NEW YORK (Reuters Health) - Findings from an Italian study provide further evidence that HIV drugs called protease inhibitors may increase the risk of artery "plaques."

Because these drugs have been shown to markedly improve the survival of HIV-infected patients, the authors do not recommend simply abandoning them. Rather, patients treated with the drugs should undergo periodic ultrasound tests to look for these plaques. If these tests show worsening of the plaque then a treatment regimen that doesn't include these drugs may be warranted.

Dr. Paolo Maggi from University of Bari and colleagues used ultrasound to evaluate the association between anti-HIV drugs and artery plaques in a total of 293 HIV-infected patients. Specifically, they looked for plaques in a blood vessel in the neck called the carotid artery. The findings are reported in the medical journal AIDS.

One hundred five patients were treated with regimens that included protease inhibitors. The remaining patients were either treated with regimens that didn't include protease inhibitors or with nothing at all.

On follow-up, 52 percent of patients treated with protease inhibitors displayed plaques on ultrasound. In contrast, the rate among other patients was only about 15 percent. Age, smoking, and immune status all seemed to influence the risk of plaques, but the strongest predictor was the use of protease inhibitors, the authors note.

These findings support previous research by the same investigators reported in 2000.

Protease inhibitor regimens appear to be "major" players in the development of artery plaques, the authors conclude. Additional studies, they say, are needed to clarify exactly how such drugs may cause plaques.

SOURCE: AIDS, April 30, 2004.

By Michelle Rizzo

NEW YORK (Reuters Health) - The transmission of drug-resistant HIV among intravenous drug users (IDUs) who participate in high-risk behaviors is high, according to a new study. In addition, such drug users were often prescribed less effective and not recommended HIV drugs.

Evidence of increasing rates of drug resistance among those recently infected with HIV "indicates a growing public health concern and warrants an examination of the problems from a prevention perspective," Dr. Ajay K. Sethi, of Case Western Reserve University School of Medicine, Cleveland, Ohio, and colleagues write the Journal of Acquired Immune Deficiency Syndromes.

The researchers examined predictors of unprotected sex and needle sharing among 638 HIV-infected drug users who completed 2731 visits between 1996 and 2000 in an ongoing study in Baltimore, Maryland.

"After taking account other factors, HIV-infected individuals were significantly more likely to engage in unprotected sex if their sexual partners were also HIV-infected," Dr. Sethi said in an interview with Reuters Health. "Also, HIV-infected women were twice as likely as men to report unprotected sex."

Among IDUs who had injected recently, there was an independent association between sharing needles and homelessness, daily injection, and trading sex for drugs. "IDUs were at higher risk of HIV and drug-resistant HIV transmission at 19 percent and 6 percent of all visits, respectively," the investigators write. Among subjects who were at high risk of HIV transmission, significant drug-resistant HIV was found at 14 percent of visits.

"Although highly active antiretroviral therapy (HAART) was widely available during the study period, less effective and not recommended regimens were prescribed to nearly half of IDUs who were potential transmitters of drug-resistant HIV," Dr. Sethi told Reuters Health. "Transmission of resistance is one consequence of continued wide-use of non-HAART regimens."

"It is likely that reducing high-risk behaviors by HIV-infected individuals would reduce the transmission of HIV, including drug-resistant HIV, to uninfected individuals," Dr. Sethi said. "Clinicians can play an important role by counseling HIV-infected patients about the importance of reducing high-risk behaviors."

In addition, he added, "access to clean needles, which has already been associated with less needle sharing and reduced transmission of HIV, would also reduce the risk of drug-resistant HIV transmission."

SORUCE: Journal of Acquired Immune Deficiency Syndromes, April 15, 2004.

By David Douglas

NEW YORK (Reuters Health) - Despite a successful response to highly active antiretroviral therapy (HAART), drug resistant strains of HIV are still found in blood cells of patients who have previously shown drug resistance, according to Belgian researchers.

"We were able to show that all drug-resistant HIV-1 variants that arise during therapy failure remain archived in the cells of the infected person for a very long period of time--at least 7 years and most probably much longer, lead investigator Dr. Chris Verhofstede told Reuters Health. This occurred "even if drug pressure was removed or if a patient subsequently responded well to a new drug combination."

As reported in the April 15th issue of the Journal of Acquired Immunodeficiency Syndromes, Verhofstede and colleagues from Ghent University Hospital studied 11 patients who had had success with HAART for mean of 59 months. All patients also had a history of receiving suboptimal therapy and had previously developed drug resistance.

In 10 of the patients, drug-resistant viral strains that had previously evolved were still detectable in peripheral blood mononuclear cells.

"These findings," Verhofstede continued, "indicate that once resistance arises against an antiretroviral, the activity of this drug will remain reduced for several years and possibly life-long, even after a withdrawal period of years. Recycling drugs is therefore not an advisable option if other alternatives are available."

These results, he added, "also argue against a possible benefit of therapy interruptions as a way to improve the effect of a subsequently introduced salvage regimen containing recycled drugs."

SOURCE: Journal of Acquired Immune Deficiency Syndromes, April 15, 2004.

© Reuters 2004. All Rights Reserved.

NEW YORK (Reuters) - Bristol-Myers Squibb, Gilead Sciences Inc. and Merck & Co. Inc. on Sunday said they are in talks to develop a combination of three anti-HIV drugs, after U.S. officials urged drug companies to provide better treatment options in developing countries.

The companies said the once-daily, fixed-dose combination would include Viread and Emtriva, both Gilead drugs. It would also include efavirenz, marketed in the United States, Canada and certain European countries by Bristol-Myers as Sustiva, and elsewhere by Merck as Stocrin.

The move follows statements by Secretary of Health and Human Services Tommy Thompson calling on drug companies to develop new combination products, which would make often complicated drug regimens easier.

Thompson also announced an expedited approval process for the combination drugs.

"We are clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in developing countries," Thompson told a news conference.

Pharmaceutical companies that make HIV drugs have often been criticized for not providing the drugs cheaply or for free in developing countries. In recent years, many have bended to public pressure and lowered costs in the developing world.

Big drug makers generally do not make much money from the sale of HIV drugs. However, Gilead has seen large profits from its flagship HIV drug Viread.

Gilead, Merck and Bristol-Myers said they are also considering certain co-packaging options for the individual products.

In a related announcement, GlaxoSmithKline Plc and Germany's Boehringer Ingelheim said they are in talks to assess co-packaging of anti-retroviral drugs for the treatment of HIV.

© Reuters 2004. All Rights Reserved.

By Paul Simao

ATLANTA (Reuters) - The number of HIV patients with Kaposi sarcoma, a once-rare cancer that became a marker for AIDS in the early days of the epidemic, has declined sharply due to the use of antiretroviral drugs, according to a European study released on Monday.

The annual incidence of the cancer fell 39 percent between 1994 and 2003, according to a study of nearly 10,000 people with HIV by the Royal Free and University College in London and a handful of other European hospitals and health centers.

Kaposi sarcoma first appears as a brownish-colored skin lesion, although it can also develop in the lungs, liver and other internal organs. Until AIDS surfaced in 1981, the cancer was seen primarily in elderly Mediterranean men.

It became one of the most common ailments plaguing AIDS patients in the 1980s.

But the introduction a decade later of highly active antiretroviral therapy (HAART) -- a treatment based on a combination of drugs -- gave doctors a powerful new weapon against the opportunistic diseases that killed many AIDS victims.

Anecdotal data and small studies had indicated Kaposi Sarcoma cases were declining as the new drugs suppressed levels of HIV in patients' blood and allowed their immune systems to recover.

The large European study was, however, the first conclusive indication of a link between the therapy and declining cases of Kaposi sarcoma. The findings were published in the May 10 online edition of the American Cancer Society journal Cancer.

In their study, the Europeans noted that those with a higher current CD4 count -- a measure of immune system health -- or who had been on HAART therapy for a longer period of time had a decreased incidence of the cancer.

"This indicates that the current CD4 count remains one of the most important prognostic factors for Kaposi sarcoma, and patients who start HAART should experience a reduction in the risk of Kaposi sarcoma if the CD4 count starts to rise," the researchers said.

The good news was partly overshadowed by a significantly increased incidence of the disease among gay men and in patients from Central and Western Europe. Kaposi sarcoma makes up 6 percent of all AIDS-defining illnesses each year.

AIDS has killed more than 21 million people around the world, including about 500,000 Americans since 1981. About 40,000 Americans become infected with HIV every year.

© Reuters 2004. All Rights Reserved.

SEATTLE - The known incidence of chlamydia rose 12 percent in Washington state last year, leading health officials to recommend that sexually active women under 25 be tested for the sexually transmitted disease at least once a year.

Nearly three-fourths of the reported cases were found in people 15 to 24 years old, said Katherine Gudgel, coordinator of the Washington state chlamydia screening project.

"This is a disease of young people," Gudgel said.

The number of cases went from 14,935 in 2002 to 16,796 last year, an all-time high, according to an annual report of sexually transmitted diseases that was issued Monday. The overall incidence rate increased from 247 per 100,000 residents to 275 per 100,000, still below the last reported national rate of 296 per 100,000.

Among women 15 to 19 in the state, the chlamydia infection rate was 2,273 per 100,000 residents compared with 391 per 100,000 for men the same age.

Syphilis, a more severe venereal disease, also increased in Washington with 82 cases last year compared with 70 in 2002.

Chlamydia, the most commonly reported infectious disease nationwide, is curable with antibiotics but shows no symptoms in about 90 percent of the infected women and 60 percent of the infected men.

Symptoms in both sexes may include painful urination, pain in the lower abdominal area and pain and discharges in the genital area.

Left untreated it can lead to pelvic inflammatory disease, ectopic pregnancy, chronic pelvic pain and infertility in women, infertility in men and higher susceptibility to infection with HIV among both sexes.

In mailings last week to about 13,000 private doctors, the state +Health+ Department asked them to test more patients for chlamydia, but Gudgel said women should not wait for doctors to raise the idea.

"If we can get women to understand how common this infection is and how silent it is ... they will hopefully say, 'I'm a young sexually active woman. I better ask my doctors to test me,'" she said.

ST. LOUIS - Researchers at Saint Louis University are testing a smallpox vaccine that could be useful for people who are HIV-positive, undergoing chemotherapy or otherwise unable to use the existing vaccine, officials said Monday.

"There are limits to the current vaccine," said Dr. Sharon Frey of the university's Center for Vaccine Development. "You can't give Dryvax to people with certain skin conditions such as eczema, or to people who are immunosuppressed."

Testing of the new MVA-BN vaccine from Bavarian Nordic is the first in the U.S.

Like Dryvax, MVA-BN is a live-virus vaccine. But the study vaccine contains a much-weakened form of the virus.

"The thinking is that the study vaccine is much more attenuated, therefore the side effects should be less," Frey said. "So the hope is you may be able to give it to someone who is immunosuppressed."

The study will enroll 90 adult volunteers into six different groups. MVA-BN will be given in three different dose strengths alone or in combination with Dryvax.

The study is sponsored by the National Institute of Allergy and Infectious Diseases.