Initial data from a large NIH-supported clinical trial offer a detailed look at the health status of people aging with HIV around the world. With 7,770 participants enrolled in 12 countries across five continents, the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE ) is evaluating the ability of a statin medication, pitavastatin, to reduce the risk of heart disease among people with HIV. By leveraging data collected from this diverse group of study participants, researchers also are learning more about the long-term health effects of HIV. They report their initial findings in an August supplement for The Journal of Infectious Diseases.
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For women, accelerated reproductive aging—a natural process that eventually leads to menopause—may heighten risk for heart disease and stroke. Among women with HIV in the REPRIEVE study, more advanced reproductive age was associated with two risk factors for cardiovascular disease: high waist circumference and high blood levels of hemoglobin. Women living in sub-Saharan Africa or Latin America and the Caribbean were more likely to experience accelerated reproductive aging than those living in high-income countries.
The initial REPRIEVE findings also provide insight into the relationship between HIV and heart disease among transgender people, about which little is known. Transgender people are disproportionately affected by HIV, and studies have suggested that hormone use as part of gender-affirming therapy may increase cardiovascular disease risk. By collecting data on gender identity and use of gender-affirming therapy, the REPRIEVE investigators aim to address this knowledge gap. Notably, their initial analysis revealed that high waist circumference was more common among transgender women, particularly those who were receiving gender-affirming therapy.
Highlights from the Ryan White Clinical Conference on HIV.gov…
The promise of long-acting injectable formulations of HIV medications to maintain viral load suppression is closer to reality, according to Constance A. Benson, MD, Professor of Medicine and Global Public Health at University of California San Diego. She shared her assessment during a session at the 2020 Ryan White HIV/AIDS Program Clinical Conference, held online earlier this month for over 600 physicians, nurse practitioners, physician assistants, and other key clinical decision makers in HRSA’s Ryan White HIV/AIDS Program-funded clinics and programs.
Bruce W. Furness, M.D., M.P.H., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues developed and evaluated a quality improvement initiative (Transforming Primary Care for LGBT People) to enhance the capacity of 10 federally qualified health centers (FQHCs; 123 clinical sites in nine states) to provide culturally affirming care.
The researchers found that FQHCs reported increases in culturally affirming practices, including collecting patient pronoun information (42.9 percent increase) and identifying LGBT patient liaisons (300.0 percent increase). Based on sexual orientation and gender identity (SOGI) from electronic health records among nine FQHCs, SOGI documentation increased from 13.5 to 50.8 percent of patients. Screening of LGBT patients increased from 22.3 to 34.6 percent for syphilis, from 25.3 to 44.1 percent for chlamydia and gonorrhea, and from 14.8 to 30.5 percent for HIV among the eight FQHCs reporting the number of LGBT patients.
“FQHCs participating in this initiative reported improved capacity to provide culturally affirming care and targeted screening for LGBT patients,” the authors write.
[On July 2, 2020], the U.S. Food and Drug Administration approved Rukobia (fostemsavir), a new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.
“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” said Jeff Murray, M.D., deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection—helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives.”
As COVID-19 cases continue to rise, it is a sobering moment to recognize and take stock of another epidemic that we have been battling for nearly four decades. The first HIV Testing Day was 25 years ago and emphasized the opportunity for individuals to take control of their health by getting tested for HIV. It has become an annual reminder that the HIV epidemic is still with us. This year the SARS-CoV-2 pandemic threatens the ability of those with undiagnosed HIV and those with other serious conditions to take control of their health.
As an infectious disease physician specializing in HIV, I worry about the many individuals who do not have easy access to HIV testing now because testing venues have been shut down by the pandemic. Already too many of my patients do not discover they have HIV until they are ill with advanced disease or AIDS. In Georgia, the state with the highest rate of new cases in the U.S., nearly one-quarter of patients are diagnosed with AIDS within one year of being diagnosed with HIV.
This means they have been living, undiagnosed, with the virus for up to 10 years and have been unable to benefit from the HIV treatment that could have kept them healthy and prevented transmission to others. This is tragic given that a strong public health system with widespread testing could prevent death.
Vaginal swab samples collected by patients performed similarly to lab-based molecular diagnostics for chlamydia and gonorrhea testing, therefore supporting the use of a new 30-minute point-of-case assay, according to findings published in JAMA Network Open.
Barbara Van Der Pol, PhD, MPH
“The new binx io CT/NG assay can facilitate a complete paradigm shift in how we offer testing for the two most commonly reported notifiable diseases in the United States — chlamydia and gonorrhea,” Barbara Van Der Pol, PhD, MPH, professor of medicine and public health at the University of Alabama at Birmingham and president of the American STD Association, told Healio. “Rates of infection with chlamydia and gonorrhea continue to rise, suggesting the need for additional tools in order to effectively reduce the burden of disease. Providers can now identify and treat infections (that are predominately asymptomatic) during a single office visit to prevent transmission and development of sequelea.”
[…] “Sample-first collection by clients seeking sexual health care (or who are eligible for routine screening according to the CDC guidelines) immediately upon arrival at the clinic can enable rapid, accurate results that allow the provider to offer both accurate treatment and appropriate counseling,” Van Der Pol said. “This is the first truly rapid molecular assay for chlamydia and gonorrhea. It is a breakthrough development.”
Among the principal reasons for recommending initiating antiretroviral treatment (ART) among pregnant patients who are HIV positive is to prevent transmission of the virus to their unborn children. This number was estimated at 1.3 million pregnant pregnant women, as of 2018. However, optimal treatment regimens remain unclear.
An international team of investigators published their study results earlier this month in Lancet HIV showing the superiority of ART containing raltegravir, an integrase inhibitor, compared with efavirenz, a nonnucleoside reverse transcriptase inhibitor. Both drugs are well established in their safety and efficacy for reducing the HIV viral load among nonpregnant patients, but the results of initiating them during pregnancy remain unclear. Is one superior?
HRSA’s HIV/AIDS Bureau recently announced five Notices of Funding Opportunity (NOFOs) for initiatives on HIV stigma reduction, implementing rapid ART initiation, and improving care and treatment for Black women with HIV. All five NOFOs are supported by the Minority HIV/AIDS Fund. Pre-application webinars begin this week.
HRSA-20-112: Reducing Stigma at Systems, Organizational, and Individual Client Levels in the Ryan White HIV/AIDS Program
This NOFO seeks applications for a training and technical assistance program to reduce stigma for people with HIV on multiple levels throughout the health care delivery system, including on an individual client level. The program will focus on implementing various stigma-reducing approaches, with an emphasis on cultural humility. The pre-application webinar will be held on May 5 from 2:00-3:00 PM (ET). Applications are due June 8. For more information and to apply.
HRSA-20-113:Building Capacity to Implement Rapid Antiretroviral (ART) Initiation for Improved Care Engagement – Evaluation and Technical Assistance Provider
This NOFO seeks applications to support a single organization that will conduct a rigorous multi-site evaluation on the implementation of rapid ART start interventions and facilitate technical assistance (TA) to a cohort of implementation sites (funded separately through HRSA-20-114, see below) to promote a “rapid start” connection or accelerated entry into HIV medical care and rapid initiation of ART for people with HIV who are newly diagnosed, new to care, or out of care. The pre-application webinar will be held April 29 from 3:00-4:30 PM (ET). Applications are due June 15. For more information and to apply.
HRSA-20-114: Building Capacity to Implement Rapid Antiretroviral (ART) Initiation for Improved Care Engagement – Implementation Sites
This NOFO seeks applications for awards to implement and evaluate “rapid start” or accelerated entry into HIV medical care, and rapid initiation of antiretroviral therapy (ART) for people with HIV who are newly diagnosed, new to care, or out of care. Awards will support organizations that have the capacity and infrastructure to support rapid start implementation, but have not yet been able to, with the goal of replicating and expanding successful rapid start models. The pre-application webinar will be held April 29 from 1:00-2:30 PM (ET). Applications are due June 15. For more information and to apply.
HRSA-20-115: Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Evaluation and Technical Assistance Provider
This NOFO seeks applications for a single organization that will lead a multi-site evaluation and provide technical assistance (TA) to a cohort of demonstration sites (funded separately through HRSA-20-116, see below). The funded recipient will provide TA and capacity building to funded demonstration sites, work collaboratively with demonstration sites to implement a comprehensive multi-site evaluation, and disseminate successful models, findings, best practices, and lessons learned within the Ryan White HIV/AIDS Program (RWHAP) community. The pre-application webinar will be held on April 30 from 1:00-2:30 PM (ET). Applications are due June 15. For more information and to apply.
HRSA-20-116: Improving Care and Treatment Coordination: Focusing on Black Women with HIV – Demonstration Sites
This NOFO seeks applications for awards to design, implement, and evaluate bundled interventions, defined as a group of evidence-informed practices put together into a package that when implemented together produces better health outcomes than when the practices are delivered separately. Bundled interventions will address socio-cultural health determinants, expand the delivery and utilization of comprehensive HIV care and treatment services, support continuous engagement in care, and improve health outcomes for Black women with HIV in a culturally sensitive and responsive manner. Funded sites will collaborate with an Evaluation and Technical Assistance Provider (see HRSA-20-115, above). The pre-application webinar will be held April 30 from 3:00-4:30 PM (ET). Applications are due June 15. For more information and to apply.
The estimated award date for all five NOFOs is September 1, 2020.
Communication between pediatricians and adolescent boys who engage in same-sex sexual intercourse may be a potential avenue to increase HIV testing in this population, according to a study published in Pediatrics.
Although it is estimated that 14.5% of HIV infections are undiagnosed in the United States, this estimation is 51.4% (>3.5-times higher) in individuals aged 13 to 24 years because of poor testing rates among those who are aged <18 years.
There have been few studies that have described HIV testing rates among minors; these data are needed to reveal opportunities for pediatrician-adolescent communication about HIV and sexual orientation, which could increase the odds of testing. This study described HIV testing rates and identified salient individual, family, school, and healthcare influences among adolescent boys who engage in same-sex sexual intercourse (ClinicalTrials.gov identifier: NCT03511131).\
There is no cure for HIV, the virus that causes AIDS. But combination antiretroviral therapy, or ART, can effectively halt the replication of the virus, nearly eliminating it from the bloodstream and prolonging life expectancy. For the therapy to work, though, people must stick to a daily regimen of two or more pills, which experts say can be a challenge for many.
Now, the results of two phase III clinical trials suggest that a monthly shot of antiretroviral drugs works just as well as daily pills, researchers report March 4 in two studies in the New England Journal of Medicine. If approved by regulators, the therapy could be a more convenient treatment for the estimated 1.1 million people living with HIV in the United States.
“From a patient perspective, these results are very positive,” says Elizabeth Tolley, an epidemiologist at FHI 360, a public health nonprofit based in Durham, N.C. Stigma can make people reluctant to keep HIV drugs around the house or to take them each day in front of a loved one, she says. A monthly alternative could be a better option for many.
Initial data from a large NIH-supported clinical trial offer a detailed look at the health status of people aging with HIV around the world. With 7,770 participants enrolled in 12 countries across five continents, the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE ) is evaluating the ability of a statin medication, pitavastatin, to reduce the risk of heart disease among people with HIV. By leveraging data collected from this diverse group of study participants, researchers also are learning more about the long-term health effects of HIV. They report their initial findings in an August supplement for The Journal of Infectious Diseases.
