Category Archives: News

This coming Thursday, May 10, the United States Food and Drug Administration (FDA) will convene its Antiviral Drugs Advisory Committee at a public session in Washington D.C. to review data and public input related to the potential use of the antiretroviral drug Truvada for HIV prevention. The Committee will vote on whether or not daily oral intake of Truvada is safe and effective when used to prevent HIV infection, an approach known as pre-exposure prophylaxis (PrEP).

Relevant background materials for the session became available today, which include the FDA’s initial evaluation of research data related to Truvada’s safety and efficacy in the context of PrEP. Using the Committee’s recommendations and its own evaluation, the FDA is expected to make a final decision on approval by June 15, 2012.
If approved, PrEP will become part of the existing suite of evidence-based HIV prevention tools. Although many questions remain regarding high costs, operational challenges, accessibility and additional implications of PrEP both within and outside the United States, the FDA’s Committee will limit their assessment to Truvada’s safety and efficacy.

You can submit data, information or views concerning this meeting to the FDA Advisory Committee in written or electronic format until May 17, 2012. Click this link to learn how to make a submission. Additional links to key documents are provided below to help advocates better understand PrEP and the FDA review process.

Additional Resources: 

• MSMGF Report: Access to HIV Prevention Services and Attitudes About Emerging Strategies (PDF)
• MSMGF Statement on FDA Review of PrEP (March 21, 2011)
• AVAC’s Primer for Public Participation in the FDA Review of PrEP
• Recent Statement by US civil society groups on PrEP
• AVAC’s PrEP Watch Website

A vaccine that elicits broadly neutralizing antibodies (bNAbs) to HIV has long seemed at least as elusive as the Holy Grail. But as more and more such antibodies are isolated from HIV-infected volunteers—revealing rare vulnerabilities on HIV—researchers are increasingly hopeful of coaxing that coveted humoral response.

Some 400 attendees at the Keystone Symposia, which paired the annual HIV Vaccines meeting with the Viral Immunity and Host Gene Influence meeting, got an update on the quest to make such vaccines. A number of talks at the conference, held March 21-26, illuminated how structural and computational biology are being applied to reverse-engineer immunogens that might induce bNAbs. Others described how next-generation DNA sequencing technologies are unraveling the genetic origins and evolution of those antibodies.

CLICK HERE to read the full article.

As the global campaign against AIDS enters its fourth decade, the development of a broadly preventive HIV vaccine remains among its most vexing challenges.

In his opening remarks at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), held March 5-8 in Seattle, Tufts University virologist John Coffin, the scientific organizer of the event, noted that the failure of previous vaccine candidates had convinced many scientists that antibodies capable of preventing HIV infection could not be elicited through vaccination.

But the 31.2% efficacy demonstrated in the RV144 vaccine trial in Thailand—which, though modest, provided the first evidence of vaccine-induced protection from HIV—has helped lift the gloom from such speculations. Volunteers in that trial who received the prime-boost vaccine combination developed low titers of gp120-binding antibodies that subsequent analyses revealed are correlated with the risk of HIV infection. Separately, a dramatic expansion in the number of broadly neutralizing antibodies (bNAbs) against HIV isolated from volunteers, and the data describing their mechanisms of action, have renewed optimism about the prospects of this vaccine strategy.

“We’re now thinking much more seriously about developing vaccines that might be based on eliciting specific antibodies,” Coffin told the international gathering of more than 4,200 HIV researchers and clinicians.

Reflecting this shift in strategy, CROI organizers selected pioneering antibody researcher Dennis Burton, professor of immunology and microbial science and director of IAVI’s Neutralizing Antibody Center (NAC) at The Scripps Research Institute in La Jolla, California, to kick off the conference. Burton observed that the recent discovery of more than two dozen potent bNAbs by his lab and others, and the elucidation of some of their structural targets on HIV’s Envelope glycoprotein, have revealed weaknesses that can be exploited for both drug and vaccine development. “The tools are all there,” said Burton. “It remains to be seen if immunogen design can take advantage of all these tools.”

But antibodies were far from the only item on CROI’s four-day agenda. The conference also highlighted investigations of the structure of HIV’s Envelope trimer and updates on the continuing analysis of samples collected in the RV144 trial. Other talks of particular interest covered new findings on how a subset of T cells influences antibody development, the evolutionary pathways of HIV and SIV, and the results of several recent studies on ARV-based prevention, which dominated the conference and provoked more than a few animated discussions.

CLICK HERE to read the full article at www.iavireport.org

Through the Department of Public Health, Substance Abuse and Prevention Control division, The Wall-Las Memorias Project (TWLMP) is doing is conducting a study on the accessibility, availably and social norms of alcohol and other substance abuse in Southeast Los Angeles which includes the cities of Huntington Park, Bell Gardens, South Gate, Maywood, Bell, and Cudahy.

In an effort to gather comprehensive data TWLMP will be conducting focus groups for young adults, ages 18-24 who are LGBTQ. Would it be possible to open up an invitation to any community groups/members that you may know in your community whether they be 18 year olds who are in high school or 18-24 year olds who are in college or working?

In appreciation of participants time a $20 gift card to Target will be given to each participant, light snacks and refreshments will be provided as well. The focus group will be recorded (with participant consent) and notes will be taken to make sure we capture the most accurate information. We will conduct the focus group at a convenient location in the community unless you have a location in mind that we can utilize.

I appreciate your time and hope to hear from you soon.

Please feel free to contact me at your earliest convenience regarding this request @ (323) 257-1056 ex.23 or lvelasquez@thewalllasmemorias.org

UNITED STATES:   “FDA Panel Considers HIV Drug for New Use”
Wall Street Journal     (05.06.12):: Jennifer Corbett Dooren

On Thursday, a Food and Drug Administration advisory panel will consider whether to recommend that FDA approve the first drug for high-risk but healthy people to take to prevent HIV infection. Truvada, made by Gilead Sciences Inc., is already one of the most widely used drugs to treat HIV infection. Gilead has submitted data from two large clinical trials to support marketing Truvada as pre-exposure prophylaxis (PrEP).

Gilead submitted one study involving about 2,500 at-risk gay and bisexual men that found the drug, in addition to other prevention measures like condom use, reduced their HIV infection risk by 44 percent. In another involving about 4,800 serodiscordant heterosexual couples, HIV infection risk was cut 73 percent among HIV-negative partners taking Truvada, interim data showed. But a study among some 2,000 women was stopped last year after it was determined it was unlikely to show whether Truvada helped prevent infection among them.

The AIDS Healthcare Foundation filed a petition in March urging FDA to reject the application, saying PrEP data are not strong enough. AHF also cited worries over side-effects, the drug’s $14,000-a-year cost, and adherence problems. However, the prevention advocacy group AVAC is among 14 organizations calling for FDA’s approval.

Dr. Rodney Wright, AHF’s board chair, said he is concerned about “a blanket approval” of Truvada for PrEP and the lack of data for it among women. Wright and other physicians already prescribe Truvada as PrEP on a limited basis, including for serodiscordant couples wishing to have children. CDC last year released interim PrEP guidelines for certain men who have sex with men, and it is weighing similar guidance for heterosexuals.

“PrEP will be the most beneficial for people at very high risk of HIV infection,” but strict adherence to the daily regimen is essential, said Jonathan Mermin, director of CDC’s Division of HIV/AIDS Prevention.

HAVANA — Yudelsy García O’Connor, the first baby known to have been born with AIDS in Cuba, is not merely still alive. She is vibrant, funny and, at age 25, recently divorced but hoping to remarry and have children.

Her father died of AIDS when she was 10, her mother when she was 23. She was near death herself in her youth.

“I’m not afraid of death,” she said. “I know it could knock on my door. It comes for everyone. But I take my medicine.”

Ms. García is alive thanks partly to lucky genes, and partly to the intensity with which Cuba has attacked its AIDS epidemic. Whatever debate may linger about the government’s harsh early tactics — until 1993, everyone who tested positive for H.I.V. was forced into quarantine — there is no question that they succeeded.

Cuba now has one of the world’s smallest epidemics, a mere 14,038 cases. Its infection rate is 0.1 percent, on par with Finland, Singapore and Kazakhstan. That is one-sixth the rate of the United States, one-twentieth of nearby Haiti.

The population of Cuba is only slightly larger than that of New York City. In the three decades of the global AIDS epidemic, 78,763 New Yorkers have died of AIDS. Only 2,364 Cubans have.

Other elements have contributed to Cuba’s success…..

CLICK HERE to read the full article on nytimes.com

This CAB will advise the Los Angeles County Division of HIV and STD Programs and the PATH Study Investigators on the delivery of services for HIV/AIDS prevention, care and treatment.

PrEP stands for pre-exposure prophylaxis. PrEP is an HIV prevention strategy of administering anti-retroviral medications to uninfected, at-risk individuals. TLC+ stands for Testing and Linkage to Care Plus Treatment. TLC+ is a framework for integrating HIV testing, care and treatment, social services and prevention-with-positives activities in provider settings or in health jurisdictions.

They are seeking a diverse CAB membership and encourage applications from individuals who have life or professional experience relevant to HIV counseling and testing, linkage to HIV medical care, re-engagement or retention in HIV/AIDS medical care, behavioral prevention, and biomedical prevention.

Applications are due by June 1, 2012.

The Division of HIV/AIDS Prevention (DHAP) recently released its inaugural annual report, Accelerating Progress, Investing for Impact. This report provides an overview of some of the HIV prevention activities conducted and supported by the Centers for Disease Control and Prevention (CDC) during late 2010 to the end of 2011.

Download PDF: [Download not found]

CALIFORNIA:   “Trying Out Free, and Anonymous, Tests for STDs”
San Francisco Chronicle     (04.28.12):: Erin Allday

On April 17, a pilot project began that allows women ages 18-30 in four Bay Area counties to test themselves at home for certain STDs free of charge. Through the website www.iknowsfbay.org, women can order test kits for chlamydia, gonorrhea, and trichomoniasis. The kits, delivered in plain white envelopes, contain a cotton swab, collection container, and instructions on taking a sample.

A few days after sending the sample to Johns Hopkins University (JHU) for analysis, the women will receive a text or e-mail notice saying their results are available online. Those testing positive will be able to get an online prescription for treatment, which they can have filled at the pharmacy of their choice. They also may be advised to seek additional testing for HIV or other STDs. The entire process should take 10-14 days.

Working with the research group RTI International, Alameda, Contra Costa, San Francisco, and San Mateo counties plan to sign up 400 women before stopping enrollment to analyze results. Each county will evaluate the data, with health officials focusing on feasibility, demand, and cost-effectiveness.

Similar efforts are underway in Baltimore and Los Angeles. Ten percent of 400 test kits received in Baltimore showed positive results for chlamydia, a JHU study found, and 95 percent of the infected women sought treatment.

To read the UNICEF statement, click here.

NEW YORK, 24 April 2012

 Over the past 20 years, adolescents have benefitted from progress in education and public health. Yet the needs of many adolescents are neglected with more than 1 million losing their lives each year and tens of millions more missing out on education, says a new UNICEF report today.

The report, for example, identifies sub-Saharan Africa as the most challenging place for an adolescent to live. The adolescent population of the region is still growing, and it is projected to have the greatest number of adolescents in the world by 2050. But only half the children in sub-Saharan Africa complete primary school and youth employment is low.

Progress for Children: A report card on adolescents highlights other alarming consequences of the benefits of progress not being equally shared among the total of 1.2 billion adolescents – defined by the United Nations as between the ages of 10 and 19 – now living in all the regions of the world.

“The disadvantages of poverty, social status, gender or disability prevent millions of adolescents from realizing their rights to quality education, health care, protection and participation,” said UNICEF Deputy Executive Director Geeta Rao Gupta. “This comprehensive report card strengthens our understanding of the problems facing the poorest and most disadvantaged adolescents. It is time to attend to their needs; they must not be left behind.”

The report points to a significant need for improved investment in all aspects of adolescents’ lives and wellbeing – even in their struggle for survival. Each year 1.4 million adolescents die from road traffic injuries, childbirth complications, suicide, AIDS, violence and other causes. In some Latin American countries, more adolescent boys die as a result of homicide than from road traffic injuries or suicide.  In Africa, complications in pregnancy and childbirth are the top cause of death for girls aged 15 to 19.

Children entering adolescence are increasingly at risk of violence – a shift from early childhood when disease and nutrition are the major threats. Adolescent girls are particularly vulnerable to violence in marriage. In a survey in the Democratic Republic of Congo, 70 per cent of girls aged 15 to 19 who had been married said they experienced violence at the hands of a current or former partner or spouse.

Adolescents, particularly girls, are often forced to abandon childhood and take on adult roles before they are ready, limiting their opportunities to learn and grown, and placing their health and safety at risk. The report says that over a third of women aged 20 to 24 in developing countries excluding China were married or in a union by the age of 18 with about one third of these being married by age 15.

Adolescent birth rates are relatively high in Latin America, the Caribbean and sub-Saharan Africa, the report says. In Niger, half of young women aged 20 to 24 gave birth before the age of 18.

Globally, 90 per cent of children of primary school age are enrolled in primary schools and secondary education systems have expanded in many countries. Secondary school enrolment however remains low in the developing world, especially in Africa and Asia. Many pupils of secondary school age are in primary schools. Sub-Saharan Africa has the worst secondary education indicators of any region.

Some 71 million children of lower secondary school age worldwide are not in school and 127 million youth between 15 and 24 are illiterate – the vast majority in South Asia and sub-Saharan Africa.

The report says significant efforts in advocacy, programmes and policy are needed to realize the rights of all adolescents. Adolescence is a critical stage of childhood at which the right investment can break the poverty cycle and result in social, economic and political benefits for adolescents, communities and nations.

But the report also notes that adolescents should be recognized as real agents of change in their communities. Programmes and policies, while protecting adolescents as children, must acknowledge their capacity for creativity, innovation and energy to solve their problems.

Full Report: Progress for Children: A report card on adolescents [PDF]