Bridging the Gap: Conference Record [Abstract book, International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

250 Abstracts 14338-14342

12th World AIDS Conference

14338 Impact of ritonavir/saquinavir versus
ritonavir/saquinavir/stavudine on patients' health-related
quality of life: Preliminary results
Pythia Nieuwkerk', E.H. Gisolf2, R. Van Leeuwen2, S.A. Danner3,
M.A.G. Sprangers. 'Academic Medical Center, PO. Box 22700 1100 De
Amsterdam Dept. Med. Psychology; 2National AIDS Therapy Evaluation Center;
3Div Infectious Diseases and AIDS Academic Medical Center, Amsterdam,
Netherlands
Objective: To compare the impact of treatment with ritonavir/saquinavir versus
ritonavir/saquinavir/stavudine in HIV infected patients on health-related quality of
life (HRQL) and to document changes in HRQL over time.
Design: From January 1, 1997, an open label multicenter clinical trial is performed in which protease inhibitor- and stavudine naive patients are randomly
assigned to RTV 400 mg bid/SQV 400 mg bid versus RTV 400 mg bid/SQV 400
mg bid/stavudine 40 mg bid.
Methods: HRQL is assessed at baseline and week 12, 24, 36 and 48 using
the Medical Outcomes Study Health Status Questionnaire for HIV (MOS-HIV)
and a Symptom Checklist. The MOS-HIV is a widely used 35-item instrument
consisting of ten subscales. The Symptom Checklist comprises 27 items referring
to disease- and treatment specific complaints that are scored on a 4-point Likert
scale. Repeated measures analysis of variance was performed to investigate
effects of treatment, time, and treatment by time interaction. P values <.01 were
considered statistically significant.
Results: By January 15, 1998, HRQL data of 105 patients are available up to
week 24. There were no statistically significant effects of treatment or treatment
by time interaction. HRQL improved significantly over time in both treatment
groups with respect to role function and overall quality of life. Patients reported an
increase of the following symptoms: diarrhoea, abdominal pain, tingling feeling
around mouth or tongue, and a numb feeling in fingers or toes. Having trouble
sleeping decreased after baseline.
Conclusions: HRQL improved from baseline to week 24 in both treatment
groups, despite an increase in reported symptoms. Completion of this ongoing
study has to be awaited to corroborate these findings and to verify if the beneficial
impact on HRQL continues over time.
14339 Impact of indinavir with zidovudine and lamivudine on the
quality of life of HIV-positive patients with <50 CD4 count
Paul Coplant, J. Pegion2, J.R. Cook1, Meibohn1, S. Rawlins1, D. Yin3,
R.Y. Leavitt'. 1 Merck Research Lab, PO Box 4, BL 2-3, West Point, PA
19486-0004; 2Villanova University Philadelphia, PA; 3Merck & Co Inc,
Whitehouse, NJ, USA
Background: We investigated the impact of indinavir, zidovudine, and lamivudine
(IDV + ZDV + 3TC) versus ZDV + 3TC versus IDV monotherapy on patient quality
of life (QoL). IDV + ZDV + 3TC compared to ZDV + 3TC has been shown to
reduce the risk of progression to AIDS or death by 50% (p = 0.001) (Hammer
NEJM 1997).
Methods: In a 24-week, double-blind trial (Protocol 039), 320 HIV-positive
individuals with <50 CD4 count were randomized to IDV + ZDV + 3TC (triple) (n
= 108), ZDV + 3TC (n = 105), or IDV alone (n = 107). Patients were protease
inhibitor- and 3TC-naive and ZDV-experienced. Change from baseline at 12 and
24 weeks in QoL was measured by the MOS-HIV questionnaire. Physical and
mental health summary scores were primary, and QoL domains were secondary
outcomes. A general linear model was fitted to change scores. Pairwise p-values
were computed. Analysis at each timepoint was based on patients with scores at
baseline and that time point.
Results: Patients missing 24 wk scores differed (10% on Triple, 35% on ZDV
+ 3TC, 17% IDV; p < 0.001).
Week Summary QoL Mean (S.E) Change Pairwise
Score from Baseline (Post-Pre) P values
Triple ZDV + 3TC IDV Triple vs IDV vs
ZDV + 3TC ZDV + 3TC
12 Physical Health 0.87 (0.78) -1.06 (0.76) 1.64 (0.76) 0.047 0.005
Mental Health 1.83 (0.83) 0.45 (0.80) 2.67 (0.80) 0.177 0.026
24 Physical Health 1.94 (0.79) 0.34 (0.91) 3.26 (0.82) 1.35 0.008
Mental Health 1.85 (0.84) 0.41 (0.97) 3.24 (0.87) 0.211 0.016
Higher scores represent improved QoL. At 24 wks, 8/10 QoL domains improved
more for IDV + ZDV + 3TC than for ZDV + 3TC and 10/10 QoL domains improved
more for IDV (4 significantly) than for ZDV + 3TC.
Conclusion: Patients taking IDV + ZDV + 3TC had significantly better MOS-HIV
physical health summary scores at 12 weeks than patients on ZDV + 3TC. The
IDV group had significantly better physical and mental health summary scores at
12 and 24 weeks versus ZDV + 3TC. Drop-out rates were significantly greater for
the ZDV + 3TC arm than the IDV + ZDV + 3TC and IDV arms, which may bias
results to the null. The addition of IDV to ZDV + 3TC did not decrease patient
QoL and appeared to improve QoL.

I14340 A global approach to assessing the quality of life of
S people with HIV/AIDS
Michael Bartos. HIV/AIDS Whoqol Group; Div. Mental Health WHO, Geneva, CH
- 1211, Switzerland; National Centre in HIV Social Research, Latrobe Univ.,
Carlton, Australia
Background: The World Health Organization (WHO) has been a leader in the
development of quality of life assessment instruments able to be applied across
a wide range of cultural and socio-economic settings and employing subjective
assessments not merely functional or health outcomes measures. In 1997 WHO
commenced development of an HIV-specific quality of life assessment module to
sit alongside an extensively tested generic quality of life assessment instrument.
Methods: Seven sites are participating in the module development in Australia,
Brazil, India (2 sites), Thailand, Zambia and Zimbabwe. In the first stage, up to
11 focus groups to discuss facets of quality of life were held in each site, primarily
comprising people living with HIV or AIDS (PLWHA) at various stages of illness.
An iterative process of translation and back-translation is employed and expert
working groups met to consolidate results and ensure cross-cultural consensus
on meanings. Pilot testing of the module at each site will be conducted in 1998
and further results will be presented.
Results: Despite considerable differences in cultural values and economic
circumstances it proved possible to develop items which were highly salient
across all settings. Key issues considered especially pertinent to PLWHA in all
sites included: (i) disclosure of HIV status; (ii) concern about anticipated disease
conditions; (iii) changes in social and family role; and (iv) the fear of losing
control over the process of dying. Issues around HIV treatments were common
to all sites but differed in emphasis. Where treatments access is unproblematic
(such as Australia) most concerns were around decision-making and side effects.
Where access to expensive treatments is difficult, considerable concern and
anger surrounds the inability to access treatments believed to be effective.
Conclusion: Despite the wide variety of circumstances in which people with
HIV/AIDS live around the globe it proved possible to develop items which robustly measured quality of life across settings. A key to success was the early
involvement of PLWHA in each site to themselves discuss what is important to
their quality of life, and build items up from there. Common issues include HIV
disclosure, anticipated disease, dying, role changes, and differential treatments
access.
S14341 1 Quality of life assessment in patients with HIV infection
in Argentina
Waldo H. Belloso12, G. Lopardo3, J. Tessler2, L.D. Stern4, V. Rodriguez5,
W. Vasen6, M. Etchegoyen7. 'Av. F Lacroze 2045 2B, 1426 Buenos Aires;
2Hospital Italiano De Buenos Aires; 3Funcei, Buenos Aires; 4Hospital Espahol,
Buenos Aires; 5Hopital Tornu; Buenos Aires; 6Fatsa, Buenos Aires; 7Hospital
Gandulfo, Lomas De Zamora, Argentina
Improving quality of life (QoL) should be a central goal of HIV infection management besides antiviral efficacy Nevertheless, there is a considerable lack of
validated instruments for QoL assessment in the context of HIV, particularly for
the spanish-speaking population.
Objective: Analyze internal consistency and validation of a Health QoL questionnaire in an HIV positive population of Buenos Aires.
Method: Prospective, multicenter trial. Core of the questionnaire was adapted
from the Brief Health Status derived from the Medical Outcomes Study and was
completed in self administered manner. Analysis was performed either in discriminative (one moment) and evaluative (longitudinal) way. Internal consistency was
studied by Cronbach's alpha and validation was performed by Construct Validity.
Statistic analysis was done using Kruskal Wallis, Mann Whitney and Spearman
Correlation tests. Spanish version was controlled by the retrotranslation method.
Results: 238 questionnaires from 9 centers were analyzed for discriminative
results and 30 were re-analyzed for longitudinal evaluation one year later. Mean
score was 67.6 (median 70.6 r 15-95.4). Cronbach's alpha for multiitem scales
was greater than 0.7 for all scales except for the Energy Scale (0.66). No correlation was found between the general score and patient's age. Validation was
documented with CD4+level (p < 0.001), number of symptoms (p < 0.0001),
number of hospitalization days and consults (p < 0.0001), and with the presence
of toxicity or AIDS defining event by the time of answering the questionnaire (p
< 0.0001). Longitudinal study showed persistance of the relation with validation
parameters over time.
Conclusions: The questionnaire demonstrated to be highly consistent and
valid for QoL assessment in our population, and might be included as quality of
care index in the future. This is probably the first controlled experience with a
QoL questionnaire evaluated for consistency and validated in spanish-speaking
HIV population from Latin America.
S14342 A qualitative study to evaluate current quality of life
assessment strategies in different HIV/AIDS populations

Clare McGrath1, Linda Abetz2, D. Grant3, K. Adesina2, P. Anderson3, A. Wu4,
A. Griffin3. 1Adelphi Mill Bollington, Macclesfield Cheshire Skio 5JB; 2MAPI
Values, Macclesfield; 3Glaxo Wellcome, Stockley Park, England; 4Johns
Hopkins University, Baltimore, USA
Issues: People with HIV/AIDS are tending to live longer and are incorporating
complex treatment regimens into their daily lives as therapies improve. As a