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Roadmap for speedy development of HIV vaccine announced

As scientific discoveries lead to promising new approaches to HIV vaccine development, and with several large-scale vaccine efficacy studies underway, a new strategy takes a fresh look at the major challenges confronting the HIV vaccine paradigm.

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The Global HIV Vaccine Enterprise, hosted by the International AIDS Society (IAS), launched a five-year strategy to accelerate the development of an effective vaccine to prevent HIV infection. The new Global HIV Vaccine Enterprise Strategic Plan (2018-2023) was unveiled at the opening of HIV Research for Prevention (HIVR4P 2018), the world’s only scientific conference dedicated exclusively to biomedical HIV prevention, in Madrid, Spain.

“This strategy presents an opportunity to address some of the most significant challenges in HIV vaccine development today,” IAS President Anton Pozniak said.

The new strategy evaluates current opportunities, challenges and obstacles in HIV vaccine research and development and recommends a series of steps to:

  • Propel the vaccine pipeline by strengthening strategies to align, amplify and accelerate development of candidate vaccines
  • Prepare for success by tackling priorities essential to clarifying the roadmap for future access to a vaccine
  • Expand resources and engagement by enlisting a diverse community of partners to support and contribute to the field.

The new strategic plan was developed through an IAS-led consultation involving HIV vaccine research and funding stakeholders, the Enterprise Strategic Advisory Group and the IAS Governing Council. The plan advances the ongoing partnership between the IAS, the world’s largest association of HIV professionals, and the Global HIV Vaccine Enterprise, which promotes coordination, collaboration and resource mobilization to accelerate HIV vaccine development.

“While the HIV vaccine landscape offers greater scientific promise than ever before, the field also faces real challenges in terms of aligning scientific priorities, developing the smartest and most effective research studies, maintaining funding and engaging and maximizing the contributions of all global stakeholders in the search for a vaccine,” Pozniak added.

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“The new strategy builds on more than a decade of work by the Global HIV Vaccine Enterprise to identify critical gaps in systems and knowledge, promote collaboration and address one of the greatest scientific challenges of our time.”

As scientific discoveries lead to promising new approaches to HIV vaccine development, and with several large-scale vaccine efficacy studies underway, the new strategy takes a fresh look at the major challenges confronting the HIV vaccine paradigm. Among these are:

  • The increasing complexity of conducting vaccine efficacy trials as more biomedical HIV prevention options become available
  • The need to address critical gaps in scientific knowledge about immune responses to HIV
  • Stagnant funding and the need to increase government and industry commitment and investment to meet emerging vaccine research opportunities
  • Uncertainty about regulatory and access pathways for a successful vaccine.

To address these challenges and others, the IAS/Enterprise plan proposes a series of near-term activities to address critical, of-the-moment challenges, along with longer-term goals and guideposts to measure achievements and guide adjustments in the strategy as the field evolves. The plan’s activities will be sequenced strategically and guided by annual implementation plans – with detailed activities, timelines and deliverables.

“This plan captures the promise and challenges of a unique and exciting moment in HIV vaccine development and offers a roadmap for action to bring us closer to the end of this epidemic,” President of the South African Research Council Glenda Grey said.

“With the support, expertise and convening power of IAS, this new strategic plan will build on the Enterprise’s longstanding role as a both a neutral convener and facilitator of collaboration in the HIV vaccine field and propel realizing our shared vision to develop a safe, effective and globally available HIV vaccine.”

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Women with HIV at increased risk of early onset menopause

Study researchers confirmed that women living with HIV experience menopause at a younger age, specifically 48 years, roughly three years earlier than uninfected women. This population additionally had higher rates of early menopause and premature menopause.

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Thanks to medical advancements, HIV-positive women now have a longer life expectancy, exposing them to numerous midlife health issues such as menopause. A new study demonstrates that women with HIV are more likely to enter the menopause transition at an average age of 48 years, 3 years younger than the general population. Study results are published online today in Menopause, the journal of The North American Menopause Society (NAMS).

Newly diagnosed HIV-positive patients who adhere to the latest therapy protocols are expected to live into their mid-70s or longer. That means these patients are now faced with aging issues that affect sexual and reproductive health, including menopause.

The average age of menopause in Canada and the United States is between 50 and 52 years. Previous studies have shown that women living with HIV are at an increased risk of early (age between 40 and 45 y) and premature (age <40 y) menopause (also known as primary ovarian insufficiency). However, this study from Canada is the first known study to determine the average age of menopause for HIV patients, the prevalence of early menopause (between 40 and 45 y) and premature menopause (before 40 y), and other correlates influencing age at menopause.

Study researchers confirmed that women living with HIV experience menopause at a younger age, specifically 48 years, roughly three years earlier than uninfected women. This population additionally had higher rates of early menopause and premature menopause. In addition, lower education and hepatitis C coinfections were also shown to influence the risk of early menopause, with other possible modifying factors including marital status and region of birth.

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Because menopause is associated with changes in mood, sexual function, reduced quality of life, and increased the risk of developing other comorbidities such as heart disease and osteoporosis, a woman’s increased risk of early menopause has implications for healthcare practitioners planning their care.

Study results appear in the article “Prevalence and correlates of early-onset menopause among women living with HIV in Canada.”

“Healthcare practitioners should be aware of the increased risk for premature and early menopause in their female patients living with HIV in order to provide appropriate counseling and management, given the known increased risk for potential adverse long-term health consequences associated with early estrogen deprivation,” says Dr. Stephanie Faubion, NAMS medical director.

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Virus characteristics predict HIV treatment efficacy with antibody treatment

HIV-1 virus characteristics were identified to predict treatment efficacy with a specific antibody treatment using sequence-based methods. The identified virus characteristics may be used to determine if a patient is a good or poor candidate for specific antibody-based treatments in the future, reducing time and cost involved in treating the virus.

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Current HIV-1 therapies have been proven to be highly effective in slowing the progression of the virus in the body with only minimal side effects. The daily antiretroviral therapy (ART) uses a combination of HIV-1 medicines. A proportion of patients diagnosed with HIV-1, however, cannot take the ART for many reasons. An alternative option includes antibody-based treatments that are currently being developed; however it is difficult to predict those that would be most appropriate for these more expensive treatments.

Now published in the Journal of Virology, research at Boston Medical Center (BMC) discovered specific virus characteristics that can help predict the efficacy of HIV-1 treatments using antibody-based treatments.

Led by Manish Sagar, MD, an infectious diseases physician at BMC, HIV-1 virus characteristics were identified to predict treatment efficacy with a specific antibody treatment using sequence-based methods. The identified virus characteristics may be used to determine if a patient is a good or poor candidate for specific antibody-based treatments in the future, reducing time and cost involved in treating the virus.

Antibody treatments bind the HIV-1 envelope protein that protects the virus and helps it avoid the immune system response. These envelope proteins also have extensive DNA sequence variation that provides virus information and whether a treatment would be effective or not. It is difficult to predict if an antibody-based therapy will be effective based on knowing the envelope sequence alone, so sequence information is commonly obtained before patients are started on HIV-1 treatments to confirm that their virus will be susceptible to the prescribed therapies.

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In the study, HIV-1 envelope sequence motifs were identified that predict treatment efficacy with a certain type of antibody treatment.

“These findings will allow physicians to make better-informed decisions on treatment plans for patients with HIV-1, ultimately treating the virus to slow it down earlier, ” says Sagar, also an associate professor of medicine and microbiology at Boston University School of Medicine. “Making this process more efficient will only improve patient care, while reducing the time and money spent on finding the right treatment for these patients.”

Antibody-based therapies that require less frequent doping are effective against drug-resistant variants, and may strengthen humoral responses, essential for defense against bacterial pathogens.

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Determinants of employability of people living with HIV

We knew this all along: People living with HIV may face discrimination in employers’ hiring practices, according to a study that specifically found that medical and socioeconomic factors may hinder their employment.

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A newer study backing what we knew all along: HIV-related discrimination.

People living with HIV may face discrimination in employers’ hiring practices, according to a study published in the American Journal of Industrial Medicine, which specifically found that medical and socioeconomic factors may hinder their employment.

This particular study included 170 people living with HIV in Turkey. It found that younger persons with HIV had a much higher probability of participation in the labor force, as did those who were wealthier and generated a higher income. Also, individuals who were working at the time of diagnosis were more likely to be employed. Illicit drug use, a longer time since diagnosis, and low CD4 T cells counts were negatively associated with employment.

“We can easily control HIV virus with anti-retroviral medication, but it is almost impossible to control socioeconomic factors such as the stigma and the prejudices, which are fueled by ignorance and the lack of awareness campaigns,” said the study’s author Durmu Özdemir, PhD, a professor at Yasar University. “There is a serious role for governments and non-governmental organizations to explain the positive impact of anti-retroviral treatment and the need for a normal life for people living with HIV.”

Earlier, in 2014, the UNAIDS (Joint United Nations Programme on HIV/AIDS) reported that on average, one in eight PLHIV report being denied health services, and one in nine is denied employment because of their HIV-positive status. Also, an average of 6% reported experiencing physical assault because of their HIV status. People living with HIV who are members of key populations also face “double stigma” since they get discriminated not only because of their HIV status, but also because of their sexual orientation and gender identity, drug use or engagement in sex work.

READ:  UNAIDS, UNDP call on 48 countries and territories to remove all HIV-related travel restrictions

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New HIV strain recorded under same group that caused pandemic

The discovery marks the first time a new subtype of HIV-1 has been identified since 2000. To stress, though: Existing treatments for HIV are effective against variants of the HIV virus, including the new subtype.

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A team of its scientists identified a new subtype of the human immunodeficiency virus (HIV), called HIV-1 Group M, subtype L. This marks the first time a new subtype of “Group M” HIV virus has been identified since guidelines for classifying new strains of HIV were established in 2000.

Group M viruses are responsible for the global pandemic, which can be traced back to the Democratic Republic of Congo (DRC) in Sub-Saharan Africa.

The findings of the study – titled “Complete genome sequence of CG-0018a-01 establishes HIV-1 subtype L” – was published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS).

“In an increasingly connected world, we can no longer think of viruses being contained to one location,” said Carole McArthur, Ph.D., M.D., professor in the departments of oral and craniofacial sciences, University of Missouri — Kansas City, and one of the study’s authors. “This discovery reminds us that to end the HIV pandemic, we must continue to outthink this continuously changing virus and use the latest advancements in technology and resources to monitor its evolution.”

Since the beginning of the global AIDS pandemic, 75 million people have been infected with HIV and 37.9 million people today are living with the virus.

To determine if a virus is in fact a new HIV subtype, three cases must be discovered independently. In this case, the first two samples of this subtype were discovered in DRC in the 1980s and the 1990s. The third, collected in 2001, was difficult to sequence at that time because of the amount of virus in the sample and the existing technology.

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With next-generation sequencing technology now available, researchers can build an entire genome at higher speeds and lower costs. In order to utilize this technology, Abbott scientists had to develop and apply new techniques to help narrow in on the virus portion of the sample to fully sequence and complete the genome.

“Identifying new viruses such as this one is like searching for a needle in a haystack,” said Mary Rodgers, Ph.D., a principal scientist and head of the Global Viral Surveillance Program, Diagnostics, Abbott, and also a co-author of the study. “By advancing our techniques and using next generation sequencing technology, we are pulling the needle out with a magnet. This scientific discovery can help us ensure we are stopping new pandemics in their tracks.”

Now this is worth stressing: Existing treatments for HIV that can suppress viral load so that people living with HIV can no longer transmit it, are effective against variants of the HIV virus, including the new subtype. This means – again to emphasize – that a new strain is not a new public health crisis. With the identification of the strain, though, doctors can now test for it.

Abbott created its Global Viral Surveillance Program 25 years ago to monitor HIV and hepatitis viruses and identify mutations to ensure the company’s diagnostic tests remain up to date. In partnership with blood centers, hospitals and academic institutions around the world, Abbott has collected more than 78,000 samples containing HIV and hepatitis viruses from 45 countries, identified and characterized more than 5,000 strains, and published 125 research papers to date to help the scientific community learn more about these viruses. 

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12% of new HIV cases in Phl in July are people who engaged in transactional sex

In total, in July, there were 1,111 newly confirmed HIV-positive individuals reported to the HIV/AIDS & ART Registry of the Philippines. This was 29% higher compared with the diagnosed cases (859) in the same period last year.

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Twelve percent (134 of 1,111) of the new HIV cases reported to the HIV/AIDS & ART Registry of the Philippines (HARP) in July engaged in transactional sex, highlighting the behavior as a driver in the still-continuing worsening HIV situation in the country.

The percentage of the newly infected who engaged in transactional sex is similar to June’s figures (also 12%, or 123 of 1,006). Even earlier, in May, it was higher at 13% (or 144 of 1,092).

For July, 94% (126) of those who engaged in transactional sex were male and aged from 15 to 58 years old (median: 29 years). Forty-eight percent (61) of the males reported paying for sex only, 37% (46) reported accepting payment for sex only, and 15% (19) engaged in both.

Also, among the eight female cases who engaged in transactional sex, 88% (7) were reported to have accepted payment for sex only; while one female reported paying and accepting payment for sex.

Surprisingly, reporting of transactional sex was included in the HARP only in December 2012. HARP identifies people who engage in transactional sex as those who reported that they either pay for sex, regularly accept payment for sex, or do both.

This is not the only population gravely affected by HIV in the Philippines.

For one, the number of diagnosed HIV infections among females has been increasing. The number of diagnosed (402) females from January to July 2019 tripled, compared to the diagnosed (131) cases in the same period of 2014, five years prior. Ninety-two percent (4,012) of all female cases since 1984 were in the reproductive age group (15-49 years old) at the time of diagnosis.

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As FYI: In the early years of the HIV epidemic in the Philippines (1984-1990), 62% (133 of 216 cases) of the diagnosed were female. But since 1991, the proportion of diagnosed males has been greater than that of females each year. From 1991 to present, males comprised 94% (65,079) of the 69,296 diagnosed cases. Also,from January 2018 to July 2019, 3% (551) of 17,909 diagnosed people are transgender women.

Second, HIV continues to greatly impact young Filipinos.

As per HARP: “The predominant age group among those diagnosed has shifted to 25-34 years old starting 2006 from 35-49 years old in 2001 to 2005.” But “the proportion of HIV positive cases in the 15-24 year age group nearly doubled in the past 10 years, from 17% in 2000 to 2009 to 29% in 2010 to 2019.”

In July, there were 59 newly diagnosed adolescents, 10-19 years old at the time of diagnosis. Further, one case was 10-14 years old, 15 cases were 15-17 years old, and 43 cases were 18-19 years old. All were infected through sexual contact (eight male-female sex, 37 male-male sex, and 14 had sex with both males and females).

There were two diagnosed cases less than 10 years old and both were infected through vertical (nee mother-to-child) transmission.

Also in July, 348 (31%) cases were among youth 15-24 years old; 95% were male. All were infected through sexual contact (34 male-female sex, 233 male-male sex, 81 sex with both males and females).

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Third, 82 Filipinos who worked overseas within the past five years, whether on land or at sea, were diagnosed in July. They comprised 7% of the total newly diagnosed cases for the month. Of these, 90% (74) were male. All were infected through sexual contact (15 male-female sex, 39 male-male sex, and 28 sex with both males and females).

Fourth, in July, 10 pregnant women were diagnosed with HIV. Six cases were from NCR and one case each from Regions 1, 4A, 7 and 11. The age of diagnosis ranged from 16 to 39.

Reporting of pregnancy status at the time of testing was also only added recently, from the year 2011. And since 2011, a total of 333 diagnosed pregnant women were reported. More than half (54%, 180) were 15-24 years old at the time of diagnosis, and 38% (127) were 25-34 years old.

HIV can be managed via taking of antiretroviral medicines. But to date, only approximately half of the total 69,512 Filipinos living with HIV are on ART.

So perhaps not surprisingly, in July2019, there were 55 reported deaths due to any cause among people with HIV. Ninety-eight percent (54) were males. Two (4%) were less than 15 years old at the time of death, six (11%) cases were 15-24 years old, 30 (54%) were 25-34 years old, and 17 (31%) were 35-49 years old. Ninety-two percent of these cases were reported to have acquired the infection through sexual contact.

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Severe anti-LGBT legislations associated with lower testing and awareness of HIV

A meta-analysis involving 44,993 men who have sex with men finds that anti-LGBT legislation is associated with lower HIV testing and awareness.

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A meta-analysis involving 44,993 men who have sex with men finds that anti-LGBT legislation is associated with lower HIV testing and awareness.

This first systematic review to investigate HIV testing, treatment and viral suppression in men who have sex with men in Africa finds that among the most recent studies (conducted after 2011) only half of men have been tested for HIV in the past 12 months. In addition, only a quarter of men living with HIV were on antiretroviral therapy or virally suppressed.

The analysis, published in The Lancet HIV journal, found that testing for HIV was higher where there was more protective and progressive legislation and fewer or no LGBT-related arrests.

Although rates of testing are substantially higher than before 2011, they are not sufficient to achieve the targets set by the UN (to have 90% of people living with HIV aware of their status, 90% of those aware also on antiretroviral therapy, and 90% of these achieving viral suppression by 2020). The findings support previous country-level studies suggesting an association between anti-LGBT legislation and access to testing and treatment.

Globally, men who have sex with men are about 28 times more likely to be living with HIV than are men in the general population, and this is particularly apparent in sub-Saharan Africa where human rights of these men are often violated. Anti-LGBT discrimination creates barriers to implementing effective HIV research, policy and health programs along with disruption of services provided by community and non-governmental organizations.

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Professor Marie-Claude Boily of Imperial College London, UK says: “Nearly one million people living with HIV still die annually because they cannot or do not get tested and engage in treatment. Our results suggest that despite improvements in recent years in Africa, engagement in HIV testing and treatment among men who have sex with men is still low, and additional efforts are urgently needed. With an estimated 67% of men who have sex with men in Africa surveyed after 2011 having ever tested for HIV, we are still a long way off achieving the UNAIDS 90-90-90 targets.”

The review used 75 independent studies conducted between 2004 and 2017 from 28 African countries to estimate HIV testing, status awareness, engagement in care, antiretroviral therapy use, and viral suppression in the men.

Over all studies conducted after 2011, the estimated proportion of participants ever tested for HIV was 67%, which was 1.3 times higher than before 2011, and was highest in southern Africa (80%) and lowest in northern Africa (34 %). In comparison, the proportion of men tested in the last 12 months was 50% in studies after 2011, which was 1.6 times higher than before 2011, and again was highest in southern but lowest in eastern Africa (67% vs 40%).

The proportion of men who have sex with men who are HIV positive and aware of their status was much lower at just 19%, and was particularly low in eastern Africa even after 2011 (9%). Overall, less than 24% of men living with HIV were currently on antiretroviral therapy, and an estimated 25% of men living with HIV were currently virally suppressed. It was not possible to look at changes over time as there was not enough data in the studies on these outcomes.

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Levels of HIV testing ever, in the past 12 months, and HIV status awareness were lower in countries with the most severe anti-LGBT legislation, compared with countries with the least severe legislation. Men were more likely to have ever been tested for HIV in countries with more protective and progressive legislation and no LGBT-related arrests from 2014-17.

The authors note some limitations, including that there were no studies in 26 African countries, including 13 countries where same-sex relations are illegal, so the new findings may not apply to the entire African continent and results may be worse in countries with more severe anti-LGBT legislation. Despite a substantial increase in the number of studies on testing for HIV, treatment and viral suppression, data remains scarce for all outcomes except HIV testing, especially from central and northern Africa. This means the study may underestimate or overestimate engagement, especially for antiretroviral therapy use and viral suppression. The authors note that this reflects the challenges of doing research among key populations that face substantial stigma.

The anti-LGBT legislation index used in the study only includes information about legislation, not how it is implemented so may not have captured the full picture. Because most of the studies included were self-reported and used non-confidential interview methods, underreporting and reporting biases are possible.

In a linked Comment article, Dr Jean Joel Bigna of the Centre Pasteur of Cameroon, Yaoundé, Cameroon, says: “Stannah and colleagues have provided important updates on the current situation regarding the HIV care cascade among men who have sex with men in Africa, and highlight areas where urgent action is needed. Governments in Africa should develop comprehensive programs and holistic interventions to provide care, support, and preventive services for this hard-to-reach stigmatized and discriminated vulnerable population. Community mobilization, health-care worker education to decrease stigma and discrimination and engagement remain crucial to end the HIV/AIDS pandemic both globally and at its epicenter in Africa. Human rights are universal and sexual orientation is no grounds for exclusion.”

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