Background: Kaletra® (LPV/r), a co-formulation of lopinavir and ritonavir is registered for the treatment of HIV1 infection in the European Union and the US and approval is pending in other countries. In France, the pre-registrational prescription of Kaletra® in patients with a medical need was allowed from March 2000 till April 2001 through the “ATU” program (“Autorisation Temporaire d’Utilisation”, Provisional Authorization for Use). Immuno-virological inclusion criteria were progressively removed to allow the use of LPV/r in a broader PI-experienced population. At baseline were collected complete demographic data, informations on patients’ histories, previous treatment experiences and most
mutational patterns of HIV Reverse Transcriptase and Protease. A total of 3819 treatment-experienced patients were accrued.
Objectives: To study in this cohort of moderately to heavily treatment-experienced patients the current therapeutic trends prior to entering the ATU program.
Results: Most meaningful demographic data include : CDC status C3 : 44%; mean CD4 : 201, mean viral load : 4.7 log. Most patients had been treated with most HIV drugs prior to joining the program : PIs used : 2 PIs : 23%, 3 : 27%, 4 or more : 36% (mean : 2.9); NRTIs used : 4 NRTIs : 28%, 5 or more : 59% (mean : 4.6). Of note, 22% patients had had 2 NRTIs or more. The resulting mutational patterns were : 4 to 5 mutations in 32% and 25% patients on HIV RT and Protease genes, respectively; 6-7 mutations : 28% and 30%; 8 or more mutations : 21% and 18%.
Conclusions: The extensively treated patients who needed the pre-registrational prescription of Kaletra were moderately immunodeficient. Most subjects were no longer naïve to at least 3 PIs and 4 NRTIs and presented with a high prevalence of more than 5 mutations on HIV RT or Protease genes.
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