Abstract Book Vol. 2 [International Conference on AIDS (14th: 2002: Barcelona, Spain)]

56 Abstracts WePeB5902-WePeB5906

XIV International AIDS Conference

WePeB5902 Efficacy of switching from a protease inhibitor (PI)
based highly active antiretroviral therapy (HAART)
to a once daily saquinavir (SQV) and low dose
ritonavir (RTV) dosing regimen in conjunction with
therapeutic drug monitoring (TDM)
J.G. Baril, P. Cote, S. Dufresne, P. Junod, F Laplante, M.A. Charron. Clinique
Medicale du Quartier Latin, Clinique Medicale du Quartier Latin, 905 boul Rene
Levesque E, Montreal, Quebec, H2L 5B1, Canada
Background: Limited experience exists for once daily SQV 1600 mg plus RTV
100 or 200 mg (SQV-r QD) based regimen as switch therapy especially in patients
who have prior antiretroviral therapy (ART) failure. We analyzed the effectiveness
of switching to SQV-r QD regimen along with TDM in our clinic.
Methods: Retrospective chart review of 12 patients who switched to SQV-r QD
while viral load (VL) was suppressed to below limit of quantification (LQ). Failure
to prior regimen was defined as having outcome VL above LQ. Following switch,
patients had at least one SQV level measurement. Extrapolated SQV trough concentrations (ETC) were calculated based on known pharmacokinetic parameters
for SQV coadministered with RTV.
Results: Evaluated were charts of 12 patients who received ART for mean 5.63
years, during which median 2.5 PI-based regimens were received for mean 3.4
years. Among 12 patients, 11 failed at least one ART; 8 at least 1 prior PI-based
regimen, and 3 at least 1 double nucleoside reverse transcriptase inhibitor regimen. After mean 39 weeks of therapy with SQV-r QD, 9 (75%) maintained VL below LQ (BLQ). Baseline CD4 count increased from median 470 to 520 cells/mm3.
In total 26 SQV levels were taken; mean ETC was 387.9 ng/ml ~ 580.7 SD. As
a result of TDM, RTV dose was increased to 200 mg QD in 2 patients and SQV
increased to 2000 mg QD in 1 patient; all 3 maintained VL BLQ at time of review.
For patients who maintained VL BLQ (n=9), the mean ETC was higher than those
who did not maintain VL BLQ (n=3); 490.3 ng/ml ~ 675.7 SD vs. 157.6 ng/ml +
88.7 SD, although not significant.
Conclusion: SQV-r QD based regimen is an acceptable option for switch in patients who experience compliance or tolerance issues even among those who
have predominantly failed at least 1 prior PI regimen. In addition, use of TDM
may potentially enhance the efficacy of SQV-r QD regimen in a switch setting.
Presenting author: Jean-Guy Baril, Clinique Medicale du Quartier Latin, 905
boul Rene Levesque E., Montreal, Quebec, H2L 581, Canada, Tel.: [phone], Fax: [phone], E-mail: [email protected]
WePeB5903 Patient choice consensus protocol of
ZDV/3TC/ABC (Trizivir) + efavirenz or
ZDV/3TC/ABC (Trizivir) + nelfinavir for the
treatment of antiretroviral naive HIV-1+ patients
R.G. Hewitt, T. Olatinwo, L.D. Esch. State University of New York, 462 Grider
Street, Buffalo, New York, 14215-3021, United States
Objective: To compare virologic response in antiretroviral naive patients who
choose one of two quadruple therapy regimens.
Methods: The authors developed a quadruple therapy consensus protocol using
the above regimens. Patients (pts) who were advised to begin antiretroviral therapy underwent adherence education and were allowed to choose their regimen
based upon pill count, pill size and anticipated side effects. Pts were followed
prospectively for up to 2 years. Adherence was measured by a standardized selfreport inquiry. Pts continue on their regimen if clinically indicated.
Results: 32 pts (27 men, 5 women) chose a regimen: 20 efavirenz (EFV), 12
nelfinavir (NFV). Median CD4 cell count and HIV RNA at baseline were 202 cells
and 5.32 log10 copies for EFV group and 156 cells and 5.56 log10 copies for
NFV group. 25 pts have completed at least 6 months of treatment. At 12 months
(n=13), HIV RNA < 50 copies achieved for 67% EFV and 86% NFV group. 5
(16%) pts stopped therapy due to psych/substance abuse problems; 4 (15%) pts
dropped an NRTI due to intolerance (1 ABC HSR, 3%) without loss of viral suppression; and 4 (15%) pts substituted one of the drugs. Virologic "blips" were
observed. Time to < 50 copies was faster in the EFV group (4 vs 5 months), but
virologic outcome at 12 months was not different (p=NS).
Conclusions: When offered a choice of Trizivir with efavirenz or nelfinavir, 60%
of patients chose efavirenz. Quadruple therapy had comparable a virologic response in both arms. Quadruple therapy appears to be tolerable for most patients
and effective at virologic suppression for adherent patients.
Presenting author: Ross Hewitt, 462 Grider Street, Buffalo, New York, 14215 -3021, United States, Tel.: [phone], Fax: [phone], E-mail: rhewitt @buffalo.edu
WePeB5904 Lopinavir/ritonavir-Efavirenz: preliminary
assessment of a potent nucleoside-sparing dual
antiretroviral regimen (the BIKS study)

C. Allavena1, A. Lafeuillade2, M. Bentata3, 0. Launay3, M.A. Valantin4,
J.M. Besnier5, C. Rabreau6, A.S. Poirier6, E. Dailly6, F Raffi6. 1Infectious
Diseases, Hotel Dieu, Nantes, France; 2Centre Hospitalier, Toulon, France;
3Hopital Avicenne, Bobigny, France; 4Hopital Pitie-Salpotriere, Paris, France;
5CHU, Tours, France; 6CHU, Nantes, France
Background: Almost all HAART regimens contain at least 2 nucleoside reverse transcriptase inhibitors (NRTIs). However NRTIs are increasingly recog
nized as the cause of mitochondrial toxicity, hyperlactatemia and hepatic steatosis. In addition, cross-resistance,within the NRTI class, of virus harbouring multiple thymidine-analogue mutations, leads to difficult problems for HAART sequencing. With the availability of very potent drugs from other classes, evaluation of
NRTI-sparing regimens is needed.
Methods: Open-label, controlled trial, to evaluate the safety, immunological and
virological activity of dual therapy with lopinavir/r (533/133 mg bid) and efavirenz
(600 mg qd) in 100 HIV-1 infected patients. Enroled patients had to be NNRTInaive and, if PI-experienced, should have less than 5 lopinavir-associated mutations (2001 French ANRS algorithm) on genotypic testing.
Results: At present, 45 patients have been enroled in the study. Characteristics
of patients at baseline were as follow: 36 male/9 female, mean CD4 cell count:
325/mL, mean HIV RNA: 4.82 log10 copies/mL, 71% antiretroviral naive. After
a median follow-up of 20 weeks, study drug discontinuation had occurred in 4
patients: Grade 4 hyperlipidemia (n=1), prurit (n=1), CNS side-effect (n=1), cutaneous rash (n=1). Mean decrease of viral load was - 1.98 log10 copies/mL at
week 4 (n= 39), - 2.56 log10 copies/mL at week 8 (n=26), with HIV RNA < 400
copies/mL in 17/26 (65%) patients at week 8. Mean CD4 cell count increase was
+ 121/mL at week 8. Mean trigyceridemia and cholesterolemia increase, from
baseline, was +2,66 mmol/mL and +1,83 mmol/mL, respectively, at week 8.
Updated (Week 24) immunological and virological efficacy as well as safety data
will be presented.
Conclusion: Lopinavir/r-Efavirenz combination deserves further evaluation as a
potent and safe NRTI-sparing antiretroviral regimen.
Presenting author: Francois Raffi, Infectious Diseases, Hotel Dieu, 44093
Nantes cedex, France, Tel.: [phone], Fax: [phone], E-mail: [email protected]
WePeB5905 Short-cycle of structured treatment interruption of
antiretroviral therapy in chronic HIV infection
G. D'Offizi, S. Topino, R. Bellagamba, A.R. Garbuglia, S. Calcaterra,
M.R. Capobianchi, V. Tozzi, P. Narciso. NationalInstitute for Infectious Diseases
L Spallanzani, NationalInstitute for Infectious Diseases, Lab.Immunopathology
-, Via Portuense 292, 00149 Rome, Italy
Background.The mounting problem of long-term side effects associated with
chronic antiretroviral therapy and the fact that acces to antiretroviral therapy is
limited to approximately 5% of the HIV-infected world, underline the importance
of pursuing new approaches towards the long term control of HIV-infection reducing the patient's reliance on HAART.
Methods: Twenty-six chronically HIV-1 infected asymptomatic patients with undetectable HIV-RNA plasma during at least two years of HAART were studied.
A clinical, immunological and virological follow-up was performed at the suspension of HAART (tO), after 1 month from the suspension (tl), at the resumption of
HAART (t2), and after 30 days from HAART-resumption (t3).
Results: In our study, we observed a relevant frequency (30%) of chronically HIV
infected patients that after a single STI were able to naturally control the viremia
for a prolonged period of time. Moreover, one patient with a high pre-HAART
viremia of 150,000 copies/ml had a delayed viral rebound at 184 days of STI and
another patient with a baseline pre-HAART viremia of 90,000 copies/ml showed
a delayed viral rebound at 150 days of STI, indicating that high baseline viremia
is not always associated to a lack of viral control. Moreover, a decrease in the
absolute count of neutrophils and platelets was observed during STI, suggesting
a viral inhibition of bone marrow function which was restored by HAART resumption. HIV DNA burden in both CD4 and CD14 cells was temporarily increased
during HAART discontinuation, but returned to pre-STI values within about two
months after therapy resumption.
Conclusions: Our data confirm that a relevant fraction of chronically HIV-infected
patients are able to sustain viral control and CD4 cell counts restoration, without
experiencing permanent toxicity during subsequent resumption of antiretroviral
drugs. Furthermore, proviral burden appears to be only transiently affected by
this protocol.
Presenting author: Fabrizio Poccia, National Institute for Infectious Diseases,
Lab. Immunopathology -, Via Portuense 292, 00149 Rome, Italy, Tel.: +39 06
55170 904/958, Fax: [phone], E-mail: [email protected]
WePeB5906 HIV in the amniotic fluid of term pregnancies
T.J. Tucker1, B. Mohlala2, M. Besser2, R. Burton2, C. Williamson2, J. Anthony2.
1SA AIDS Vaccine Initiative / UCT SAA VI, P0 Box 19070, Tygerberg, 7505,
South Africa; 2University of Cape Town, Cape Town, South Africa
Background: The mode of HIV transmission in utero is unknown. Cesarean section (C/S) and AZT or nevirapine during the peri-partum period reduces transmission. No data has been published on viral load (VL) in amniotic fluid (AF).
This study aimed to investigate whether HIV is detected in AF and its possible
transmission role.

Methods: Consenting HIV-1 positive women with healthy, singleton pregnancies
undergoing elective C/S at 38 weeks, receiving either single dose of NVP four
hours before surgery or the AZT Thai regimen (and their babies) were investigated for HIV VL in AF and plasma, cord blood at birth and blood at 6-10
weeks. CD4/8, FBCs and placental bed biopsies were taken at C/S. AF was taken
prior to membrane incision for Kleihauer-Betke testing, to detect blood contamination. Samples were taken at surgery Samples were stored within 4 hours.