AIDS Drug Assistance Program Waiting List Still Growing Steadily

So far this August, Florida’s AIDS Drug Assistance Program has added another 110 people to its waiting list, which remains the longest in the United States.

The 3,861 Floridians on the list as of Aug. 18 represent 42 percent of all US residents waiting for help from state ADAPs, according to the National Alliance of State & Territorial AIDS Directors.

The total number of Americans on ADAP waiting lists dropped slightly, from 9,217 on Aug. 11 to 9,201. Twelve states have ADAP waiting lists.

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Life with Hope

The newly opened Mother Teresa House at North Church Street offers independent living in a residential setting for people with HIV/AIDS. More than 80 people attended the Aug. 22 dedication of the 5,723-square-foot home, including Rep. John Carney (D-Del.) and Jane C.W. Vincent, regional director of the Philadelphia office of the US Department of Housing and Urban Development (HUD).

The house and furnishings cost more than $1 million. Of that amount, HUD provided $630,000. The house is built on three lots, and its interior was designed for comfort and practicality.

Mother Teresa House is separately incorporated but sponsored by the nonprofit Ministry of Caring. It is part of a $5 million group of building and renovation projects undertaken by the ministry. HUD will provide $29,200 in annual rental support for the home.

M. Eileen Schmitt, board of directors’ president for Mother Teresa House, thanked all those who helped make the home a reality. “This house initially was a controversial project with a lot of difficulty getting it approved,” she said.

HUD “took a lot of criticism for funding small ‘boutique housing’ ... for five, 10, 15 people,” Vincent noted. Nevertheless, “It’s beautiful, just beautiful,” she said of the facility, adding, “That’s what it’s all about ... welcome home.”

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Tuberculosis Booster Shot's Effectiveness May Complicate Vaccination Schedules

A study of 214 infants finds that an experimental TB vaccine is most effective when it is not given with other vaccines.

In many developing countries, newborn babies are often given the bacille Calmette-Guerin (BCG) vaccine against TB. Though that protection wears off after a few years, BCG confers other benefits: Children who receive it have fewer cases of diarrhea, fewer allergic reactions, and better responses to hepatitis and polio vaccines. Infants given BCG are more likely to survive to age five. A booster vaccine for BCG would make its TB-preventive abilities last longer.

Lead author Dr. Martin O.C. Ota, of the Gambian Medical Research Council Laboratories, and colleagues studied the TB vaccine candidate MVA85A. When given with the BCG vaccine, MVA85A produced a good response against TB; however, this benefit was diminished when MVA85A was given in combination with other vaccines children typically receive at age four months. These include vaccines against diphtheria, whooping cough, tetanus, and polio.

Ota said the study’s results are a cause of concern for health care providers in Africa, who try to give babies as many vaccinations as possible at once. “Every additional visit is an extra cost to the mother,” increasing the chance that her children will not receive all their shots, Ota explained.

Providers may need to rethink the order in which they give vaccinations so as to better protect children against TB, the team concluded.

The study, “Immunogenicity of the Tuberculosis Vaccine MVA85A Is Reduced by Coadministration with EPI Vaccines in a Randomized Controlled Trial in Gambian Infants,” was published in Science Translational Medicine (2011;3(88):88ra56).

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51 Percent of HIV-Affected Households in Cambodia Live in Hunger: UN Development Program

The largest and most comprehensive survey ever conducted in Cambodia finds 51 percent of households in which a member has HIV/AIDS do not have enough food to eat, compared to 35 percent of non-affected households.

A total of 4,172 households took part in the survey, including 2,623 HIV-affected and 1,549 non-affected households. An estimated 75,000 Cambodians in 60,000 households are living with HIV/AIDS.

According to the survey, 27 percent of respondents with HIV reported having lost their jobs or other source of income following diagnosis. Sixty-five percent of affected households had a least one loan. More than 25 percent of household members with HIV had caregivers.

Twenty-three percent of women with HIV/AIDS reported verbal abuse as a result of their status vs. 16 percent of affected men. Seven percent of HIV-positive women said they had experienced physical threats or abuse due to their infection, compared to 4 percent of men.

Sixty-five percent of people with HIV had low self-esteem: 49 percent were ashamed of their status; 47 percent felt they should be punished; and 16 percent reported suicidal thoughts.

The “Socioeconomic Impact of HIV at the Household Level in Cambodia” survey was produced by the UN and the National AIDS Authority. “The report will be an important base for us to find ways to improve the livelihoods for the HIV-affected households,” said Tia Phalla, NAA’s vice chair.

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Taiwan Hospital Transplants Five HIV-Infected Organs

Last week in Taiwan, five transplant recipients received organs from a deceased HIV-infected donor due to a lapse in operating procedures, the Taipei-based National Taiwan University Hospital (NTUH) announced on its website over the weekend.

NTUH said a transplant staff member believed he had heard the English word “non-reactive” during a briefing given over the telephone about the organ donor’s HIV test. But “reactive,” or HIV-positive, was in fact said. Information about the result was not double-checked as standard operating procedures require, NTUH said. “We deeply apologize for the mistake,” said the hospital.

A Health Department team will investigate the transplants and decide on any penalties against NTUH, where four of the operations occurred, said Shih Chung-liang, a department official. One surgery, a heart transplant, was performed at the National Chengkung University Hospital (NCUH).

All the organ recipients are now receiving AIDS drugs, said an NTUH official, who spoke anonymously, lacking authorization to talk with the media. However, the recipients will probably contract HIV, and their treatment will be further complicated by the anti-rejection medications, said Yao Ke-wu, head of the health department in Hsinchu city, where the donor lived. The mistake could have been avoided had Taiwan mandated that NTUH ask his department for the donor’s medical history, Yao said.

Some surgical staff who performed the transplants are worried about their own infection risk. Team members who transplanted the man’s heart “were depressed, and on the verge of panic,” said Lee Nan-yao, an NCUH physician.

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Iran Releases Jailed HIV Doctor: Family Source

On Monday, the second of two brothers known for their HIV work in Iran was released from a Tehran jail. Arash Alaei and his brother Kamiar were arrested in June 2008 for allegedly conspiring against the regime of President Ahmadinejad. Arash ultimately served nearly three years of his six-year sentence.

“He was among 100 Iranian political prisoners who got a pardon today due to the coming end of the Ramadan religious holiday, Eid al-Fitr,” said Kamiar, who was freed earlier this year after an 870-day stint. On his Facebook webpage, Kamiar thanked friends, family and colleagues for their “tireless help and support.” He is currently pursuing a doctorate in public health in Albany, N.Y.

In the late 1990s, the two physicians developed a best-practices model of treatment, prevention, and care for HIV patients, starting at a prison in their hometown of Kermanshah. The brothers are recognized for their pioneering work with HIV-positive injection drug users.

Physicians for Human Rights helped organize a letter-writing campaign in 80 countries to appeal for the brothers’ release.

Arash is now with his mother at the family’s home in Tehran, Kamiar said. “He is happy since his other political cellmates got released, too,” he added.

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More Teens Getting HPV Vaccines, but Not Enough, CDC Reports

In a new report using data from its National Immunization Survey-Teen, CDC found coverage with routine adolescent vaccines is rising, but “the increase in [human papillomavirus] coverage among adolescent females is lagging, with only one-third having received the full three-dose series.”

The proportion of female teens who had received at least one dose of HPV vaccine grew from 44.3 percent to 48.7 percent from 2009 to 2010, while the proportion who had received all three doses rose from 26.7 percent to 32 percent. The survey collected information on more than 19,000 youths ages 13 to 17.

“As in previous years, coverage with =1 dose of HPV was higher among older compared with younger adolescent females,” the authors wrote. “Among females with adequate time to complete the series, 30.4 percent had not done so. HPV completion rates were lower among certain populations (i.e., blacks, Hispanics and those living below poverty) known to have higher cervical cancer rates.

“Although HPV vaccination is only universally recommended for females aged nine through 26 years, 2009 [Advisory Committee on Immunization Practices] guidance states that HPV vaccination may be administered to males aged nine through 26 years. Only 1.4 percent of males aged 13 through 17 years received the vaccine in 2010,” according to the report, which also detailed increased uptake of the vaccines MenACWY (meningococcal conjugate) and Tdap (tetanus, diphtheria, acellular pertussis).

“Although adolescent vaccination is increasing, additional strategies are needed to meet ‘Healthy People 2020’ vaccination objectives for adolescents, particularly for HPV vaccination, because the increase in HPV coverage significantly lags behind other adolescent vaccines,” the authors wrote. “A new 2012 Healthcare Effectiveness Data and Information Set measure requiring health plans to track the number of females who receive three HPV doses by age 13 years is expected to lead to increased HPV vaccination rates.”

“Stronger provider recommendations for HPV vaccination, implementing reminder-recall systems, eliminating missed opportunities, and educating parents of adolescents regarding the risk for HPV infection and the benefits of vaccination, are needed to effectively protect adolescent girls against cervical cancer,” the team concluded.

The report, “National and State Vaccination Coverage among Adolescents Aged 13 through 17 Years - United States, 2010,” was published in CDC’s Morbidity and Mortality Weekly Report (2011; 60(33):1117-1123).

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Clothing Line with Mandela's '46664' Prison ID Debuts

South African manufacturer Seardel on Wednesday debuted a clothing line bearing the “46664” number worn by Nelson Mandela during his 18 years as a prisoner on Robben Island.

Seven to nine percent of the revenue generated by sales of the men’s and women’s clothing will be donated to Mandela’s 46664 Foundation, which works to fight HIV/AIDS.

The line initially will be available in Stuttafords stores in South Africa, Botswana, and Namibia, with plans to expand to the United States and Europe. Next year, the label hopes to launch its own line of specialty shops.

Finally freed in 1990, Mandela was elected president in South Africa’s first free election in 1994.

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Hong Kong Reports 101 New HIV Cases in Second Quarter

The Hong Kong Health Department reports logging 101 new HIV cases in the second quarter of 2011, bringing the city’s total since 1984 to 5,036.

The new cases comprise 78 males and 23 females. The routes of infection were reported as heterosexual exposure (34 cases), homosexual/bisexual exposure (33) and drug injection (four), with the cause of 30 cases undetermined.

Also in the second quarter, 23 people received new AIDS diagnoses, bringing Hong Kong’s total number of cases since 1985 to 1,221. TB was the most common AIDS-defining illness in the second quarter.

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Condoms for Victoria Prisoners

Starting next week, authorities will begin distributing safe-sex kits to inmates in two men’s prisons and two women’s prisons in Victoria.

“Condoms and dental dams can significantly reduce transmission of sexually transmitted infections and some blood-borne viruses,” said Andrew McIntosh, corrections minister. “There are more than 5,000 prisoners who leave prison every year, so it is important to take steps to protect both prisoners and the community from infectious disease.”

The policy change comes five years after an ombudsman recommended it. “Evidence from other jurisdictions shows that condoms and dental dams have had no negative impacts to prison security and safety,” McIntosh said. The products will be available at prison health centers, and inmates will be given information about safe-sex practices.

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37 Percent of Teens Say They Tried Sex, 7 Percent Say They Were Raped: Poll

In a fall 2010 survey of about 1,700 suburban Cook County students from 20 public high schools, 37 percent reported they were sexually experienced. Among those reporting intercourse within the preceding three months, about 62 percent said they used a condom.

By race/ethnicity, 61 percent of African Americans, 49 percent of Hispanics and 24 percent of Caucasians reported sexual activity. About 6 percent said they had sex for the first time before age 13. About 7 percent of all teens said they had been physically coerced to have sex.

During the preceding year, 13 percent said they had seriously considered suicide, and 9 percent actually attempted it. Among all students, 40 percent had tried cigarettes and 33 percent marijuana at least once. About 29 percent reported being offered, sold or given illegal drugs on school grounds in the preceding year.

“In general, there are so many things that we need to tackle, it’s kind of like, where do we start?” said Amy Poore, a spokesperson for the Cook County Department of Public Health (CCDPH).

One starting point would be better sex education in schools, Poore said. Data like these could help in applying for grants or passing state legislation, she said.

“Most schools don’t have comprehensive sex education and are teaching abstinence only, but clearly we have a high amount of students who are engaging in sexual activity,” said Poore.

The suburban area’s first Youth Risk Behavior Survey was conducted with local help from CCDPH, the Children’s Memorial Hospital Child Data Lab and school administrators.

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More Gender Equality Leads to More Sex, Global Study Shows

A new study finds that countries that had higher gender equality rankings also generally reported more casual sex, more sex partners per capita, younger ages for sexual debut, and greater tolerance/approval of premarital sex. Roy Baumeister of Florida State University presented his research on worldwide “sexual economics” at the recent American Psychological Association meeting in Tallahassee, Fla.

Baumeister’s research used two data sets on 37 countries, including an international online sex survey of 317,000 people and data specific to gender equity and related topics.

“Women’s sexuality has a kind of value that men’s sexuality does not,” explained Baumeister. “Men will basically exchange other resources with women to have sex, but the reverse doesn’t work. Women ... can trade sex for attention, for grades, for a promotion, for money, as in prostitution or sex with a celebrity.”

Supply and demand dictates that whichever sex is more scarce has more power, said Baumeister, with the caveat that this theory applies only to heterosexual interactions.

“In countries where women are at a big disadvantage, they restrain sex, so the price is high and men make a lifetime commitment to support them to get sex,” Baumeister said. “Men will do whatever is required for sex.”

Mark Regnerus, an associate professor of sociology at the University of Texas-Austin, said Baumeister’s theory is a “perspective through which to understand sexual relationships and sexual behavior.” Regnerus’ research on the subject attributes the rise of the “hook-up” culture in colleges to the fact that so many more women are getting a higher education.

Baumeister’s study, “Cultural Variations in the Sexual Marketplace: Gender Equality Correlates with More Sexual Activity,” was published in the Journal of Social Psychology (2011;151(3):350-360).

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Top Court to Review HIV Sex Law

The Supreme Court of Canada on Thursday announced it will hear two appeals that concern the risk of HIV transmission in the era of antiretroviral therapy. Both cases involve people with undetectable viral loads, where the possibility of infecting a serodiscordant partner is reduced but not eliminated.

A Quebec case concerns a woman who, court documents say, did not tell her former spouse she had HIV before having unprotected sex. Experts told the court the risk of transmission was one in 1,000 for unprotected sex, and would have been one in 50,000 had condoms been used. A case in Manitoba involves similar issues.

The Supreme Court does not usually give reasons for taking cases. However, lower courts have asked the Supreme Court to review its own test for what constitutes serious risk.

“Issues of condom usage and viral load raise difficulties of proof perhaps not contemplated or even known when the Supreme Court developed the test,” wrote Judge Freda Steel for the Manitoba appeals court last year. “In light of these concerns and the developments in the science, the Supreme Court may wish to consider revisiting the test ... to provide all parties with more certainty.”

“In light of its numerous social, ethical, and moral ramifications, the initiative of revisiting the entire notion of transmission risks for serious infectious diseases, in the context of Canadian criminal law, should be the responsibility of Parliament,” wrote Judge Jacques Chamberland for the Quebec appeals court.

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South Africa's HIV Infections Fall to 5.4 Million

On Thursday, South Africa’s deputy president responded to a parliamentary request for an update on national HIV/AIDS efforts. AIDS-related deaths are down, he said, but getting a handle on new infections continues to be a struggle.

“South Africa has invested a large amount of resources into its HIV response,” said Kgalema Motlanthe in his report. “The number of deaths due to HIV-related causes is beginning to show a decline due to the intensification of antiretroviral [ARV] treatment.” But, “The rate of new infections continues to outpace our prevention efforts, and thus prevention programs will be prioritized in the new national strategic plan, which is being developed for the term 2012 to 2016.”

South Africa has more HIV cases than any country in the world. Motlanthe said there are 5.38 million infections among the population of 50 million, down from a UN-estimated figure of 5.6 million in 2009. Around 1.3 million South Africans are receiving ARVs though the government’s drug program, making it the largest worldwide.

Government statistics place South Africa’s infection rate at 10.6 percent of the overall population, with 16.6 percent of people ages 15-29 and just under 30 percent of pregnant women infected, Motlanthe said. However, mother-to-child HIV transmission has declined from 10 percent to 3.5 percent during the last three years, he said.

South Africa recently wrapped up a national HIV testing initiative that reached nearly 14 million people, of whom 2 million tested positive. And the government has announced it will provide ARVs to all HIV patients whose CD4 counts fall below 350 cells per microliter, based on new studies that show earlier treatment saves lives; previously the protocol was 200 cells per microliter.

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New HIV Infections Drop 20 Percent in Asia-Pacific

The latest UNAIDS report on Asia-Pacific shows that annual new HIV infections there dropped from about 450,000 in 2001 to 360,000 in 2009, a decline of 20 percent.

“I think it is very important to make the world understand that we are at the crossroads today in Asia and the Pacific, because efforts have been made,” UNAIDS Executive Director Michel Sidibe said at the report’s release in Pusan, South Korea. Governments have invested in prevention programs and increased access to antiretroviral drugs, said the agency.

The region has some 4.7 million people living with HIV/AIDS, most of them in Burma, Cambodia, China, India, Indonesia, Malaysia, Nepal, Pakistan, Papua New Guinea, Thailand, and Vietnam. In particular, Burma, Cambodia, India, and Thailand have significantly reduced their infection rates by initiating programs for sex workers and their clients, UNAIDS noted.

However, “We cannot be complacent,” Sidibe cautioned. “In Asia particularly we are seeing a growing number of infections among most-at-risk populations.”

Though access to antiretroviral therapy increased three-fold from 2006 to 2009, the treatment remains unavailable to approximately 60 percent of people in need across the region. And while countries such as China, Malaysia, Pakistan, Samoa, and Thailand largely fund their own HIV/AIDS programs, many less-developed Asian nations continue to rely on outside aid, said UNAIDS.

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California Lawmakers OK Statewide Rules on Circumcision

On Tuesday, the California Senate Judiciary Committee unanimously approved a measure that will block local jurisdictions from banning male circumcision. AB 768 is in part a response to a San Francisco ballot measure that sought to outlaw the procedure on boys under age 18.

Nationally, efforts are underway to limit male circumcision. Critics say it is an unnecessary surgery on a healthy and defenseless child that can have lasting sexual and mental health problems. Supporters, including researchers, say male circumcision can reduce the risk of STDs and cancer. Jews and Muslims consider the practice an important religious rite.

Backed by two Democratic lawmakers, the measure declares that the surgical removal of the foreskin has health, cultural, and other benefits. “It’s a medical procedure, and it has value,” said Assembly member Mike Gatto of Los Angeles, a co-author of AB 768.

Supporters say the bill is needed to prevent a patchwork of laws throughout the state governing the practice. “The decision to perform male circumcision should be left up to the parents in consultation with their physician, wherever they reside,” said Ryan Spencer, a spokesperson for the California Medical Association.

The San Francisco ballot measure drew national attention. In June of this year, a group including Jewish and Muslim city residents sued to block it. On July 28, San Francisco Superior Court Judge Loretta Giorgi ordered it struck from the November ballot, saying California law specifies that only the state, not cities, can regulate medical procedures, and that it violated protections of religious freedoms under the US Constitution.

Gatto said AB 768 is necessary in case Giorgi’s ruling is overturned on appeal. Further, the Jewish specialists who perform circumcisions, mohels, might not be covered by state law on medical procedures.

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HIV-Positive Rural Kenyans Lack Food During Drought

Every morning, Julia Aukot walks 17km to eastern Kenya's Isiolo town in search of work so she can feed her six children and ailing husband; the journey is punishing, but as her family's sole breadwinner, she has no choice.

"Here in the village, there is [absolutely] nothing you can do to make money to buy food. So every morning at six, I go to Isiolo town to do menial jobs for people and... buy food for my children and my husband," the 39-year-old told IRIN/PlusNews.

When she cannot find work, Aukot begs on Isiolo's streets - which she finds deeply humiliating - or visits a nearby slaughter house to scrape what little meat is left on the carcasses.

"After they have taken the good meat from the slaughtered animals, I follow them with a knife and cut meat from the remaining skins," she added. "When I gather enough, I take it home and we eat; my children and husband have now gotten used to eating the meat without any ugali [maize meal, a Kenyan staple]. I can't afford maize flour."

A 90kg bag of maize, which in April 2011 cost about KSh2,500 (US$27.10), now costs as much as KSh4,800 ($52).

Aukot's husband used to help out, but the poor diet the family has subsisted on recently has left him very weak. He is on antiretroviral medication, and insufficient food increases the side-effects of the drugs, leaving him unable to contribute to the family income.

"He is sick, it's not his fault; if he doesn't eat, the medicine can't help him," said Aukot. "I can't sit back and watch him just waste away... he is so weak - for me, there is no difference between him and the children."

Partly because of a prolonged dry spell, some 3.6 million Kenyans need emergency food assistance. While Aukot and her family qualify for aid, poor roads mean the food does not reach her village. Most villagers walk to Isiolo town to access food aid, but the weakest often do not have the energy to walk that far.

"We have food meant for the hungry people but some areas are just too hard to reach," an aid worker in Isiolo told IRIN/PlusNews. "By the time the food [aid] gets to them, many have already gone without anything to eat for days."

Lillian Naseo, a community social worker in Isiolo, asks local well-wishers to donate food, which she then shares with people living with HIV and those infected with tuberculosis.

Too weak to walk

"They can't walk to look for food, not just for themselves but also their families, so I beg for them... I walk into restaurants and when they give me leftovers, I take them to these people," she said. "But this is not enough because I don't know all those living with HIV in Isiolo District."

According to local health officials, Isiolo's HIV prevalence rate is more than 4 percent.

By the time the food [aid] gets to them, many have already gone without anything to eat for daysJunnius Mutegi, the district nutrition officer for Garba Tulla District, in upper Eastern Kenya, says: "Life is hard for everybody, but when food aid is not getting to people in the rural areas early enough, many of those suffering from HIV find it extremely difficult to survive, because they can't make the journeys to trading centres to look for food. It is either you get it to them or they die of hunger."

On a dusty street corner in Garba Tulla, Hawa*, 41 and HIV-positive, begs passers-by for money and food. She is too weak to work and without a strong support network, she says her options are to beg or die.

"I need to eat but I can't work and I rely on relief food, but it doesn't come every day, so I moved to town to beg," she told IRIN/PlusNews. "In the village you can't beg, because everybody is just like me... they need food just like me."

According to Mutegi, the situation calls for new ways to ensure the most vulnerable have access to food assistance.

"I think the situation now calls for some innovativeness, so that even if the roads are bad, we can use camels or donkeys to ensure food reaches those who need it in good time," he said. "People living with HIV and taking antiretrovirals seriously need food... Otherwise we are faced with a situation where people will start to default on their drugs, and it is bad if we get there."

*not her real name

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Canadian HIV Law Confusing for Health Care Providers

The lack of clarity over when a person with HIV has a legal obligation to disclose their HIV-positive status to a sexual partner is resulting in "anxiety, confusion and contradictory HIV counselling advice," according to a new study on the impact of HIV criminalisation in Canada.

Vague "significant risk" decision

A 1998 Supreme Court decision created Canada's current law, which obligates people with HIV to disclose their HIV-positive status before engaging in conduct that poses a “significant risk” of transmitting the virus. Non-disclosure prior to sex that poses a "significant risk" renders the sex non-consensual, so that HIV exposure is considered to be a sexual assault.

Since the Supreme Court was not explicit regarding what constitutes a “significant risk” this has led to inconsistent and overly-broad interpretations by Canada's police and lower courts.

Some people have been charged and/or convicted for having sex with a condom and/or oral sex alone while others have been acquitted for unprotected anal sex. Although the Courts of Appeal of Manitoba and Quebec have recently ruled that when a condom is used or when a person has an undetectable viral load there is no significant risk of transmission and, therefore, there is no duty to disclose, these decisions may yet be reversed. The Supreme Court is scheduled to hear the prosecution’s appeal in at least one of these cases in 2012.

As part of a criminal law reform project to encourage a more evidence-informed application of the criminal law, Eric Mykhalovskiy, an Associate Professor in the Department of Sociology at York University in Toronto interviewed 28 healthcare and HIV service providers, and a further 26 people with HIV participated in four focus group interviews. The interviews took place in three cities in the province of Ontario – Toronto, Ottawa and Hamilton – between January and September, 2010.

Anger, fear and confusion for people with HIV

A consistent theme in the focus group interviews with HIV-positive individuals was that there was a disconnect between what science (and public health) knew to be epidemiologically important risks and the lack of consistent legal recognition of these risks and how to reduce them, such as by using condoms.

The legal uncertainty over which sexual acts pose a "significant risk", thus triggering the obligation to disclose, left many study participants "angry, confused and frightened" notes Professor Mykhalovskiy. Although some participants with HIV claimed to disclose in all sexual circumstances, others said they were less open about their HIV-positive status as a result of the law. A few participants admitted that they have responded to the situation by withdrawing from sex altogether.

Inconsistent and contradictory counseling

Healthcare providers also admitted to struggling with the tension between unclear legal concepts of "significant risk" and public health-focused safer sex counselling. This has resulted in people with HIV being provided with inconsistent and contradictory information about their legal obligation to disclose.

Some healthcare providers have responded to the vagueness of the law by advising patients to disclose to all sexual partners, regardless of the transmission risks they pose.

Professor Mykhalovskiy notes that "a troubling consequence" is that detaching disclosure from scientific assessments of "significant risk" can result in a "blanket moral obligation" to disclose, which was not the intention of the Supreme Court.

Don't ask, don't tell

Healthcare providers emphasised how HIV criminalisation has impeded their ability to establish trust with their HIV-positive clients and patients, creating a chill in their counselling relationships. Mindful that medical and counselling records could be used in criminal proceedings, healthcare workers are cautioning their patients about the limits of client confidentiality, resulting in a 'don't ask, don't tell' approach. Professor Mykhalovskiy notes a perverse circularity of public health/criminal law relations as counselling and record keeping are done with an "eye to the law" in anticipation of their potential use in criminal proceedings.

Fears of false allegations of non-disclosure

People with HIV and healthcare providers also voiced concerns over the difficulties of proving (non) disclosure in court. Some people with HIV – notably female migrants of African origin – voiced concerns that they were vulnerable to arrest and prosecution following false allegations of non-disclosure. Professor Mykhalovskiy notes that "in the context of unequal relationships, the legal requirement to disclose can be subject to manipulation...partners can use false claims of non-disclosure to control and threaten" people with HIV.

Prosecutorial guidelines may establish clarity

Professor Mykhalovskiy notes that "while the use of the criminal law may be warranted in some circumstances, the expansive use of a vague legal concept of significant risk does little good either for preventing HIV transmission or for the credibility of the criminal justice system." He concludes that the establishment of prosecutorial guidelines may create some clarity regarding disclosure obligations, potentially mitigating some of the problems described in this study.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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Maine to Lose a Third of Its Federal HIV Funding in 2014

Maine is bracing for the loss of a third of its federal funding for HIV AIDS, as the feds target scarce dollars to urban states with high caseloads.

Maine was facing immediate cuts, but Maine Center for Disease Control Director Dr. Sheila Pinnette successfully appealed the decision, according to Capitol News Service.

But Pinnette warns that the cuts are coming. "What's the impact? Well, our priority for the state of Maine is to continue to do HIV testing," she says. "We feel that it's very important to continue carrying out the practices we have over the last 10 years, such as target outreach, HIV testing and continue to strengthen our partnerships."

Pinnette says Maine's strategy has paid off: She says the state is expecting only about eight new cases of HIV-AIDS to be diagnosed this year.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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Canada Denies Deportation Appeal of HIV-Positive Man

Canada's highest court has decided not to hear a deportation appeal that could have added another legal wrinkle to refugee claims from HIV/ AIDS patients.

That wrinkle would have required the Supreme Court of Canada to determine if sending a refugee home to a country with a lack of health-care resources was effectively a death sentence.

That was the argument from an HIV-positive Zimbabwe man who argued he would not receive proper health care in his home country, putting his life at risk should he be deported.

The Supreme Court was his last chance to appeal his deportation.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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Earlier HIV Testing and Entry Into Care Needed for Latinos

Latinos are more likely to start HIV care later in the course of illness than blacks or whites, according to University of North Carolina data published in the September 1 issue of Clinical Infectious Diseases. These findings, the authors conclude, indicate that strategies to improve earlier HIV testing among Latinos—particularly in new settlement areas like North Carolina—are needed.

Latinos have become the largest immigrant group in the United States and now represent the fastest grouping minority group, making up one sixth of the U.S. population. While immigration from Latin-American countries is hardly new, many Latinos are bypassing border states, such as California, Arizona or Texas, and major metropolitan areas, such as New York and Chicago, for smaller cities and towns in the Midwest and the Southeast, where expanding economic opportunities await.

Between 1990 and 2000, the Mexican immigrant population in the Southern states grew more than 300 percent, according to a 2005 report released by the Pew Hispanic Center in Washington, DC. Yet despite their growing numbers, Latinos have less education and English language proficiency and frequently lack health insurance. What’s more, many Latino immigrants are undocumented and thus further marginalized from the health care system.

These disparities are evident in the HIV/AIDS epidemic among Latinos in the United States. The U.S. Centers for Disease Control and Prevention estimates that the rate of HIV infection among Latinos is 2.5 times that of whites and that they tend to be diagnosed late, with lower CD4 cell counts, higher viral loads, more AIDS-defining opportunistic infections and longer hospital stays than whites.

Ann Dennis, MD, MS, of the University of North Carolina at Chapel Hill and her colleagues document some of the challenges in providing care for Latinos living with HIV in North Carolina, a state that has experienced a recent and rapid increase in the Latino population.

Between 1999 and 2009, 853 patients began HIV care through the University of North Carolina Center for AIDS Research Clinical Cohort. Sixty-one percent were black, 28 percent were white, and 11 percent were Latino.

Though Latinos were clearly a small minority in the cohort, they tended to enter care with more advanced HIV infection, including presenting with an AIDS-defining condition at diagnosis. Average initial CD4 counts were lower for Latino patients (186 cells) than white patients (292 cells) and black patients (302 cells). Latinos also accounted for 86, 75 and 50 percent of all presenting cases of active tuberculosis, histoplasmosis and toxoplasmosis, respectively.

In a statistical analysis performed by the researchers, Latinos were 1.29 times more likely to present to care late than whites or blacks.

Interestingly, late presentation was significant only for Latino men but not for women, likely because women receive a diagnosis at the time of pregnancy.

Though the study did not document the country of origin or immigration status of the patients, an accompanying editorial by Carlos Del Rio, MD, of Emory University’s Rollins School of Public Health in Atlanta assumed that most were Mexican and undocumented.

“Also, [Dennis and her colleagues] do not tell us about the response to antiretroviral therapy among their patients, but it was likely good,” De Rio writes. “Data suggest that the clinical progression of HIV disease in Latinos is similar to that in whites once the ‘playing field is leveled,’ that is, once medical care is initiated and health care access is not a factor. In fact, they may even do better. In a recent study…undocumented Hispanics were diagnosed with more advanced HIV disease, but once diagnosed and in care, they were more likely than other populations to be retained in care, with undetectable viral loads and with a significant increase in CD4 count.”

Dennis’s team concludes that comprehensive public health programs focusing on early HIV testing and further studies to understand the barriers to use of public health resources by Latinos are needed. “While I do not disagree with them,” Del Rio comments, “I think that the interventions necessary go well beyond public health and are both political and cultural. Illegal immigration and health care are the intersection of two broken systems, and unfortunately politicians have chosen to turn a blind eye on the public health consequences of further restricting access to health care for undocumented immigrants.”

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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Start Earlier, Say Treatment Guidelines for Children Living With HIV

Children living with HIV who have CD4 cell counts below 500 and are not yet receiving antiretroviral (ARV) therapy should be started on treatment, according to revised guidelines released by the U.S. Department of Health and Human Services (DHHS) on August 11. Other revisions, which update a previous version published in August 2010, include updated treatment options for HIV-positive children beginning therapy for the first time.

Since the pediatric HIV/AIDS treatment guidelines were first developed in 1993, dramatic advances in medical management have been documented. Death rates among children living with the virus in the United States have decreased by more than 80 percent to 90 percent since the introduction of ARV drug combinations. Other advances, including resistance testing and the ability to measure ARV drug levels, have enabled health care providers to more carefully choose very effective initial regimens while preserving selected drugs and drug classes for second- or third-line regimens.

Much like in adults living with HIV, pediatric therapeutic strategies continue to focus on early initiation of ARV regimens capable of maximally suppressing viral replication to prevent disease progression, preserve immunologic function and reduce the development of resistance. At the same time, availability of new drugs and drug formulations has led to regimens with less frequent dosing schedules that improve adherence. Improved monitoring and dosing schedules have also led to a decrease in drug failure due to toxicity.

Meanwhile, the widespread use of ARV treatment during pregnancy has resulted in a dramatic decrease in the transmission rate to infants, which is currently less than 2 percent in the United States and thus means fewer children are being born with HIV. Challenges, however, remain. Those less fortunate children still require state-of-the-art care. Children living with HIV are, as a group, growing older, bringing new challenges of adherence, drug resistance, reproductive health planning, management of multiple drugs, and long-term complications from HIV and its treatments.

In an effort to stay ahead of these challenges, the DHHS remains committed to interpreting pediatric research data in order to maintain best practices for providers caring for children living with HIV.

According to the most recent Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, children age 5 and older who are living with HIV and do not have symptoms but do have CD4 cell counts below 500 should be started on treatment, similar to the recommendation for adults. The previous version of the guidelines recommended treatment for asymptomatic children older than 5 once their CD4s fall below 250.

Kaletra (lopinavir/ritonavir), combined with two nucleoside reverse transcriptase inhibitors (NRTIs), is the preferred ARV regimen for children between 2 weeks and 3 years old. Viramune (nevirapine) combined with two NRTIs is considered the alternative option in this very young population.

For several years, Kaletra has also been a preferred protease inhibitor option for children living with HIV who are 6 years old or older. It is now joined by Norvir (ritonavir)–boosted Reyataz as a preferred option for this age bracket.

Preferred NRTI combinations are also revised in the new guidelines. In addition, new sections highlight the latest research on nervous system problems, gastrointestinal side effects and kidney toxicity, as they relate to the use of ARVs in children.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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HIV Linked to False Negative Hep C Results Using Some Rapid Assays

When it comes to testing people living with HIV for hepatitis C virus (HCV) antibodies using rapid assays, some tests appear more accurate than others, according to a U.S. Centers for Disease Control and Prevention (CDC) study of three assays reported in the September 15 issue of the The Journal of Infectious Diseases. OraSure’s OraQuick HCV Rapid Antibody Test was the most accurate of the three in specimens that also contained HIV antibodies, followed by Chembio’s DPP HCV Test and, lastly, by MedMira’s Multiplo Rapid HIV/HCV Antibody Test.

Specimens from people living with HIV were 11 times more likely to have a false result than those from HIV-negative people using the Chembio test, and four times more likely using the MedMira test, Bryce Smith, PhD, of the CDC and his colleagues report. HIV infection was unlikely to affect the accuracy using the OraSure assay.

Much like rapid HIV testing, there is a great deal of interest in “point-of-care” (POC) assays that can document antibodies to HCV within minutes of a sample being collected. With regular antibody tests, which need to be processed by labs and can take a few weeks to yield results, many people do not return for their results. With POC assays, results can be provided while the patient is still present, along with important information such as the need for follow-up testing and care.

Companies have developed POC assays to look for HCV antibodies, which indicate past exposure to the virus and the need for viral load testing to determine whether or not the infection is chronic and potentially causing liver damage. OraSure’s assay has been approved by the U.S. Food and Drug Administration, whereas two other lead contenders—Chembio’s assay and MedMira’s test—have not.

For POC testing and linkage-to-care to be maximally effective, however, the assays need to be both highly sensitive and specific. The more specific the test, the lower the risk of false-positive results. And even more important, as the goal is to capture as many real infections as possible through testing, the more sensitive the assay, the lower the risk of false-negative results.

To explore the accuracy of POC tests for hepatitis C, the researchers tested a panel consisting of 1,100 specimens drawn from 1997 to 1999 from people reporting injection drug use. The specimens were tested with the three rapid assays, along with a standard antibody test conducted by a laboratory known to be highly accurate.
Roughly half of the specimens contained HCV antibodies. Forty-three of the 1,100 specimens contained HIV antibodies.

The sensitivities of the three assays, across the board, were 92.2 to 98 percent for the Chembio test, 86.8 to 88.3 percent for the MedMira test and 97.8 to 99.3 percent for the OraSure test.

False results—both positive and negative—varied. Chembio’s assay had 0.2 percent false positives, and false negatives ranged from 2.2 to 3.9 percent. MedMira had 0.2 percent false positives, and the range of false negatives was from 11.7 to 13.4 percent. And OraSure had a false-positive range from 0.4 to 0.6 percent and a false-negative range from 0.7 to 2.2 percent.

Of particular interest, false results using the Chembio and MedMira assays were strongly associated with the presence of HIV antibodies in the specimens, which suggests these tests are less effective among people living with HIV who require testing for HCV antibodies. Conversely, HIV antibodies were not associated with false results using OraSure’s FDA-approved assay.

Smith’s group noted that finding HCV antibody false-negative results among HIV-positive individuals isn’t a new phenomenon. In fact, the 8.5 percent rate of false-negative results among HIV-positive samples across all three assays compared favorably to a European study that found a false-negative rate of 22.4 percent among people living with HIV when using rapid tests. Even standard antibody tests are associated with false-negative results when testing samples from people living with HIV, on the order of 3.8 to 5.5 percent.

Further exploration of POC assays for HCV antibodies among people living with HIV is needed, the authors conclude. They write that it is necessary to “establish an expected proportion of false-negative results. Also, demonstration projects should be conducted to see how these assays would be implemented in HIV testing settings, including the development and testing of HCV-specific prevention messages.”

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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Nationwide HIV Cure and Aging Advocacy Initiative Planned; Scholarships Available

Treatment Action Group (TAG), a New York City–based organization of activists, is urging advocates from all 50 states to join a leadership network that will work closely with members of Congress to advance aging- and cure-related HIV research. The initiative will begin with a three-day gathering October 11 to 13 in Washington, DC, for which scholarships are available.

“Historically,” TAG explains in a statement introducing the initiative, “federal research funding is considered a wise investment for the future health of the nation, and has enjoyed strong bi-partisan support from lawmakers in Congress. However, with the recent economic crisis and mandates on short-sighted spending cuts, funding for the National Institutes of Health (NIH), where much of AIDS research happens, is in serious jeopardy.”

While there have always been members of Congress who have steadfastly supported the NIH, TAG contends, many are no longer in office. What’s needed—and groups like TAG cannot do this alone—is a concerted effort by people living with HIV/AIDS and advocates from across the nation to “find new allies and reactivate long-standing support in Congress.” In the absence of such efforts, “scientific advances necessary for the cure, and desperately needed new interventions for HIV and aging related illnesses, will die on the vines of discovery.”

TAG’s new initiative hopes to bridge the gap between people living with HIV and people elected to Congress. It aims to build a national network of HIV/AIDS activists and other leaders committed to working with Congressional representatives in Washington, DC, and in their home states to build grassroots support.

This will be a year-round campaign, and participants will need to commit, on average, two hours of their time per week.

Full scholarships covering round-trip travel, two nights in a hotel and per diem are being awarded in support of the three-day visit to Capitol Hill in October. The deadline for submitting applications is September 2.

Scholarship recipients will also receive individual assistance on effective message development before the DC visit, ongoing training and support online, as well as skills-building sessions via conference calls and webinars.

Priorities will be given to people from the following states: Alabama, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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Transitional Care Programs Needed in U.S. Jails and Prisons

Substantially more needs to be done to transition incarcerated people living with HIV into supportive health care services upon release from jails and prisons in the United States, according to a comprehensive review and analysis of available data published in the September 1 issue of Clinical Infectious Diseases.

According to Sandra Springer, MD, of the AIDS Program at Yale University School of Medicine and her colleagues, five distinct factors need to be addressed to improve outcomes among prisoners reentering the community: pre- and post-release case management, continuation of antiretroviral (ARV) therapy, treatment of substance use disorders, continuation of mental illness treatment and reduction of behaviors associated with the ongoing transmission of HIV.

Nearly 10 million people are released from incarceration every year in the United States—8.6 million people are transiently held in jails during criminal justice proceedings, and 597,000 are paroled from prisons after completing sentences. “The sheer magnitude of the incarcerated population and the disproportionate prevalence of HIV infection and acquired immune deficiency syndrome (AIDS) within the criminal justice system (CJS),” Springer and her colleagues write, “result in 16.9 percent of all HIV-infected individuals in the U.S. being within the CJS annually.”

An upswing in initiatives focusing on testing incarcerated individuals for HIV and linking those found to be positive for HIV to care and treatment has helped reduce AIDS-related death rates in the United States. However, Springer explains, “released prisoners infected with HIV not only continue to experience increased HIV-related mortality but have worsened HIV treatment outcomes, represented by increases in [viral loads] and decreases in CD4+ [counts].”

Not only would transitional programs that fully support continuity of care and ARV treatment benefit the people living with HIV being released from jails and prisons, but the programs would also have the potential to decrease the possibility of ongoing transmission of the virus. And while transitional programs do exist, Springer and her colleagues demonstrate, a great number of missed opportunities remain.

Take case management services, for example. These are currently the mainstay of prisoner-release programs for inmates living with HIV—but much less so for individuals held temporarily in jails while awaiting court appearances. The services aim to provide a seamless system of care, reduce recidivism, maintain overall health and avert drug use. Yet, according to the authors, it’s still not clear how much case management is required to maximize results—studies are needed to address this unanswered question. What’s more, many prisoners lose medical and social entitlements upon incarceration and are ineligible to reapply until released, often leaving a considerable gap in the provision of care until entitlements are restored.

Even under the best of circumstances, however, case management services alone appear to be insufficient, because they are often unable to effectively address the multiple complex needs that are often required to ensure successful transition after release from prison.

According to the report by Springer’s group, prisoners also face obstacles maintaining adherence to ARV therapy after release, particularly after having received compulsory medical care and adherence guidance (for example, directly observed therapy) during incarceration. After prisoners reenter the community, factors such as insufficiently treated substance use and/or psychiatric disorders, homelessness, unemployment, complicated ARV regimens and multiple health problems can lead to poor adherence of a prescribed regimen or discontinuation of therapy altogether.

Though adherence counseling strategies have been shown to change patients’ knowledge, attitudes and beliefs about medical treatment and to improve their adherence to ARV regimens, studies have not determined the best possible programs for individuals released from prisons. While continuation of directly observed therapy (DOT) has been shown to be effective among released prisoners—it’s the only adherence intervention to be explored thus far in well-designed trials—the costs of bringing DOT programs to scale may be prohibitive.

Community re-entry programs are also needed for formerly incarcerated individuals with substance abuse and mental illness disorders, as both have been independently linked to decreased ARV treatment adherence. More than 80 percent of prisoners living with HIV had substance use disorders before incarceration, Springer’s group explains. In addition, an estimated 56 percent of state prisoners, 45 percent of federal prisoners and 64 percent of local jail inmates self-report having mental illness. After release, only 46 percent to 69 percent were eventually treated.

Multiple interventions aimed at addressing these issues have been identified and may work best when used together. According to Springer’s group, multi-pronged approaches to substance use and mental illness need to be introduced during incarceration and as part of comprehensive release programs to help foster HIV treatment adherence while transitioning back into the community.

Finally, more needs to be done to identify prisoners living with HIV and to test and treat incarcerated individuals with other sexually transmitted infections (STIs). Despite the availability of rapid assays, many HIV-positive individuals continue to pass through jails without learning their HIV and other STI infection statuses because of logistical, financial and legal constraints.

In conclusion, Springer’s group notes, the many challenges facing prisoners living with HIV as they reenter the community have been identified. What’s needed now, particularly with so many public health programs beginning to focus intently on retention in care to ensure health outcomes, are efforts to overcome these obstacles in jails and prisons. “Although uniform structural approaches may overcome some barriers, effective programs will require integrated approaches and individualized treatment plans,” the authors write. “Existing community resources are insufficient to address these complex needs. Innovative solutions are urgently needed that involve partnerships between all existing stakeholders, including individual inmates, the CJS and communities, to overcome existing impediments.”

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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PrEP: Real-World Risks Need to Be Identified

Will pre-exposure prophylaxis (PrEP) have unintended public health consequences, such as increased risky sexual behavior or the transmission of drug-resistant HIV? This is a central question that will need to be carefully considered by the U.S. Food and Drug Administration (FDA) and international agencies currently faced with the task of approving, endorsing and financially supporting PrEP, which is the use of antiretrovirals (ARVs) as prevention, according to an August 16 article published online by the scientific journal Nature.

“Several studies in the past year have reported that the very drugs used to treat people with HIV can also stop healthy people from becoming infected,” Erika Check Hayden of Nature writes. “But people taking the drugs may adopt riskier behaviors because they feel protected—a phenomenon known as ‘risk disinhibition’—undermining the benefit of the drugs and potentially infecting others. Moreover, those who become infected while taking the preventive regimen might develop drug-resistant viruses that they could then transmit to others.”

These issues will likely be addressed by experts at a meeting to be convened by the Forum for Collaborative HIV Research on Friday, August 19, in Washington, DC. And as Hayden notes, the lingering public health questions are now of particular importance, in light of Gilead Sciences’ announcement in January that it plans to move forward with an FDA approval request for its fixed-dose combination tablet Truvada (tenofovir plus emtricitabine) as PrEP.

Though the FDA typically bases approval decisions on the results of clinical trials, PrEP studies completed thus far do not provide clear guidance regarding the risks of this particular prevention strategy in real-world settings, the Nature article suggests.

“Some of the successful trials found that people on PrEP actually used condoms more frequently while receiving PrEP treatment, countering the risk-disinhibition argument,” Hayden explains. “And only a few instances of drug resistance occurred, and these did not compromise patients’ treatments. But the controlled setting of a clinical trial, in which participants received intensive prevention counseling and were tested monthly for HIV, is very different from the real world.”

Questions regarding whom to treat with PrEP, particularly in many developing nations struggling to support treatment programs for those living with HIV and in need of treatment, also remain unanswered.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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Exercise Guidelines Published for People with HIV Over 50

A combination of aerobic and resistance exercises, three times a week for at least six weeks, is recommended to improve cardiovascular, metabolic and muscle function in people living with HIV older than 50 years of age, according to suggested guidelines published ahead of print by the Journal of the Association of Nurses in AIDS Care.

A great deal has been written about the potential benefits of regular exercise, particularly for older individuals living with, or at risk for, various age-related health complications. Because people living with HIV appear to face a higher risk of certain age-related problems—notably increased rates of cardiovascular disease (CVD) and various metabolic health issues at younger ages—and may also be taking numerous medications, there has been interest in utilizing drug-free lifestyle changes to improve disease-free survival.

Anella Yahiaoui, a research assistant at the University of Washington, and her colleagues set out to develop exercise recommendations for people living with HIV, based on the quantity and quality of exercise-based research that has been conducted and published.

Much of the available HIV-specific research—12 studies were included in the analysis—focused on younger individuals and primarily demonstrated positive effects of aerobic and resistance exercise on symptoms of wasting syndrome, notably muscle size and strength. Data were limited with respect to the effects of exercise on today’s most concerning age-related health complications among people living with HIV.

Yahiaoui’s team therefore included data from studies exploring the benefits of exercise in frail HIV-negative adults over the age of 65 and HIV-negative adults over the age of 55 with metabolic syndrome—a group of risk factors, similar to those seen in HIV-positive people with lipodystrophy, that occur together and increase the risk for CVD, stroke and type 2 diabetes.

Among the HIV-negative study volunteers with metabolic syndrome, exercise was independently associated with improvements in lipid levels and markers of insulin resistance, compared with matched patients who did not exercise. Among frail patients, some studies showed benefits associated with aerobic and resistance exercise, whereas others did not.

Based on the review of published data, Yahiaoui and her colleagues were able to devise a handful of key recommendations for people living with HIV over the age of 50. Aerobic exercise, for example, should be performed at least three times a week for 20 to 40 minutes, aiming for a heart rate between 50 and 90 percent of the maximum heart rate.

Resistance exercises—which includes weight lifting and calisthenics, such as pushups, pull-ups and sit-ups—should involve each major muscle group and be performed after an aerobic exercise has been completed, again at least three times a week. One or two sets of six to eight repetitions of each exercise, with 20 to 30 seconds between each set, is the recommended initial goal, eventually building up to three sets of ten repetitions of each exercise as endurance and strength improves.

Stretching, before and after exercising, is also recommended to prevent injuries.

There is, however, the possibility of too much of a good thing, the authors warn. Athletes who exercise frequently and strenuously are at an increased risk of various infections, which can potentially lead to serious health problems in people living with HIV. In turn, Yahiaoui’s group cautions, exercise should not exceed 90 minutes of strenuous activity.

“Further research is warranted to study the benefits and risks of physical exercise in older HIV-infected patients,” the authors conclude.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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Gilead 'Quad' Performed Similarly to Atripla in Phase III Study

A study of Gilead Science’s "quad" fixed-dose combination tablet containing the experimental integrase inhibitor elvitegravir and boosting agent cobicistat, along with tenofovir and emtricitabine, has met its primary objective—"non-inferiority" compared to mainstay therapy Atripla—according to an announcement by the company.

According to Gilead—full results have not yet been presented or published—88 percent of those who took the quad tablet in the study had undetectable viral loads (less than 50 copies) after 48 weeks of treatment, compared with 84 percent of those who took Atripla. The clinical trial enrolled 352 people living with HIV starting antiretroviral therapy for the first time.

CD4 increases were significantly more substantial among those receiving the quad compared to Atripla: 239 versus 206 cells, respectively.

The company claims rates of moderate-to-severe adverse events were similar between the quad-treated and Atripla-treated groups. Discontinuation rates due to adverse events were comparable in both groups of the study.

The Phase III research program for Gilead’s quad tablet includes two studies (Studies 102 and 103) evaluating the all-in-one regimen versus a standard of care among people starting HIV treatment for the first time. Like the encouraging results from Study 102, highlighted in the Gilead statement, data from a Phase II study also suggest the quad has similar efficacy to Atripla.

Study 103, still under way, is comparing the efficacy, safety and tolerability of the quad tablet, compared with Norvir (ritonavir)-boosted Reyataz (atazanavir) combined with Truvada (tenofovir plus emtricitabine).

Gilead plans to submit the results from Study 102 for presentation at a scientific conference early next year.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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New Three-in-One HIV Med Complera Approved

Complera, a complete single-tablet regimen containing Janssen Therapeutics’ Edurant (rilpivirine) and Gilead Sciences’ Viread (tenofovir) and Emtriva (emtricitabine), was approved August 10 by the U.S. Food and Drug Administration (FDA), according to an announcement by Gilead. Complera, the second all-in-one fixed-dose combination tablet for people living with HIV, is approved for those starting antiretroviral (ARV) therapy for the first time.

The approval of Complera is supported by 48-week data from two Phase III randomized studies (ECHO and THRIVE) conducted by Tibotec, a subsidiary of Janssen, evaluating the safety and efficacy of Edurant compared to Sustiva (efavirenz) among first-time treatment takers, with both drugs typically used in combination with Truvada (tenofovir plus emtricitabine). Both regimens were comparable in terms of efficacy, with fewer volunteers in the Edurant group experiencing side effects, notably the central nervous system problems associated with Sustiva use.

A bioequivalence study, conducted by Gilead, demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as Edurant plus Viread and Emtriva.

Complera is the second complete ARV treatment regimen for HIV available to first-time treatment takers in a single once-daily pill. The first, Atripla (efavirenz plus Truvada), is marketed by Gilead and Bristol-Myers Squibb and was approved by the FDA in July 2006.

Several points should be considered before initiating therapy with Complera, according to the Gilead announcement. First, people starting treatment with high viral loads (100,000 copies or higher) were more likely to experience virologic failure while using Edurant in clinical trials, compared with those taking Sustiva. Also, when treatment failed, those taking Edurant were more likely to develop resistance to the drugs in their regimen than those taking Sustiva. Finally, Complera is not recommended for patients younger than 18 years of age, nor is it recommended for patients with moderate/severe kidney problems.

Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of Complera in July 2009. Under the terms of the agreement, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of Complera in the United States, Canada, Brazil, the European Union, Australia and New Zealand. Janssen will be responsible for the commercialization of Edurant as a stand-alone drug, a non-nucleoside reverse transcriptase inhibitor, and will hold rights to co-sell Complera in these territories.

A marketing application for the fixed-dose combination tablet is currently pending in the European Union.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

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New Antiretrovirals Factory to Operate in Mozambique in 2013

Construction is underway in Mozambique on a new pharmaceutical factory that will manufacture antiretrovirals and other products, the Mozambican News Agency reported Wednesday.

The facility is set for completion early next year, with manufacturing to begin in 2013, Jose Luis Telles, head of Brazil’s Oswaldo Cruz Foundation, was quoted as saying. “The factory, which will employ 88 Mozambicans, will manufacture 20 different medicines for the treatment of a number of diseases, especially antiretroviral drugs,” Telles said.

Promoted by Brazil’s former President Luis Inacio Lula da Silva, the project has been in planning since 2003, but Brazil’s Senate only green-lighted it in 2009.

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