Long-term efficacy and safety of first-line therapy with once-daily saquinavir/ritonavir.
BACKGROUND
The aim of this study was to assess the long-term efficacy and safety of first-line treatment with once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors (NRTIs).


METHODS
A total of 272 antiretroviral-naive patients with a CD4+ T-cell count of 200-350 cells/mm3 were treated with two NRTIs and saquinavir/ritonavir 1,600/100 mg per day for > 24 weeks. Patients were followed up every 12 weeks for CD4+ T-cell counts, HIV RNA levels, clinical and laboratory toxicities. Intention-to-treat analyses were used for the first 24 weeks of treatment and as-treated analysis after week 24.


RESULTS
The median baseline CD4+ T-cell count was 269 cells/mm3 and HIV RNA was 4.7 log10 copies/ml. At a median follow-up time of 56 (interquartile range [IQR] 25-113) weeks, 262/272 (96.3%) had HIV RNA < 400 copies/ml, with a median HIV RNA decline of -2.89 (IQR 3.31--2.37) log10 copies/ml (P < 0.001) and a median rise in CD4+ T-cell count of 192 (IQR 117-317) cells (P < 0.001). At weeks 24, 48, 72 and 96, 249/272 (91.5%), 157/164 (95.7%), 113/126 (89.7%) and 84/90 (93.3%) had HIV RNA < 400 copies/ml, respectively; at the same time points, 83.8%, 92.7%, 85.7% and 85.6% had HIV RNA < 50 copies/ml. Drug-related adverse events were reported in 6.30%. Significant rises in total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein were seen.


CONCLUSIONS
First-line highly active antiretroviral therapy with once-daily saquinavir/ritonavir plus two NRTIs showed strong antiviral efficacy.
Ananworanich
Jintanat
J
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand. jintanat.a@hivnat.org
Gayet-Ageron
Angele
A
Ruxrungtham
Kiat
K
Chetchotisakd
Ploenchan
P
Prasithsirikul
Wisit
W
Kiertiburanakul
Sasisopin
S
Munsakul
Warangkana
W
Raksakulkarn
Phitsonu
P
Tansuphasawadikul
Somboon
S
LeBraz
Michelle
M
Jupimai
Thidarat
T
Ubolyam
Sasiwimol
S
Schutz
Malte
M
Hirschel
Bernard
B
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D016049:Didanosine / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006678:HIV / Q000235:genetics; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006949:Hyperlipidemias / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage*; D019438:Ritonavir / Q000008:administration & dosage* / Q000009:adverse effects; D019258:Saquinavir / Q000008:administration & dosage* / Q000009:adverse effects; D018119:Stavudine / Q000008:administration & dosage; D013785:Thailand; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
D004338:Drug Combinations; D017320:HIV Protease Inhibitors; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D018119:Stavudine; D016049:Didanosine; D019258:Saquinavir; D019438:Ritonavir