European Journal of Medical Research - Deutsche AIDS ...

June 27, 2007 EUROPEAN JOURNAL OF MEDICAL RESEARCH
79
suggest that cross-trial comparisons between different regimens
should be discouraged. In the light of intensive marketing
strategies focussing on assumed (and often minor) advantages
of antiretroviral agents, more data on confounding factors
with possible impact on treatment response is needed.
D.2 (Vortrag)
Results of LORAN trial:
double-protease-inhibitor, RTI-sparing regimen in
therapy-naïve HIV-1-infected patients
Ulbricht K.U. 1 , Stoll M. 1 , Behrens G.M. 1 , Salzberger B. 2 ,
Jessen H. 3 , Jessen A.B. 3 , Kuhlmann B. 4 , Trein A. 5 ,
Heiken H. 1 , Schmidt R.E. 1
1 Medizinische Hochschule Hannover, Klinische Immunologie,
Hannover, Germany, 2 University of Regensburg, Regensburg,
Germany, 3 Praxis Motzstr., Berlin, Germany, 4 Praxis
Georgstr., Hannover, Germany, 5 Praxis Schwabstr., Stuttgart,
Germany
Background: Double-PI regimens are a reliable therapeutic
option in salvage therapy. However, first-line therapy demands
combinations including RTI. Apart from resistance and
toxicity, common problems in RTI-therapy, triple RTI therapies
are less efficient, whereas boosted PI-based regimens
postpone the incidence of resistance for years. In the LORAN
study, a 72-week, randomized trial among HAART-naïve patients,
LPV/r is combined with either CBV (ATZ+3TC) or
ATV. Primary endpoints are metabolic side effects and QOL,
secondary endpoints are virological and immunological response.
The relevance of this study approach is emphasized
by recently published data on Mono-PI-therapy.
Methods: Treatment-naïve HIV-1-infected patients with need
for HAART were randomly assigned to either treatment arm.
In this substudy, we analysed virological failure in both
groups, defined as VL >50 copies/mL at week 24. Comparisons
between treatment arms were performed using Fisher_s
exact test. Plasma HIV-1 from patients at baseline and at virological
failure was analysed genotypically.
Results: In this substudy, we present 24-week data of 67 patients
focusing on virological response. 24/30 patients in the
CBV-LPV/r arm show virological response (6 discharged before
week 24) vs. 15/37 in the ATV-LPV/r arm (14 discharged,
6 of them due to virological failure). Referring to
non completion equals failure, the intent-to-treat analysis revealed
significant differences for virological failure in the
LPV/r-ATV arm compared to the control group: Chi-Q
p=0.015, Fisher´s Exact Test p=0.021. With regard to 47 onstudy
subjects in week 24, there are 14 failures observed in
the ATV-LPV/r arm vs. no failure in the CBV-LPV/r arm
(Chi-Q and Fisher´s Exact test: p 250 or adherence
problems in history. We used the fixed combinations
CBV (AZT/3TC) and TVD (TDF/FTC) as well as the single
substances. The analysis started in January 2005 and is still
ongoing. So far we observed 28 pregnancies of HIV-positive
women treated with the regimens mentioned above.
Baseline characteristics: 22 (80%) of the 28 pregnant
women were migrants, mostly from African countries. The
mean age was 32 years. 12 (43%) patients were ART-naiv.
Median CD4-count at baseline: 338/l; median viral load at
baseline: 46.000 copies/ml. Mean time of starting antiretroviral
treatment during pregnancy: 32. week of pregnancy.
Results: The mean time of delivery was the 38. week of pregnany.
The mode of delivery was an elective caesarean section.
Median CD4-count at delivery: 465/l; median viral load at
delivery: < 50 copies/ml. The mean birth weight was 2.800 g.
The antiretroviral transmission prophylaxis was tolerated
well. There were no discontinuations due to any side effects
or adherence problems. No case of vertical transmission has
been observed in the 28 born children.
Conclusions: Since MTCT-prophylaxis with AZT/TDF plus
FTC or 3TC was effective and safe in our analysis it could be
considered as a new option for the treatment of pregnant
women.