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The May 16 edition of [...]]]> Editor’s Choice
Main Category: HIV / AIDS
Also Included In: Aid / Disasters
Article Date: 16 May 2012 – 14:00 PDT

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The May 16 edition of the Global Health themed issue of JAMA reveals a larger drop in all-cause adult mortality in those African countries with more intense operation of the AIDS relief program PEPFAR.

The article’s background information states:

“The effect of global health initiatives on population health is uncertain. Between 2003 and 2008, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the largest initiative ever devoted to a single disease, operated intensively in 12 African focus countries.”

PEPFAR has undertaken a coordinated effort to raise treatment, prevention and care of HIV and increased the delivery of expanded antiretroviral therapy (ART) supporting wide-scale prevention efforts in view of the rapidly increasing HIV epidemic.

Eran Bendavid, M.D., M.S., from California’s Stanford University, and his team decided to assess the association between PEPFAR’s implementation and trends in adult mortality given that the initiative’s impact on all-cause adult mortality is not known.

The team used person-level data from the Demographic and Health Surveys (DHS) to conduct cross-country and within-country analyses of adult mortality defined as the annual probability of death per 1,000 adults between the ages of 15 to 59 years old, and PEPFAR activities. They then compared the adult mortality across 9 African ‘focus countries’, including Ethiopia, Kenya, Mozambique, Namibia, Nigeria, Rwanda, Tanzania, Uganda and Zambia with the adult mortality in 18 African ‘non-focus countries’ for the duration of one decade, from 1998 to 2008.

The study included data from 41 surveys across 27 countries, between 1998 and 2008, on 1,538,612 African adults. The DHS registered 60,303 deaths during this time period that were included in this study.

A data analysis showed a relatively larger decline in death rates amongst adults in focus countries between 2004 and 2008, namely a decrease from 8.30 per 1,000 adults in 2003 to 4.10 per 1,000 in 2008, whilst the mortality rate in non-focus countries dropped from 8.5 in 2003 to 6.9 in 2008 during the study period.

After adjusting for variables, such as country-level and personal characteristics, the likelihood of all-cause mortality was lower in the focus countries than in the non-focus countries.

The team also analyzed district-level data for Tanzania and Rwanda and even though high and low PEPFAR activity districts counted similar populations, the program intensity was considerably different between both groups. The findings revealed that Tanzanian adults living in regions with above-midpoint PEPFAR intensity had a lower risk of mortality than adults living in regions with below-midpoint intensity, whilst the comparison amongst Rwandan adults was similar, with a lower death risk for adults living in regions with above-midpoint PEPFAR intensity.

The researchers also discovered that a total of 740,914 all-cause adult deaths were averted between 2004 and 2008, due to PEPFAR’s efforts.

The figure was calculated by using the results of each focus country and generalizing it to the size of each country’s adult population. In comparison, PEPFAR was linked to an estimated number of 631,338 averted HIV-specific deaths during the same period.

The researchers write:

“In conclusion, we provide new evidence suggesting that reductions in all- cause adult mortality were greater in PEPFAR’s focus countries relative to the non-focus countries over the time period from 2004 through 2008. Our analysis suggests an association of PEPFAR with these improvements in population health.”

Editorial: PEPFAR and Maximizing the Effects of Global Health Assistance

Ezekiel J. Emanuel, M.D., Ph.D., of the University of Pennsylvania in Philadelphia writes in an associated editorial, the “article by Bendavid et al is welcome news in helping to document the even greater benefits of PEPFAR not only on HIV/AIDS but on overall mortality in countries. However, the further question that must be asked by ethically responsible people and policy makers becomes: Is PEPFAR worth it? Many other global health programs are improving the health of poor people worldwide but are not funded anywhere near the level of PEPFAR. The fundamental ethical, economic, and policy question is not whether PEPFAR is doing good, but rather whether other programs would do even more good in terms of saving life and improving health. Clearly, besides treatment for HIV/AIDS, there are other highly effective and lower-cost interventions for the world’s poor.”

Written By Petra Rattue

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“HIV Development Assistance and Adult Mortality in Africa”
Eran Bendavid, MD, MS; Charles B. Holmes, MD, MPH; Jay Bhattacharya, MD, PhD; and Grant Miller, PhD, MP
JAMA , May 2012, doi:10.1001/jama.2012.2001

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A drug that has been shown [...]]]> Main Category: HIV / AIDS
Also Included In: Preventive Medicine;  Compliance
Article Date: 16 May 2012 – 0:00 PDT

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A drug that has been shown to prevent HIV infection in a significant number of cases must be combined with behavioral approaches if the U.S. health care establishment is to succeed in reducing the spread of the virus, according to the American Psychological Association.

“Exclusive reliance on a drug to prevent HIV or any sexually transmitted disease could actually result in a worse outcome if those at risk don’t understand how their own behavior affects treatment,” said Perry N. Halkitis, PhD, chair of APA’s Committee on Psychology and AIDS. “We know that medical intervention depends on human behavior. The fact that only 28 percent of HIV-positive Americans in care achieve full viral suppression suggests very clearly that any medical intervention depends fully on behavioral as well as social and political factors.”

A Food and Drug Administration panel recommended on May 10 that the FDA approve the drug Truvada to prevent HIV infection. APA has been monitoring the use of this and other drugs to prevent and treat HIV/AIDS. While heartened by the addition of Truvada to the treatment mix, APA believes HIV prevention treatment must include both medical and behavorial approaches in order to succeed. In February, APA passed a resolution emphasizing the need for prevention research that incorporates strategies to deal with mental health, and substance abuse issues, behavior change and adherence. Entitled “Combination Biomedical and Behavioral Approaches to Optimize HIV Prevention,” the resolution calls upon Congress, the executive branch and other governmental and nongovernmental agencies to increase support for further research to identify and disseminate effective strategies to prevent and treat HIV and other sexually transmitted infections.

“Truvada by itself is not a magic bullet,” Halkitis said. “The research to date shows that individuals taking the drug have had challenges adhering to the need to take it every day. It’s also important for anyone taking it as a preventive measure to continue to practice safe sex. These are all behaviors that need to be guided by multidisciplinary health care teams that include psychologists.” APA President Suzanne Bennett Johnson, PhD, agreed, warning. “if people taking the drug are not fully adherent and then contract HIV, that could lead to drug resistance.”

APA’s resolution cites research that shows a combination of behavioral and biomedical approaches work best to prevent HIV and other sexually transmitted infections. It references a 2010 study that tested adherence to Truvada within a group of men at high risk for infection, which found that 91 percent of those who later tested positive for HIV showed no detectable levels of the drug in their bloodstream, meaning they were not taking the drug as prescribed.

The resolution also points out that drugs “may be out of reach for certain populations (e.g., human trafficking victims, sex workers, people living in poverty, children, etc.).” According to news reports, Truvada costs between $11,000 and $14,000 per year, making it inaccessible to many.

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Tenofovir, the anti-HIV drug, is [...]]]> Editor’s Choice
Main Category: Pregnancy / Obstetrics
Also Included In: HIV / AIDS
Article Date: 15 May 2012 – 14:00 PDT

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Tenofovir, the anti-HIV drug, is safe to use during pregnancy according to a new study published in PloS Medicine. The researchers, led by Diana Gibb from the MRC Clinical Trials Unit in London, UK, found that the drug does not increase the risk of kidney problems, birth defects or growth abnormalities in infants born to HIV-positive women in Africa.

The team examined data from the Development of AntiRetroviral Therapy of Africa (DART) trial in order to determine what affect Antiretroviral therapy (ART – a combination of anti-HIV drugs) had on infants born to Ugandan and Zimbabwean HIV-positive women who took ART during pregnancy.

The majority of women the team examined were taking a tenofovir-containing combination of anti-HIV drugs before and throughout their pregnancies. After comparing infants exposed and not exposed to tenofovir-containing ART during pregnancy, the researchers found that that out of the 226 live births, there was no increase in the proportion of infants who died shortly after birth (3%) or had birth defects (3%).

In a follow-up study, the team found that 14 of the 182 surviving infants died – giving a one-year mortality rate of 5%. This figure is comparable to the normal infant mortality rate in the region (2-4%), and significantly lower than infants born to severely HIV-Infected untreated mothers.

In addition, none of the surviving infants were HIV-positive, none suffered kidney problems or bone fractures during follow-up and the researchers found no effect on growth at two years.
The researchers explained:

“We observed no evidence that tenofovir versus non-tenofovir ART had any adverse effects on pregnancy outcomes or on congenital, renal, bone, or growth abnormalities up to age 4 among children born to women with severe HIV immunodeficiency at ART initiation and exposed throughout the intrauterine period.

Our findings suggest tenofovir-containing ART is a reasonable choice in pregnancy and that tenofovir pre-exposure prophylaxis is also reasonable for women who are at high risk of seroconverting during pregnancy.”

They conclude:

“Detailed safety of tenofovir for pre-exposure prophylaxis will need confirmation from longer term follow-up of larger numbers of exposed children.”

Written By Grace Rattue

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What [...]]]> Main Category: Heart Disease
Also Included In: HIV / AIDS
Article Date: 15 May 2012 – 3:00 PDT

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What is the connection, if any, between sudden cardiac death and people with HIV/AIDS? And can that knowledge help prolong their lives?

In a comprehensive, 10-year UCSF study, researchers found patients with HIV/AIDS suffered sudden cardiac death at a rate four times higher than the general population.

“As part of my ongoing research in 2010, we were looking at every instance of sudden death in San Francisco,” said first author Zian H. Tseng, MD, an electrophysiologist and an associate professor of medicine in the UCSF Division of Cardiology. “I noticed that many of these cases involved individuals with HIV infection who were dying suddenly. I wondered if there was some sort of connection there.”

He posed this question to Priscilla Hsue, MD, a UCSF associate professor of medicine and the director of the HIV Cardiology Clinic at San Francisco General Hospital and Trauma Center (SFGH), who is one of a few cardiologists in the country who specializes in HIV. To her knowledge, no one had ever explored the link between HIV and sudden death, and that is when they began collaborating on this research.

In a paper scheduled to be published May 15 in the Journal of the American College of Cardiology, Tseng, Hsue and other researchers conducted a retrospective study of 2,860 HIV patients from April 2000 to August 2009 at SFGH’s Ward 86, the first HIV/AIDS-specialized clinic, to comprehensively characterize all deaths. They studied medical records, death certificates, paramedic reports, and interviews with family members, doctors, and other clinicians.

Sudden Cardiac Death and HIV/AIDS

During that period, eight percent died during an average of 3.7 years of follow up. Cardiac-related deaths accounted for 15 percent of overall mortality. Of that group, 86 percent died of sudden cardiac death.

“To put that in context, we’re able to compare the rate of sudden death in this population with the overall San Francisco population,” Tseng said. “So adjusted for age, race, demographics, and other variables, the rate of sudden death in the HIV population is more than four times higher than the general population.”

“The fact that the vast majority of cardiac deaths were sudden is surprising and implies that we as clinicians need to be aware of this potential health issue among patients with HIV,” Hsue added. “Our findings also highlight many things that we still don’t know about HIV and sudden death. Did these individuals die of unrecognized coronary artery disease? What can we be doing as clinicians to identify patients at risk and to intervene beforehand?”

Categorizing Sudden Cardiac Death

By 2003, sudden cardiac death made up the largest number of non-AIDS deaths among HIV-positive patients in San Francisco. These deaths were largely among individuals with evidence of well-controlled HIV disease.

Researchers used well-published criteria for retrospectively identifying death as either HIV-related or sudden death-related. If there was any doubt, they classified sudden death as an HIV death.

“In other words, for someone with a CD4 (T-cell) count less than 50 who died suddenly, we classified that as an HIV death, rather than a sudden death because of the profound immunodeficiency,” Tseng said.

More than 17,000 people with AIDS died in 2009 worldwide, and more than 619,000 people have died since the epidemic began. Still, the number of people living with HIV continues to rise. More than 1.2 million people in the United States are HIV-positive, according to the U.S. Department of Health Human Services.

“Now that HIV-infected individuals are living longer with the benefit of antiretroviral therapy, non-AIDS conditions are becoming increasingly important and at the top of this list is cardiovascular disease,” Hsue said.

Researchers believe HIV changes the electrophysiology of the heart in a way so pronounced that it causes conduction abnormalities. And many HIV medications can throw off the heart’s electrical cycle by prolonging the QT interval, which increases the risk of sudden death. These and other variables could be contributing factors.

“Acknowledging the limitations of a retrospective analysis, what’s exciting about this study is that it opens up many related questions we can ask in future studies, such as which high-risk patients might benefit from defibrillator implantation?” Tseng said.

Tseng is in the middle of a prospective citywide study on sudden cardiac death, including studying HIV patients and monitoring their progress.

Tseng is the first author of the paper; Hsue is the senior author; co-authors include Eric Secemsky, MD, of the UCSF Department of Medicine; David Dowdy, MD, PhD, ScM, of the Johns Hopkins Bloomberg School of Public Health’s Department of Epidemiology; Eric Vittinghoff, PhD, MPH, of the UCSF Department of Epidemiology and Biostatistics; Brian Moyers, MD, of the UCSF Division of Cardiology; Joseph Wong, MD, of the UCSF Department of Medicine and San Francisco VA Medical Center; and Diane Havlir, MD, of the San Francisco General Hospital HIV/AIDS Division.

This study was supported by funds from the U.S. National Institutes of Health (NIH). Tseng has received minor honorarium from Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
University of California – San Francisco

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Article Opinions: 2 [...]]]> Featured Article
Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 11 May 2012 – 8:00 PDT

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On Thursday, a panel of outside experts that advises the US Food and Drug Administration (FDA) voted to support
approval of the daily pill Truvada to prevent HIV in healthy people.

The FDA is not obliged to follow the advice of its Antiviral Drugs Advisory Committee, but should it do so, then Gilead Sciences
Inc’s Truvada will be the first drug indicated for reducing the risk of uninfected individuals acquiring the AIDS virus.

Truvada (emtricitabine and tenofovir disoproxil fumarate) has been used to treat people already infected with HIV-1 in the
United States since 2004. According to Gilead, it is currently the most-prescribed antiretroviral treatment in the US.

The 22-member panel voted 19 to 3 in favor of approving the pill as a pre-exposure prophylaxis or PrEP in non-HIV-infected
men who have sex with men (the highest risk group).

It also voted 19 to 2 (with 1 abstaining) in favor of use in uninfected partners of HIV-infected individuals, and 12 to 8 (with 2
abstaining) in those at risk of HIV infection through sexual activity.

The voting took place after 11 hours of deliberations and public consultation in Silver Spring, Maryland.

The panel reviewed efficacy and safety data from several clinical studies of Truvada for PrEP. These included two large
placebo-controlled Phase 3 trials, and several other clinical studies on the use of Truvada for HIV risk reduction.
The Phase 3 trials were supported by the US National Institutes of Health and the University of Washington.

According to a report from Reuters, one of the panel members who voted against using the drug to prevent HIV infection, said
she did so because the clinical studies did not measure the risk of kidney problems in black people, considered to be the group
most at risk of developing kidney side effects when taking AIDS drugs.

Dr Lauren Wood of the National Cancer Institute said:

“I don’t think that is adequate when you’re talking about the population that is most at risk.”

Those who welcome the panel’s decision see it as another tool for preventing HIV infection, alongside safer sex, condom use and
regular HIV testing.

Others are against the drug because of concerns that it could give users a false sense of security, and that it could also lead to a
drug-resistant strain of HIV.

The FDA is expected to reach a decision by 15 June.

Click here for important safety
information about Truvada (from the manufacturer).

Written by Catharine Paddock PhD

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Safer indoor sex [...]]]> Main Category: Sexual Health / STDs
Also Included In: HIV / AIDS;  Women’s Health / Gynecology
Article Date: 11 May 2012 – 1:00 PDT

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Safer indoor sex work spaces provide important and potentially life-saving benefits to sex workers including reduced exposure to violence and HIV and improved relationships with police, according to a study published by the Gender and Sexual Health Initiative of the BC Centre for Excellence in HIV/AIDS (BC-CfE) and the University of British Columbia (UBC).

The qualitative evaluation study published in the America Journal of Public Health interviewed 39 women living in low-threshold, supportive housing programs for sex workers in poverty and using drugs. These programs, operated by Atira Women’s Resource Society and RainCity Housing and Support Society in Vancouver, Canada, offer an innovative harm reduction model that promotes the health and safety of the most marginalized sex workers.

Security measures include women-only buildings (residents, staff), supportive guest policies (clients sign-in at front desk), video cameras onsite, staff available to call police in case of violence, and health and safety resources onsite, including bad date sheets and condoms. Based on the success of the programs to date, these models have now been extended to reach more sex workers across a number of housing programs in Vancouver.

Sex workers interviewed in the study had all previously worked on the street and described how supportive housing programs increased their control over negotiating sex work transactions, including the capacity to refuse unwanted services, negotiate condom use and avoid violent predators. Women’s accounts contrast the safety afforded by these environments with their very limited options to controlling their safety when seeing clients in cars, alleys and clients’ homes.

“This research shows that safer indoor sex work spaces dramatically reduce the risks to the health and safety of sex workers,” says Dr. Kate Shannon, senior author of the study, director of BC-CfE’s Gender and Sexual Health Initiative and assistant professor of medicine at UBC. “We have previously shown that displacement and lack of safer indoor options for street-based sex workers are directly associated with elevated rates of violence and HIV risk. The evidence is clear: We need to scale up access to safer sex work spaces and remove legal barriers to their formal implementation and evaluation.”

The publication of the study follows the landmark decision by the Ontario Court of Appeal that allows sex workers to legally work in safer indoor spaces starting next year. The court concluded that laws preventing sex workers from working together under one roof or hiring security staff fail to protect sex workers and exacerbate harms. While the decision is not currently binding outside Ontario, if upheld by the Supreme Court of Canada the government will be forced to ensure the laws are brought in line with the evidence.

“We have created policies and practices that support women’s choice and ensure their health and safety are protected,” says Amelia Ridgway, Manager of RainCity Housing. “Women have the right to govern their own bodies. We believe that housing is a human right and this is about providing women with the most basic human rights around protection from violence within a harm reduction framework.”

“This is about promoting and protecting the basic rights of women who do sex work and live in poverty,” adds Janice Abbott, CEO of Atira Women’s Resource Society. “The contradictory nature of Canada’s criminalized prostitution laws is that sex workers in higher-end neighbourhoods can operate largely free of persecution out of their own apartments, but the most marginalized women in sex work continue to be criminalized and victimized by restrictive and arbitrary policies and enforcement.”

The women interviewed said safer sex work spaces reduce some of the anonymity and isolation that mark street-level transactions, allowing onsite staff and workers to identify violent predators. They added that safer spaces where sex workers can bring clients indoors support increased solidarity between sex workers and promotes their ability to self-regulate safer industry standards.

Improved relationship between sex workers and police

An important finding of the study is improved relations between sex workers and police. “As evidence has shown time and time again, current criminalized laws and enforcement of these laws create an adversarial relationship between sex workers and police,” says Dr. Shannon. “These findings align with the new guidelines by Vancouver Police Department to not harass or arrest sex workers.”

As one sex worker in the study explains: “On the corner, doing it in the car, I used to be scared all the time, paranoid about cops, scared of getting charged. It is a lot easier now. I can come and go [to this safer space], and cops actually say hi to me. It is different.” Another sex worker adds, “Now police just check me out and help me be safe.”

“We need to view safer sex work spaces as an evidence-based public health imperative,” concludes Dr. Perry Kendall, BC’s Provincial Health Officer. “This research clearly demonstrates that safer sex work models bring street-based sex workers indoors and away from violent predators, and support their access to health, security and safety.”

“Safer sex work spaces support better health and safety, period,” said Dr. Patricia Daly, Chief Medical Health Officer, Vancouver Coastal Health. “We need to ensure that evidence-based safer sex work models are supported, and where possible expanded, to reach marginalized individuals.”

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Women who have [...]]]> Main Category: Sexual Health / STDs
Also Included In: Women’s Health / Gynecology;  HIV / AIDS
Article Date: 10 May 2012 – 0:00 PDT

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Women who have experienced multiple forms of violence, from witnessing neighborhood crimes to being abused themselves, are more likely to engage in risky sexual behavior, according to a new report in the Psychology of Violence.

Researchers from The Miriam Hospital’s Centers for Behavioral and Preventive Medicine say certain patterns of violence in both childhood and adulthood may make a woman more likely to take significant sexual risks, such as having unprotected sex or a high number of sexual partners.

The findings offer new insight on the known link between exposure to violence and HIV/STD risk behavior, particularly among low-income, urban women, who may experience high rates of violence.

“Sadly, our results show that many women must cope with multiple forms of violence, and that some combinations of violent experiences put women at risk for HIV, other STDs or unplanned pregnancy – not to mention the risks from the violence itself,” said lead author Jennifer Walsh, Ph.D., of The Miriam Hospital’s Centers for Behavioral and Preventive Medicine.

Although previous research has linked sexual risk behavior and diverse forms of violence – including childhood maltreatment and sexual abuse, intimate partner violence and exposure to community violence – very few studies have considered patterns of violence and their impact on sexual risk-taking, even though some women experience multiple types of violence.

The current study included 481 women attending an urban STD clinic who were assessed for previous history of violence and current sexual risk-taking behaviors. The women were primarily African American and most were socioeconomically disadvantaged. Overall, women reported high rates of exposure to violence compared to the general population. All types of violence were interrelated, with women who experienced one type of violence being more likely to experience other forms as well.

Using a statistical technique known as latent class analysis to find common patterns in the data, researchers identified four classes of women with different experiences of violence: women with low exposure to violence (39 percent); women who were predominantly exposed to community violence (20 percent); women who were predominantly exposed to childhood maltreatment (23 percent); and women who experienced multiple forms of violence (18 percent).

The team found women who reported experiencing multiple forms of violence and those who were exposed to community violence had the highest levels of sexual risk behavior, including lifetime number of sexual partners and alcohol and drug use before sex.

Walsh believes the study has several clinical implications. “Given the ties between multiple violent experiences and sexual risk-taking, clinicians working with women who experience violence or who are at risk for HIV/STDs may need to consider the overlap between the two in order to impact sexual health consequences,” she said.

She adds, “The clustering of different types of violence suggests clinicians who work with women who have experienced one type of violence should inquire about other types of violence in order to get a complete picture.”

With the understanding that multiple violence experiences are common for women with the highest sexual risk, Walsh also suggests interventionists working to reduce HIV risk may want to provide women with resources for coping with intimate partner and community violence, or for overcoming childhood maltreatment or abuse. Similarly, those working with women experiencing intimate partner violence or other forms of violence may want to address strategies for safer sex.

“These findings also highlight how social and community context influence individuals in complex ways, how social and health problems often cluster, and the need to broaden risk reduction programs to include couples as well as focusing on individuals,” notes Michael Carey, Ph.D., director of The Miriam Hospital’s Centers for Behavioral and Preventive Medicine and a co-investigator on the study.

Either way, the authors say further research is needed to better understand how and why violent experiences are associated with sexual risk behavior in order to develop more effective interventions.

Walsh says that the research is especially timely, coming on the heels of a recent Presidential memorandum establishing a working group known as “Intersection of HIV/AIDS, Violence Against Women and Girls, and Gender-related Health Disparities.” The working group aims to address both the rising incidence of HIV among women and girls as well as the increasing rates of domestic violence and sexual assault.

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In order to reduce HIV and TB in [...]]]> Main Category: HIV / AIDS
Also Included In: Tuberculosis;  Public Health
Article Date: 10 May 2012 – 0:00 PDT

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In order to reduce HIV and TB in African prisons, African governments and international health donors should fund criminal justice reforms, experts from Human Rights Watch say in this week’s PLoS Medicine.

“Overcrowding is driving HIV and TB transmission in African prisons, and alleviating overcrowding by increasing the availability of non-custodial alternatives including community service and bail and improving access to legal representation should be understood as essential public health measures for HIV and TB prevention and control,” say Joseph Amon and Katherine Todrys from the international human rights organisation.

Rates of HIV and tuberculosis in sub-Saharan Africa are many times higher in prison than in non-prison populations, due in part to overcrowding and a lack of adequate prevention and treatment services in the prisons. Almost all prisoners eventually leave prison and, along with visitors and prison officers, represent a potential bridge for disease transmission between prison and community populations.

“Thousands of individuals are detained in African prisons unjustly and unnecessarily, including spending long periods in pretrial detention, because of weak criminal justice systems,” the authors say. That contributes to the overcrowding that leads to the spread of the diseases.

The authors reached these conclusions by surveying prison commissioners and medical directors in 10 East and Southern African countries with high HIV and TB rates. They also conducted in-depth interviews with prison officials and hundreds of prisoners in Zambia and Uganda and heard many distressing accounts of dire conditions and extreme delays in sentencing, trials, and appeals. One man in a Zambian prison had been held for three years before he first saw a judge.

Furthermore, international human rights law requires countries to maintain adequate prison conditions and provide a minimum level of health care equivalent to that available to the general population. But the authors found significant gaps in the availability of HIV- and TB-related prevention and care.

The authors conclude: “Both increased resources for health, as well as structural interventions addressing criminal justice failures, are necessary to address HIV and TB and advance prisoner and public health. African governments have a responsibility to address the life-threatening conditions in prisons, which are contrary to international law and standards, and to improve prisoners’ access to justice.”

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A long-term follow-up analysis of [...]]]> Main Category: HIV / AIDS
Also Included In: Immune System / Vaccines;  Men’s Health
Article Date: 09 May 2012 – 1:00 PDT

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A long-term follow-up analysis of participants in the Step Study, an international HIV-vaccine trial, has confirmed that certain subgroups of male study participants were at higher risk of becoming infected after receiving the experimental vaccine compared to those who received a placebo. The vaccine used in the study did not contain the HIV virus, but it did contain HIV genes which were delivered to cells using a vector that employed a type of cold virus known as adenovirus serotype 5 (Ad5).

Of the 1,836 men examined in this study, 172 became infected with HIV. Within 18 months of enrollment or one year after the last vaccination, men who had neutralizing antibodies to Ad5 or who were uncircumcised, or both, had a two- to four-fold increased risk of acquiring an HIV infection, according to findings published in the online edition issue of the Journal of Infectious Disease.

However, the study also found that the risk level waned after about 18 months to be equal to that of volunteers who received a placebo.

Why this association occurred, what the biological mechanisms were and why the risk of infection lessened with time are unknown and require more study, according to Ann Duerr, M.D., a member of the Vaccine and Infectious Disease Division of Fred Hutchinson Cancer Research Center, who led the data analysis.

“There seems to be some kind of biologic phenomena that affects infection risk,” she said.

The current study indicated that self-reported risk behaviors, such as unprotected sex, did not differ significantly between the vaccine and placebo arms of the Step trial.

The research also confirmed there was no elevated risk of infection in vaccinated men who were circumcised and who were Ad 5 seronegative (men who had no neutralizing antibodies to the adenovirus vector used in the vaccine). An earlier interim analysis of the Step Study data, done after immunizations in the vaccine trial were halted in 2007, also detected this relationship between Ad5 sero-status and vaccine-associated HIV risk. Today, only men who are circumcised and Ad5 seronegative are eligible to receive experimental HIV vaccines that use the adenovirus serotype 5 as a biological delivery mechanism.

Duerr said scientists need a better understanding of what happened biologically to men who became infected, before those who are uncircumcised or seropositive for Ad 5 are enrolled in future vaccine trials in which the adenovirus serotype 5 vector is used.

Ad 5 is used as a vector because it elicits a strong immune response by CD8 T cells. These cytotoxic T lymphocytes are thought to be responsible for controlling HIV infection.

In the current study, researchers analyzed data from male Step Study participants who enrolled in a trial that provided follow-up for up to four years after they enrolled in the Step study, or until Dec. 31, 2009, whichever came first.

The Step Study enrolled 3,000 male and female volunteers in North and South America, the Caribbean and Australia between 2004 and 2007. Injections in the study were halted in September 2007 after researchers detected a lack of effectiveness by the vaccine to prevent HIV acquisition or reduce HIV viral load in infected participants, and a higher-than-expected number of HIV infections in certain subgroups of vaccinees.

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Article [...]]]> Main Category: HIV / AIDS
Also Included In: Lymphoma / Leukemia / Myeloma;  Genetics
Article Date: 04 May 2012 – 0:00 PDT

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HIV patients treated with genetically modified T cells remain healthy up to 11 years after initial therapy, researchers from the Perelman School of Medicine at the University of Pennsylvania report in the new issue of Science Translational Medicine. The results provide a framework for the use of this type of gene therapy as a powerful weapon in the treatment of HIV, cancer, and a wide variety of other diseases.

“We have 43 patients and they are all healthy,” says senior author Carl June, MD, a professor of Pathology and Laboratory Medicine at Penn Medicine. “And out of those, 41 patients show long term persistence of the modified T cells in their bodies.”

Early gene therapy studies raised concern that gene transfer to cells via retroviruses might lead to leukemia in a substantial proportion of patients, due to mutations that may arise in genes when new DNA is inserted. The new long-term data, however, allay that concern in T cells, further buoying the hope generated by work June’s team published in 2011 showing the eradication of tumors in patients with chronic lymphocytic leukemia using a similar strategy.

“If you have a safe way to modify cells in patients with HIV, you can potentially develop curative approaches,” June says. “Patients now have to take medicine for their whole lives to keep their virus under control, but there are a number of gene therapy approaches that might be curative.” A lifetime of anti-HIV drug therapy, by contrast, is expensive and can be accompanied by significant side effects.

They also note that the approach the Penn Medicine team studied may allow patients with cancers and other diseases to avoid the complications and mortality risks associated with more conventional treatments, since patients treated with the modified T cells did not require drugs to weaken their own immune systems in order for the modified cells to proliferate in their bodies after infusion, as is customary for cancer patients who receive stem cell transplants.

To demonstrate the long-term safety of genetically modified T cells, June and colleagues have followed HIV-positive patients who enrolled in three trials between 1998 and 2002. Each patient received one or more infusions of their own T cells that had been genetically modified in the laboratory using a retroviral vector. The vector encoded a chimeric antigen receptor that recognizes the HIV envelope protein and directs the modified T cell to kill any HIV-infected cells it encounters.

As is standard for any trial, the researchers carefully monitored patients for any serious adverse events immediately after infusion – none of which were seen. Additionally, because of the earlier concerns about long-term side effects, the U.S. Food and Drug Administration also asked the team to follow the patients for up to 15 years to ensure that the modified T cells were not causing blood cancers or other late effects. Therefore, each patient underwent an exam and provided blood samples during each of the subsequent years.

Now, with more than 500 years of combined patient safety data, June and colleagues are confident that the retroviral vector system is safe for modifying T cells. By contrast, June notes, the earlier, worrying side effects were seen when viral vectors were used to modify blood stem cells. The new results show that the target cell for gene modification plays an important role in long-term safety for patients treated. “T cells appear to be a safe haven for gene modification,” June says.

The multi-year blood samples also show that the gene-modified T cell population persists in the patients’ blood for more than a decade. In fact, models suggest that more than half of the T cells or their progeny are still alive 16 years after infusion, which means one treatment might be able to kill off HIV-infected cells for decades. The prolonged safety data means that it might be possible to test T cell-based gene therapy for the treatment of non-life threatening diseases, like arthritis.

“Until now, we’ve focused on cancer and HIV-infection, but these data provide a rationale for starting to focus on other disease types,” June says. “What we have demonstrated in this study and recent studies is that gene transfer to T cells can endow these cells with enhanced and novel functions. We view this as a personalized medicine platform to target disease using a patient’s own cells.”

Co-first authors on the paper are John Scholler and Troy L. Brady from Penn. Co-authors include Wei-Ting Hwang, Gabriela Plesa, Michael Kalos, James L. Riley, Bruce L. Levine, and Frederic D. Bushman, also from Penn. Additional co-authors include Gwendolyn Binder-Scholl at Adaptimmune LLC., Ashley N. Vogel, now enrolled at Lake Erie College of Osteopathic Medicine, Kristen M. Hege from Celgene Corporation in San Francisco, Steven G. Deeks from University of California, San Francisco, Ronald T. Mitsuyasu from University of California, Los Angeles, and Wendy B. Bernstein and Naomi E. Aronson from Walter Reed National Military Medical Center in Bethesda.

The project was supported by a grant from the National Institutes of Health (1U19AI082628), the University of Pennsylvania Center for AIDS Research, and the Infectious Diseases Clinical Research Program, a Department of Defense program funded in part with federal funds from the National Institute of Allergy and Infectious Diseases under InterAgency Agreement Y1-AI-5072.
University of Pennsylvania School of Medicine

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