HIV/AIDS • CID 2006:42 (1 January) • 145
H I V / A I D SB R I E F R E P O R T
Improved Lipid Profiles and
Maintenance of Virologic Control
in Heavily Pretreated HIV-Infected
Patients Who Switched from Stavudine
to Tenofovir Treatment
Carl Knud Schewe,1Renato Maserati,3Gernot Wassmer,2Axel Adam,1
and Lutwin Weitner1
1Praxis St. Georg, Hamburg, and
und Epidemiologie, Universita ¨t zu Ko ¨ln, Germany; and
Clinic, Infectious Diseases, IRCCS Policlinico San Matteo Hospital,
University of Pavia, Pavia, Italy
2Institut fu ¨r Medizinische Statistik, Informatik
A retrospective chart analysis of 66 human immunodefi-
ciency virus type 1 (HIV-1)–infected patients whose treat-
ment was switched from stavudine to tenofovir without any
other treatment changes was conducted. The mean totalcho-
lesterol values decreased significantly within 3 months after
the tenofovir substitution and remained significantly less
than baseline values during 18 months of follow-up (mean
decrease, 36 mg/dL;
P p .002
fovir provided effective control of HIV-1 infection, with sta-
ble CD4+cell counts and continued suppression of plasma
HIV-1 level following the treatment switch from stavudine.
). Regimens containing teno-
include tenofovir may be associated with beneficial effects on
blood lipids in HIV-1–infected individuals, compared withreg-
imens that include stavudine [1–5]. To investigate the impact
of replacing stavudine with tenofovir in combination antiret-
roviral regimens, we conducted a retrospective, computerized
chart analysis of patients from 2 HIV treatment centers caring
for 1860 patients in Hamburg, Germany (Praxis St. Georg),
and Pavia, Italy (IRCCS Policlinico San Matteo Hospital).
We identified 66 HIV-1–infected patients whose treatment
had been switched from stavudine to tenofovir without any
additional changes to either their antiretroviral regimen or
their concomitant lipid-lowering therapy. No change in lipid-
Received 12 June 2005; accepted 30 August 2005; electronically published 29 November
Reprints or correspondence: Dr. Carl Knud Schewe, Praxis St. Georg, Brennerstr. 71, 20099
Hamburg, Germany (firstname.lastname@example.org).
Clinical Infectious Diseases 2006;42:145–7
? 2005 by the Infectious Diseases Society of America. All rights reserved.
lowering treatment was allowed within 1 month prior to the
switch from stavudine to tenofovir, and patients had to have
been receiving stable stavudine treatment for at least 1 month.
The first switch was performed in August 2001, at which time
tenofovir became available within an expanded access program
in Germany. Patients were observed until any change in their
combination antiretroviral regimen occurred. They were mon-
itored at the time of treatment switch (baseline) and every 3
months thereafter. The time point of the last observation in-
cluded in the current analysis was 1 August 2004. Plasma HIV-
1 RNA load was measured using the Roche Cobas Amplicor
HIV1 Monitor 1.5 (lower limit of detection, 50 copies/mL),
and CD4+cell count was measured using flow cell cytometry.
Cholesterol (total, high-density lipoprotein and low-density li-
poprotein) and triglyceride serum levels were determinedusing
standard laboratory methods. Changes in quantitativevariables
were assessed using Student’s t test for paired observations.
Pairwise McNemar tests with respect to baseline values were
performed to assess the change in viral load (!50 copies/mL
vs. ?50 copies/mL and !400 copies/mL vs. ?400 copies/mL).
Two-sided P-values were calculated.
The 58 men and 8 women had a mean age of 46 years (range,
defined as Centers for Disease Control and Prevention stage C
or a CD4+cell count nadir of !200 cells/mL. The median du-
ration of prior antiretroviral therapy was 8.7 years (range, 1–
13.5 years). The patients were treated with stavudine for a
median duration of 54 months (range, 1–95 months; mean,
48.2 months). Reasons for switching therapy from stavudine
(11 reason may apply per patient) included lipodystrophy (32
patients), polyneuropathy (21 patients), hyperlipidemia(11pa-
tients), elevated liver function test values (10 patients), and an
elevated plasma viral load (10 patients). Some degree of phy-
sician-defined lipodystrophy was present in 79% of patients.
Ten patients received concomitant lipid-lowering therapy for a
median duration of 18 months (range, 4–47 months).
At the time of treatment switch, 49 patients receivedprotease
inhibitor–sparing regimens (comprising tenofovir, 1 or 2 nu-
cleoside reverse-transcriptase inhibitors, and 1 nonnucleoside
reverse-transcriptase inhibitor; 27 patients received efavirenz,
and 22 patients received nevirapine), 17 patients received reg-
imens containing a protease inhibitor (14 received lopinavir-
ritonavir), and 2 patients received regimenscontaining3classes
of antiretroviral drugs. The median duration of follow-up after
the treatment switch from stavudine to tenofovir was 18
months (range, 4–36 months; mean, 21 months). At the time
by guest on February 2, 2016