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