This data, presented at the 9th European AIDS Conference, established that none of the 19 patients who met criteria for resistance testing and had resistance testing results available through week 360 demonstrated primary protease inhibitor resistance.
Data from phase II study of 100 treatment-naive patients taking Kaletra in combination with lamivudine and stavudine show that 59% of patients had an undetectable viral load (HIV RNA less than 50 copies per milliliter) and 61% had HIV RNA less than 400 copies per milliliter, using an intent-to-treat analysis, which categorizes any patient who does not complete the study as a treatment failure. Of the 62 patients remaining on treatment at week 360, 98 percent had HIV RNA less than 400 copies per milliliter.
Of the 19 patients who had resistance data available through 360 weeks, none demonstrated evidence of resistance to lopinavir (0/19) or stavudine (0/19). Three patients (3/19) demonstrated lamivudine resistance. Correspondingly, no evidence of phenotypic resistance to any protease inhibitor was observed.
“Over the years, this study has helped us better understand the benefit Kaletra brings to patients new to therapy,” said Dr Scott Brun, divisional vice president, Infectious Disease Development, Abbott.