NEWS

03/01/1996



<TITLE> FDA APPROVES SECOND PROTEASE INHIBITOR TO TREAT HIV

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P96-4                              Food and Drug Administration

FOR IMMEDIATE RELEASE              Ivy F. Kupec (301) 443-3285

March 1, 1996                                            



FDA APPROVES SECOND PROTEASE INHIBITOR TO TREAT HIV



     The Food and Drug Administration today approved the second

in a new class of AIDS drugs called protease inhibitors.  

Ritonavir, the new drug, received full approval for use alone or

in combination with nucleoside analogue medications, such as AZT,

in people with advanced HIV disease.  Ritonavir also received

accelerated approval for less advanced HIV disease.  FDA approved

the drug about two months after receiving its application for its

marketing.

     "Even as we celebrate this milestone, we must recommit

ourselves to President Clinton's goal of finding a cure," said

HHS Secretary Donna E. Shalala.  "We must also face the new

challenge of providing life-prolonging medications to all who

need them."

          "The review of ritonavir is the fastest approval of any

AIDS drug so far -- 72 days," said Commissioner of Food and Drugs

David A. Kessler, MD.  "This drug provides real hope for patients

with AIDS.  Patients will live longer."  

     FDA based its approval for ritonavir on data showing that

the drug not only improves laboratory markers, such as CD4 counts

                             -more-

                                     Page 2, P96-4, Ritonavir

and viral load, but that it can reduce disease progression and

mortality in people with advanced HIV disease. 

     Both protease inhibitors and nucleoside analogues chemically

inhibit HIV development, although at different points in the

replication process.  FDA approved the first nucleoside analogue,

AZT, in 1987 and the first protease inhibitor, saquinavir, in

December 1995.

     In clinical studies, ritonavir was studied alone and in

combination with nucleoside analogues in HIV-infected people in

various stages of disease.  Each of these trials monitored

changes in participants' CD4 cell counts, an indication of immune

system strength and viral load, a measure of the amount of virus

that can be detected in the bloodstream.

     The largest of the studies also examined mortality rates in

advanced HIV patients.  The cumulative mortality rate among

ritonavir participants was approximately 40 percent of that seen

in the placebo-controlled participants, and ritonavir

participants also experienced a 50 percent greater reduction in

disease progression during the six months of the study.

     Another study compared patient groups on ritonavir alone,

ritonavir in combination with AZT, and AZT alone.  Those in the

groups taking ritonavir experienced a marked increase in their

CD4 cell counts and a significant decrease in their viral load. 

     A third noncomparative study assigned 32 HIV-infected

individuals to receive a triple combination of ritonavir plus AZT

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                                       Page 3, P96-4, Ritonavir

and ddc.  Again, the results showed marked increases in CD4 

counts and significant decreases in viral load.

     For patients with less advanced HIV disease, none of these

studies included clinical endpoints.  Accelerated approval for

ritonavir in this patient population requires that longer-term

data be collected.

     Accelerated approval is a regulatory mechanism under which

FDA bases early marketing approval for a product on laboratory

markers such as CD4 cell counts until information about clinical

endpoints such as disease progression or mortality is available.

     Adverse events associated with ritonavir treatment

included diarrhea, nausea, vomiting, weakness, tingling, liver

inflammation, elevation of lipid levels and taste disturbance. 

FDA has worked with the drug manufacturer to assure that

potentially severe drug interactions with ritonavir are clearly

highlighted in the package label and that patient education

materials are made available to patients.

     Abbott Laboratories is marketing ritonavir under the trade

name Norvir.

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