Customize your JAMA Network experience by selecting one or more topics from the list below.
Stephen J.LurieMD, PhD, Contributing EditorIndividualAuthor
To the Editor: The feasibility of induction-maintenance
therapy for human immunodeficiency virus type 1 (HIV) infection has been studied
as a strategy to simplify antiretroviral regimens.1-3
In the Amsterdam Duration of Antiretroviral Medication study, maintenance
dual therapy after 26 weeks of quadruple induction therapy resulted in less
viral suppression than prolonged induction therapy.3
However, a prolonged quadruple regimen may have a negative impact on patients'
quality of life (QOL) because of pill burden and adverse effects. We compared
QOL in maintenance vs prolonged induction therapy.
Antiretroviral-naive HIV-infected patients with a CD4 cell count of
at least 200 × 106/L (200/µL) and 1000 HIV RNA copies/mL
received 26 weeks of induction therapy comprising stavudine, lamivudine, saquinavir,
and nelfinavir. If the plasma HIV RNA concentration at weeks 24 and 25 was
less than 50 copies/mL, patients were randomly assigned to receive prolonged
4-drug induction or maintenance therapy (either stavudine and nelfinavir or
saquinavir and nelfinavir). From week 26, plasma HIV RNA concentrations were
assessed by an ultrasensitive assay procedure (Amplicor HIV-1 Monitor Ultrasensitive;
Roche Diagnostics, Branchburg, NJ) with a variable quantification limit. Clinical
results have been reported elsewhere.3
In a subsample, QOL was assessed at weeks 24 and 48 by the Medical Outcomes
Study (MOS) HIV Health Survey, comprising 10 subscales.4
We calculated changes in QOL scores from week 24 to week 48. Effect sizes
for between-group differences were calculated by dividing mean differences
by pooled SDs.5 Effect sizes equaling 0.20,
0.50, and 0.80 are considered to indicate small, moderate, and large effects,
respectively.5 We calculated correlation
coefficients between the plasma HIV RNA concentration at week 48 and changes
in QOL scores. Analysis was by intention to treat.
Ten of 16 patients assigned to receive maintenance therapy and 9 of
15 patients assigned to receive prolonged induction therapy participated in
the QOL study. Both groups were comparable (P>.20)
in terms of age (39 vs 44 years), sex (91% vs 100% men), Centers for Disease
Control and Prevention HIV classification A (73% vs 67%), median baseline
CD4 cell count (370 × 106/L vs 420 × 106/L),
and median baseline HIV RNA log10 copies/mL (4.50 vs 4.58).6
Participants were similarly comparable to those who did not participate.
Patients assigned to receive maintenance therapy showed more decline in QOL
scores than patients assigned to receive prolonged induction therapy on the
following MOS-HIV subscales: physical function (−11 points; effect size,
0.4), role function (−18 points; effect size, 0.4), social function
(−17 points; effect size, 0.5), overall QOL (−19 points; effect
size, 0.7), health distress (−17 points; effect size, 0.7), health perceptions
(−13 points; effect size, 0.5) and energy/fatigue (−8 points;
effect size, 0.3). At week 48, plasma HIV RNA was higher in the maintenance
group than in the prolonged induction group (2.3 log10 copies/mL
vs 1.6 log10 copies/mL; P=.05), although
concentrations in both groups were quite low. A higher plasma HIV RNA concentration
was correlated with more decline in QOL scores for energy/fatigue (r=−0.51; P=.03), social function (r=−0.66; P=.003), health
distress (r=−0.64; P=.005),
health perceptions (r=−0.55; P=.02), and overall QOL (r=−0.58; P=.009) (Figure 1).
HIV indicates human immunodeficiency virus type 1. Values on the
y-axis that are less than 0 indicate decline in quality of life, whereas values
greater than 0 indicate improvement in quality of life. Solid line is regression
and regression prediction line of the mean; dashed lines, 95% confidence interval.
Horizontal line indicates no change in quality of life. There were 10 patients
allocated to maintenance therapy and 9 to prolonged induction therapy.
Quality-of-life scores declined more during maintenance therapy than
during prolonged induction therapy. The data from this small unblinded study
raise the interesting possibility that the negative effects of inferior viral
suppression on QOL were greater than the added burden of a 4-drug regimen.
Funding/Support: This work was supported by
grant 1325 from the AIDS Fund, Amsterdam, the Netherlands. The original antiretroviral
study was financially supported by Roche and Bristol-Myers Squibb.
Previous Presentation: Presented in part at
the 6th Conference on Retroviruses and Opportunistic Infections; Chicago;
Ill, January 31-February 4, 1999 [Abstract 100].
Fontanarosa PB, Nieuwkerk PT, Reijers MHE, Weigel HM, Lange JMA, Sprangers MAG. Quality of Life in Maintenance vs Prolonged Induction Therapy for HIV. JAMA. 2000;284(2):178–179. doi:10.1001/jama.284.2.175
Create a personal account or sign in to: