SAN FRANCISCOA clinical trial reported at the 39th Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC) suggests
that people infected with HIV who are taking complicated
protease-inhibitor-containing regimens to suppress the virus may be
able to safely switch to a simplified maintenance regimen requiring
only two pills twice a day.
Current regimens of highly active antiretroviral therapy (HAART),
which include a protease inhibitor and two other anti-HIV agents,
require patients to take large numbers of pills daily (up to 20 in
some regimens). Furthermore, use of protease inhibitors has been
associated with adverse events such as hyperlipidemia. These
difficulties with HAART often lead to patient noncompliance with
The studys objectives were to see if a switch to
simplified therapy leads to comparable virological suppression and to
compare CD4 rates and lipid abnormalities, said M. Opravil, MD,
of the Division of Infectious Diseases, University Hospital, Zurich,
All patients in this randomized study previously had been treated
with more than 6 months of HAART containing protease inhibitors; had
shown HIV suppression for more than 6 months (fewer than 50 copies/mL
of HIV-1 RNA); and had no prior virologic failure while taking the
nucleoside analog reverse transcriptase inhibitors zidovudine
(Retrovir, AZT) and lamivudine (Epivir, 3TC).
Simplified maintenance therapy included the nucleoside analog
abacavir (Ziagen), 300 mg twice daily, plus the combination tablet
Combivir (150 mg of 3TC plus 300 mg of AZT) twice daily. Control
patients in the study continued their protease-inhibitor-containing
regimen. HIV-1 RNA was measured every 4 weeks.
Evaluation after 12 weeks of 153 patients (74 who continued protease
inhibitors and 79 switched to the simplified therapy) found no
appreciable differ-ences in CD4 or CD8 counts between the two patient
Virologic failures (defined as two consecutive plasma HIV-1 RNA
levels greater than 400 copies/mL) also were similar two
failures, at week 25 and 26, for the continuation arm, and three
failures, at week 4, 8, and 16, for the simplified therapy arm. Dr.
Opravil noted that the failures tended to occur somewhat faster with
A significant decrease in cholesterol levels with an increase in
high-density lipoprotein (HDL) values was seen in the patients on the
simplified therapy, Dr. Opravil said.
Longer Follow-up Needed
It is too early to state that simplified therapy has the same
potency as regimens containing a protease inhibitor, Dr.
Opravil said in an interview with Oncology News International.
But there are indications that lipid abnormalities stemming
from protease inhibitors may be reversed when therapy is switched,
which could result in a lower risk of cardiovascular disease. We need
a longer follow-up time.