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City of Hope and Griffith University Researchers Use Novel Method to Block HIV in Mice

Scientists developed an anti-HIV protein called ZPAMt that can be delivered to affected areas using exosomes, nanosized parts of cells able to reach difficult-to-access areas of the body, such as the brain.

DUARTE, Calif.–(BUSINESS WIRE)–Researchers at City of Hope, a world-renowned research and treatment organization for cancer and diabetes, and Menzies Health Institute Queensland at Griffith University have developed a novel anti-HIV protein that suppressed HIV levels in the bone marrow, spleen, and brain of mice and prevented the virus from replicating in those regions, according to a new study published in Nature Communications today.


Their research demonstrates that scientists could engineer nanosized parts of cells called exosomes to carry therapeutic cargo to hard-to-reach places, including the nearly impenetrable blood-brain barrier. This innovative delivery system paves the way for a future where it’s conceivable that engineered exosomes could carry cargo that either suppress infectious diseases or restructure genetic material so that pathogens are rendered harmless.

“This innovative technology could become a viable way to deliver therapies not only for HIV but also for other diseases, including ones that affect the brain, such as Alzheimer’s and Parkinson’s,” said Professor Kevin Morris, Ph.D. from City of Hope’s Center for Gene Therapy and Griffith University’s School of Pharmacy and Medical Sciences. Morris is senior author of the new study.

Human immunodeficiency virus attacks cells that help the body fight infection, making an individual more vulnerable to other infections and diseases. Many researchers believe one way to cure HIV is to “block and lock” the disease in a process that obstructs the ability of the virus to replicate and locks it in a dormant state.

“The ZPAMt HIV protein repressor we developed is packaged into exosome nanoparticles and can enter cells where it epigenetically silences HIV,” Morris said. “We show that these nanoparticles can systemically ‘block and lock’ HIV expression. This is the first time that block and lock has been successfully delivered to treat HIV in vivo in the brain.”

HIV can enter the human body in a dormant-like state; it is able to hide from the body’s immune system and evade treatments. Then, it can reactivate later. HIV hiding in the brain is especially difficult to treat because of the blood-brain barrier, which prevents both toxins and therapies from entering the brain.

Currently, there is no cure for HIV, so once someone contracts it, he or she will have it for life. An estimated 1.19 million people in the United States had HIV at the end of 2019, according to the Centers for Disease Control and Prevention.

The research was supported by the National Institutes of Health’s National Institute of Mental Health (R01 113407-01).

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHopeTM, a subsidiary launched in 2019, serves employers and their health care partners by providing access to NCI-designated cancer center expertise. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About Griffith University

Griffith University is a comprehensive research-intensive university ranked in the top 2% of universities globally with 50,000 students spanning six campuses in South East Queensland, Australia. Its research excellence, innovative teaching and learning practices, and strong industry ties makes it one of the leading providers of higher education in the Asia–Pacific.

Contacts

Zen Vuong

626-409-9367

[email protected]

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Magellan Rx Management’s AIDS Drug Assistance Program Center of Excellence Expands Program That Significantly Improves Medication Adherence and Quality of Care for Patients with HIV

PHOENIX–(BUSINESS WIRE)–Magellan Rx Management, the full-service pharmacy benefits management division of Magellan Health, Inc. (NASDAQ: MGLN) has expanded Navigate Whole Health to include the AIDS Drug Assistance Program (ADAP) that applies an innovative and comprehensive approach to managing the quality of care for persons receiving treatment for HIV. Through the program, clinical pharmacists partner with providers to manage complex cases by promoting best-practices for HIV treatment and closing care gaps. The Navigate Whole Health ADAP program also supports participating ADAPs in meeting Health Resources & Services Administration (HRSA) performance measures.

“Navigate Whole Health ADAP offers a unique opportunity to support participating ADAP customers, providers and their members by concentrating on HIV/AIDS treatments, comorbid chronic diseases, behavioral health conditions, and social determinants that interfere with outcomes,” said Caroline Carney, MD, chief medical officer, Magellan Health. “We are using data science to tailor interventions to deliver the right supports to prevent interruptions in therapy and address behavioral healthcare, including depression and substance abuse.”

Adherence to antiretroviral therapy (ART) is critical to reducing viral load, transmission, and resistance. For most patients, nearly perfect (>95 percent) adherence is necessary to achieve optimal viral suppression and clinical success. However, the national average rate of adherence to ART is around 70 percent, and the total annual unadjusted costs per patient for non-adherence to HIV ART therapy ranged from $16,957 to $30,068.1,2

The Navigate Whole Health ADAP pilot program was conducted for nine months. An analysis of the first three months of intervention shows a 26.7 percent increase in HIV/ART medication adherence in six months post intervention. This program also addresses behavioral concerns, like depression, and achieved a 60 percent increase in members being adherent to their antidepressant medication adherence. “It is particularly encouraging to note that 100% of the recommendations made by Magellan clinical team were accepted by prescribers,” says Astha Chopra, vice president, clinical effectiveness, Magellan Health.

ADAP Center of Excellence

Magellan Rx established a national ADAP Center of Excellence (COE) with a dedicated call center to provide timely service and continuity of care. The dedicated ADAP team provides a multi-faceted approach to State ADAP programs across the country with a best-in class operating paradigm to help improve patient outcomes and prevent HIV. Navigate ADAP is one of the ways the Magellan Rx ADAP COE helps improve clinical quality for ADAP members.

“With over three decades of experience in serving some of the largest state ADAP programs, our Magellan team is deeply invested in the national effort to combat AIDS and the HIV epidemic through education, awareness, research and access to medications for those living with the disease. We invested in the Center of Excellence to leverage significant expertise on behalf of all our ADAP customers and their members. This program is one of many examples of our commitment to this work.” Meredith Delk, general manager and senior vice president, government markets, Magellan Rx Management.

About Magellan Rx Management: Magellan Rx Management, a division of Magellan Health, Inc., is shaping the future of pharmacy. As a next-generation pharmacy organization, we deliver meaningful solutions to the people we serve. As pioneers in specialty drug management, industry leaders in Medicaid pharmacy programs and disruptors in pharmacy benefit management, we partner with our customers and members to deliver a best-in-class healthcare experience.

About Magellan Health: Magellan Health, Inc., is a leader in managing the fastest growing, most complex areas of health, including special populations, complete pharmacy benefits and other specialty areas of healthcare. Magellan supports innovative ways of accessing better health through technology, while remaining focused on the critical personal relationships that are necessary to achieve a healthy, vibrant life. Magellan’s customers include health plans and other managed care organizations, employers, labor unions, various military and governmental agencies and third-party administrators. For more information, visit MagellanHealth.com.

1.

Machtinger EL, Bangsberg DR. Adherence to HIV Antiretroviral Therapy. HIV in Site Knowledge Base Chapter; May. 2005. [Accessed on 2021 Mar 16]. Content Reviewed; January 2006. http://hivinsite.ucsf.edu/InSite?page=kb-03-02-09.

2.

Cutler RL, Fernandez-Llimos F, Frommer M, Benrimoj C, Garcia-Cardenas V. Economic impact of medication non-adherence by disease groups: a systematic review. BMJ Open. 2018;8(1):e016982. Published 2018 Jan 21. doi:10.1136/bmjopen-2017-016982

(MGLN-GEN)

Contacts

Media: Lilly Ackley, [email protected], (860) 507-1923

Investor: Darren Lehrich, [email protected], (860) 507-1814

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Merck Presents New Data from Ongoing Phase 2a Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Investigational, Once-Monthly, Oral Islatravir for HIV-1 Prevention at IAS 2021

Results from this study support the safety profile of oral islatravir PrEP regimen through 24 weeks versus placebo

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a Phase 2a clinical trial evaluating the safety, tolerability and pharmacokinetics (PK) of six monthly oral doses, over 24 weeks, of islatravir, the company’s investigational nucleoside reverse transcriptase translocation inhibitor, versus placebo for pre-exposure prophylaxis (PrEP) of HIV-1 infection in adults at low-risk of contracting HIV-1. After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo. Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. The levels of islatravir in peripheral blood mononuclear cells (PBMCs) also remained above the pre-specified efficacy PK threshold for PrEP at both doses studied (60 mg and 120 mg) eight weeks after the last study dose. These data were shared as a late-breaking oral presentation during the virtual 11th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).

The 24-week analysis of investigational, once-monthly oral islatravir not only builds upon the PK data we have already seen, but also provides encouraging support for the safety and tolerability profile of this HIV-1 PrEP regimen,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “As part of our commitment to understanding the potential for our HIV medicines in a broad range of patients, we focused on the enrollment of diverse patient populations at risk for HIV, including women, who have one of the highest unmet needs in HIV prevention.”

Islatravir is currently being evaluated across a variety of dosing regimens, for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a monotherapy. An overview of the islatravir treatment and prevention development program is available here, which includes our two Phase 3 IMPOWER trials evaluating islatravir as once-monthly oral PrEP across diverse populations of people who may benefit from additional HIV-1 prevention options.

Phase 2a Oral Study Results for Investigational Islatravir

In the ongoing Phase 2a (NCT04003103) randomized, double-blind, parallel assignment, placebo-controlled, multicenter trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned (2:2:1) to one of three oral once-monthly therapy groups: islatravir 60 mg, islatravir 120 mg or placebo. Participants received once monthly oral doses of islatravir or placebo over a 24-week blinded therapy period, followed by a 12-week blinded follow-up in all groups and a 32-week unblinded follow-up in the islatravir groups to characterize the terminal elimination phase. Outcome measures for safety, tolerability and PK will be analyzed through week 68.

Of the 242 randomized participants at this 24-week analysis, which concludes the dosing portion of the study, 92% (n=222/242) completed dosing and 8% (n=20/242) discontinued the study intervention before week 24. Less than 1% (n=2) of participants discontinued due to an AE. Of the total participants, 67.4% (n=163/242) were female, 52.9% (n=128/242) were white, 41.7% (n=101/242) were Black or African American and 14.9% (n=36/242) were Hispanic or Latino. Unblinded safety data showed that both doses of islatravir were generally well tolerated versus placebo over 24 weeks and most AEs were mild (73.5%). The most common AEs (occurring in >5% of participants) in the islatravir 60 mg, islatravir 120 mg and placebo groups respectively were headache (10.3% [n=10/97], 9.3% [n=9/97] and 4.2% [n=2/48]), diarrhea (5.2% [n=5/97], 5.2% [n=5/97] and 8.3% [n=4/48]) and nausea (5.2% [n=5/97]), 7.2% [n=7/97] and 4.2% [n=2/48]). There were no serious drug-related AEs in people who received islatravir. The study enrolled a population at low-risk for HIV infection as evidenced by no confirmed HIV infections occurring during the treatment period.

The PK analysis showed that trough concentrations (the lowest level between doses) of islatravir triphosphate in PBMCs following either 60 mg or 120 mg monthly doses continue to remain above the pre-specified PK threshold for HIV-1 prophylaxis of 0.05 pmol/106 PBMCs and were sustained through eight weeks after the last dose of islatravir.

About Islatravir (MK-8591)

Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, including the ILLUMINATE clinical trials program for once-daily treatment. Islatravir is also being studied for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single agent across a variety of formulations, including the IMPOWER clinical trials evaluating an oral once-monthly regimen.

Our Commitment to HIV

For more than 35 years, Merck has been committed to scientific research and discovery (R&D) in HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

About Merck

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Melissa Moody

(215) 407-3536

Sienna Choi

(908) 873-4311

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Raychel Kruper

(908) 740-2107