BANGKOK, July 13 -- PRNewswire/ AsiaNet
Clinical trial demonstrates high potency combined with good tolerability
Data from a new study with the HIV protease inhibitor Invirase(R)
(saquinavir mesylate) has demonstrated the best HIV RNA response yet seen in a
large group of HIV-infected patients given highly active antiretroviral
therapy.(1-8)
The data announced today at the XV International AIDS Conference in
Bangkok show that a convenient once daily regimen of boosted Invirase(R) plus 2
NRTIs delivers excellent antiviral potency:
- 96% of patients achieving HIV RNA levels of <400 copies/ml
- 91% achieving undetectable levels of virus (<50 copies/ml) after
24 weeks. 1
- CD4 count increase of 109 cells/mm3 at 24 weeks
- CD4 count of 380 cells/mm3.
Commenting on the results, Michael S. Saag, Professor of Medicine and
Director, UAB AIDS Outpatient Clinic, Birmingham, Alabama, USA said "The
antiviral efficacy of Invirase shown in this study is the best we have seen
across similar HAART studies. The good news for patients is that the
outstanding level of HIV suppression achieved is also combined with good
tolerability."
The data are reported from the induction phase of the STACCATO study in
which once daily Invirase/r 1600/100 mg + 2 NRTIs was administered to 167
treatment-naive HIV-infected patients for 24 weeks.
The STACCATO study is being conducted in participation with the HIV
Netherlands Australia Thailand Research Collaboration (HIV-NAT). Dr. Jintanat
Ananworanich, coordinator for STACCATO at HIV-NAT said, "These data
demonstrate that Invirase, when combined with ritonavir, is a highly active
regimen. The level of response we have seen could make a real difference both
in terms of clinical outcome and adherence to therapy."
More about the study
The STACCATO study (Swiss-Thai-Australia Treatment Interruption Trial) is
an international open label randomized study designed to evaluate the
efficacy, safety and tolerability of continuous daily boosted Invirase + two
NRTIs versus CD4 cell count guided treatment interruption. Prior to
randomisation to the comparative phase of the study patients participate in a
24 week induction study.
The induction study population reported here was made of the first 74 men
and 93 women to be enrolled into STACCATO. At the start of the induction
study the median HIV RNA was 4.7 log10 copies/ml and median CD4 count 256
cells/mm3. The 2NRTIs used was d4T/ddI which was later changed to
Tenofovir/3TC.
Using an intent-to-treat analysis, at 24 weeks the median reduction in
HIV RNA was -2.9 log10 copies/ml, with a median CD4 count increase of 109
cells/mm3. Of the 167 patients entered into the study two were lost to follow
up. Drug-related adverse events were mostly mild and self limiting; no severe
or life-threatening events were recorded.
References:
1. Ananworanich J, Ruxrungtham K, Siangphoe U et al. XV IAC, 2004, poster
TuPeB4469
2. Gulick RM, Ribaudo HJ, Shikuma CM et al. New Eng J Med 2004; 350: 1850-1861
3. Podzamczer D, Gathe J, Schwartz R et al. 9th EACS 2003; oral F1/3
4. Raffi F, Saag M, Cahn P et al. 2nd IAS 2002; abstract 38
5. Schurmann D, Gathe J, Sanne I et al. HIV 6, 2002; poster PL14.4
6. Staszewski S, Gallant JE, Pozniak A et al. 10th CROI 2003; poster 564b
7. Van Leth F, Phanuphak P, Ruxrungtham K, et al. Lancet 2004; 363:1253-1263
8. Walmsley S , Bernstein B, King, M et al. N Engl J Med, 2002, 346:2039-2046
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Notes to Editors:
HIV-NAT
The primary goal of HIV-NAT is to conduct HIV clinical research in
Thailand according to the ICH Harmonised Tripartite Guideline and the
Declaration of Helsinki for Good Clinical Practice. Studies at HIV-NAT are of
several kinds: investigator-initiated to answer locally relevant research
questions; participation in pharmaceutical industry sponsored multi-centre
trials; collaboration with bodies such as the US National Institutes of
Health and operation research conducted as part of the Columbia University
MTCT+ initiative and the Thai Red Cross "treat parents and save orphans'
project.
HIV-NAT is grateful to patients for their participation in STACCATO and
to the following Swiss organizations: Swiss National Science Foundation
through the Swiss HIV Cohort Study, State of Geneva, Sidaide Foundation,
Wilsdorf Foundation, for financial support. We thank Roche for financial
support and supply of Invirase and to Abbott and Gilead for providing
ritonavir and tenofovir respectively for use in the study.
For further information please contact:
HIV-NAT contact:
Dr Jintanat Ananworanich
HIV-NAT
Telephone: +66-1-341-4644
Roche contact:
Dr Nina Hautzinger
F. Hoffmann-La Roche
Telephone: +41(0)61-688-13-65
Mobile: +41(0)79-593-43-07
SOURCE: Roche
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