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WELLCOME STATEMENT ON EARLY INTERVENTION

 BERLIN, Germany, June 8 /PRNewswire/ -- The following statement was issued today by Wellcome, a research-based pharmaceutical company, at the IX International Conference on AIDS in Berlin:
 A number of presentations at the IX International Conference on AIDS have addressed a question of interest to researchers, clinicians and patients -- when is the optimal time to initiate antiretroviral therapy in HIV disease? The debate revolves around the concept of "early invention" -- initiation of therapy during the asymptomatic stage, even with cell counts above 500/MM3 -- versus "late" or "deferred intervention" -- initiation of therapy when the patient's CD4 cell count declines to fewer than 500/MM3, the patient develops symptoms or progresses to full-blown AIDS (CD4<200). Much of this discussion involves Retrovir(R) brand zidovudine (AZT) and the value of CD4 counts in evaluating clinical benefit.
 "The question is how much additional survival benefit does therapy with Retrovir (zidovudine or AZT) provide when given earlier rather than later," said David Barry, M.D., vice president of Research, Development and Medical Affairs at Burroughs Wellcome Co. Barry noted that it is well established and accepted that Retrovir increases survival when taken during the later stages of HIV infection such as AIDS or ARC.
 "Whether even more benefit for patients can be obtained by initiating intervention early has been the subject of some discussion this week. Several rigorously controlled studies -- ACTG 016, ACTG 019 and EACG 020 -- have demonstrated a clear clinical and immunologic benefit while others such as Concorde -- have shown only an immunologic benefit. The most critical point, however, is that no currently available monotherapy will provide as long lasting benefit as we would all desire," said Barry. "The most important thing we can do now is to focus on identifying the best combinations and the optimal time to initiate them, so we can help people manage their disease over the long term."
 COMMON QUESTIONS RE: EARLY AZT
 Q. Is there any value to early intervention with AZT?
 Absolutely. In numerous clinical trials, Retrovir has been shown to provide benefit to patients who initiate therapy early. ACTG 019 determined that patients who take Retrovir while asymptomatic (CD4 200-500) prolong their symptom-free stage. EACG 020 indicated similar benefit for patients with higher CD4 cells (>400). Still other data released at this conference by Harrison et al (PO-B26-1992) support early intervention with Retrovir, indicating a direct relationship between the stage of disease in which therapy is initiated and the patient's ability to maintain that stage for the longest possible time.
 Q. Is there a survival benefit to AZT?
 Yes. It is well established that Retrovir improves survival when taken in advanced disease. The question is whether or not there is ADDITIONAL mortality benefit if monotherapy is initiated earlier in the disease.
 Q. If survival benefit in early therapy is unknown, what value is there to early AZT?
 Early therapy with AZT prolongs the asymptomatic stage of disease, keeping patients healthier longer than they would be if the disease progressed unchecked. In addition, by prolonging the asymptomatic stage, patients will be healthier candidates for new or additive therapies that will be developed in their lifetime. It's also worth noting that AZT is well tolerated when taken early in disease, with most side effects being mild and transient.
 Q. Many people know that Retrovir works but believe it should be saved for when a patient really needs it -- when they are sick. Why not take a wait and see attitude?
 Even during clinical latency, the virus is actively replicating (Fauci, Haas, PS-01-3, Nature), giving seemingly healthy people a false sense of security. In other infectious diseases, it is common practice to start therapy as early as possible to control microbial progression. Initiating therapy at CD4 500/MM3 is advantageous because of its proven clinical benefits and the desire to control virus replication as early as possible. While AZT cannot restore a damaged immune system, it can slow disease progression and help maintain the immune system's capacity to protect the body from opportunistic infections.
 Q. Should monotherapy with AZT continue as standard early therapy?
 At this point in time, yes. In the U.S. and certain European countries, therapy with AZT in early stages of disease is the standard. However, new data may eventually prove that combinations are more effective than monotherapy with Retrovir when initiated early. Wellcome is actively involved in combination research to determine the optimal drugs to treat patients with early disease.
 Q. Are there subgroups of patients that benefit more from early therapy?
 We know of no subgroup of patients that does not benefit from therapy with AZT, regardless of sex, race, age or mode of transmission. In fact, emerging data (EACG 020) would suggest that additional patients (CD4 400-750 may benefit from early intervention with Retrovir.
 Q. Is CD4 a reliable surrogate market to show drug benefit?
 CD4 is an adequate but incomplete marker in HIV disease. While


it is a strong indicator of clinical deterioration, it is a less precise marker of a drug's efficacy. In the future, we suspect that markers such as virus replication and viral resistance as measured by polymerase chain reaction (PCR) technology may gain wider use. For the time being, CD4 is the best and most practical marker available.
 Q. What does Wellcome think of the Concorde study? Has this opinion changed as more data have been released?
 We find the results of Concorde to be consonant with other monotherapy trials that were initiated in the 80's. However, the management of asymptomatic HIV infection has changed considerably with current scientific opinion suggesting that early combination therapy might provide a better strategy. Given this trend, we think the question of more interest to researchers, clinicians and patients alike is what the optimal combinations are and when should they be initiated.
 Wellcome's perspective on Concorde has remained consistent as more data have been presented. While we would ultimately like to be able to review subgroup analyses to learn the most from this trial, we firmly believe that the future of HIV management lies in early combination therapy.
 Q. Doesn't Concorde contradict or invalidate the results of other clinical trials such as ACTG 019? How does Wellcome reconcile these seemingly disparate data?
 Wellcome sees less inherent contradiction among these studies than taking them at face value would suggest. The Concorde study reaffirms Retrovir's ability to interfere with viral replication and prolong the time until disease progression when started early in asymptomatic patients. It also shows that Retrovir is well tolerated, even at higher than currently recommended doses and especially among the asymptomatic population.
 Burroughs Wellcome Co. is a member of the Wellcome Group which is dedicated to discovering, developing, producing and marketing quality healthcare products worldwide.
 Burroughs Wellcome has five medications used in the management of HIV disease and related opportunistic infections including Retrovir brand zidovudine (AZT).
 For more information, call Kathy Bartlett (919) 248-4302, or Doug Stokke (919)248-8611, at Burroughs Wellcome Co. in Research Triangle Park, N.C.
 -0- 6/8/93
 /CONTACT: Kathy Bartlett, 919-248-4302, or Doug Stokke, 919-248-8611, both of Burroughs Wellcome Co./


CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU:

MM -- CH004 -- 6656 06/08/93 15:31 EDT
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