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BURROUGHS WELLCOME STATEMENT ZOVIRAX USE IN TREATING CHICKENPOX

 RESEARCH TRIANGLE PARK, N.C., Dec. 20 /PRNewswire/ -- Recommedndations of the American Academy of Pediatrics' (AAP) Committee on Infectious Diseases were issued December 1992 on the use of Zovirax(R) (acyclovir), in the treatment of chickenpox. Burroughs Wellcome Co. disagrees strongly with the AAP opinion that this medication not be recommended routinely for treatment of varicella in healthy children. As with most other viral infections in children, including measles, varicella is usually a self-limited disease with a low frequency of severe complications. However, this is not always the case. Because of the impossibility of predicting who will have serious disease and who will not, it is a well established modern pediatric practice to treat and vaccinate many children for certain diseases. Physicians should consider treatment of chickenpox with Zovirax in light of the proven efficacy and safety profile of the medication, the potential seriousness of varicella and the fact that the course of the disease cannout be predicted. Treatment decisions for each child are best made on the basis of an informed discussion among the physician and parent.
 KEY FACTS ABOUT ZOVIRAX BRAND ACYCLOVIR
 -- Benefits: Double blind, placebo controlled clinical trials involving approximately 1,000 children (2-18 years old) have been conducted to confirm the safety and efficacy of Zovirax (acyclovir) for chickenpox. These studies clearly showed significant benefit in treating children both in terms of relieving the cutaneous disease (reduction of the number of lesions overall as well as the number of persistent lesions, reduction of itching, accelerated healing) as well as reduceing other constitutional symptoms and signs (fever, anorexia and lethargy). Most of the Zovirax recipients began to feel better within 24 hours, whereas those who received placebo did not begin improvement until 48-72 hours later. Nearly all of the children treated with Zovirax in the largest of the clinical trials(1) had a mild illness of three to four days' duration while 20 percent of the children given placebo had a prolonged illness, with progressive disease persisting for more than six days. It is difficult to predict which child will have a severe episode of chickenpox and which will not. In the clinical trials, there were no disease characteristics at entry that were predictive of disease course.
 -- Seriousness of Varicella: Varicella infections can be quite serious. Fifty to 100 children die each year and 4,500 are hospitalized with this illness. Although some hospitalizations occur in "high risk" individuals (such as asthmatics or immunocompromised children), approximately 80 percent involve otherwise healthy children(2). It cannot be predicted which children will develop complications of varicella.
 -- Zovirax Use: Zovirax has been available for over 10 years for other indications and is marketed in over 90 countries in a variety of formulations. The oral formulations of Zovirax have been widely used in the United States since 1985 for treating a variety of other herpesvirus infections. Over four million people in the U.S. alone, of which 100,000 are children, receive Zovirax each year. Moreover, hundreds of thousands of people have received the medication on a continous basis for a number of years for managing recurrent genital herpes. Zovirax is the most widely studied antiviral in medical history. Over 12,000 people have participated in U.S. clinical trials and over 55,000 have been involved in post marketing surveillance studies.
 -- Long Term and Short Term Adverse Effects: Zovirax is well tolerated and adverse reactions in general tend to be mild and infrequent. In the chickenpox studies, the number of adverse events were similar to those seen with placebo and included diarrhea, abdominal pain, rash, vomiting and flatulence.
 Data collected on children and adolescents who were treated with Zovirax for chickenpox do not indicate any effect on normal immune response at one month, one year and three years(3). Long term immunity studies would need to span decades since chickenpox generally occurs in childhood, and a recurrence in the form of shingles usually occurs in advanced age. Nevertheless, there is no evidence to indicate that treatment of chickenpox with Zovirax would have any effect in increasing or decreasing the incidence or severity of subsequent recurrences of zoster later in life.
 Development of resistence to Zovirax, when used in chickenpox, is unlikely as a practical matter because of the short course of therapy (5 days) in people with normal immunity. Resistance to Zovirax has been rarely documented in varicella zoster virus isolated from treated patients, and then only in severely immunocompromised patients (such as those with HIV infection) who have required chronic or repeated courses of therapy.
 -- Recognition of disease within 24 hours: Wellcome's clinical trial experience shows that parents readily recognize chickenpox in their children. Parents are particilarly sensitzed to chickenpox when their child has been exposed through another case in the household or through an outbreak in the school or daycare setting. There was little difficulty enrolling children in studies within 24 hours of the appearance of the rash. This is noteworthy given the cumbersome nature of clinical trials as compared to the more routine interactions between parents and their pediatricians.
 -- Cost of Treatment: The cost of an average course of Zovirax therapy for chickenpox is similar to the cost of many currently prescribed antibiotic treatments for otitis media. Zovirax is dosed by weight, therefore the cost varies according to the amount prescribed. The cost of treating an average five year old at Burroughs Wellcome Co.'s price would be about $30.
 -- Value of Therapy: Chickenpox can be disruptive to family life and can be costly in terms of lost productivity for parents working outside the home. The overall cost of chickenpox in the United States is estimated to be approximately $400 million per year. This is probably a conservative estimate since it assumes a half day of workplace absenteeism(4). Based on the typical duration of the disease, some studies estimate that work loss would be 2.7 days for a typical case and 6.5 days for a complicated case(5). Additional factors that can inflate this cost include shared child care by more than one working parent and the burden of single parent households. A study of Zovirax in adults with varicella in the military demonstrated an earlier return to normal activities (1.8 days) based on time to full crusting of lesions(6). Most parents would agree that reducing absence from work by one or more days would be desirable and would help reduce the overall impact of this disease on their family and society in general.
 NOTE: Full prescribing information available upon request.
 REFERENCES:
 1. Dunkle, L., et al. A controlled study of acyclovir for
 chickenpox in normal children. N Engl J Med 1991; 325 1539-1544.
 2. Jackson AM, Barry FB, Olson LC. Complications of varicella
 requiring hospitalization in previously healthy children.
 Pediatric Infect Dis J 1992; 11:441-5.
 3. Rotbart, HA, Levin, MJ, Hayward, AR. Immune responses to
 varicella zoster virus infections in healthy children. Jnl of
 Infectious Dis; (manuscript submitted).
 4. Sullivan-Bolyai, Yin EK, Cox P., et al. Impact of chickenpox
 on households of healthy children. Pediatric Inf Dis J 1987;
 6:33-5.
 5. Preblud SR, Orenstein WA, Koplan JP, et.al. A benefit-cost
 analysis of a childhood varicella vaccination program. Postgrad
 Med J. 1985; 61: 17-22.
 6. Wallace MR, Bowler WA, Murray NB, et al. Treatment of adult
 varicella with oral acyclovir: a randomized, placebo controlled
 trial. Annals of Internal Medicine 1992; 117:358-363.
 -0- 12/20/92
 /CONTACT: Kathy Bartlett, 919-248-4302, or Karen Collins, 919-248-3231, both of Burroughs Wellcome Co./


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

MM -- CHSU001 -- 8551 12/20/92 18:34 EST
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