaluated for viral response.
Methods: Plasmas from the first 154 ARV-n patients (74 NVP and
80 PL) who used ZDV and 3TC as their only background drugs were assayed
using the Amplicor ultrasensitive assay (limit of detection 50 c/mL).
Analysis included response to below limit of detection (BLD) ever (nadir).
at 6 months. and at 12 months. Sustained suppression was evaluated for
treatment, BL HIV RNA, and CD4+ count using logistic and Cox
regression models.
Results: BL plasma HIV RNA was >100,000 copies/mL for 58% of patients
and >50,000 copies/mL for 75%. Using below 400 copies/mL, 36% of NVP patients
achieved nadir responses below detection vs 49% of PL patients.
NVP+ZDV+3TC was superior to PL+ZDV+3TC in all comparisons, p<0.01. The
%BLD at 12 mo with NVP+ZDV+3TC was as high in the patients with BL >500,000
c/mL as in patients with lower BL viral loads, 54% (13/24) and 46%
(23/50) respectively. Logistic and Cox regressions demonstrated treatment,
BL CD4+ count (p<0.01) predicted durability of suppression, but not BL
HIV RNA.
Conclusion: NVP+ZDV+3TC is effective in suppression of HIV RNA
for at least 48 weeks, even in patients with advanced AIDS and high pretreatment
viral loads. BL CD4+ count predicted durability of response.
Key Words: HIV RNA, Treatment, virology
|
