|
48-week
Efficacy of Once-daily Saquinavir Soft-gel/Ritonavir in Patients
with Undetectable Viral Load after 3 Years of Antiretroviral Therapy
Regimens
based on ritonavir-boosted
protease inhibitors are being increasingly used. Some
of these regimens can be dosed safely once daily,
thus simplifying the regimen and offering greater convenience to
patients, often resulting in better adherence.
The
aim of the current study was to evaluate
the efficacy and safety of once-daily saquinavir-soft-gel-capsules
(Fortovase) boosted by ritonavir (Norvir)
[SQV-SGC/RTV] 1600 mg/100 mg plus dual
nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients with plasma viral load (pVL) <50
HIV-1 RNA copies/mL following 3 years of antiretroviral therapy.
A
total of 69 patients with pVL <50 copies/mL after 162 weeks of
antiretroviral treatment started SQV-SGC/RTV 1600 mg/100 mg once-daily
while continuing dual NRTIs.
Previous
treatment consisted of 66 weeks of treatment with a half/full dose
of zidovudine/ZDV
(Retrovir)/zalcitabine (ddC;
Hivid), followed by 2 years of SQV-SGC twice a day (bid)
plus ZDV/lamivudine/3TC
(Epivir) or didanosine/ddI
(Videx)/stavudine/d4T (Zerit).
Efficacy
(pVL), safety and immunological changes (CD4 cell counts) were evaluated
after 48 weeks in this open-label, single-arm prospective study.
Results
· SQV-SGC/RTV
once-daily was well tolerated.
· No
patient changed regimens or was lost to follow-up.
· After
48 weeks, 63 of 69 patients (91%) had pVL <50 copies/mL
(five of the six remaining patients had pVL <400 copies/mL,
and one patient had an unexplained rise to 39 500 copies/mL,
which decreased to <50 copies/mL 12 weeks later).
· Median
CD4 count increased from 534 cells/ L
at the start of the SQV-SGC/RTV once-daily treatment to 664 cells/L
(P<0.001).
· Compared
to the preceding 48 weeks on bid SQV-SGC, the CD4
cell count improved significantly on once-daily SQV-SGC/RTV
(P<0.001).
Conclusions
In
conclusion, the authors write, “These data support the use of SQV-SGC/RTV
1600 mg/100 mg once-daily with two NRTIs as a convenient,
safe and cost-saving regimen to maintain viral suppression and CD4
counts for 48 weeks in this pre-selected cohort on highly active
antiretroviral therapy (HAART) with pVL <50 copies/mL.”
“The
CD4 count rise may be a result of continued immune
reconstitution in patients with well-controlled infection.”
04/06/05
Reference
P
Cardiello and others. The 48-week efficacy of once-daily saquinavir/ritonavir in
patients with undetectable viral load after 3 years of antiretroviral
therapy (6)2: HIV Medicine 122-129.
March 2005.
|
