Sixteen pharmaceutical companies from the year-old Inter-CompanyCollaboration on AIDS Drug Development (ICC) have reached aconsensus on a protocol to allow rapid evaluation of triple drugcombinations for the treatment of AIDS. ICC scientific chair, JuergenDrews of Hoffman-La Roche made the announcement Thursday at thefirst meeting of the National Task Force on AIDS Drug Development(NTFADD) in Arlington, Va.ICC plans to start clinical trials testing for four separate triple drugcombination therapies in AIDS patients to look for a synergistictherapeutic effect. Each trial will enroll 100 patients and will collectdata on four endpoints: CD4 levels, plasma viral RNA levels, adverseevents and development of viral resistance.If any one of the four triple combinations looks promising, the therapywould be tested in a full-scale Phase III trial with a proper controlgroup. The ICC consensus protocol employs a design known as a"continuous cohort variable regimen," which has worked in the past tofind successful combination therapies for leprosy, tuberculosis andcertain cancers."One cannot expect miracles but if any of the twelve drugs that the ICChas looked at have therapeutic potential in combination, then we have agood chance to find it," Drews told BioWorld.The four drug combinations to be studied are as follows (manufacturerin parentheses): AZT (Wellcome plc) plus ddC plus proteinaseinhibitor RO31-8959 (both from Hoffman-La Roche); AZT plus ddI(Bristol-Myers Squibb) plus Nevirapine (Boehringer Ingelheim); AZTplus ddI plus 3TC (Glaxo); and AZT plus ddC plus Nevirapine.Drews said the combinations were selected on the basis of synergiesobserved in vitro, the lack of overlapping toxicities and simplelogistics, such as availability. Only three of the drugs currently haveFDA approval (AZT, ddC and ddI). The other drugs will be testedunder existing investigational new drug applications (INDs) filed bythe respective companies.The trials could begin enrolling patient in two to three months, if ICCobtains FDA approval. Drews said that the companies will use contractresearch organizations (CROs) yet to be selected and that they willdivide costs evenly."We got our act together, that's the take-home message," said Drews."The ICC has produced some real results."ICC member companies include: Merck & Co., of Whitehouse Station,N.J.; Eli Lilly & Co., of Indianapolis, Ind.; AB Astra, of Sweden;Bristol-Myers Squibb, of New York; Boehringer IngelheimInternational GmbH, of Germany; Burroughs Wellcome Co., ofBritain; DuPont Merck, of Wilmington, Del.; Glaxo Holdings plc, ofBritain; Hoechst AG, of Germany; Hoffman-La Roche, of Switzerland;Miles Laboratories (U.S. unit of German firm Bayer AG); Pfizer Inc. ofNew York; Sigma Tau, of Italy; SmithKline Beecham plc, of Britain;Aji Pharma USA (unit of Japanese firm Ajinomoto Co.); and SyntexCorp., of Palo Alto.Cooper Plan Gets CBO ScorePreliminary analyses from the Congressional Budget Office (CBO)indicate that the health care plan drafted by Rep. Jim Cooper (D-Tenn.)would cost at least $150 billion between 1996 and 2000, according to areport in Thursday's Washington Post. The $150 billion representshealth care spending in excess of revenues under Cooper's plan.The negative CBO score is a blow to proponents of managedcompetition, a philosophy of health care reform based on newinsurance regulations to stimulate competition and curb health carecosts rather than direct government intervention. The CBO calculatedlast January that President Clinton's Health Security Act, the only otherplan to receive review so far, would add $74 billion to the federaldeficit by the year 2000.Chuck Ludlam, vice president of government relations at theBiotechnology Industry Organization (BIO), said that the CBO scoresmay not bode well for foes of price controls. BIO has been a staunchcritic of any price reviews for new drugs."We have seen quite clearly that the CBO will give a health care plancredit for cost savings in direct proportion to how strict the pricecontrols are. This is part of the problem that our industry faces inCongress," Ludlam told BioWorld. "Those in favor of price controlshave a friend in the CBO."CBO scorings are not subject to review or appeal and are critical tosurvival for any proposed legislation. The agency has been given thetask of estimating national health care spending between 1996 and2000 under all of the major competing health care plans. Newlegislation must be deficit-neutral to comply with current budget laws.
-- Lisa Piercey Washington Editor
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