Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks.
OBJECTIVE
The KLEAN study extension assessed the long-term efficacy and safety of fosamprenavir-ritonavir (FPV/r) and lopinavir-ritonavir (LPV/r), both administered with abacavir/lamivudine (ABC/3TC) fixed dose combination, over 144 weeks.


METHODS
KLEAN was an open-label, noninferiority study that randomised antiretroviral-naïve patients to FPV/r twice daily (bid) or LPV/r bid with ABC/3TC once daily (qd). Patients with a viral load of <400 copies/mL at Week 48 were eligible to participate in the KLEAN study extension (up to 144 weeks) and continued with their previously randomised therapy.


RESULTS
The KLEAN study extension (48 to 144 weeks) randomized 199 patients. The proportion of TLOVR responders (HIV-1 RNA <50 copies/mL) at Week 144 was 73% and 60% in the FPV/r and LPV/r arms, respectively. The proportion of TLOVR responders (<50 copies/mL) was the same irrespective of baseline HIV-1 RNA (>100,000 or 100,000 copies/mL). The Week 144 median (interquartile range) change from baseline CD4+ cell count was 300 (236-433) cells/mm3 and 335 (225-444) cells/mm3 in the FPV/r and LPV/r arms, respectively. Diarrhea was the most frequently reported adverse event. A small proportion of patients (FPV/r, 13%; LPV/r, 9%) discontinued study medication due to adverse events. Three patients (FPV/r, 1; LPV/r, 2) experienced virological failure between Week 48 and Week 144.


CONCLUSIONS
The findings of the KLEAN study extension (48 to 144 weeks) support durable viral suppression with both FPV/r and LPV/r treatment regimens when used in combination with ABC/3TC irrespective of viral load at baseline. Both regimens were well tolerated and had similar safety profiles.
Pulido
F
F
Hospital Universitario 12 de Octubre, Madrid, Spain.
Estrada
V
V
Baril
J G
JG
Logue
K
K
Schewe
K
K
Plettenberg
A
A
Duiculescu
D
D
Yau
L
L
Vavro
C
C
Lim
M L
ML
Pharo
C
C
D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000592:standards* / Q000627:therapeutic use; D002219:Carbamates / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D015224:Dideoxynucleosides; D004338:Drug Combinations; D005260:Female; D005663:Furans; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000494:pharmacology / Q000592:standards* / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics; D006801:Humans; D019259:Lamivudine / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D010755:Organophosphates / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D011744:Pyrimidinones / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D013449:Sulfonamides / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D019562:Viral Load; D055815:Young Adult; D000099227:Abacavir
D019380:Anti-HIV Agents; D002219:Carbamates; D015224:Dideoxynucleosides; D004338:Drug Combinations; D005663:Furans; D017320:HIV Protease Inhibitors; D019259:Lamivudine; D061466:Lopinavir; D010755:Organophosphates; D011744:Pyrimidinones; D012367:RNA, Viral; D019438:Ritonavir; D013449:Sulfonamides; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir; C426859:fosamprenavir