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Objective:
To report virological outcome and safety of patients who completed 48 weeks
of therapy within an expanded access program of Lopinavir/r at a single
treatment Center.
Patients and Methods: Between July 00 and Jan
01, ninety seven (97) patients with virological failure to at least 1 PI
based combination and more than 1 HAART regimen were offered Lopinavir/r as
part of a rescue treatment.
Results:
74 % were male, mean age 37 years. 53 % had a prior AIDS defining condition.
Median BSL pVL and CD4 were 290500 cps/ml (5.47 log10) and 130
cells/mm3 respectively. Prior exposure to protease inhibitors was
2.7 (mean) drugs (range 1-5) and 70 % had prior received NNRTI’s. A
subgroup of 55 patients (57 %) patients had completed a washout period (> 4
weeks) before recommencing therapy and 42/97 (43 %) initiated Lopinavir/r
based combinations without interruption of the failing regimen. 43/97 ( 44
%) received a second PI ( Saquinavir, Amprenavir or Indinavir). 25 patients
discontinued therapy (OI´s related death = 5, GI intolerance = 11,
virological failure = 9, lymphoma = 1). Ten patients experienced Grade
III-IV increases in Chol/TG levels. At 48 weeks, 80 % (59/74) had > 1 log10
reduction from baseline HIV RNA. In an intention-to-treat analysis, 43 %
(42/97) achieved < 500 cps/ml at 48 weeks in the entire group and 47 %
(26/55) in the washout subgroup versus 69 % (29/42) in those who received
continue therapy (p > 0.1).
Comments:
Within this cohort, rescue therapy including Lopinavir/r allowed sustained
reductions in plasma HIVRNA below 500 copies/ml through 48 weeks of therapy
in greater than 40 % of patients with no treatment limiting toxicity.
Interruption of therapy prior initiation of a rescue regimen with
Lopinavir/r did not improve virological outcome at 48 weeks of follow up.
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