FDA to quickly clear Merck protease, after approving Abbott's
New booklet explains protease inhibitors to patients
HIV strain resistant to new protease inhibitors
Study says 3TC prevents HIV mutations
FDA will review Chiron viral load test
Study finds PWAs with experienced doctors live longer
Celgene begins distributing Thalidomide
HIV hits two more teens per hour
New HIV vaccine to be tested on humans in Sweden
Pomegranates could help in battle against AIDS
Crypto in drinking water blamed for Nevada outbreak
Study: emergency rooms called a bargain
Man with AIDS tested HIV-negative, CDC says
Shalala backs OAR budget authority
General denouces military ban on HIV+
NY bill is passed to block loss of insurance
Employee dismissed after Marinol detected during screening
FDA Commissioner David Kessler stated that the agency would approve the protease inhibitor by the time the pharmaceutical concern was ready to ship it, noting that "we don't want to hold up their launch." Merck Research Laboratories President Edward Skolnick said that his company would be prepared to start distributing the drug in mid-March or early April of this year. Crixivan was recommended for approval following the presentation of studies which found that 40 percent of the patients who took the drug alone and 90 percent of the patients who took the drug in combination with AZT and 3TC had their HIV fall below detectable levels.
Meanwhile, the FDA's approval of Abbott Laboratories' protease inhibitor Norvir, known generically as ritonavir, occurred just 72 days after Abbott submitted its application.
The agency awarded full approval for use of the drug in late-stage AIDS patients and limited approval for its use in others. Abbott spokesman Doug Petkus said that Norvir will be available in two weeks. The rapid approval -- the fastest AIDS drug approval ever -- was supported by Patrick Korten, a spokesman for the Pharmaceutical Research and Manufacturers of America, who said that the approval was "good news" for AIDS patients, but noted that drugs for other diseases are not receiving such rapid authorization.
Responding to the FDA's quick approval, President Clinton said in a statement, "Our national investment in AIDS research is paying off. Among scientists, as among many people living with HIV, despair is giving way to hope."
"We cannot stop now," he added. "We must recommit ourselves to finding a cure."
"This drug provides real hope for patients with AIDS," FDA Commissioner David Kessler said in a statement. "Patients will live longer."
Abbott said AIDS patients would be able to get the drug almost immediately. It gave no price for it, but AIDS activists said they expected it would cost about $8,500 a year per patient.
Enthusiasm for the new protease inhibitors has come from both medical specialists and the AIDS community because it seems to pick and fight HIV where conventional drugs leave off.
The conventional drugs, called nucleoside analogs, work to slow progression of HIV by interferring with the protein necessary for HIV to reproduce. But they seem less effective as HIV progresses, when the protease inhibitors seem to work, prolonging the patient's life.
The FDA has directed the drug companies to continue their trials of the new therapies to assess their impact on a wide variety of patients in various stages of HIV infection.
The Abbott drug is the second protease inhibitor approved by the agency. The first was saquinavir, made by Roche Holding, Ltd., last December.
New booklet explains protease inhibitors to patients
A new booklet for patients that explains how protease inhibitors work is now available, according to a press release issued by The International Association of Physicians in AIDS Care. Written by Dr. Martin Markowitz, of the Aaron Diamond Research Center in New York, the new consumer booklet explains how protease inhibitors interact with other antiretroviral drugs and discusses drug resistance.
The International Association of Physicians in AIDS Care is distributing the booklet, which was made possible by an unrestricted educational grant from Abbott Laboratories. Translations will soon be available in French, German, Italian, Spanish and Portuguese. The brochure also contains a glossary and a list of 10 protease inhibitors, which are in various development stages. Requests for copies should be made to IAPAC via fax at (312) 419-7160, e-mail at IAPAC@aol.com or by writing to IAPAC, 225 W. Washington St., Suite 2200, Chicago, IL 60606-3418.
HIV strain resistant to new protease inhibitors
Some HIV-infected patients, who have not been treated with the new protease inhibitors, have already developed strains of the virus that are resistant to the new drugs, report researchers at the University of California at Los Angeles. Dr. Andrew Kaplan and colleagues say that nearly one-third of 246 protease coding sequences from 12 HIV-positive patients had mutations that seemed to be resistant to the virus. If some of the viruses in a patient are resistant to the drug, Kaplan said, the virus has "a huge head start."
The researchers analyzed samples of viral enzymes from 12 infected patients who had never been exposed to a protease inhibitor. One-third of the enzyme samples showed mutations that would let the virus laugh away the onslaught of the new drugs, researchers reported in the journal Virology.
Drug resistance has been the recurring nightmare of AIDS patients and doctors, but "what surprised us was the presence of resistant viruses prior to treatment," said Dr. Andrew Kaplan, director of UCLA's Retrovirology Facility.
He and colleagues are trying to create screening tests to see whether a person has a pre-existing resistance to protease inhibitors before starting on the drugs.
Another version of such a test might let a person monitor any developing resistance. Kaplan said the AIDS virus is "like a quick-change artist" in its ability to develop new forms. The UCLA study found that the virus had often developed more than one mutation, a first that let it wiggle partially out of the death grip of the protease inhibitor and a second that brought viral activity back up to normal.
"The critical point in terms of how the virus works is that even if there are only a tiny number of resistant viruses present, once you give the drug, the drug will kill off all the sensitive ones," Kaplan said. "What's left are the resistant ones, which then become 100 percent resistant."
Pennsylvania state welfare official Carol Ranck told a group of Philadelphia people living with HIV disease this month that coverage for viral load testing under state programs would depend on ultimate FDA approval of the tests.
An official name for the virus has not been chosen, but it has been referred to as Kaposi's sarcoma associated herpes virus or human herpes virus 8. Ganem's team of scientists is now working on a blood test to help diagnose Kaposi's sarcoma and is also studying the effectiveness of three drugs--acyclovir, gancyclovir, and foscarnet--in combating the Kaposi's virus. The identification of the virus may lead to more effective treatments for Kaposi's sarcoma, a clearer idea of how it is transmitted, and a better understanding of how viruses cause cancers.
AIDS Treatment News #242
1-800-TRIAL-1-2
A study of 403 adult men diagnosed with AIDS from 1984 through 1994 within an HMO found large differences in survival depending on physicians' experience, measured in large part by how many AIDS patients they had cared for.
"After AIDS diagnosis, median survival among patients of physicians with the least AIDS experience was 14 months, versus 26 months among patients of physicians with the most experience. After controlling for severity of illness and year of AIDS diagnosis, patients cared for by physicians with the most experience had a 31 percent lower risk of death compared to patients cared for by physicians with the least experience.
The adjusted relative risk was 44 percent lower for patients of the most experienced physicians among 244 patients diagnosed from 1989-1994, controlling for CD4 cell count and severity of illness."
Other data suggested that the difference may have been largely due to better use of PCP prophylaxis, including better monitoring to know when prophylaxis should begin.
"Among 212 patients with CD4 cell counts of <200 mm3 prior to AIDS diagnosis, patients of physicians with greater experience had a significant increase in CD4 cell count monitoring, prophylaxis against Pneumocystis carinii pneumonia (PCP), and a decrease in the proportion of patients diagnosed with PCP as their AIDS-defining illness."
This result should reinforce the importance of people finding out if they have HIV, and getting medical care if they do. No treatment at all -- including no PCP prophylaxis no matter how much it is needed -- is worse than treatment by the least experienced physicians. In the U.S. and some other countries, PCP prophylaxis is clearly the most important AIDS-related treatment in reducing the risk of death. And it is inexpensive, so there is seldom any economic obstacle to receiving it.
Also, this result suggests that HIV care does need to be a specialty among physicians, instead of being left to general practitioners. Inexperienced AIDS physicians should be working under supervision so that their patients can be assured of adequate care.
This finding also emphasizes the importance of the development of accepted guidelines and standards of care for HIV treatment. Today the situation is chaotic, with vast differences among physicians, and many patients receiving inadequate care.
The drug is being supplied for treatment of cachexia, a severe wasting condition in people with AIDS. The program has been put in place in response to a request from the FDA.
"The program's launch assures a reliable supply of thalidomide of consistent quality and increases its availability to patients who may benefit from the therapy," said Matthew Tarosky, Regulatory Management Officer of the FDA Division of Antiviral Drug Products.
Roughly 100,000 US AIDS patients suffer from severe weight loss, according to industry and government estimates.
Under an agreement with the FDA, Celgene receives $328 for 100 50mg capsules, resulting in a cost of $550 for a 12-week supply of Synovir at a dose of 100mg per day. This enables the company to defray costs associated with manufacturing and shipping together with the cost of administering and managing the program. A portion of the Synovir distributed will be provided free of charge to economically disenfranchised patients.
Last December, Celgene finalized plans for increasing production of Synovir to 10 million capsules annually, roughly sufficient for treating up to 25,000 patients, depending on dosing and duration of therapy.
The protocol for the expanded access program complements Celgene's placebo-controlled HIV wasting trial and provides patients who fail to meet the admission criteria of that study access to the drug.
The new program is open to patients experiencing AIDS-related weight loss, including those with coincident opportunistic infections or malignancies and also those who have previously failed to respond to other therapies aimed at treating HIV wasting. More severely ill patients may receive Synovir via a salvage arm of the trial.
UPI Science Writer
Every hour, HIV infects up to two more Americans under the age of 20, warned a White House report released this month.
A quarter of the 40,000 to 80,000 new infections in the United States are in people from ages 13 to 20, said the report "Youth and HIV/AIDS: An American Agenda."
Even when analysts use the lower estimate of new infections, calculations show one teenager catching the incurable disease every hour.
"AIDS is now the number one killer of Americans between the ages of 25 and 44," said Patricia Fleming, national AIDS policy director. Because HIV can take years to kill its victims, "we know that many (young adults) were infected with HIV when they were in their teens and early 20s," Fleming said.
"For many Americans, the AIDS time bomb is lighted during adolescence and it explodes in early adulthood," she added.
Describing the new report as "a call to action," she urged AIDS educators to "stop treating adolescents like large children or small adults." Instead, she said, scientists and medical professionals "must pay attention to the biological and behavioral factors of puberty that have a major impact on HIV transmission."
"They think they're invincible," commented Judith Billings, superintendent of public instruction for the state of Washington, who is herself HIV-positive.
Teenage fearlessness is "a wall we have to get over," she said. "Education is the key to preventing the spread of HIV/AIDS," Billings said, clarifying that she favors AIDS education in schools as well as in the home.
Leaving parents to deliver the anti-AIDS message misses a great opportunity -- a chance to reach the large numbers of young people in schools -- she said. Also, "the fact is that many (parents) are not themselves very well informed or very comfortable talking about it," Billings said.
The anti-AIDS message may need new messengers for adolescents, warned Dana Cappiello, co-founder of the AIDS charity, Until There's a Cure Foundation based in San Mateo, Calif.
"Let's face it -- when you were young, did you listen to your parents?" she asked mostly post-adolescent reporters attending the conference releasing the report.
Warnings about AIDS are "more believable when they're delivered by their peers," Cappiello said.
Young AIDS activists attending the report release pressed Fleming with questions on why previous reports had not led to more action, whether the government would step up efforts to develop leadership among the youngest AIDS activists, and how the government was planning to reach teenage runaways living on the street and other high-risk youth.
Fleming listed current programs, but said, "Much more needs to be done."
Miguel Bustos, a 25-year-old White House intern who worked on the report and spoke kindly of it, commented, "Right now, kids are dying because adults are arguing about what to tell them about AIDS."
Britta Wahren, a Professor at Sweden's Karolinska Institute, which awards the prestigious Nobel medicine prize, told Reuters the tests would begin in about a month on nine people infected with HIV.
Tests on animals showed the immune system had reacted positively to similar genetic vaccines. "It looks promising ... but it remains to be seen if it works as well on humans," she said.
The genetic vaccine, which does not have a specific name and is not sponsored by a drugs company, consists of single genes from the HIV-virus which are injected into a patient's muscle.
"This is a so called naked DNA which is ... directly injected into the muscle where it moves to the cell's nucleus and starts producing protein," Wahren said.
The process activates the immune system to go into battle against the virus, she said.
Several similar vaccines are based on the same principle, among them flu vaccines.
Wahren said results of the tests in Sweden would answer the question as to whether it is possible to improve the immune system in humans suffering from HIV.
"We should see the results in a few months. If it works we will continue with more tests," she said.
The patients who will receive the injections have HIV but not AIDS and their infections are at an early stage, which may make them more susceptible to treatment.
The Karolinska Institute is cooperating with the Swedish Institute for Infectious Disease Control and the Soder Hospital in Stockholm for the research project.
Professor Gordon Stewart, Nottingham University's head of applied biochemistry and food science, said: "It could eventually be used to control the spread of herpes and as protection against HIV, in the form of a vaginal douche."
The substance was discovered by researchers at the eastern England university who were looking for quicker ways of detecting food poisoning bacteria such as salmonella.
Stewart told the university's magazine: "The new virucide is profoundly active over short exposure times...if there is viral contact it would act as an anti-viral agent."
Professor Steven Myint, a virologist from nearby Leicester University, who was called in to evaluate the substance's potential, told Reuters at least two years of development will be needed before any possible commercial use.
"We are only at the stage of identifying the active ingredient," he said.
It was already clear it could not be a cure for AIDS, although it might help to stop its spread.
The British government has given a local firm, Rio Pharmaceuticals, a 45,000-pound ($68,000) grant for a 12-month feasibility study for the virucide.
Dr. Susan T. Goldstein of the CDC and her colleagues present a review of the surveillance and microbiology records of 36 laboratory-confirmed cases of Cryptosporidium parvum infection in HIV-positive individuals in the Annals of Internal Medicine.
The outbreak occurred "...despite state-of-the-art water treatment and water quality better than that required by current federal standards," Dr. Goldstein observed.
The outbreak also affected persons not infected with HIV but, in 1994 alone, 78.2% of the confirmed cases were in HIV-positive individuals. "The potential for low-level, waterborne transmission may be greater than previously appreciated...." and "...we should not assume that municipal drinking water is 'risk free'."
The report underscores the importance of surveillance and the need for guidelines to prevent water-borne cryptosporidiosis in HIV-positive individuals, according to the authors.
The study of six Michigan hospitals published in the New England Journal of Medicine found that the average cost of treating a patient for a minor ailment in the emergency room was $62, but the marginal cost - the expense for each additional visit - was only $24. This compared to $53 for a first-time visit to the doctor's office.
The study's conclusions contradict beliefs of health experts and may focus national attention on health insurance policies restricting emergency room usage. Just last month the American Hospital Association reported that emergency room use in the U.S. has declined for the first time in a decade.
Dr. Robert Williams' study is one of the few in the nation to examine emergency room costs, and perhaps the only significant study that has examined the actual cost of providing care based on the severity of the medical condition treated.
The man was a long-time blood plasma donor, but an investigation found no proof that his plasma had infected anyone. The Food and Drug Administration (FDA) is about to license a new HIV test that is significantly different from the one used since 1985, one that would may have detected the man's HIV infection. The new test detects the p24 antigen, an HIV protein, while the current one detects HIV antibodies. The test is controversial, though, because it would add millions of dollars to testing costs, but only detect a few more cases. However, the new test can detect HIV about six days before the standard one does, catching four to six contaminated blood donations per year that the standard test would have missed.
Republicans in Congress have tried to take away the OAR's control over the National Institute's of Health (NIH) $1.4 billion AIDS budget, but NIH director Harold Varmus has supported keeping the OAR's budgetary powers. Some institute directors object to the OAR's role, but Shalala said the law that gives the office its authority should take precedence over a stop-gap funding measure passed in January to fund NIH up to the end of the fiscal year. The measure has been interpreted to mean that the OAR should be bypassed, sending 1996 funds directly to the individual institutes. Rep. John Porter (R-Ill.) called NIH's decision to bypass the OAR entirely "mechanical." AIDS activists and researchers say the move could limit the OAR's authority in AIDS research.
Under the new provision, which was sponsored by Rep. Robert Dornan (R-Calif.), 1,049 service members with HIV would be discharged within five months.
In the past, people serving in the military who had cancer, diabetes, or other conditions that made them "permanent non-deployables" could be forced to retire, while people with HIV could not.
The new law to force the discharge of all HIV-positive military members is supported by people who say it will end the double standard that has been favoring people with HIV. They say all personnel who cannot be deployed should be discharged with medical and financial benefits. Currently, HIV-infected service members are taken from active duty and assigned to desk jobs. When they develop AIDS, they are retired from service with benefits. However, service members who are classified as non-deployable for other medical reasons, may be discharged depending on their individual service's standards and how many non-deployables can be retained.
Gov. George Pataki has not said if he will sign the bill, which was designed to eliminate a legal technicality that had threatened coverage for chronically ill patients who purchased their own insurance.
Empire notified the State Insurance Department that it was going to cancel the policies, which cover medication, home care, and some doctors' bills, because the company had lost some $70 million last year. Empire expected that the affected policyholders would be able to switch to other plans, which was not possible because of a Federal Medicare law that prohibits insurers from selling coverage that duplicates Medicare benefits to individuals eligible for Medicare. Without the bill, the 650 people would have been forced to seek Medicaid benefits, which has strict financial ceilings.
According to the February 9 issue of AIDS Policy & Law, this lawsuit may "...break new ground in balancing employees' medical needs against employers' business needs."
The plaintiff, Kim Allred, who was employed by Solaray Inc., a vitamin manufacturer based in Ogden, UT, had concealed his illness from his employers prior to the drug test.
Solaray cited Allred's functional impairment due to the medication and failure to inform the company of his illness as the basis of the termination.
According to the lawsuit, which was filed for the plaintiff by the ACLU, Allred experienced no "...limiting neurological side effects that would preclude his ability to work." ACLU attorney Jensie Anderson said this is "...one of the most egregious cases the ACLU has come across." Anderson added that "Solaray has engaged in precisely the kind of employer discrimination and abuse of power that prompted Congress to pass the Americans with Disabilities Act."
Attorneys for Solaray claim that AIDS is not the issue. Rather, it is the use of a psychoactive drug by an employee whose job requires precision and attentiveness. Allred's job was night-shift quality control inspector.
The plaintiff is seeking a court order to enjoin Solaray from violation of the Americans with Disabilities Act, along with back salary and damages. Lawyers for the plaintiff maintain that their attempts to settle the matter out of court have failed.