HIV/AIDS • CID 2008:46 (15 May) • 1609
H I V / A I D SM A J O R A R T I C L E
Evaluating Adherence to Highly Active Antiretroviral
Therapy with Use of Pill Counts and Viral Load
Measurement in the Drug Resources Enhancement
against AIDS and Malnutrition Program in
Massimo Magnano San Lio,1Riccardo Carbini,2Paola Germano,1Giovanni Guidotti,3Sandro Mancinelli,4
Noorjehan Abdul Magid,5,9Pasquale Narciso,6Leonardo Palombi,4Elsa Renzi,8Ines Zimba,10
and Maria Cristina Marazzi7
1Community of Sant’Egidio, Drug Resources Enhancement against AIDS and Malnutrition (DREAM) Program,
Statistics,3Italian National Institute of Health,
of Infectious Diseases “L. Spallanzani,” and
Perugia, Italy; and
2Italian National Institute of
5University La Sapienza,
8University of Perugia, Health Education Center,
4Tor Vergata University, Department of Public Health,
7Libera Universita ` Maria Ss. Assunta, Rome, and
9Machava DREAM Center, Matola, and
10DREAM Center of Benfica, Maputo, Mozambique
treatment in Africa is a dramatic challenge. The objective of our study was to explore the results of a computerized
pill count method and to test the validity, sensitivity, and specificity of this method with respect to viral load
measurement in an African setting.
We performed a prospective, observational study involving patients who received first-line highly
active antiretroviral therapy in Mozambique from 1 April 2005 through 31 March 2006. Enrolled patients had
received treatment for at least 3 months before the study. For defining treatment adherence levels, pill counts were
used, and the results were analyzed with viral load measurements at the end of the observation period.
The study involved 531 participants. During the 12 months of observation, 137 patients left the
program or discontinued first-line therapy. Of the remaining 394 patients, 284 (72.1%) had 195% treatment
adherence; of those 284 patients, 274 (96.5%) had a final viral load !1000 copies/mL. A Cox proportional hazards
analysis revealed that the relationship between 195% treatment adherence and the final viral load was closer than
that between 190% treatment adherence and viral load.
Treatment adherence 195% maximizes the results of the nonnucleoside reverse-transcriptase
inhibitor–based regimen. The pillcountmethodappearstobeareliableandeconomictoolformonitoringtreatment
adherence in resource-limited settings.
Maintaining treatment adherence among the growing number of patients receiving antiretroviral
From the end of 2002 through June 2006, the number
of persons receiving antiretroviral therapy (ART) in
sub-Saharan Africa increased from ∼50,000 to 11 mil-
lion . Preventative measures must be taken now to
offset the eventuality of large numbers of patients ex-
periencing first-line treatment failure . Optimal
Received 2 September 2007; accepted 31 December 2007; electronically
published 4 April 2008.
Reprints or correspondence: Dr. Massimo Magnano San Lio; Piazza Sant’ Egidio
3/a, 00153 Rome, Italy (email@example.com).
Clinical Infectious Diseases2008;46:1609–16
? 2008 by the Infectious Diseases Society of America. All rights reserved.
treatment adherence is crucial for viral suppression [3–
5] to prevent the evolution from HIV infection to AIDS
 and progression to death [7–8].
In general, in Africa, first-line ART consists of 2
nucleoside analog reverse-transcriptase inhibitors and
(NNRTI), with the aim of making treatment receipt
simple to improve adherence rates. Among patients
who have moderate-to-high levels of treatment adher-
ence, NNRTI resistance has been less common than
protease inhibitor resistance, because rates of viral sup-
pression have been significantly higher in the NNRTI-
treated group [9–14].
Determining the threshold of HAART adherence is
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1616 • CID 2008:46 (15 May) • HIV/AIDS
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