| HIGHLIGHTS FROM IDSA
�97 CMV Viral Load As
Predictor of Survival
Data presented at the 35th Annual Conference of
the Infectious Disease Society of America indicate that the level of cytomegalovirus (CMV)
viral load in the blood of people infected with HIV/AIDS is a clear indicator of the risk
that person faces of CMV and developing clinical CMV disease and death. Participants in
the study who tested positive for CMV, as determined by the CMV PCR (or polymerase chain
reaction) test, had a 3.4 fold � 340 percent � greater chance of developing
clinical CMV disease and a 2.5 fold � 250 percent � greater risk of death.
The study also found that therapy with CYMEVENE�
(oral ganciclovir capsules) significantly reduced CMV viral load and increased survival
when compared to placebo.
"The connection between CMV viral load and survival
gives us important insight into the clinical risk of people with HIV/AIDS," said
Stephen Spector, MD, University of California, San Diego, the study�s lead
investigator. "Using the CMV PCR test, we can gauge a person�s risk of disease
progression and death much better. This knowledge can help guide treatment decisions that
extend patient survival."
The data presented are from an analysis of long-term data
collected from more than 600 patients who participated in Roche study 1654 (N Engl J
Med 1996;334:1491-1497). This was a randomized, double-blind study comparing treatment
with CYMEVENE versus placebo in patients who were HIV positive and taking two nucleoside
analogues. Plasma samples were drawn at baseline and every two months for the duration of
the study.
The data found that participants in the placebo group who
were PCR-positive for CMV had a 3.4-fold risk of developing CMV compared to participants
who were PCR-negative. Participants who were PCR positive two months after study
initiation had a 48 percent risk of developing CMV disease compared to 20 percent in those
participants who were PCR negative for CMV.
The study also compared CMV viral load to HIV RNA viral
load with disease progression and death rate. While HIV RNA viral load did offer some
predictive value of the risk of disease progression and death, the predictive value of CMV
viral load measurements was much stronger. In addition, CD4 cell measures did not
correlate with the risk of disease progression and death.
CMV, a herpesvirus, affects approximately 50 percent of the
general adult population. In individuals with healthy immune systems, CMV remains in the
body in a dormant state. In individuals with compromised immune systems, such as people
with HIV/AIDS, the virus can reactivate and cause serious disease, including retinitis, or
infection of the retina of the eye.
CYMEVENE inhibits CMV replication, thereby slowing the
progression of CMV disease. CYMEVENE-IV (intravenous) is indicated only for the treatment
of CMV retinitis in immunocompromised patients, including people with HIV/AIDS, and for
the prevention of CMV disease in transplant recipients at risk for CMV disease.
Oral CYMEVENE is indicated for the prevention of CMV
disease in solid organ transplant recipients and in individuals with advanced HIV
infection at risk for developing CMV disease. CYMEVENE capsules are also indicated as an
alternative to the I.V. formulation for maintenance treatment of CMV retinitis in
immunocompromised individuals, including people with HIV/AIDS, in whom retinitis is stable
following appropriate induction therapy and for whom the risk of more rapid disease
progression is balanced by the benefit associated with avoiding daily I.V. infusions.
The clinical toxicity of CYMEVENE-IV and CYMEVENE capsules
includes granulocytopenia, anemia, and thrombocytopenia. In animal studies, ganciclovir
was carcinogenic, teratogenic, and caused aspermatogenesis.
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