Viracept to be available for kids with HIV
Benova threatens suit over TPAC comments
New treatments tied to drop in BC deaths
SF docs encourage protease use
Clinton sets study on medical marijuana
US rules limit curbs on HMO treatments
AIDS Action concerned about Clinton budget
Viracept to be available for kids with HIV
Viracept (nelfinavir mesylate), the new protease inhibitor developed by Agouron Pharmaceuticals, Inc., will be made available to HIV-infected children aged 2 to 13 years through an expanded access program, the first time a protease inhibitor has been made widely available to children with HIV.
The company said it was "encouraged by preliminary evidence of safety and tolerability" from an ongoing study of Viracept in children. Agouran will make the drug available without charge to any HIV- infected child until the drug is approved for marketing in the United States.
Expanded access programs represent an effort by the Food and Drug Administration (FDA) to make investigational drugs available at the earliest opportunity to people for whom no comparable or satisfactory therapy exists. Agouron announced last month that it submitted a New Drug Application (NDA) for Viracept covering both tablet and pediatric powder formulations in the United States. No pediatric formulation of an HIV protease inhibitor has yet been approved by FDA. HIV protease inhibitors have been available for children only through small clinical trials.
In response to the unmet need for HIV treatment options for children, an oral powder formulation of Viracept has been developed simultaneously with a tablet formulation for adults. The oral powder formulation of Viracept can be mixed with milk, formula or soft foods such as pudding. Pharmacokinetic data from an initial pediatric study show that blood levels of Viracept comparable to those seen in adults can be achieved by administration of either the oral powder or tablets. Viracept has been generally safe and well tolerated by children in the study. Preliminary results of the pediatric study are expected to be presented at The Fourth Conference on Retroviruses and Opportunistic Infections later this month.
A toll free information service will be available after January 7, 1997 for physicians, health care professionals and parents interested in the Viracept Pediatric Expanded Access Program. The number, 800-621-7111, is available Monday through Friday from 8:00 a.m. to 6:00 p.m. EST to answer calls. Calls placed before or after these hours will be returned during operating hotline hours, the company announced.
Agouron is currently conducting the Viracept Expanded Access Program for people 13 years of age and older, unable to use any of the three approved HIV protease inhibitors because of intolerance, contraindication or prior failure and who have CD4+ T cell counts of less than or equal to 50 cells/mm3. To date, more than 1,000 people have enrolled in the program.
Agouran has also announced that a large, comparative, multicenter clinical trial of nelfinavir (Viracept) will be conducted by the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA).
The CPCRA trial, which is funded by the National Institute of Allergy and Infectious Diseases, will specifically target HIV-positive populations that are underrepresented in clinical trials, including people of color, women and injection drug users, the press release continued.
The clinical trial will compare the outcomes of 1,300 HIV-positive subjects, all with 100 or fewer CD4+ cells per cubic millimeter, who will randomly receive nelfinavir or another protease inhibitor, ritonavir (Norvir), in combination with nucleoside analogues. Researchers plan to treat the subjects for a minimum of one year. For study site and enrollment information, interested individuals can call (800)-TRIALS-A.
Benova threatens suit over TPAC comments
In a letter to The Philadelphia AIDS Consortium, Benova, Inc., which is responsible for the enrollment of Medicaid-eligible Pennsylvanians in the new Medicaid managed care program, Health Choices, has threatened to sue TPAC executive director Larry Hochendoner and two of TPAC's HIV-positive board members, Kiyoshi Kuromiya and Roy Hayes, for comments they made in a press release last week on behalf of the Ad Hoc Coalition on HealthChoices.
The statement demanded that DPW rescind its $12 million contract with Benova, saying it has already failed.
Hochendoner was quoted in the statement as saying that "the community is outraged by the gross mismanagement being allowed by the Commonwealth of Pennsylvania, through this contract." Kuromiya, a PWA and director of Critical Path AIDS Project, said in the statement that "the issue is that the Commonwealth of Pennsylvania is simply wasting $12 million by continuing this contract with Benova, a contract that they are either incapable or unwilling to fulfill. This is gross fiscal mismanagement, bordering on fraud, and it must be corrected. This has now become an issue for all taxpayers living in this Commonwealth and it has become an issue that must be addressed immediately."
Hayes, former chairperson of We The People and co-chair of TPAC's consumer caucus of people living with AIDS, said that "Benova is entirely unprepared to deal with the realities of enrollment into a mandatory managed care system. Last year alone, according to the Associated Press, an advisory panel recommended suspension of Benova for poor performance in a similar project in Connecticut."
To date, there is no existing list of HIV specialists available to assist persons with HIV and AIDS in their enrollment, the coalition charged. Instead, when a person living with HIV or AIDS contacts Benova, they are provided with telephone numbers for the four participating HMOs and asked to contact those organizations directly. "If the client is to call the HMO directly the should be no need for enrollment counselors, like those supposedly provided by Benova. This is a completely inadequate process," Hochendoner said.
Meanwhile, Kuromiya has found, in his travels on the Internet, the minutes of a meeting in October 1996 of the San Bernardino Medical Society (Inland Empire Health Program), San Bernardino, California, regarding Benova's performance in that area. The minutes read:
"IEHP Physician Advisory Committee Update. Dr. Susheela Bala was unable to attend this evening, so provided a written report of the last IEHP Physician Advisory Committee she attended on October 24. IEHP has 60,000 patients, all from contractors like Tower, etc. Benova, the outside enrollment agency has not performed - no patients have been enrolled through Benova. This has resulted in a loss of more than 20,000 patients/month to IEHP. DHS has now contracted with a new enrollment agency, Maximus. DHS is spending $109 million on this company for 3 years for enrollment. The State has piles of completed forms waiting to be processed. DHS has no man power for this process."
New treatments tied to drop in BC deaths
New AIDS drugs have cut the death rate among patients in British Columbia dramatically, according to data released this month.
In the last three months of 1996, the death rate among British Columbia people with AIDS fell to 23 per 1,000 from 70 per 1,000 at the beginning of 1994, said Dr. Robert Hogg, manager of the province's AIDS drug treatment program.
"It's dramatic. We attribute the drop to people going from monotherapy to double (drug) combination or triple (drug) combination therapy," Hogg said.
The data are thought to be the first in the world based on an entire population rather than just sample groups, he said. Researchers said they were perhaps the best indication so far of the success of new therapies.
Researchers elsewhere have also had startling success with combination therapies including protease inhibitors, a new type of drug introduced in the past year, but the scope of their patient studies has not been as big.
The British Columbia patients took different drugs in varying combinations. About 2,100 people with HIV participate in the province's AIDS drug program.
But Hogg stressed that the new treatments do not cure AIDS and it was not yet known if the effectiveness of the new drugs would wear off.
SF docs encourage protease use
UC San Francisco AIDS researchers have published a review and commentary on the use of protease inhibitors for HIV-infected patients.
The review is intended to assist clinicians and their patients "in the rational use of this potent class of drugs."
The researchers support the widespread use of the new drugs in combination with nucleoside analogues (reverse transcriptase inhibitors) such as zidovudine, ddI, ddC, 3TC or d4T. "We encourage the use of protease inhibitors but the bottom line is there is no magic formula or pattern. Each drug offers unique and important characteristics and the decision on which drugs to use is a decision that has to be individualized to each patient," said James O. Kahn, M.D., UCSF associate professor of medicine, co-director of the AIDS Program at San Francisco General Hospital, and senior author of the review.
"The bottom line is that these are powerful new drugs but they haven't been studied for the long periods that other drugs have been studied," said Kahn. "We wrote this review because much of the information on protease inhibitors is available only in abstracts or from pharmaceutical companies. This is an attempt to put all the information together and into some perspective."
While there have been other reviews of protease inhibitors, this is the first to be published in a peer-reviewed journal. The researchers used peer-reviewed publications, abstracts from national and international conferences and product registration information through September 1996 in their review, which is published in the Jan. 8, 1997 issue of the Journal of the American Medical Association (JAMA).
The four drugs included in the review are the FDA-approved saquinavir mesylate (Invirase), ritonavir (Norvir), and indinavir sulfate (Crixivan). The fourth drug, nelfinavir mesylate (Viracept) has not been FDA approved, but is being offered through an expanded access program.
The researchers emphasized that protease inhibitors work best in combination with nucleoside analogues. They commented that patients will develop resistance to each of these drugs and cross-resistance (to other protease inhibitors) is also likely. They emphasized that these drugs must be used at full doses and attention paid to ensuring that the patient complies with the dosage schedule.
"Long term efficacy of these potent therapies will occur only if viral resistance is avoided," the researchers wrote. "Noncompliance with dosing regimens or frequent `drug holidays' may result in an accelerated development of resistance." And, they commented, since protease inhibitors taken alone (monotherapy) appear to result in an increased risk of resistance by HIV, the drugs should be used in combination with one, and preferably, two nucleoside analogues.
All of the three FDA-approved protease inhibitors have different safety and tolerability profiles, which means they have differing adverse effects on patients, the researchers said. The most common side effects are diarrhea, nausea, gastrointestinal discomfort, and rash. However, these effects are relatively uncommon and usually mild. The researchers commented that the use of the new drugs along with nucleoside analogues has resulted in the hope that HIV can become a long-term manageable disease. They point out, however, that many questions remain to be answered, including the best time to initiate therapy, whether these therapies are equal in efficacy and tolerability, whether patients can comply outside a monitored research setting and, finally, the important question of who will pay for these combination therapies, which currently can cost more than $10,000 per year.
"Until these issues are addressed," they wrote in summation, "clinicians and their patients must apply emerging data to each situation cautiously, searching for unique, individualized, therapeutic strategies."
"Although these drugs are clearly powerful, there's limited long term data," said Steven Deeks, M.D., UCSF assistant professor of medicine and first author of the review. "These drugs were approved in record time by the FDA and we are still learning about some of the pros and cons. Nevertheless, it is clear they work and they should be made widely available. However, one of the major questions that remains to be answered is who is going to pay for them."
Clinton sets study on medical marijuana
White House drug chief Barry R. McCaffrey has requested that the National Academy of Sciences' Institute of Medicine "provide a comprehensive assessment of the state of scientific knowledge and to identify gaps in the knowledge base about marijuana," the Clinton administration announced Tuesday. The $1 million study will evaluate research findings on topics such as the neurological effects of marijuana, as well as its benefit as a therapy for glaucoma, nausea, AIDS, and cancer. The administration has opposed state laws that allow the use of marijuana for certain medical conditions.
US rules limit curbs on HMO treatments
New federal rules have been issued which attempt to address the dilemma of trying to contain costs while also easing fears that patients will not receive necessary care.
The new regulations from the Health Care Financing Administration will restrict the financial penalties which may be assessed against Medicare and Medicaid providers who order referrals or expensive procedures. Health maintenance organizations (HMOs) will still be able to link physicians' pay to their abilities to keep costs down, though financial losses for doctors who refer patients to specialists or prescribe elaborate tests and treatments more often than an HMO prefers will be limited. The new rules may have a significant impact on the ability of people living with HIV disease to access specialty care under HealthChoices, the Medicaid managed care program to begin on February 1st.
Despite hundreds of media reports and specific studies which have linked managed care to incentives to deny care for expensive, chronically ill patients, industry officials and federal officials both say they are not aware of any specific evidence of problems stemming from an HMO's financial incentives, but rather they note both the public's concern about the issue and the need to reassure it.
AIDS Action concerned about Clinton budget
The AIDS Action Council has expressed deep concern "that in an effort to balance the federal budget by the year 2002, President Clinton will call for deep cuts in domestic discretionary spending programs and entitlement programs (including Medicaid) that people living with HIV/AIDS depend upon, as well as HIV prevention and AIDS research programs that are vital to ending this epidemic."
The group said that it has received information that as administration officials prepare the fiscal year (FY) 1998 budget, the Clinton proposal contain major cuts in housing, health and social service programs. "While it does not appear likely that AIDS programs will be cut in the President's FY 98 budget, many AIDS programs will not receive any increases and others will experience only modest increases. Adequate additional funding for all AIDS programs is urgently needed."
AIDS Action also said that the Clinton Administration may recommend a restructuring of the Medicaid program in order to significantly reduce federal spending for this program and contribute to the President's balanced budget goal. This could mean that the contribution per Medicaid beneficiary is set or "capped" at a maximum level ("per capita cap"). "While this is a less draconian response than a Medicaid block grant," the group said, "this 'per capita cap' could threaten the health care available to people with AIDS in the Medicaid program."
Because HIV disease is a costly condition to cover, states could lose money by covering AIDS patients under a per capita cap with the reduced federal contribution. In order to save money, states could choose to modify the benefit package by eliminating optional benefits like prescription drug coverage. States might also choose to eliminate optional eligibility categories like "medically needy" individuals -- a group of Medicaid beneficiaries which also includes many individuals living with HIV/AIDS.
AIDS Action said that these critical budget decisions are being made right now, and will be finalized sometime in mid-January. The group asks supporters of AIDS funding to contact President Clinton and tell him "it is unacceptable to balance the federal budget by undercutting the federal response to the AIDS epidemic and the health care, housing and social services necessary to keep people with HIV/AIDS alive." They said that President must support adequate funding increases for AIDS programs including AIDS research at the NIH, HIV prevention at the CDC, all programs of the Ryan White CARE Act, and the HOPWA program at HUD, and must not cut or restructure the Medicaid program.
President Clinton can be contacted at The White House, 1600 Pennsylvania Ave., Washington, DC 20500, or by calling the White House Comment Line at 202/456-1111. The White House fax number is 202/456-2461, and the President can be e-mailed at president@whitehouse.gov.
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