New Long-Term Observational Study Shows Durable Viral Suppression of Boosted REYATAZ(R) (atazanavir/ritonavir)-Based Regimens in a Real-Life Setting in Treatment-Experienced HIV Patients

GLASGOW, Scotland, November 9, 2010 - Results from a European Observational Study, which included 1,294
antiretroviral (ARV)-experienced patients presented today at the Tenth
International Congress on Drug Therapy in HIV Infection (HIV10), demonstrated
a low rate of discontinuation and sustained virologic suppression with
REYATAZ(R) (atazanavir/ritonavir)-based regimens over a follow-up period of
up to five years.(1)

The aim of this study was to investigate the long-term outcomes of
REYATAZ/ritonavir-containing regimens in ARV-experienced patients in a
real-life clinical setting. The primary endpoint of the cohort study was the
proportion of patients who remained on treatment over time by baseline HIV-1
RNA level (<500 copies/mL and >= 500 copies/mL). Secondary endpoints were
reasons for discontinuation, time to virologic failure (defined as either two
consecutive HIV-1 RNA >= 50 copies/mL or one HIV-1 RNA >= 50 copies/mL
followed by discontinuation) and long-term safety profile.(1)

The results of the study revealed that 56% of patients with baseline
viral suppression (<500 copies/mL) (n= 722) and 53% of those with detectable
viral load (>= 500 copies/mL) (n= 540) remained on treatment after 3 years
with a median time to discontinuation of 4 versus 3.6 years, respectively.
The overall discontinuation rate in the study was low (43%) with the reasons
for discontinuation including adverse events (11%), withdrawn consent (6%)
and lack of efficacy (6%). After three years on a REYATAZ/r-based regimen,
75% of patients with baseline HIV-1 RNA levels <50 copies/mL remained
suppressed and 51% of patients with baseline HIV-1 RNA levels >=50 copies/mL
achieved and maintained virological suppression.(1)

Long-term safety outcomes from this real-life study were consistent with
data observed in clinical trials: diarrhoea (4%), renal and urinary disorders
(3%), nausea (<1%) and jaundice (<1%) were reported. Discontinuations due to
hyperbilirubinemia were infrequent (<1%) and no new or unexpected adverse
events were observed.(1)

"Prior to this cohort study, less was known about long-term outcomes and
the length of time on treatment in experienced patients after switching,"
said Professor Jan van Lunzen, M.D., Ph.D. of The University Medical Centre
Hamburg-Eppendorf in Germany. "This cohort study shows in a real-life setting
that a significant proportion of treatment-experienced patients stayed on an
atazanavir/ritonavir-containing regimen for up to five years," he added.

Study Design

This real-life long-term cohort was a non-comparative, retrospective,
observational study that collected data from three European databases (France
- DatAids; Germany - KompNet; Sweden - InfCare). Clinical data from 1,294
ARV-experienced adult patients who started an atazanavir/ritonavir-based
regimen between October 2004 and March 2007 were collected every six months
(maximum follow-up of five years). Patients were predominately male (74%);
their median age was 43 years and 75% had prior exposure to protease
inhibitors (PIs).

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Sources:

(1) Jansen K, et al. Long-Term Efficacy and Safety of
Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced
HIV Patients. Poster P031 accepted to HIV 10.

Annie Simond, +33-01-58-83-65-66, or Joanna Ritter, +33-01-58-83-65-09, both for Bristol-Myers Squibb