Study supports investment in HIV prevention among black gays
Roche starts first protease combo trial
US rejects use of new shingles drug
California county closes needle exchange program
Court decision enhances PWA privacy
FIGHT enrolls for new nutrition trial
Study supports investment in HIV prevention among black gays
by Lidia Wasowicz
United Press International
While there has been little research on HIV prevention in minority homosexuals, scientists said last week that they are beginning to understand what measures are most effective in these groups -- which account for more than 10 percent of all AIDS cases in the United States, and which comprise the majority of cases among men who have sex with men in Philadelphia.
The latest studies show that AIDS is increasing fastest among black homosexuals and bisexuals, said John Peterson, formerly with the University of California, San Francisco, Center for AIDS Prevention Studies and now at Georgia State University in Atlanta.
"Despite the need for interventions in this population, there were no data available from controlled trials on HIV risk behavior changes among black gay and bisexual men following participation in HIV prevention programs," Peterson said.
His study, published in the journal AIDS, developed and evaluated the impact of a tailor-made HIV risk reduction program aimed at changing high-risk sexual behavior among African American gay and bisexual men.
As expected, the greater the participation, the lesser the odds of engaging in risky acts, the study indicated, showing men who participated in three sessions practiced more safe sex than those who attended only one session.
On the 15th anniversary of the first published report of AIDS in the United States -- on June 5, 1981, by the Centers for Disease Control and Prevention in Atlanta -- it is high time research such as his went into high gear, Peterson said.
"As we enter into the next 15 years of the AIDS epidemic, we need to concentrate research and prevention efforts on groups that are at extremely high risk for HIV/AIDS," said Peterson, noting the disease has spread from the originally reported five cases in Los Angeles to more than 500,000 nationwide.
In the study, 318 black men took either a single, three-hour course or three, three-hour sessions on prevention. Of the participants, 67 percent had sex with men only and 33 percent with both genders; 26 percent had injected drugs, and 38 percent had sold their sexual services for money.
At the beginning of the study all of the subjects reported comparable rates of risky behavior; at the 12-month follow-up, however, the rates of unprotected anal intercourse in the triple session group declined by 50 percent. And they remained at the low level at the 18-month follow- up. Rates for those attending the single session went down only slightly.
"A multiple session intervention is more warranted than a single session intervention as a risk reduction approach for African American gay and bisexual men," Peterson said.
"While both interventions included multi-faceted components, only in the multiple session intervention did we see a substantial reduction in high-risk behavior."
Roche starts first protease combo trial
Hoffmann-La Roche Inc., has started the first clinical trial using a combination of two HIV protease inhibitors, saquinavir (Invirase) from Roche and ritonavir (Norvir) from Abbott Labs. A total of 120 HIV-infected patients, both antiretroviral drug-experienced and drug-naive, with CD4+ T-cell counts from 100-500, will be enrolled at sites in seven U.S. cities.
In vitro and animal studies have shown that ritonavir increases blood levels and anti-HIV efficacy of saquinavir, while the combination does not significantly increase ritonavir blood levels. Dose reductions of either or both drugs in combination may be possible. In vitro HIV resistance to each drug apparently involves different HIV mutations, so cross-resistance is not expected to be a major problem.
US rejects use of new shingles drug
by Lauran Neergaard
Associated Press
Government advisers have rejected a medicine that promised easier treatment for the excruciating disease shingles, saying Americans would be at risk for the same drug-caused deaths that sparked scandal in Japan.
The Japanese government says 15 people died in a month when they took the shingles drug sorivudine together with some common anti-cancer drugs.
Bristol-Myers Squibb had gambled that the U.S. government would allow sorivudine to sell here despite the Japanese tragedy, as long as the drug bore strong warnings to doctors about the lethal interaction.
Bristol-Myers spent six years studying sorivudine, saying one dose a day healed the severely painful shingles as well as the five daily doses required of standard medication -- and possibly healed the disease a day faster.
But scientific advisers to the Food and Drug Administration decided Thursday that while sorivudine does work, it doesn't offer enough advantage over three existing shingles drugs to risk selling it.
"Can you accept even one death ... when there is alternative therapy?" asked Dr. Scott Hammer of New England Deaconess Hospital, before the 7-2 vote.
The panel did, however, urge Bristol-Myers to better study sorivudine, saying it may one day prove important for treating certain very sick patients.
The FDA is not bound by advisory panel decisions but usually follows them.
Every year, some 600,000 Americans get shingles.
The chicken pox virus lies dormant for years after the childhood bout, until it erupts into excruciating blisters that are acutely sensitive to light, temperature, even the touch of clothing. Although most people recover, shingles occasionally causes life-threatening complications in people with weak immune systems, particularly from AIDS or certain types of cancer chemotherapy.
A Japanese company began selling sorivudine in 1993, but withdrew it after the 15 deaths.
Bristol-Myers already had licensed sorivudine and was testing it here, but knew of the possibility of the lethal drug interaction and so avoided cancer patients, testing only people with the AIDS virus.
Bristol-Myers proposed selling sorivudine with the strongest warning available here, a large black box on the package telling doctors not to prescribe it to patients taking any cancer drugs related to 5-FU, widely prescribed for colon, breast and other solid tumors.
Although chemotherapy itself puts cancer patients at risk for shingles, less than 10 percent of Americans with the solid tumors 5-FU treats get shingles simultaneously, Smaldone said. Immune-compromised patients most often get leukemia and lymphomas, which 5-FU doesn't help.
But U.S. doctors routinely prescribe drugs that are not supposed to be taken together, despite warnings, said Dr. Raymond Woosley of Georgetown University. Also, patients can use numerous different doctors and don't always tell the latest doctor what drugs they already are using.
It is unfair to Bristol-Myers to reject sorivudine "because we are not able to educate physicians," acknowledged panel chairman Dr. Fred Valentine of New York University, who nonetheless voted against sorivudine.
He urged the FDA to find out how often drug warnings are ignored and search for solutions to the problem.
California county closes needle exchange program
Santa Clara county recently disbanded its needle exchange program after state Attorney General Dan Lungren threatened county supervisors with suit and possible jail time. The supervisors voted 4-1 to halt the program which has distributed nearly 80,000 needles since late 1994. The county had budgeted $60,000 annually for the program. Before voting to abolish the program, Supervisor Blanca Alvarado called the Lungren threat "very, very cruel."
Like San Francisco county, Santa Clara county had declared a local emergency in response to the AIDS epidemic as a way of skirting state law against the distribution of drug paraphernalia. The supervisors had said that the public health benefits the program offered were more important than any appearance that the county was condoning the use of illegal drugs. The attorney general threatened suit on the grounds that counties could not use the public-health emergency declaration to skirt the law.
The Santa Clara program had attracted about 50 addicts a night during its biweekly exchange, and studies have estimated that the program prevents almost 30 infections a year, and saves the county $1.6 million a year in medical costs. Before the vote to halt the program, 20 people got up to speak in favor of the program. No one spoke out against the program. The general consensus is that Lungren is using the issue in attempt to woo conservative voters in his likely run for governor.
In nearby San Francisco, Mayor Willie Brown asserted that the city will not back down from its own needle exchange. A Lungren spokesperson declined comment on whether or not the attorney general would threaten to sue San Francisco.
San Francisco currently gives about $234,000 to the Prevention Point Needle Exchange. The program dispenses needles at 11 locations in the city, and during the last half of 1995 distributed 900,000 needles to more than 31,000 people.
Court decision enhances PWA privacy
A Connecticut Supreme Court ruling that a doctor can be sued for disclosing that a patient has HIV, even if no harm is intended, sends a warning to health care workers, social workers, teachers, and anyone else entrusted with such knowledge.
The case involved a woman who told her doctor she had HIV while she was being treated for a gall bladder problem. The case was the first of its kind to reach the state Supreme Court, two lower courts having ruled that the doctor did not "willfully" disclose the information or intend to harm the woman. The Supreme Court decided, however, that no one should disclose HIV-related information, whether harm is intended or not. The patient settled with Doris Marselle, the doctor's assistant who disclosed the information, and is now planning to sue the doctor.
FIGHT enrolls for new nutrition trial
Philadelphia FIGHT is enrolling a clinical trial which will test whether food supplements, like Sustacal and Ensure, will prevent people from experiencing severe weight loss, known as wasting syndrome. The trial is for people who have less than 100 t-cells, and who have not recently lost weight. The importance of this trial is that it will help determine whether nutritional supplements actually keep people from experiencing wasting, and whether this, in turn, will lead to better survival for people with AIDS.
Everyone participating in the trial will receive free food supplements. For more information, please call Philadelphia FIGHT at 215/985-4448, or write them at 1233 Locust Street, 5th Floor; Philadelphia, PA 19107.