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

48 Abstracts WePeB5869-WePeB5872

XIV International AIDS Conference

apy (DOT) inpatient intervention to facilitate adherence for persons with refractory
non-adherence.
Methods: Success Through Anti-Retroviral Therapy (START) is a DOT intervention organized by AIDS Healthcare Foundation. Providers refer participants for
non-adherence on the basis of provider/patient assessment, repeated hospitalizations, failure of viral suppression, and prior attempts to improve adherence.
Participants are admitted to a skilled nursing facility for 4-6 weeks where community volunteers, social workers, and medical staff supervise DOT, HIV education, and psychosocial support groups designed to address individual barriers
to adherence. Adherence is assessed periodically after discharge by viral load
PCR(VL) and patient/provider report. We assessed univariate associations adherence using Chi-square and t-tests(a=.05).
Results: 104 START participants(mean age 40 yrs, 10% female) were followed
for a mean of 24(stdv=11) months after discharge. 90% had AIDS. 11 participants
died and 20 were lost to follow-up. Of the remaining 85 participants, 75% maintained adherence to ARV as reported by both patient and provider and confirmed
by suppressed VL.
19% achieved sustained VL<50 copies and 40% maintained VL<1000 copies.
Of 21(25%) who did not sustain adherence, failure was attributed to relapse of
substance abuse or psychiatric disease exacerbation. Adherence did not vary by
race, age, gender, or risk group.
Conclusions: START achieved sustained adherence in 75% and viral suppression in 40% of previously non-adherent participants with advanced HIV disease.
Short-term inpatient DOT interventions may facilitate long-term adherence and
viral suppression in patients with refractory non-adherence.
Presenting author: Charles Farthing, AIDS Health Foundation, 8631 3rd Street,
Suite 740-E, Los Angeles, CA 90048, United States, Tel.: [phone], Fax:
[phone], E-mail: [email protected]
WePeB5869 Evaluation of adherence in HIV-infected patients
treated with a once daily regimen combining
Saquinavir Soft Gel Capsule and Ritonavir in
lmea015 Study
C. Lamotte', G. Peytavin', J. Gerbe', F Mentre', X. Panhard', F. Boue2,
G. Spiridon3, M.A. Valantin4, C. Michelet5, E. Bouvet', E. Dohin6, P. Yeni1,
R. Landman1. 1Bichat Hospital Pharmacy Dept., Paris; 2Beclere Hospital,
Clamart; 3Cochin Hospital, Paris; 4Pitie Salpetriere Hospital, Paris; 5Rennes
Hospital, Rennes; 6 Produits Roche, Neuilly, France
Background: Saquinavir Soft Gel Capsule and Ritonavir (SQV-SGC/RTV) once
daily (qd) regimen was supported by the in vitro and in vivo pharmacokineticpharmacodynamic relationships previously established for SQV and by the concept of decreasing pills burden, more convenient schedule and finally enhancing
the adherence and quality of life. The objective was to investigate the adherence
and the quality of life associated with this SQV-SGC/RTV (1600/100 mg) qd regimen with 2 NRTIs in 36 patients (pts) enrolled in this prospective study.
Methods: Pts were assigned to answer a self-reported standardized questionnaire (SRSQ) at day 15 (D15), month 1 (Ml), M2 and M3 parallel to SQV plasma
determinations and virological response. Questions related to treatment adherence over the last 3 days were the drug forgiven, the most difficult drug to take,
the respect of the instruction for the intake of studied medication and the tolerance.
Results: 84.4% pts reported no difficulties for the intake of the regimen over the
3 months study duration. 4/36, 6/34, 4/35 and 4/36 pts reported a lack of adherence considering all drugs and only 2/4, 1/6, 0/4 and 0/4 pts related their forgetting intake to SQV-SGC/RTV at D15, M1, M2, M3, respectively. All but 4 pts with
adherence difficulties reported their forgetting intake of one or more drugs at a
single period. When repetitive forgetting occurred, non adherence was related to
intolerance (n=1), to the NRTI bid regimen since the morning dose was forgiven
(n=1), to the difficulty of the intake of SQV-SGC/RTV (n=1). One pt reported an
intake of 7 instead of 8 pills of SQV-SGC, because of a lack of pills. SRSQ results
were closely related to Plasma SQV concentrations. 66% patients complained
about SQV-SGC and/or RTV over the total duration of the study.
Conclusion: In this highly active qd regimen, adherence showed dynamic evolution over time and was acceptable despite a SQV-SGC inadequate galenic formulation over a short term evaluation period.
Presenting author: Gilles Peytavin, Pharmacy Department, Bichat Hospital, 46
rue Henri Huchard, 75018 Paris, France, Tel.: [phone], Fax: +33 1 42
63 58 25, E-mail: gilles.peytavin @bch.ap-hop-paris.fr
WePeB5870 A combination of poor adherence and a low
baseline susceptibility score is highly predictive
for HAART failure
K. Van Vaerenbergh1, I. Derdelinckx1, S. De Geest2, H. Bobbaers1,
A. Carbonez3, A. Deschamps1, V. De Graeve', V. De Saar', H. Ceunen', K. De
Smet4, B. Maes', W. Peetermans1, Y Schrooten', J. Desmyter1, E. De

Clercq', M. Van Ranst', E. Van Wijngaerden', A.M. Vandamme'. 'Rega
Institute and University Hospitals, Katholieke Universiteit Leuven, Belgium;
2University of Basel, Basel, Switzerland; 3Universitair Centrum voor Statistiek,
Katholieke Universiteit Leuven, Belgium; 41nnogenetics NV, Ghent, Belgium
Objective: To study the relationship between adherence, virologic response to
HAART and the presence and development of genotypic resistance.

Methods: In a prospective single-center study, adherence was monitored using
electronic event monitoring (EEM) and linked to subsequent virologic outcome after 2 years. Four adherence parameters were scored: drug taking adherence (TA),
dosing adherence (DA), timing adherence (TiA) and drug holidays (DH). Genotypic resistance at baseline and after therapy failure was scored retrospectively by
sequencing and the Line Probe Assay (LiPA) and a genotype-based susceptibility
score was calculated.
Results: Forty-one patients had been receiving HAART including a protease inhibitor for 16 months when EEM was performed for nearly 4 months. Fourteen
patients were on their first regimen. Thirty-one patients responded to the therapy
by a drop in viral load to below 50 c/ml over almost the entire time of HAART monitored. Ten patients did not respond; they either never reached an undetectable
viral load or had a rebound in viral load. Overall median adherence rates were
high with a median drug TA of 98.1% (IQR: 4.8), a median DA of 91.5% (IQR:
17.1), a median TiA of 85.9% (IQR: 30.8), and a median number of DH of 1
(IQR: 4). All adherence parameters were better in responders compared to nonresponders, TA and DH being significantly different. The susceptibility score was
significantly higher in responders compared to non-responders, being 2 (IQR: 1)
and 1 (IOR: 1.5) respectively (p=0.02). Stepwise logistic regression showed that
poor adherence, especially the number of drug holidays, and a low susceptibility
score were highly predictive for therapy failure.
Conclusions: In our patient population, a combination of poor adherence and a
low baseline susceptibility score were highly predictive for HAART failure.
Presenting author: Inge Derdelinckx, Minderbroedersstraat 10, 3000 Leuven,
Belgium, Tel.: [phone], Fax: [phone], E-mail: inge.derdelinckx@uz.
kuleuven.ac.be
WePeB5871I Rapid fluorometric method for the measurement of
HIV protease inhibitor levels in patient serum
Z. Gan', J. Ma', J. Wallman', R.M. Novak2, M. Teodorescu3. 'Norzyme Inc,
Thera Test Labs Inc, Chicago, IL, United States; 2University of Illinois, Chicxago,
United States; 3 TheraTest Labs Inc, Chicago, United States
Background: Therapeutic drug monitoring of protease inhibitors (PI) has been
shown to be a useful clinical tool in managing PI treatment. We describe a 96
well microtiter plate method for rapid measurement of HIV protease inhibitor levels in patient serum. The method is designed for TDM use in clinical laboratories.
Methods: A microtiter plate with pin inserts in each well was designed; each pin,
which is coated with the HIV enzyme substrate labeled with FITC is immersed into
each well. Patient serum (or plasma) is diluted 1:50 in buffer, heated at 1000C for
15 min., then mixed in the microwell with HIV protease. The plate is incubated
for 1 h at 42oC. The enzyme cleaves the substrate from the pin, releasing FITC
into the well. The amount of FITC released is measured fluorometrically. The PI
inhibits the enzyme reducing the fluorescent signal. Standard PI inhibition curves
are created with known amounts of the test PI in serum. The components of the
test are stable in kit format (Levoprin- ZGTM) for at least 9 months at 4-8oC.
Results: The method had high sensitivity: both trough and peak levels of each
of the commercially available PI were measured. Examples of accuracy of measurement: 3 serum specimens were spiked with 1.3, 3.3 and 10 [g/ml of indinavir
and measured 12 separate times by two investigators. The mean +SD of the levels measured by the Levoprin-ZG were 1.42~0.19; 3,21~0.51 and 10.29~0.74,
respectively. Also 3 specimens were spiked with nelfinavir, 0.7, 2 and 4 ig/ml
and 0.7~0.09, 1.98~0.17, 3.88~0.27, respectively, were measured. These results were better than those obtained when the same specimens were sent to
a reference laboratory for measurement by LCMS method. In combinations containing ritonavir the total protease inhibitory capacity was measured.
Conclusions: A rapid method, which could be used close to the point of care to
measure the overall level of PI in patient serum, has been developed.
Presenting author: Marius Teodorescu, TheraTest Labs Inc, 2201 W Campbell
Pk Dr, Chicago, IL, 60612, United States, Tel.: [phone], Fax: [phone]
7056, E-mail: [email protected]
WePeB5872 Functional measurement of HIV protease inhibitor
levels in patient serum by a rapid fluorometric
method
R.M. Novak1, Z. Gan2, J. Ma2, J. Wallman2, M. Teodorescu3. 'University of
Illinois, 2201 W Campbell Pk Dr, Chicago IL, 60612, United States; 2Norzyme
Inc., Chicago, United States; 3 Thera Test Labs Inc, Chicago, United States
Background: Therapeutic drug monitoring of protease inhibitors has been shown
to be a useful clinical tool in managing PI treatment. We describe a fluorometric
96 well microtiter plate method of measuring HIV protease inhibitors in patient
serum and compare our results with those obtained from a reference laboratory
performed by HPLC/MS (LCMS) method.
Methods: A microtiter plate with pin inserts in each well was designed; each pin,
which is coated with the HIV enzyme substrate labeled with FITC is immersed into

each well. Patient serum (or plasma) is diluted 1:50 in buffer, heated at 10C for
15 min., then mixed in the microwell with HIV protease. The plate is incubated
for 1 h at 42oC. The enzyme cleaves the substrate from the pin, releasing FITC
into the well. The amount of FITC released is measured fluorometrically. The PI
inhibits the enzyme reducing the fluorescent signal. Standard PI inhibition curves
are created with known amounts of the test PI in serum. The components of the
test are stable in kit format (Levoprin- ZGTM) for at least 9 months at 4-8oC