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Positively Aware May/June 2007

Conference Round-up

New lipo drug, rapid testing, and more news from CROI

by Enid Vázquez

News from the 14th Annual Retrovirus Conference, held in Los Angeles in February.

New therapy for stomach fat

Dr. Steven Grinspoon of Massachusetts General Hospital reported good results with TH9507, a drug available only in clinical studies that is being used to reduce the increased stomach fat often seen after use of HIV drugs. The research team not only saw more than twice the fat reduction that they were hoping to see, but a significant decrease in blood lipid levels as well.

“Cardiovascular risk is ignored too much by the press and the media. Abdominal fat is itself a significant indicator of cardiovascular risk,” Grinspoon said in a press conference.

After 24 weeks of once-daily subcutaneous injections, there was an average 15.2% decrease in visceral adipose tissue (VAT), compared to an increase of 5% for the placebo group (people taking fake medication). Results are from abdominal CT (CAT scan).

Visceral fat is deep. Sitting directly on the internal organs, it is more dangerous in regards to cardiovascular disease than subcutaneous fat, which is superficial, lying underneath the skin.

Sure enough, the department found that men newly diagnosed with HIV were two-and-a-half times as likely to also have chlamydia as men who tested HIV-negative, and more than twice as likely (2.2 fold) to have gonorrhea.

Waist size dropped by an average of three centimeters (slightly more than one inch), but the results of detailed questionnaires of the people in the study are not out yet, so it’s not clear how much of a difference they are seeing in their appearance. (In an e-mail to Positively Aware, one study participant said his doctor told him that “unsafe sex” was a side effect of the drug, as people renew their social lives.) Swollen waistlines are not only dangerous, but deeply distressing, and have prevented many people from going on HIV therapy.

Grinspoon said there was an 18% change in triglycerides, which is “better than some lipid-lowering drugs even though this is not a lipid-lowering drug.”

TH9507 is a growth hormone releasing factor analog. Growth hormone itself has long been used by people with HIV to control stomach fat. “We did not give growth hormone,” Grinspoon explained. “We gave a precursor [beginning step] to growth hormone. It’s a more natural, more gentle physiological way to promote the body’s own growth hormone.”

Headache and arthralgia (joint pain, but without swelling) were seen in more than 10% of both therapy and placebo groups. Grinspoon said the treatment is much more tolerable than growth hormone. There was no significant change in fasting or 2-hour glucose and insulin levels. This was important because increased blood sugar and insulin levels are seen with growth hormone.

Results from a “confirmatory” study are coming from Europe, Canada, and the U.S., Grinspoon said. (In Chicago, the study is being conducted at Northstar Healthcare.)

In an interview with Medscape.com, Dr. Andrew Carr, an HIV specialist from Australia who’s conducted research on lipodystrophy, said, “I’ll be very interested to see whether the second Phase 3 trial can show the same results. If it does, then this is obviously going to be one potential—and the first proven—strategy for visceral adiposity in this patient population.”

“A similar change to growth hormone should be a good thing, but real effect on heart health would take a long time and a lot of money to see,” Grinspoon said. “I urge you to help us raise the money and we will give you those results.”

Rapid HIV testing and STIs in San Francisco

The San Francisco Department of Health tried something new in its efforts to contain the epidemic. Gay and bisexual men who tested positive with the use of a rapid HIV test were started on treatment for chlamydia and gonorrhea at the same time without waiting for those test results to come in. It’s known that having one sexually transmitted infection (STI) increases the risk of becoming infected with HIV, and vice versa.

Sure enough, the department found that men newly diagnosed with HIV were two-and-a-half times as likely to also have chlamydia as men who tested HIV-negative, and more than twice as likely (2.2 fold) to have gonorrhea.

In terms of percent, 22.7% of the men testing positive (50 out of 220) had chlamydia vs. 8.9% of those testing negative (426 of 4,809). For gonorrhea, 27.3% of the positive men (60 of 220) had it compared to 12.3% (592 of 4,809). Results are from 2004–2006.

“The high prevalence of chlamydia and gonorrhea, regardless of HIV status, highlights the importance of screening for both infections at all exposed anatomic sites. …Presumptive same-day chlamydia and gonorrhea treatment among gay men with newly identified HIV infection should be studied to limit the further transmission of both STD and HIV,” the department noted in its abstract.

In presenting the department’s findings during an oral session, Katherine Scott said the department is moving towards 100% rapid testing.

Treating herpes and HIV

More news on STIs and HIV: a collaboration between the U.S. Centers for Disease Control and Prevention (CDC) and the Thai government found that herpes treatment in positive women helped reduce the amount of HIV shedding in the genital tract. Eileen Duime of the CDC noted that herpes doubles the risk of getting infected with HIV. Fifty of 67 women (75%) had HIV shedding at enrollment into the study, and herpes treatment with acyclovir led to a reduction in shedding for 34 of them (55%). Duime said the researchers hope that the results will help inform policies on acyclovir suppression.

These children are underrepresented in HIV treatment, with only a small percent receiving therapy for the virus.

Risk reduction: Don’t get crazy

Dr. Ume L. Abbas of the University of Pittsburgh and colleagues used a “complex mathematical model” to estimate the effectiveness of PrEP on heterosexual HIV transmission in sub-Saharan Africa. (PrEP stands for pre-exposure prophylaxis—the use of HIV medications before exposure to prevent infection.) PrEP could be very helpful in slowing the epidemic, but she said that in another scenario, if people stop taking PrEP and continue their sexual risk behavior, it will not have a significant public health impact. Similar findings have been reported before, including studies in people. Medicines can serve as prevention, but so can risk reduction.

Not leaving children to die—the Baylor international model

Dr. Mark Kline reported on the Baylor College of Medicine International Pediatric AIDS Initiative (see also the March/April 2006 Positively Aware). Kline led the Houston institute, which was already providing pediatric HIV care, to open clinics around the world to serve other children.

Kline reported that as of the end of 2006, there were 2.3 million children around the world infected with HIV, with approximately 530,000 new infections last year alone. These children are underrepresented in HIV treatment, with only a small percent receiving therapy for the virus. In Botswana, where the first BIPAI clinic on the African continent opened, 57.7% of all deaths under the age of five are due to HIV/AIDS.

There are seven clinics in Africa (Botswana, Burkina Faso, Lesotho, Libya, Malawi, Swaziland, and Uganda), one in Romania, and one in China. Median CD4% is steadily increasing with the length of time the centers are in existence. Ninety-three percent of the children treated remain alive and on treatment, with only 10% needing to switch their therapy.

But Kline said it is not enough. “Pilot programs must be scaled up quickly to serve 800,000 children in urgent need of HIV care,” he told his audience.

In addition, BIPAI often treats adult members of the children’s family. “We care for families or arrange for care in clinics nearby. Across Africa children are being therapeutically abandoned as the adults are receiving care. We don’t want to do that to their families,” Kline said.

Another important goal of BIPAI is to train the country’s own medical providers, including many recruited back after having left for better-paying positions elsewhere. BIPAI does not recruit people already working in public health. All in all, the initiative provides support for regional and national scale-up of pediatric and family HIV/AIDS care and treatment. e

Author’s note: Doctors and interns interested in joining the Pediatric AIDS Corps should visit www.bayloraids.org.

News Briefs
Hepatitis B drug Baraclude may cause HIV drug resistance; Women in HIV vaccine study wrongly told they are positive for the virus by outside medical providers. Visit www.tpan.com or see the upcoming July/August 2007 Positively Aware.

 
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