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

34 Abstracts WePeB5809-WePeB5812

XIV International AIDS Conference

WePeB5809 Adherence to antiretroviral therapy (ART) in
HIV-infected children and adolescents is
associated with age, treatment duration and
perceived benefit from therapy
R. Weigel1, I. Grosch-Woerner', I. Jaeger2, E. Lainka3, K. Lenz1, D. Schmidt4,
F. Sollinger5. 1 Charitd, Otto Heubner Center, Charitd Campus Virchow, Station
63, HIV-Kindertagesklinik, Augustenburger Platz 1, 13353 Berlin, Germany;
2Children's Hospital University Frankfurt, Frankfurt a.M., Germany; 3Children's
Hospital University Duesseldorf, Duesseldorf, Germany; 4Childrens Hospital
University Bonn, Bonn, Germany; 5Dr von Haunersches Kinderspital University
Munich, Munich, Germany
Background: Adherence in childhood and adolescence depends on caregivers
and is intertwined with an increasing responsibility of adolescents for medication
intake. Little is known about factors influencing adherence to ART in this age.
Methods: In a multicenter trial 92 patients (9 yrs., 0-16) attending 5 pediatric HIVclinics were enrolled between 4/99 and 4/01. To measure adherence to current
ART and to find associated factors 2-hour structured interviews with caregivers
administering ART and adolescents with disclosed diagnosis were performed by
nurses or social workers. Pediatricians answered a short questionnaire for each
patient. Only patients receiving regular and correct doses without reporting failure
to adhere were assigned to group A. Patients reporting any irregularities entered
group B.
Results: Overall, ART lasted 16 months in median and was mainly a triple combination. The majority of patients had no additional medication and took ART twice
daily. The median dose of ART per week was 56 units measured as capsules,
tablets or, in case of syrup, scoops or syringes.
Patients in group A (n=24) were significantly younger and treated shorter with
the regimen (5 vs. 10 yrs., 12 vs. 19 mths.). They stated more frequently to feel
better, that blood results improved, that status of health is more stable and that
complaints improved (95% vs. 72%, 100% vs. 84%, p<0,05; 100% vs. 73%, 91%
vs. 62%, p<0,01). They all knew that CD4-cells had been measured compared
to 84% in group B (p<0,05). The latter group requested more information about
meaning of CD4-cells, viral load and how medication works. Differences in type
of combination, frequency or dose of ART were not significant.
Conclusions: School-age and ART duration >1 year may be risk factors for poor
adherence. A positive response to ART could improve adherence. Clear therapy
goals, discussion of laboratory results and regular feedback may be of further
benefit.
Presenting author: Ralf Weigel, Charite Campus Virchow, Station 63, HIVKindertagesklinik, Augustenburger Platz 1, 13353 Berlin, Germany, Tel.: +49
30450 566517, Fax: [phone], E-mail: [email protected]
WePeB5810 Intensive Adherence Program - Optimizing
adherence to HAART
S. Szabo, C.W. James, D.C. Sparks, K.C. McNelis, J. Heinssen, S. Chanpimol,
A. Bincsik. Christiana Care Health Services, Wilmington, United States
Background: Adherence to highly active antiretroviral therapy (HAART) has been
shown to be the most important factor for achieving successful outcomes. Interventions associated with the assessment and improvement of adherence in
HIV/AIDS are paramount. We developed a multidisciplinary Intensive Adherence
Program (lAP) to improve adherence to HAART. The methodology and preliminary data were previously presented (13th ANAC conference; abstract 37).
Methods: All patients undergo HAART readiness assessment and if adherence
barriers are identified, patients are enrolled in lAP. Barriers are addressed proactively and education is conducted, involving the patient in the selection of HAART
Adherence tools offered include pillboxes, medication planning cards and beepers. Patients are also encouraged to write a personal goal statement for adherence. Once patients initiate therapy, they are followed closely through telephone
calls and frequent visits with physicians and pharmacists.
Results: Over a 2 year period, 23 patients were evaluated. 39% of patients
screened were treatment-experienced. Adherence barriers were identified in 61%
of the patients; multiple barriers were identified in 57% of these patients. Mean
pretreatment CD4 count and viral load (VL) parameters were 246 cells/mm3
and 244,000 copies/ml, respectively. Mean duration of HAART was 10.2 months.
53.8% of patients achieved undetectable VL (<50 copies/mI) at 6 months. At the
end of follow-up, 61.5% and 38.5% of patients had VL less than 400 and 50,
respectively; mean CD4 and VL were 322 cells/mm3 and 8800 copies/ml, respectively.
Conclusion: Despite prior treatment experience and multiple adherence barriers, a significant number of patients achieved an undetectable viral load while
enrolled in lAP. Approximately one-third of the patients had a rebound in VL after
6 months, suggesting the need for periodic reassessment of adherence barriers
and the importance of an ongoing adherence program.
Presenting author: Susan Szabo, HIV Community Program, Wilmington Hospi
tal Annex, PO Box 1668, Wilmington, DE 19899, United States, Tel.: [phone]
1315, Fax: [phone], E-mail: [email protected]

WePeB581 1 Tolerability of Medication Assessment (TOMA)
Instrument demonstrates correlation between
severity of drug side effects, impact on activities
of daily living (ADLs), and perceived quality of life
(QOL)
C.S. Sipes1, S.G. Jones2, E. Kauschinger3, B. Brown4, B. Johnson5, C. Joy6,
C. Buscemi3, D. Rossi7, B. Berger8, M. Relf6. 1Abbott Labs, 6795 old ranch trail,
Littleton, Colorado, 80125, United States; 2F/orida International University
Miami, United States; 3University of Miami, Miami, United States; 4Howard
Brown Health Center, Chicago, United States; 5Luck Care Center, Chicago,
United States; 6 Whitman-Walker Clinic, Washington, DC, United States;
7'University of Texas, Dallas, United States; 8University of Il///inois, Chicago,
United States
Background: The TOMA is a tool used to explore patient perceptions of how
side effects of antiretroviral (ARV) medications make them more or less tolerable to take by examining the potential impact of side effects, ADLs and perceived
QOL. Tolerability related issues are important to identify, as poor or reduced tolerability to ARV medications may result in non-adherence leading to development
of resistance and subsequent treatment failure. Defining why patients do or do
not take their ARV medications is key to managing patients with HIV/AIDS.
Methods: This is a prospective, multi-center, longitudinal study designed to assess the relationship (correlation) between side effects and their impact on ADLs
and perceived QOL. The TOMA instrument also allows results to be stratified into
different sub populations based on characteristics such as gender, class of ARV
medication used, time since HIV diagnosis, baseline viral load and CD4. The patient self-assessment questionnaire is administered at baseline and at weeks 2,
4, 8, and 12, after starting or switching ARV therapies.
Results: A total of forty-five patients have been evaluated through December
2001(54.5% male, 45.5% female; 28.1% ARV naive, 71.9% ARV-experienced).
Results demonstrate a statistically significant correlation between intensity of
symptoms and degree of impact on ADL and QOL. Of the 14 symptoms identified in the Department of Health and Human Services (DHHS) guidelines, nine
have a correlation of 0.70 or higher for intensity of symptoms and impact of ADLs,
through baseline and week 2. Five symptoms continue to be highly correlated
through week 4.
Conclusions: Results suggest that side effects from ARV medications have an
impact on ADLs and perceived QOL that may cause patients to be non-adherent
to their ARV regimen. Further, results demonstrate that some symptoms may be
more tolerable than others with regard to impact on ADL, perceived QOL, and
adherence.
Presenting author: Carolyn Sipes, 6795 old ranch trail, Littleton, Colorado,
80125, United States, Tel.: [phone], E-mail: [email protected]
WePeB5812I Differences in clinical indicators and adherence to
Highly Active Antiretroviral Therapy (HAART)
among naive and antiretroviral
treatment-experienced clients attending
adherence support programs in New York State
P.T. French1, M. Waters2, L. Weiss3, J. Tesorierol, R. Finkelstein3, B. Agins2,
G. Birkhead4. 1New York State Department of Health, AIDS Institute, Menands,
United States; 2New York State Department of Health, AIDS Institute, office of
program evaluation and research, aids institute, 150 broadway, 5th floor,
menands, new york, 12204, United States; 3New York Academy of Medicine,
New York City, United States; 4New York State Department of Health, AIDS
Institute, Albany, United States
Background: The Treatment Adherence Demonstration Project consists of 14
programs that provide multi-faceted adherence support using a network of HIV
medical and non-medical providers. We looked at differences between naive and
antiretroviral treatment-experienced (TE) groups at baseline and compared adherence and clinical indicators over time.
Methods: Baseline and follow-up interviews include demographics, psychosocial
data, and 3-day self-report of adherence. Viral load and CD4 cell count data are
collected by chart review. Differences between groups were analyzed using the
chi square test of independence, paired sample T-tests, and independent samples T-tests.
Results: Complete data regarding antiretroviral experience and adherence were
available for 986 clients. Mean time at follow-up 1 (Fl) and follow-up 2 (F2) was 5
and 9 months, respectively. At baseline, naive clients were significantly less likely
to have undetectable viral loads and CD4 cell counts over 200 (p<.01). However,
at Fl and F2, nalve clients were more likely to be adherent and to have undetectable viral loads (p<.01). Overall, clients experienced mean decreases in logic
viral load of 1.0 and 0.9 copies/ml and mean increases in CD4 of 57 and 74 between baseline, F1 and F2, respectively (p<.001). Independently, both nalve and
TE groups exhibited significant improvements in clinical indicators from baseline
to F1 and F2 (p<.001). Naive clients experienced log10 viral load decreases of
2.2 (Fl) and 2.3 (F2), compared to decreases of 0.8 (Fl) and 0.6 (F2) among TE

clients (p<.001). Similarly, significant differences were observed between naive
and TE groups in mean CD4 improvement (Fl), with increases of 105 and 45,
respectively (p<.001).
Conclusions: Naive and TE clients enrolled in adherence support programs experienced significant virologic and immunologic improvements, although nafve
clients exhibited enhanced clinical benefits and higher rates of adherence.