APV30002 (SOLO) a randomized, open-label study of LEXIVA/r (1400/200 mg) QD vs NFV (1250 mg) BID in combination with ABC/3TC BID in 649 ART-naive patients.
* (ITT RD=F) Rebound or discontinuation = failure
•
43% of all patients had VL >100,000 c/mL at baseline
•
Median CD4+ cell count was 170 cells/mm3
at baseline
•
Median increase in CD4+ cell count from
baseline was 203 cells/mm3 with LEXIVA/r vs 207 cells/mm3 with
NFV
... across all rising baseline VL strata
LEXIVA, BID
APV30001 (NEAT) a randomized, open-label study of LEXIVA (1400 mg) BID vs NFV (1250 mg) BID in combination with ABC/3TC BID in 249 ART-naive patients.
† (ITT RD=F) Rebound or discontinuation = failure.
•
45% of all patients had VL >100,000 c/mL at baseline
•
Median CD4+ cell count was 212 cells/mm3 at baseline
•
Median increase in CD4+ cell count from baseline
was 201 cells/mm3 with LEXIVA vs 216 cells/mm3 with NFV
PI-experienced patients: efficacy
compared to Kaletra®
LEXIVA/r, BID
APV30003 (CONTEXT) a randomized,
open-label study of LEXIVA/r (1400/200 mg) QD or LEXIVA/r (700/100 mg) BID vs LPV/r (400/100 mg) BID in combination with 2 NRTIs in 315 PI-experienced patients.
‡ (ITT RD=F) Rebound or discontinuation = failure.
•
PI experienced = prior exposure to 1-2 PIs
•
Median increase in CD4+ cell count from baseline
was 81 cells/mm3 with LEXIVA/r BID vs 91 cells/mm3
with LPV/r BID
•
This study was not large enough to reach a definitive
conclusion that LEXIVA/r BID and LPV/r BID are clinically equivalent
•
LEXIVA/r QD is not recommended for PI-experienced
patients
