The Food and Drug Administration (FDA) today approved
Prezista (darunavir), a new drug for adults whose infection
with the human immunodeficiency virus (HIV) has not
responded to treatment with other antiretroviral drugs.
Prezista, a new HIV protease inhibitor, is approved to be co-
administered with a low-dose of ritonavir and other active
anti-HIV agents. Ritonavir, a protease inhibitor approved in
1996, slows the breakdown of Prezista in the body thereby
increasing the concentration of Prezista in the patient's
system.

Infection with HIV causes AIDS, which results in more than
15,000 premature deaths each year in the United States and
more than 2.8 million deaths each year worldwide.

"This approval offers new hope to HIV patients who too often
urgently need new therapies in order to maintain their
health," said Andrew C. von Eschenbach, MD, Acting
Commissioner of Food and Drugs. "This drug is not a cure,
but when combined with other standard therapies, it
presents one more major step in our effort to help patients
combat the effects of the disease."

Today's accelerated approval is based on evidence from two
randomized, controlled studies comparing the safety and
effectiveness of a Prezista-ritonavir combination with other
ritonavir-boosted protease inhibitor combinations. Patients in
both arms of these trials also used other anti-HIV agents
(nucleoside reverse transcriptase inhibitors) with or without
enfuvirtide, a fusion inhibitor that inhibits the virus from
entering the cell. In these studies, patients on a Prezista-
ritonavir combination experienced higher rates of reduction
of their HIV viral load than patients on other ritonavir-
boosted protease inhibitor combinations. Seventy percent of
treatment-experienced patients achieved a virologic
response, improving the treatment outcome, with Prezista-
ritonavir in combination therapy compared to 21 percent in
control group at week 24.

The most common side effects reported by patients on the
Prezista-ritonavir regimen included diarrhea, nausea, and
headache. About seven percent of patients on this
combination therapy experienced skin rashes ranging from
mild to serious.

The risks and benefits of Prezista have not been established
for adults who have not been previously treated for HIV, or
for children.

As a condition of the accelerated approval, the manufacturer
is required to conduct post-marketing trials to verify and
describe the clinical benefits of Prezista. Other
postmarketing studies that the manufacturer has committed
to conduct include studies in pediatric populations, studies
to better define certain drug-drug interactions, and to
evaluate the drug in patients with varying degrees of liver
impairment to identify appropriate dosing for this patient
population.

Patients are advised to take Prezista and ritonavir with food,
and not to use the combination therapy together with St.
John's wort or various other drugs, including certain
anticonvulsants, antihistamines, sedatives and a few of the
protease inhibitors.

Prezista — taken as two pills, twice daily — will cost $25 a
day, according to J&J unit Tibotec Therapeutics.

FDA Approves New HIV Treatment for Patients Who Do Not
Respond to Existing Drugs FDA NEWS JUNE 23 2006. FDA
approves new drug to treat HIV AP June 23 2006
Prezista
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