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

12th World AIDS Conference

Abstracts 32321-32325 585

32321 D4T plus 3TC or AZT plus 3TC - Viral load suppression
after 12 months
Eva Wolf1, G. Hammel2, T. Zwingers2, A. Goetzenich3, H. Knechten4,
H. Jaeger1. 1KIS, Curatorium for Immunedeficiency Mozartstr. 3, D-80336
Munich; 2estimate GmbH, Augsburg; 3DAGNAE, Aachen; 4DAGNAE/PZB for the
ART 96 Evaluation Group, Aachen, Germany
Rationale: According to a national, observational, non-randomized survey on
ART, in the German clinical reality still two thirds of N = 828 patients that started antiretroviral therapy in summer 1996 had been assigned to a combination with only
two NRTIs. Almost one half of these pts received either d4T + 3TC or AZT + 3TC.
Objective: To compare immunological and virological efficacy, durabilitiy of
treatment effect and clinical outcome for d4T + 3TC and AZT + 3TC as initial ART
and to assess treatment changes and strategies.
Methods: As part of this multicentre (80) study on ART 325 pts having started
treatment with AZT + 3TC were compared to 73 pts on d4T + 3TC. Pts are
beeing monitored 3-monthly for viral load (VL), CD4 cells, AIDS events and ART
changes. Data were analysed on an intent-to-treat basis, regardless of treatment
changes, and based on pts continuing their initial treatment up through month 12.
Results: Intent-to-treat analysis

Initial ART Basel.
D4T + 3TC
AZT + 3TC

CD4
(median)
253/1I (n = 73)
270/lI (n = 325)

VL
(median)
56 kEq/ml
63 kEq/ml

M. 12 delta CD4
(mean)
+151/l (n = 49)
+106/Il (n =22)

VL-%
- 500 cop./ml
39.2
38.0

p =0.03.
By month 12 37.0% (of the pts with at least one follow-up visit) switched from
d4T + 3TC; 28.8% switched from d4T + 3TC to a triple combination. 49.8%
switches were reported in the AZT + 3TC group; 33.8% switched from AZT + 3TC
to a triple combination.
On-treatment analyses 44.4% of the pts remaining on d4T + 3TC up through
month 12 had a viral load below 500 copies/ml compared to 35.4% in the AZT +
3TC group (difference statistically not significant).
Conclusion: Analysis shows that the two regimens are comparable concerning efficacy and tolerability with a trend in favour of d4T + 3TC. Although the
percentage of pts with a VL - 500 cop./ml is low as compared to studies with
initial triple regimens, in a subgroup of pts an initial double regimen seems to be
justifiable. Further studies have to show whether the use of an ultrasensitive VL
assay with a detection limit of 50 cop./ml facilitates early identification of the pts
having adequately responded to double therapy with assumably longer durability.
388*/32322 Strategies to optimise adherence to highly active
antiretroviral treatment
Hernando Knobel1, A. Carmona2, S. Grau2, P. Saballs', J.L. Gimeno1,
J.L. Lopez Colomes1. 1Dept. Infectious Diseases, 2Dept. Pharmacy - Hospital
Del Mar, Salvador Espriu, 85 101a, Barcelona, Spain
Objective: To determine if hospital pharmacy intervention with individual intense advice and follow-up in combination with the attending physician improves
adherence to antiretroviral therapy.
Methods: Between January-December of 1997 patients treated with ZDV +
3TC + indinavir were randomised (2/1) to conventional care (the attending
physician prescribed the treatment) or hospital pharmacy intervention (HPI)
(adaptation of treatment to the patient style of live, explanation of clinical benefits
of optimal adherence, telephone support). Adherence was estimated based on:
structured questionnaire, pill counts, pharmacy records, and defined as good,
when more than 90% of prescribed drugs were taken. Antiretroviral drugs were
always supplied by the hospital pharmacy, free for the patients.
Results: 186 patients (male 73%; CDC category A: 54%; I.D.U: 48%; naive:
30%; mean age: 36.3; CD4 cell count: 239/mm3; mean follow-up: 180 days). Conventional: 122 patients; HPI.: 64 patients. Results at week 24 are summarised:
(Viral load by Nasba ultrasensitive, 50 copies/mm3).

Methods: The medication adherence clinic is part of a large county HIV primary care clinic. Adult HIV-infected patients with a history of, or risk factors for
non-compliance were referred to the medication adherence clinic for medication
counseling upon start of new HAART. We counseled all patients, provided a written schedule, setup pillbox, identified risk factors for noncompliance, documented
pharmacist interventions, and scheduled follow-up visits. We documented HIV
RNA at baseline and after 3 months.
Results: We counseled a total of 122 patients (mean 1.6 visits/patient). Demographics: mean age 39 (21-79), men (73%), women (27%), Afro-American/Haitian
(51%), Caucasian (35%), Hispanic (14%). Mean initial viral load was 140,788
(<400- > 750,000 copies/ml PCR). Sixty percent of the visits resulted in an intervention, for a total of 114 interventions. Interventions were: side effect management (21%), change interval/schedule (17%), dosage adjustments (12%), obtain
refill/prescription (10%), initiate 01 prophylaxis (9%), add/discontinue medications
(7%), schedule with/without food (7%), less pills taken than prescribed (6.5%),
drug interaction (5%), and illiterate/language barrier (5%). Currently, 81 patients
are evaluable for outcome. Overall, 49% achieved HIV RNA < 400 copies/ml
3 months after the counseling clinic and initiation of HAART. A breakdown of
patients who achieved an undetectable viral before vs. after the counseling clinic
is as follows: treatment naive (0% vs. 52%; n = 29), nucleoside experienced only
(0% vs. 48%; n = 21), protease inhibitor experienced (13% vs. 45%: n = 31) (p -
0.05).
Conclusion: In our antiretroviral experienced, non-compliant patient cohort.
few patients obtained an undetectable viral load prior to referral. A significantly
higher proportion of patients achieved an undetectable viral load on subsequent
therapy after the pharmacist-counseling clinic. In treatment experienced patients,
the incorporation of a pharmacist into the HIV care team had a significant impact
on patient outcome.
32324 1Adherence patterns in patients with symptomatic
Mycobacterium avium complex (MAC) infection taking a
twice-daily clarithromycin regimen
Charles Flexner1, D. Noe2, C. Benson2, J. Currier3, A. Andrade1, A. Shaver4.
ACTG 223 Study Team, NIH Bethesda MD; 1Johns Hoppkins Univ, Osler 524,
600 N. Wolfe Street Baltimore, MD 21287-5554; 2Univ Of Colorado Denver CO,
3Univ Of Southern California Los Angeles CA; 4NIH, Bethesda MD, USA
Objectives: To measure adherence patterns in patients with advanced AIDS
taking anti-mycobacterial medication for treatment of symptomatic MAC infection.
Design: Substudy of a large, randomized, prospective, controlled, multi-center
clinical trial with three treatment arms: clarithromycin (CLA) + rifabutin (RBT),
CLA + ethambutol (ETH), and CLA + RBT + ETH.
Methods: All trial participants were issued CLA in identical containers fitted
with a computerized medication event monitoring device (MEMS, Aprex Corp.,
Menlo Park, CA) to quantify adherence. Subjects were instructed in proper use
of the device, and were told to take CLA every 12 hours. MEMS' monitoring was
conducted for the first 12 weeks of treatment, or until subject withdrawal from the
trial. MEMS" devices were mailed to a central facility for downloading of data.
Results: Of the first 93 trial participants, 2 refused to use the device, 6 lost the
device or failed to return it, 6 were issued devices which suffered battery failure
and yielded no data, and 20 withdrew from the study within the first four weeks
due to a negative baseline MAC blood culture, an adverse event, or disease
progression. More than two weeks of continuous monitoring data were available
from 69 subjects (76% of total issued devices), and these were used to conduct a
dose interval analysis. 8054 intervals were included in the analysis. The individual
subject median dose interval was 12.2 hours. 64% of the subjects had a median
dose interval between 11.5 and 12.5 hours. Only 26% of the subjects had the
central 80% of their dose intervals fall between 8 and 16 hours. 11.5% of the
subjects had 20% or more of their dose intervals exceed 24 hours.
Conclusion: MEMS" device monitoring allowed a thorough and quantitative
analysis of adherence patterns in ill AIDS patients participating in a multi-center
clinical trial. 85% of patients provided data which could be used in a pharmacodynamic analysis. The majority of patients had significantly prolonged dosing
intervals during at least part of the period monitored. This may have implications
for the development of resistance to anti-MAC drugs used for the treatment of
symptomatic infection in patients with AIDS.
S32325 | The impact of the ALR alarm device on antiretroviral
(AR) adherence among HIV-infected outpatients in
Harlem
Sharon Mannheimer, Y. Hirsch, W. El-Sadr. Harlem Hospital-Columbia University
506 Lenox Ave. Room 3101A New York, NY 10037, USA
Objectives: To assess the impact of the ALR' ALR" ("A Little Reminder") on AR
adherence.
Design: Prospective intervention
Methods: Adult HIV-infected outpatients receiving ARs -1 mo. were eligible.
At baseline (BL), participants (pts) were given an ALR, a small, portable medi
cation alarm programmed to sound daily at the specific times of their medication
doses. Demographic data, self-reported adherence and pt assessment of the
ALR" were collected at BL & follow-up (1 & 3 mo.) using detailed standardized
questionnaires. Pt follow-up is ongoing.
Results: Among 49 pts, mean age was 43 y, mean CD4 was 380, 74% were
African American, 14% Latino, 41% women and 47% former injection drug users
(IDU). Prior AR duration was a mean of 2.9 ~ 2.7 y, current AR use was a mean

Adherence
(Good)
Conventional 52.4%
HPI 77.1%
P 0.0005

Increased CD4
cell count
55.1 1 33
86.3 1 36
0.1

Undetectable
viral load
55.6%
63.4%
0.1

Decreased
viral load (log)
0.97 ~ 0.5
1.91 ~ 1.2
0.04

Conclusions: The interaction between hospital pharmaceutics and the attending physician with individual intense advise improves adherence and had a
tendency to improve effectiveness of antiretroviral treatment.
S390* /32323 Interventions and patient outcome from a
pharmacist-based HIV medication adherence
referral clinic
Kathleen Graham12, L.H. Beeler2, S. Renae3, M.G. Sension3. 11335
Washington Street, Hollywood Florida A 33019; 2Nova SE Univ/N Broward
Hospital Dist, 3N Broward Hospital Dist HIV Research, FT Lauderdale, FL, USA
Objective: To describe pharmacist interventions made during patient counseling
sessions at a medication adherence referral clinic and to evaluate subsequent
patient virologic response to therapy.