UC Berkeley epidemiologist led seminal AIDS, air pollution studies.

Warren Winkelstein Jr.

Dr. Warren Winkelstein Jr., professor emeritus of epidemiology and a former dean at the University of California, Berkeley, who is credited with leading definitive studies on AIDS transmission, air pollution and other health issues, died Sunday, July 22. He was 90.

Winkelstein died at his home in Point Richmond of complications from an infection.

Winkelstein’s distinguished career spanned six decades and was marked by numerous accomplishments, such as leading the landmark San Francisco Men’s Health Study that began in the early 1980s, a time when little was known about a mysterious new disease called AIDS.

“That study was the first to provide us information about how HIV was transmitted, the length of the virus’s incubation period, and what behaviors put people at greater risk,” said S. Leonard Syme, UC Berkeley professor emeritus of epidemiology, who first met Winkelstein in 1960. “There were only four AIDS research grants awarded at that time, and Winkelstein’s was the only one that started with a population of healthy people, rather than people who already had AIDS, and observed them over time. It was amazing work, and that research became the definitive study of how AIDS was spread.”

To this day, the San Francisco Men’s Health Study stands as one of the largest and best described cohorts of people at risk for HIV/AIDS, Syme said.

Winkelstein was born on July 1, 1922, in Syracuse, N.Y. He was in the inaugural class of students at the Putney School in Vermont, a progressive preparatory high school that emphasizes experiential education. He served in the Army in World War II before continuing his education at the University of North Carolina, where he received his bachelor’s degree in sociology in 1943. He went on to earn his medical degree from Syracuse University in 1947, and his master’s degree in public health from Columbia University in 1950.

After graduation, Winkelstein served a year with the U.S. Public Health Service, where he was assigned to work on a Special Technical and Economic Mission to North Vietnam. This work was a forerunner to the creation of the U.S. Agency for International Development.

In 1951, Winkelstein joined the Erie County Health Department in Buffalo, New York, as a district health officer. Two years later, he became director of the department’s Division of Communicable Disease Control, a position he held until 1956. During his tenure there, he headed one of the largest trials ever conducted of the Salk polio vaccine.

Winkelstein also established the Epidemiology Research Program at the State University of New York, Buffalo, and while there he led one of the first studies to successfully isolate air pollution as the cause of health problems in low-income neighborhoods. That work helped influence the development of U.S. air quality standards.

“I was an executive secretary at the NIH (National Institutes of Health) at that time, and we had never seen a grant proposal like his before,” Syme recalled. “He proposed a way to study the health effects of air pollution that could separate out the confounding variables associated with poverty. That had never been done before. He kept picking topics that no one else had looked at, and his research has really changed our lives.”

In 1968, Syme, by then a faculty member at UC Berkeley, helped recruit Winkelstein to a growing division of epidemiology at the School of Public Health. Winkelstein joined as a professor of epidemiology and served as the school’s dean from 1972 to 1981. He was considered a valued and trusted colleague and thoughtful mentor to scores of graduate students in public health. 

“Warren Winkelstein was one of America’s greatest epidemiologists,” said Dr. Arthur Reingold, UC Berkeley professor of epidemiology and associate dean for research at the School of Public Health. “He was world-renowned for his pioneering studies in the history of epidemiology, and for his superb teaching skills. He was an important mentor to dozens of epidemiologists, and beloved by several generations of students. He will be sorely missed.”

Among other achievements credited to Winkelstein is the first case-control study of risk factors of coronary heart disease in women, and his pioneering research on the link between tobacco smoke and cervical cancer.

Winkelstein remained active after his retirement in 1991. He continued to teach graduate courses on ethics in epidemiology and the history of the field. He also wrote biographical sketches of prominent figures in the field of epidemiology, including John Snow; Edward Jenner; his mentor, Abraham Lilienfeld; and Janet Elizabeth Lane-Claypon, who conducted a classic study of breast cancer epidemiology in the 1920s.

Winkelstein was preceded in death in 2004 by his third wife, Veva Winkelstein. He is survived by his three children, Rebecca Yamin of Philadelphia.; Joshua Winkelstein of Holt, Mich.; and Shoshana Winkelstein of Oakland; as well as by three grandchildren and three great-grandchildren.

A campus memorial service will be held from 4 to 7 p.m. on Monday, Sept. 10, at the Great Hall of The Faculty Club. Click here for a map.

Gifts may be made in Winkelstein’s memory to The Warren Winkelstein Epidemiology Graduate Student Support Fund. Checks should be made payable to the UC Berkeley Foundation and sent to the School of Public Health, 417H University Hall, University of California, Berkeley, CA 94720-7360. The name of the fund should be noted on the check.

Related links:

• Influential epidemiologist and esteemed professor (Q&A by UC Berkeley School of Public Health)
• Preventing heart attack and stroke (2003 Oral History interview with Winkelstein)

Pledge draws nearly 4,000 online signatures worldwide.

UCSF's Steven Deeks speaks at the International AIDS Conference while Robert Silician of John Hopkins University School of Medicine looks on.

Nearly 4,000 people around the world have shown their support for ending the global AIDS epidemic by signing an online declaration during the XIX International AIDS Conference.

The “Washington, D.C. Declaration” outlines a nine-point action plan that includes focusing on HIV prevention, ending discrimination against HIV patients, boosting research investment and making treatment available to all those who need it.

The document is the official declaration of AIDS 2012, which has brought together thousands of medical experts, health care professionals, activists and people living with HIV under this year’s theme “Turning the Tide Together.” The biennial meeting hosted by the International AIDS Society began July 22 and runs through July 27.

Written by a committee of international experts, the declaration grew out of a partnership with the International AIDS Society, the International AIDS Conference and UC San Francisco. It’s been translated into 11 other languages to maximize the reach around the world.

Previous declarations signed during the International AIDS Conference, most notably the Durban Declaration in 2000, have greatly impacted the world’s perception of HIV and rallied support against the disease.

The Durban Declaration garnered more than 5,000 signatures by physicians and scientists who spoke out against then-South African president Thabo Mbeki and others who denied that HIV causes AIDS. The declaration stated that the evidence showing HIV causes AIDS is “clear-cut, exhaustive and unambiguous, meeting the highest standards of science.”

Diane Havlir, M.D., chief of the UCSF Division of HIV/AIDS at San Francisco General Hospital and Trauma Center and U.S. co-chair of the conference, said the Washington, D.C. Declaration is another prime opportunity to advance the conversation about the disease.

“Declarations are used as a moment for an audience, when the world’s attention is focused on the International AIDS Conference, to say something very, very important. And we think in 2012 we have something very, very important to say, and that is that we now for the first time ever — we’ve never really said this before — we think we can begin to end AIDS,” Havlir said.

Experts say there’s been a lot of progress made against HIV over the past two decades but challenges remain.

According to UNAIDS, more than 2.5 million deaths have been averted since 1995 thanks to access to HIV treatment, and new infections in 2010 totaled 2.7 million — 21 percent below the number at the peak of the epidemic.

However, for each patient who goes on treatment, two more people are newly infected. As of 2010, an estimated 34 million people worldwide were living with HIV — an increase of 17 percent from 2001.

Recent scientific advances, including evidence that HIV drugs can work in prevention, have renewed optimism in the search for a cure.

Elly Katabira, president of the IAS and international chair of AIDS 2012, said the declaration is “an important opportunity for people the world over to stand together and call for the leadership and resources necessary to begin the march toward the end of AIDS.”

Related link:
UCSF focus on XIX International AIDS Conference

UCSF School of Dentistry oral pathologist honored for his contributions to his field.

John Greenspan, B.D.S., Ph.D., considers himself naturally curious. When he started seeing a rare form of cancer of the lymphatoid system in young San Francisco men during the early 1980s, he was intrigued.

John Greenspan, UC San Francisco

“It’s called Burkitt’s lymphoma, and I thought this was strange,” said Greenspan, a distinguished professor of oral pathology with the UC San Francisco Department of Orofacial Sciences and the associate dean for global oral health with the UCSF School of Dentistry. “We typically saw it in Africa. But in this country, we only used to see it rarely, for example, in immunosuppressed patients, such as kidney transplant recipients. So we ended up seeing one of the first AIDS lymphoma patients reported in the world.”

His tenacity led to major research breakthroughs in the oral aspects of AIDS and the role of viruses in oral lesions.

In recognition of Greenspan’s work, the American Dental Association (ADA) this week named him the recipient of its 2012 ADA Gold Medal Award for Excellence in Dental Research, one of the top honors in the field of American dentistry.

“I’ve known most of the people who have received this award, and several of them are my personal heroes,” Greenspan said. “So there is a tremendous sense of pride.”

It is also a source of pride for the UCSF School of Dentistry.

“The award of this prestigious medal by the ADA to Dr. Greenspan not only recognizes his groundbreaking work but also sets aside UCSF and the UCSF School of Dentistry as an institution where such work is fostered and conducted,” said John Featherstone, M.Sc., Ph.D., dean of the UCSF School of Dentistry. “It brings honor and prestige to both the recipient and to UCSF.”

Identifying oral lesions

During the early days of the AIDS crisis, Greenspan worked closely with his wife, Deborah Greenspan, B.D.S., D.Sc., now chair of the UCSF Department of Orofacial Sciences. In her clinical practice, she started seeing a white lesion on the tongue of gay men. She consulted with her pathologist husband, who suggested a biopsy to find out what was causing it. That work led to the Oral AIDS Center at UCSF. It was instrumental in teaching physicians, nurse practitioners and other clinicians how to identify oral lesions associated with HIV infection.

In the 1980s, Deborah and John Greenspan discovered oral viral lesions called hairy leukoplakia, which is linked to HIV/AIDS.

“At the same time my colleagues in the medical AIDS clinics and labs wanted me to start a specimen bank of serum and tissue of these patients,” Greenspan said. “I was willing to do it because I was already getting interested in the issues, the problems and saw this as a chance to make a contribution.”

He started the UCSF AIDS Specimen Bank, which will celebrate its 30^th anniversary in December. This repository has been a crucial part of the HIV/AIDS research programs at UCSF and led to his role as director of the AIDS Research Institute at UCSF for nine years.

Greenspan and his wife have made major contributions to HIV research and care including the discovery of hairy leukoplakia — an oral viral lesion that appears as raised white areas of the tongue — and its link to AIDS.

“These were regular moments in a regular working day of a working year,” Greenspan said. “Starting in late 1981, there was a 10-year period of discovery. Our work was very, very gradual and that was on top of what we do during a normal working week.”

Major breakthroughs and prejudice

Greenspan’s finding linking oral lesions with HIV-positive gay men in San Francisco made headlines after it was published in 1984 by The Lancet, a weekly peer-reviewed general medical journal. Then a year later, he and his wife identified a connection between hairy leukoplakia and Epstein-Barr virus (EBV), a virus that is most commonly known to cause infectious mononucleosis and some types of cancer such as forms of non-Hodgkin’s lymphoma.

By late 1985, they were heavily identified with AIDS.

“We were met with jokes, fears, homophobia and fear of contagion,” said Greenspan. “We just sailed through that with the argument that whatever we do has to be based on science, and if you base it on science, it will protect you. So it became not so much about fighting stigma, but setting an example.”

The Greenspans’ research has helped change dental standards in the United States.

“The work of Dr. Greenspan and his colleagues has provided guidelines that enable dentists to recognize early oral manifestations of HIV/AIDS and thereby assist with early diagnosis and referral for treatment,” Featherstone said.  “This is of particular importance in the global health world.”

Changing dentistry culture

The ADA adopted standardized universal infection control policies, including upgrading facilities so that hand instruments and dental hand pieces could be sterilized.

“There was a huge controversy because sterilization destroys the hand pieces. So they had to redesign the device and dentists had to buy new hand pieces and new equipment. So dentistry is completely different post the AIDS period,” he said. “The ADA did a wonderful job of basing their recommendations to their members and patients on data.”

Greenspan will receive his award from the ADA in October during a formal presentation in San Francisco.

“While I appreciate the acknowledgment, there’s a whole team of people who did the work,” he said. “Sometimes I was the leader and sometimes I wasn’t. A big team of faculty investigators, fellows and students — probably over a hundred collaborators — we’ve worked with over the years. And then there are the patients and in the early days, we lost many of them along the way. They deserve the acknowledgment as well.”

The ADA Gold Medal Award for Excellence in Dental Research was established in 1985 and is presented once every three years to honor individuals who contribute to the advancement of the dental profession or who help improve the oral health of the community through basic or clinical research.  The honoree receives $25,000 and a gold medallion. Additionally, the recipient serves a three-year term on the ADA Council on Scientific Affairs.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. For further information, please visit www.ucsf.edu.

Related link:
UCSF focus on XIX International AIDS Conference

UC San Diego’s Davey Smith is seeking new ways to help stop transmission of the disease.

Davey Smith, UC San Diego

Davey Smith, M.D., associate professor of medicine in the Division of Infectious Diseases at the University of California, San Diego, School of Medicine and the VA San Diego Health System is one of three recipients of the 2012 Avant-Garde Award for HIV/AIDS research.  This prestigious award, announced today by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, is intended to stimulate high-impact research that may lead to groundbreaking opportunities for the prevention and treatment of HIV/AIDS in drug abusers.

Smith will receive $500,000 per year for the next five years to support a project for HIV prevention for drug users and other high-risk groups. His research group will work to develop a system that integrates patient demographics, geographic location, drug use and HIV strain in order to map patterns of new HIV infections as they occur.  Such a system is designed to ensure quick delivery of prevention resources that are tailored to specific groups at risk for HIV, with the goal of stopping transmission of the disease, particularly among illicit substance users.

“We believe this could be the key to ending HIV transmission in some of the most at-risk populations in San Diego and, in turn, other communities,” said Smith.

Smith is a translational research virologist who works both at the UC San Diego Antiviral Research Center, where he is medical director of the Early Intervention Program, and as director of the Center for AIDS Research (CFAR) Translational Virology Core. His primary research focus is on the transmission of HIV and finding new ways to interrupt the spread of the disease.

In 2010, Smith was one of two recipients of the HIV Medicine Association’s 2010 HIV Research Award, recognizing up-and-coming HIVMA members who have made outstanding contributions to HIV medicine early in their careers.  He is also a member of the San Diego County HIV Planning Council, where he chairs the standards of care committee.

Research suggests recommended dose adjustment may not be necessary, particularly in non-Caucasian populations.

Annie Luetkemeyer, UC San Francisco

In January, the U.S. Food and Drug Administration (FDA) issued new guidelines on dosing of an HIV medication used to treat people infected with both HIV and tuberculosis (TB) because of a potential interaction between two of the main drugs used to treat each disease.

The drug rifampin, used for treating TB, can lower levels of the HIV medicine efavirenz, so the FDA recommended that patients who weigh more than 50 kg (110 pounds) and who are taking both medications should get 30 percent larger doses of efavirenz (an increase from 600 mg to 800 mg).

Now, a new analysis by conducted by researchers with the Adult AIDS Clinical Trials Group (ACTG) at UC San Francisco and the San Francisco General Hospital and Trauma Center (SFGH) suggests this recommended dose adjustment may not be necessary, particularly in non-Caucasian populations.

As described in a talk at the XIX International AIDS Conference in Washington, D.C., today (July 23), the new FDA guidelines were based on several small studies in European TB patients and one in healthy volunteers, indicating a decrease in efavirenz levels with rifampin. The guidelines were also informed by a mathematical model, which showed that increasing efavirenz to 800 mg when given with rifampin would increase levels to those seen on the regular dose of 600 mg.

These data may not apply to patients in African and Asian populations because of genetic differences that lead to higher efavirenz levels — or even in the United States, where more than half the people with TB and HIV co-infections are African American or Asian American.

“To make the recommendation across the board that all patients who weigh more than 50 kg should increase the dose of efavirenz is not supported by our research. Doing so may lead to more drug toxicity without improving the effectiveness of efavirenz in TB patients,” said Annie Luetkemeyer, M.D., an assistant professor of medicine at UCSF and an ACTG researcher at SFGH.

How the two drugs interact

TB and HIV co-infections, while relatively rare in the United States, form a particularly devastating one-two punch in many parts of the world. Having HIV makes you twice at least twice as likely to develop tuberculosis, and TB is now the number one killer of people with HIV worldwide.

The problem is particularly pronounced in sub-Saharan Africa, where, according to the World Health Organization, about 60 percent of the people in the world with HIV/AIDS live and where a third of the 22 countries with the highest levels of TB are located.

Clinical evidence strongly suggests that people who have HIV and TB should be treated simultaneously for both diseases. Waiting to treat HIV until after TB treatment doubles the likelihood of death, and starting HIV treatment early in the course of TB reduces the risk of death and new AIDS complications in patients with advanced AIDS. Even waiting six weeks to start HIV treatment can increase this risk, said Luetkemeyer.

But rifampin and efavirenz, two of the front line drugs used to treat both diseases, interact through a liver enzyme in the human body known as cytochrome P450, which generally breaks down and metabolizes most drugs. When someone takes the anti-TB drug rifampin, it increases levels of these P450 enzymes, and they, in turn, break down the HIV drug efavirenz.

The FDA issued its new guidance specifically to address the concern that adults on both drugs who weigh more than 50 kg would run the risk of not having enough efavirenz, and they recommended that people simply take 30 percent larger doses of the anti-HIV drug (substituting 800 mg of efavirenz for the normal 600 mg dose).

However, the metabolic effect observed in the studies that the FDA looked at is also influenced by genetics, and people in African and Asian populations may be slower metabolizers than people in the predominantly white populations involved in the trials upon which the FDA based its recommendation.

In recent years, Luetkemeyer and her colleagues have collected clinical data specifically looking at how best to co-administer drugs for HIV with drugs for other infections through a large, randomized, multicenter ACTG clinical trial called STRIDE.

The main goal of the STRIDE study was to evaluated optimal timing of HIV treatment initiation in patients starting TB treatment with advance AIDS. The study was also able to look at how giving efavirenz and rifampin together impacted efavirenz levels and the effectiveness of the HIV treatment regimen and to see if weight made a difference in efavirenz levels or effectiveness.

What the STRIDE data showed in technical terms was that the effectiveness of the HIV drug efavirenz did not decrease as a result of its interaction with rifampin in patients weighing more than 50 kg compared to those weighing less than 50 kg. In addition, patients weighing more than 50 kg did not have more subtherapeutic efavirenz levels than those weighing less than 50 kg. In fact, in black patients efavirenz levels actually were higher while taking efavirenz compared to efavirenz levels once the rifampin was stopped.

In other words, said Luetkemeyer, increasing the doses of efavirenz may increase its side effects without making it more effective. The drugs are also expensive, and when prescribing more than is necessary across an entire population may strain budgets that already are stretched thin.

The STRIDE data reinforce data from other researchers that have shown efavirenz levels increase in many non-white patients on rifampin and that a standard dose of efavirenz has been as effective in TB patients on rifampin as in HIV patients without TB. Three quarters of the STRIDE study participants were black, however, so this study cannot address whether the dose adjustment is advisable in Caucasian patients.

While the FDA does not have the authority to regulate health systems, companies and products in other countries, it nevertheless has a powerful worldwide influence on health care because many poor countries have no similar government agencies to review available scientific data and issue guidance to doctors.

The talk, “Relationship between weight, efavirenz (EFV) concentrations and virologic suppression in HIV+ patients on rifampin (RIF)-based TB treatment in the ACTG 5221 STRIDE study” by AF Luetkemeyer, S. Rosenkranz, D. Lu, P.S. Lizak, P. Ive, S. Swindells, C. Benson,  B. Grinzstejn, I. Sanne, D.V. Havlir, F. Aweeka and the Adult AIDS Clinical Trials Group A5221 Team will be at 4:30 p.m. ET today (July 23) in Session Room 7.

The abstract is available online.

This work was funded by the National institutes of Health.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. For further information, please visit www.ucsf.edu.

Study measures hair, blood samples from infants born to HIV-positive mothers.

Monica Gandhi, UC San Francisco

Researchers from the University of California, San Francisco,  and Makerere University in Uganda have used hair and blood samples from 3-month-old infants born to HIV-positive mothers to measure the uninfected babies’ exposure — both in the womb and from breastfeeding — to antiretroviral medications their mothers were taking. The results, they said, are surprising.

“We found high levels of exposure to three antiretroviral medications in the hair samples of HIV uninfected infants at 12 weeks of life,” said study senior author, Monica Gandhi, M.D., M.P.H., associate professor of medicine at the UCSF Division of HIV/AIDS at San Francisco General Hospital and Trauma Center (SFGH).

“From looking at plasma level data at the same time point, we believe that transfer of two of the medicines from mother to baby occurs exclusively in the womb and transfer of the third medication occurs both in the womb and through breastfeeding.”

The findings could lead to new ways to protect infants from HIV transmission and to better understand the development of toxicities and resistance to the drugs, the researchers said.

A single plasma level of a medication reflects drug exposure over approximately 24 hours. Measuring the concentrations of antiretrovirals in a small hair sample reveals exposure over the past month. The team therefore measured both plasma and hair levels of medications in babies whose mothers were taking HIV medications to get a better idea of when drugs are being passed from mother to baby. “Since fetuses start growing hair in the womb, hair sampling gives us an opportunity to examine exposures to drug before birth,” said Gandhi.

UCSF researchers have pioneered the use of hair sampling for measuring antiretroviral levels. The procedure is now a standard measure in many research studies, equivalent in HIV clinical care to measuring hemoglobin A1C to monitor average blood glucose levels in patients with diabetes.

In the study, the team took hair and blood samples from two groups of HIV-positive mothers, all of whom breast-fed their infants. For 45 mother/infant pairs, the mothers’ antiretroviral regimens included a protease inhibitor, lopinavir, boosted by ritonavir, another antiretroviral medication. The other 64 mothers were on an efavirenz-based regimen.

Infants in the lopinavir group had levels of the drug in their hair that measured 87 percent of the levels found in their mothers’ hair. The levels of ritonavir were about 45 percent of the levels found in their mothers’ hair. When the researchers looked at the drug levels in the blood drawn from the mothers and infants at 12 weeks, they found the expected levels of lopinavir and ritonavir in the mothers, but none of either in the blood of the infants.

“The inability to find drug in the infants’ blood at 12 weeks tells us that the lopinavir and ritonavir in their hair is not due to recent exposure, so breast-feeding did not transfer these drugs to the infants. Our conclusion is that the lopinavir and ritonavir were transferred to the babies in the womb, and lopinavir at quite a high level,” said Gandhi.

In the efavirenz group, researchers found infant drug levels in hair samples that were about 40 percent of the levels found in their mothers. Additionally, they found that infants had levels in their blood that were about 15 percent of what was found in their mothers.

These findings indicate a moderate transfer of efavirenz both in the womb and during breastfeeding said Gandhi.

“Our findings, as we verify them, will have important implications. One, being able to measure drug exposures of fetuses in the womb and during breast-feeding can help us understand how to better protect infants from HIV transmission from HIV-positive mothers during pregnancy, birth and after birth. Antiretroviral medications are delivered prophylactically to HIV-positive mothers and newborns to prevent transmission, and fetuses derive protection from transmission if their HIV-positive mothers are on an antiretroviral regimen,” she said.

“Second, the development of resistance to antiretroviral medications in infants is an important issue. HIV develops resistant mutations after fairly low levels of exposure to the class of medications to which efavirenz belongs, non-nucleoside transcriptase inhibitors (NNRTIs). Additionally, hair sampling for antiretroviral exposure levels will ultimately help us monitor toxicities associated with these medications in infants.”

Using hair to measure exposure to antiretrovirals has advantages in that it is a painless, bloodless, biohazard-free method of collecting a stable specimen from HIV patients. It measures drug exposure over time and has been shown to be more predictive of treatment response than the “snapshot” of exposure provided by a single plasma level of medication.

Gandhi said that researchers are finding hair sampling to be a very useful tool in several settings. One use is in resource-limited settings where collecting, storing and handling blood draws is difficult and expensive. Hair is snipped, wrapped in foil and needs no refrigeration.

Another setting is in monitoring drug exposures in uninfected people. Researchers have been using the technique to measure adherence/drug levels in some of the pre-exposure prophylaxis trials, where high-risk uninfected patients take antiretrovirals to prevent getting infected with HIV. Non HIV-infected individuals cannot be monitored for adherence to antiretrovirals like HIV-infected individuals (where levels of HIV in the blood are measured routinely to indicate how well they are taking their pills) so hair levels provide a novel and reliable indicator of adherence.

A third setting is for monitoring prenatal exposures. Hair sampling is the only way currently to measure how much antiretroviral exposure fetuses are getting in the womb long-term. Cord blood measurements of antiretrovirals at birth, which are expensive and cumbersome to collect, still only reflect exposure to the babies over the short term. And collecting hair levels is a much easier technique for monitoring drug exposure levels in infants, especially when compared to blood draws.

This work was presented today (July 21) during the 4th International Workshop on HIV Pediatrics, which takes in Washington, D.C. preceding the XIX International AIDS Conference. A poster presentation of the same data, titled, “Lopinavir and efavirenz concentrations in paired hair samples as a marker of cumulative exposure among postpartum women and breastfeeding infants in Tororo, Uganda,” will be unveiled at the XIX International AIDS Conference at 3 p.m. ET on Sunday (July 22).

Abstract: http://pag.aids2012.org/abstracts.aspx?aid=13646.

Study co-authors include Jane Achan, Deborah Cohan, Frances Aweeka, Julie Mwesigwa, Yong Huang, Albert Plenty, Edwin Charlebois, Theodore Ruel, Veronica Ades, Tamara D. Clark, Paul Natureeba, Moses R. Kamya, and Diane V. Havlir (principal investigator of the study), from the Infectious Diseases Research Collaboration, UCSF-Makerere University, Tororo, Uganda.

The National Institute of Child Health and Human Development, the Office of AIDS Research, the National Institute of Allergy and Infectious Diseases, and the President’s Emergency Plan for AIDS Relief provided funding for this research.

The UCSF Division of HIV/AIDS at San Francisco General Hospital and Trauma Center is affiliated with the AIDS Research Institute (ARI) at UCSF. UCSF ARI houses hundreds of scientists and dozens of programs throughout UCSF and affiliated labs and institutions, making ARI one of the largest AIDS research entities in the world.

UCSF is a leading university dedicated to advancing health worldwide through advanced biomedical research, graduate level education in the life sciences and health professions, and excellence in patient care.

Infection with AIDS virus need not spread to uninfected partners.

Deborah Cohan, UC San Francisco

Truvada this week became the first drug approved by the U.S. Food and Drug Administration (FDA) for the prevention of HIV infection and AIDS in individuals at “high risk.”

The FDA evaluation relied heavily on two large studies. One was a UC San Francisoc-led study of men and transgender women who have sex with men, which found that Truvada reduced risk of infection by 42 percent. The second, Partners PrEP, was a study in Africa of HIV transmission in heterosexual couples. Researchers found that risk was reduced by 75 percent.

Apart from the specific populations studied in these large-scale trials, others deemed to be at high risk also can lower their chances of becoming infected. For instance, Deborah Cohan, M.D., M.P.H., a UCSF obstetrician and gynecologist who specializes in the care of pregnant women with HIV, has been evaluating the use of Truvada in pregnant women in the U.S. who are uninfected, but whose male partners have HIV.

“There is a growing body of evidence to suggest that pregnancy increases the risk of HIV acquisition,” she said.

Additional large studies, including FEM-PrEP and TDF2, also have shed light on Truvada use in women. “The data that support its use for women are for resource-limited settings outside the U.S.,” Cohan said. “One of the things that was clear … is that adherence to the treatment is key, and that perception of risk probably drives adherence.”

Testing pre-exposure prophylaxis (PrEP)

Cohan is expanding this research, creating a multi-center collaborative project to study the treatment approach, called pre-exposure prophylaxis (PrEP), in uninfected women who intend to become pregnant. Cohan runs the UCSF Perinatal HIV Clinic as part of the Women’s HIV Program at UCSF and is medical director of the Bay Area Perinatal AIDS Center (BAPAC) at San Francisco General Hospital and Trauma Center.

“Now that there is FDA approval we want to try to identify optimal candidates for this intervention, and to understand how to optimize adherence to prescribed therapy,” she said. “This includes understanding peoples’ perception of risk,” she said.

An individual’s risk of infection — and how much taking a daily Truvada pill may reduce it — depends on several factors, such as the precautions sexual partners already may be taking.

Research has made it clear that, when HIV-infected individuals lower levels of virus in their blood by taking antiretroviral therapy, they not only prevent progression of HIV-associated disease, they also greatly reduce the risk of transmitting the virus to their sexual partners.

Among heterosexual couples, if HIV levels in the HIV-positive partner remain suppressed with antiviral therapy, the risk of HIV transmission to the uninfected partner appears to be especially small, Cohan said. “It’s officially not zero, because we know of at least one case report,” she said.

In addition, condom use is effective in preventing the spread of HIV, and avoiding the sharing of needles is an effective strategy for preventing the spread of HIV that stems from injection drug use.

Of course, couples trying to conceive do not use condoms, and keeping viral loads low in HIV-infected individuals requires reliable adherence to antiretroviral therapy, Cohan said. The U.S. Centers for Disease Control and Prevention last year estimated that barely 1-in-4 HIV-infected individuals in the U.S. has achieved viral suppression, which the agency defined as the presence in the blood of 200 or fewer copies of the virus per milliliter.

HIV-negative partner may gain control to remain uninfected

“Just relying on HIV-positive partners taking their medications and being virally suppressed does not guarantee that they’re not going to transmit HIV to their HIV-negative partners,” Cohan said.

“What we do for pregnant women who are on PrEP is to try to get their male partners onto antiretrovirals if they are not yet on them,” she said. “We ask that their partners’ providers obtain monthly measures of viral loads to make sure they are suppressed. That’s not standard practice. Usually people may get viral loads every three months, or even less often if they have been suppressed for a while.

“I think that this gives control to the negative partner to keep herself HIV-negative,” Cohan said.

When blood tests indicate that one partner is HIV-positive and the other is HIV-negative, the couple may be described as “serodiscordant.”

“Many of the women I know who are in serodiscordant relationships are in excellent communication with their partners, and their partners’ providers are in excellent communication with us,” Cohan said.

“But probably more frequently the woman doesn’t necessarily know whether her partner is taking antiretrovirals regularly, or how often he is having viral loads checked. In many cases his HIV provider may not even know that he is sexually active with an HIV-negative woman.”

Who will prescribe Truvada?

Sorting out how individuals who can lower their infection risk with PrEP will be able to pay for Truvada is one question on the minds of many, but there are additional issues when it comes to getting Truvada into the hands of patients, Cohan said.

“Many HIV clinics are not set up to take care of HIV-negative individuals,” Cohan said. “They may be reimbursed for the numbers of encounters that they have with HIV-positive patients. Many of them are not prepared to care for and to be reimbursed for caring for HIV-negative people.

“On the flip side, most OBGYN clinics and most general practice clinics that don’t provide HIV care, per se, don’t feel equipped to prescribe Truvada for HIV-negative women in serodiscordant relationships.

“From my standpoint it’s relatively straightforward — there are going to be protocols established,” Cohan said. “Still, it’s unfamiliar. At most places they are not comfortable prescribing antiretrovirals if it’s not an HIV clinic.”

Related link:
UCSF focus on XIX International AIDS Conference

Respeto/Proteger is six-session HIV prevention program presented to small groups of couples.

Deborah Koniak-Griffin, UCLA

An HIV prevention program for young Latino parents that was created in a community-academic partnership between the UCLA School of Nursing and the National Latino Fatherhood and Family Institute (NLFFI) is now recognized by the federal government as a model program that enhances the health and quality of care of at-risk populations.

Respeto/Proteger (Respecting and Protecting Our Relationships), an HIV prevention program targeting young Latino parents with children who are at least 3 months old, was added to the list of evidence-based programs that reduce teen pregnancy, sexually-transmitted infections and associated sexual risk behaviors.

Fifty percent of new HIV infections worldwide occur in people 25 and younger. HIV disproportionately affects ethnic/racial minorities and women and most cases are acquired through sexual transmission.

“Young, inner-city Latino parents are at risk for acquiring HIV due to a combination of factors – childhood poverty, social oppression, community violence and social isolation,” said Janna Lesser, Ph.D., R.N., who led the study during her postdoctoral work at UCLA and is currently an associate professor at the University of Texas Health Science Center at San Antonio’s School of Nursing. “These behaviors can lead to early initiation of unprotected sexual relationships, relationship violence and substance abuse.”

Respeto/Proteger is a six-session, 12-hour HIV prevention program presented to small groups of couples in community and clinic settings. Couples are defined as individuals who have been involved in a romantic relationship for at least three months; the male partner is not required to be the child’s biological father.

“The program was based on findings that showed that young men and women are willing to make profound changes in their lives when they become parents,” said Deborah Koniak-Griffin, R.N.C., Ed.D., F.A.N.N., director of the Center for Vulnerable Populations Research at the UCLA’s School of Nursing. “The curriculum integrates basic information about HIV awareness and prevention with culturally relevant discussions and activities on taking responsibility for your actions and being a role model.”

Development of Respeto/Proteger was initially supported through a collaborative community partnership grant from the California HIV/AIDS Research Program and subsequently evaluated through a federally-funded clinical trial. Based on a comprehensive review by Mathematica Policy Research and its partner, Child Trends, Respeto/Proteger met the U.S. Department of Health and Human Services’ established criteria to be classified an evidence-based model. The curriculum was designed and evaluated by Koniak-Griffin, Lesser and Jerry Tello, director NLFFI.

Respeto/Proteger is the third program developed by UCLA’s School of Nursing that was recognized as a model program by the Department of Health and Human Services. The list is compiled by the federal government’s Health Resources and Services Administration (HRSA), a division of the U.S. Department of Health and Human Services. HRSA, which is the primary federal agency for improving access to health care services for people who are uninsured, isolated or medically vulnerable, provides leadership and financial support to health care providers in every state and U.S. territory, and its grantees provide health care to uninsured people, those living with HIV/AIDS and pregnant women, mothers and children. It periodically publishes lists of community health initiatives that it deems as evidence-based models that have proven to enhance the health or quality of care for at-risk populations.

The UCLA School of Nursing is redefining nursing through the pursuit of uncompromised excellence in research, education, practice, policy and patient advocacy.

UCLA is California’s largest university, with an enrollment of nearly 38,000 undergraduate and graduate students. The UCLA College of Letters and Science and the university’s 11 professional schools feature renowned faculty and offer 337 degree programs and majors. UCLA is a national and international leader in the breadth and quality of its academic, research, health care, cultural, continuing education and athletic programs. Six alumni and five faculty have been awarded the Nobel Prize.

UCSF’s Jay Levy reflects on AIDS epidemic on eve of International AIDS Conference.

Halfway down a long corridor in the middle of UC San Francisco Medical Center, a white-coated Jay Levy, M.D., paused recently to reflect on HIV — a disease that has defined a generation, continues to plague the world and may yet be vanquished.

Jay Levy, UC San Francisco (Click image for larger view)

To Levy, who co-discovered HIV in 1983, the question is not how far we have come — it’s how far we have to go. In his laboratory, he and his colleagues continue to uncover the biological mysteries of the virus, currently exploring how to use stem cell approaches to cure HIV infections and looking for the secrets of natural immunity to the virus.

He offered his perspective on AIDS on the eve of the XIX International AIDS Conference in Washington, D.C., where he and dozens of UCSF faculty will discuss the latest developments on the epidemic with tens of thousands of colleagues and other attendees from around the world. Faculty at UCSF and San Francisco General Hospital and Trauma Center are global leader in AIDS research and have been at the forefront of confronting the epidemic since its onset 30 years ago. They continue to set the standard of care for people with HIV worldwide.

HIV research is a field, Levy said, in which scientists traditionally have worked hard for long stretches without finding immediate answers. The experience for Levy, who joined the Department of Medicine and the Cancer Research Institute at UCSF in 1972, has been both rewarding and frustrating. Today, scientists still have many fundamental and unanswered questions about how it interacts with the immune system.

“When they asked me 20 years ago where are we in our knowledge of the immune system, I said: ‘2nd grade,’” Levy recalled. “Perhaps now we’re in 5^th grade — we’ve got a lot to do.”

The roads behind and ahead for HIV

Levy remembers the day in August 1981 when Paul Volberding, M.D., now the director of the AIDS Research Institute at UCSF, called his lab and asked for his advice about a mysterious condition he’d seen in a patient.

Volberding was then a young physician at San Francisco General Hospital and Trauma Center. He’d gone there to become head of the cancer service, after finishing a postdoctoral fellowship with Levy. Volberding was puzzled by a patient with the hallmark lesions of a rare skin cancer known as Kaposi’s sarcoma. He had no idea what had caused the lesions or that the disease was already spreading in San Francisco.

“We didn’t know what was happening in the community. At the time we thought this was a rare event,” said Levy.

This patient was one of the first and then one of many in San Francisco who would develop AIDS. As the epidemic exploded in San Francisco over the coming years, it would affect some 20,000 lives in the city and tens of millions more worldwide.

He and his colleagues, in what is now called the Laboratory for Tumor and AIDS Virus Research, got to work and soon isolated the virus, in 1983. But they then learned one of the big lessons of HIV: no matter the advance made, there is often so much further to go.

Once the virus was identified, many in the field began predicting that a vaccine would be right around the corner. But it has yet to be realized, despite decades of work.

The same story can be told in many other areas of HIV science: despite continual hope and some amazing successes, there have been many failures and there remain many lingering challenges, said Levy.

Moving from the corridor to an interview at his desk in the small office he has kept for more than 30 years — a modest space that yet sports photographs of himself with such Hollywood celebrities as Elizabeth Taylor — he admitted he knows this mixed bag of success as well as anyone.

An elusive search for a resistance factor

One of the big projects Levy and his colleagues have been tackling for the last 20 years has been the search for an elusive protein that is part of the immune system and contributes to the long-term survival of certain people with HIV.

In the early 1980s, people with HIV who remained healthy for a year despite the infection, were regarded as long-term survivors; they were then only expected to live a few more years with the virus. This changed as time marched on. “Now we have people who are documented surviving for more than 30 years without any need for therapy with their immune system functioning very well,” said Levy.

Behind this phenomenon may be an elusive immune function that some people seem to have and that Levy and his colleagues identified in the mid-1980s. Through this function, the body actively resists HIV infection and suppresses the virus.

Levy’s hypothesis is that certain people are long-term survivors because their immune system has mastered the ability to naturally resist the virus. White blood cells in their body, called CD8+ lymphocytes, produce an as-yet to be identified “resistance factor” known as the CD8+cell antiviral factor, CAF. This human protein blocks HIV replication.

“A major aim in the laboratory is to identify the full nature of CAF. Then, we can produce it and discover how everybody’s immune system can make this factor,” he said. Levy remains hopeful that they will achieve this important goal.

AIDS 2012: a historic meeting

The intersection of history with hope is a theme of the AIDS 2012 international conference this month—hope because AIDS 2012 will witness the latest science in a number of promising areas that give renewed cause for optimism, including work toward an HIV cure.

The meeting itself is historic because it will be the first to take place in the United States since 1991. That’s because a longstanding U.S government ban on travel and immigration into the U.S. by HIV-positive individuals was not lifted until January 2010, and during the ban years, the conference organizers protested the restriction by not hosting any of the gatherings on U.S. soil.

“It’s gratifying to know that finally we are going to have this international AIDS meeting in the United States after more than two decades,” Levy said. “It’s been very sad for us not to be able to host this important conference where so many ideas are voiced and people gather from all over the world.”

Related links:

• Focus on XIX International AIDS Conference
• UCSF launches AIDS blog
• UCSF leaders play key role in “DC Declaration” to end global AIDS epidemic
• AIDS/HIV briefing at UCSF highlights International AIDS Conference agenda
• UC Health community impact brochure

UCSF study shows risk of female-to-male transmission increased threefold.

Craig R. Cohen, UCSF

An investigation led by UC San Francisco has found that the risk of female-to-male HIV transmission is increased threefold for women with bacterial vaginosis, a common disorder in which the normal balance of bacteria in the vagina is disrupted.

“Previous research has shown that bacterial vaginosis can increase a women’s risk of becoming infected with HIV as much as 60 percent. Our study is the first to show that the risk of transmitting HIV is also elevated. Our findings point to the need for additional research to improve the diagnosis and treatment of bacterial vaginosis, which is extremely common in sub-Saharan Africa, the region of the globe with the highest burden of HIV,” said the study’s lead author, Craig R. Cohen, M.D., M.P.H., professor of obstetrics, gynecology and reproductive sciences at UCSF.

The study is being published in the June 26 issue of PLoS Medicine.

The new research assessed the association between bacterial vaginosis and female-to-male HIV transmission risk in a prospective study of 2,236 HIV positive women and their uninfected male partners from seven African countries. After controlling for socio-demographic factors, sexual behavior, male circumcision, sexually transmitted infections, pregnancy and levels of HIV in the blood of the women with HIV, bacterial vaginosis was associated with a significantly increased risk for female-to-male transmission of HIV.

Bacterial vaginosis is a condition where the normal balance of microorganisms naturally found in the vagina is altered. This disruption of vaginal flora takes place when bacteria that are helpful are reduced and more harmful bacteria are increased. Besides increasing the risk of becoming infected with HIV, bacterial vaginosis can increase the risk of acquiring other sexually transmitted infections and increase the risk of preterm delivery. In addition, HIV-infected women with this disorder may have higher levels and greater shedding of the virus from the cervix and vagina.

“We looked at the increased shedding of HIV in the genital tract, but that was not sufficient to explain the increased risk of female-to-male HIV transmission. It is also possible that bacterial vaginosis causes inflammation and that could be a factor. We don’t really understand the relationship between vaginal flora and inflammation,” said Cohen.

In addition, he said, “we think it’s likely that the sharing of genital tract microbiota between women and men may be implicated as a cause of the transmission risk. The interrelationship of the sharing of flora remains poorly understood and is an important avenue for future research.”

Notwithstanding the need for better understanding of the role of vaginal flora, the development of more therapeutics for bacterial vaginosis, including better drugs and probiotics, would be a significant boost to women’s health in general, as well as help decrease HIV acquisition and transmission risks, added Cohen.

Study co-authors include Jairam R. Lingappa, Jared M. Baeten, Ting Hong and Connie Celum from the University of Washington, Musa O. Ngayo and Elizabeth A. Bukusi from the Kenya Medical Research Institute, Carol A. Spiegel from the University of Wisconsin, Deborah Donnell from the Fred Hutchinson Cancer Research Center, Saidi Kapiga from the London School of Hygiene and Tropical Medicine, and Sinead Delany from the University of Witwatersrand.

Funding for this research was provided by the Bill & Melinda Gates Foundation.

The AIDS Research Institute (ARI) at UCSF houses hundreds of scientists and dozens of programs throughout UCSF and affiliated labs and institutions, making ARI one of the largest AIDS research entities in the world.

UCSF is a leading university dedicated to advancing health worldwide through advanced biomedical research, graduate level education in the life sciences and health professions, and excellence in patient care. For further information, please visit www.ucsf.edu.

Drug combo is much better than AZT alone in protecting infants from acquiring HIV.

Karin Nielsen-Saines, UCLA

Non-breastfed babies born to HIV-positive mothers who didn’t receive antiretroviral therapy during pregnancy are routinely given zidovudine, commonly known as AZT, shortly after birth to prevent mother-to-child transmission of the virus that causes AIDS.

While effective, this strategy doesn’t always protect the infant from acquiring the virus during the mother’s labor and delivery. But a new UCLA-led study published June 21 in the New England Journal of Medicine finds that a two- or three-drug combination given to infants within 48 hours of birth can reduce the risk of such intrapartum HIV acquisition by about half, compared to AZT alone.

“Our research demonstrates that even in very high-risk situations where mothers are only identified as being HIV-positive when they give birth or shortly after birth, there is still an effective strategy that can be undertaken to prevent transmission of HIV to the baby,” said Dr. Karin Nielsen-Saines, a professor of pediatric infectious diseases at the David Geffen School of Medicine at UCLA and the study’s lead investigator. “While giving AZT alone to the infant can reduce intrapartum transmission to some degree, our data demonstrates that with the use of two- or three-drug regimens to the baby, you can cut transmission to half of what can be achieved with AZT alone.”

The study is the first randomized controlled study of post-exposure HIV prophylaxis for babies born in countries where the standard of care is to give the child AZT to prevent infection, said Nielsen-Saines, who is also a member of the UCLA AIDS Institute. Babies born to HIV-infected mothers who have not received antiretroviral therapy (ART) stand a 25 percent chance of becoming infected during the mother’s pregnancy or at birth. Their chances increase to about 40 percent when they are breastfed, which is why HIV-positive women are advised not to breastfeed in many countries.

The study involved 1,684 formula-fed infants born to HIV-positive mothers in the United States, Brazil, Argentina and South Africa. Within 48 hours of birth, researchers assigned the newborns to one of three groups: 566 were placed in the AZT-alone group; 562 in an AZT plus nevirapine group; and 556 in a group receiving AZT, nelfinavir and lamivudine.

Of the 1,684 infants, 140 were found to be infected with HIV — 97 were born with the infection (transmission occurred during pregnancy) and 43 were infected during the birth process.

Among the babies who became infected during the birth process, 24 in the AZT-alone group were found to be infected at 3 months of age, compared with 11 in the AZT/nevirapine group and 12 in the AZT/nelfinavir/lamivudine group. Using Kaplan–Meier statistics, this translated into a transmission of 4.8 percent in the AZT-alone group, 2.2 percent in the two-drug group and 2.4 percent in the three-drug group. (Kaplan–Meier estimates incorporate survival probabilities, time in follow-up and other factors.)

Therefore, giving two or three drugs to babies born to mothers who had received no HIV treatment significantly reduced HIV transmission, compared with AZT alone.

The researchers also found that the two-drug therapy was less toxic to the infants than the three-drug alternative.

Nielsen-Saines noted that the findings are applicable only to high-risk infants — those whose mothers didn’t receive antiretroviral therapy during pregnancy. Babies born to HIV-positive women who are being effectively treated with antiretrovirals throughout pregnancy already have a less than 1 percent chance of acquiring HIV from their mothers.

“Our results support combination ART regimens instead of zidovudine alone for prophylaxis in the infants of mothers who have not received antenatal ART,” the researchers write. “Ease of use, reduced toxicity, availability, and low cost suggest that zidovudine plus nevirapine is an attractive option for prophylaxis in infants at high risk for perinatal HIV-1 infection.”

The Eunice Kennedy Shriver National Institute of Child Health and Development of the National Institutes of Health (NICHD HHSN267200800001C/ N01-HD-8-0001) sponsored the study, which was also supported by the National Institute of Allergy and Infectious Diseases (U01 AI047986/ U01 AI068632).

Other study authors were D. Heather Watts, Valdilea G. Veloso, Yvonne Bryson, Esau C. Joao, Jose Henrique Pilotto, Glenda Gray, Gerhad Theron, Breno Santos, Rosana Fonseca, Regis Kreitchmann, Jorge Pinto, Marisa M. Mussi-Pinhata, Mariana Ceriotto, Daisy Machado, James Bethel, Marisa G. Morgado, Ruth Dickover, Margaret Camarca, Mark Mirochnick, George Siberry, Beatriz Grinsztejn, Ronaldo I. Moreira, Franciso I. Bastos, Jiahong Xu, Jack Moye and Lynne M. Mofenson.

The UCLA AIDS Institute, established in 1992, is a multidisciplinary think tank drawing on the skills of top-flight researchers in the worldwide fight against HIV and AIDS, the first cases of which were reported in 1981 by UCLA physicians. Institute members include researchers in virology and immunology, genetics, cancer, neurology, ophthalmology, epidemiology, social sciences, public health, nursing and disease prevention. Their findings have led to advances in treating HIV, as well as other diseases, such as hepatitis B and C, influenza and cancer.

Nearly 1/2 don’t know it.

Lillian Gelberg, UCLA

Recent government studies show that hepatitis C, which can destroy the liver and necessitate a liver transplant, now kills more American adults than AIDS, and new UCLA research shows just how prevalent the disease is among homeless adults in downtown Los Angeles.

In a study published in the July–August issue of Public Health Reports, researchers found that 26.7 percent of homeless adults tested and surveyed in downtown Los Angeles’ skid row were infected with the hepatitis C virus (HCV) — more than 10 times the 2 percent rate among the general U.S. population. Of those surveyed, 46.1 percent were unaware that they were infected. Four percent of the sample were HIV-positive.

Few of the infected homeless adults surveyed had ever received any treatment for their HCV, said Dr. Lillian Gelberg, professor of family medicine at the David Geffen School of Medicine at UCLA, who led the study with Dr. Marjorie Robertson of the Public Health Institute’s Alcohol Research Group. Less than 3 percent of those who knew they were infected had ever been treated.

“Their hepatitis C can result in high costs to the public and the health care system if progression of their disease is not halted through treatment,” said Gelberg, who is also a professor of public health at the UCLA Fielding School of Public Health. “The costs of their untreated hepatitis C may start escalating soon, as many are approaching 20 years of infection, which is the point at which we see escalating risk for liver cirrhosis and end-stage liver disease, requiring expensive health services utilization and liver transplantation.”

The study surveyed 534 homeless adults from 41 shelters and meal programs in the skid row area between June 2003 and February 2004. Most were males and the majority were African Americans. Each was tested for hepatitis B and C and for HIV. Overall, the researchers found that HCV prevalence was significantly higher among those homeless individuals who had injected drugs or been in prison; who were 40 years of age and older; who had less education; or who were U.S.-born.

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