AHF Files Brief Against CVS at the US Supreme Court OutBuro lgbt professional entreprenuer networking online community gay lesbian transgender queer bisexual nonbinary

AHF Files Brief Against CVS at the U.S. Supreme Court

9th Circuit Court of Appeals ruled earlier that HIV patients may make a discrimination claim under the Affordable Care Act against CVS for requiring HIV patients to use mail-order pharmacies or to go to a few of CVS’s selected specialty pharmacies, where patients say they are not getting full service

In 2018, AHF warned the U.S. Department of Justice that the then-proposed CVS merger with Aetna would create a monopoly-like behemoth that would harm patients, which appears to be the case here with pharmacy choice

WASHINGTON–(BUSINESS WIRE)–AIDS Healthcare Foundation (AHF), the largest global AIDS organization, filed a brief of amicus curiae with the Supreme Court of the United States earlier today in CVS Pharmacy, Inc. vs. Doe, a case set to be heard and decided by summer 2022.

In December 2020, the U.S. 9th Circuit Court of Appeals ruled in Doe vs. CVS Pharmacy, Inc. that people living with HIV can state a discrimination claim under the Affordable Care Act against CVS Pharmacy, Inc., for requiring them to use mail-order pharmacies to obtain HIV/AIDS medications or to go to one of a few designated “specialty” pharmacies that are little more than pick-up stations, as part of in-network pharmacy services for private insurance plans. CVS appealed the ruling and the Supreme Court agreed to hear the case. In its brief, AHF asks the Supreme Court to affirm the earlier judgement of the Ninth Circuit.

“For people living with HIV/AIDS, real specialty pharmacies and pharmacists that focus on HIV/AIDS and in-person treatment provide demonstrably superior care than do mail-order pharmacies and retail pharmacies. We believe that CVS’s denial of choice in pharmacy services for HIV/AIDS patients is both wrong and discriminatory,” said Jonathan M. Eisenberg, Deputy General Counsel — Litigation for AHF.

AHF’s amicus curiae brief focuses on three primary arguments:

  1. That U.S. Statutory Law Requires Courts to Protect People Living with HIV/AIDS from Disability Discrimination by Healthcare Providers,
  2. That Coerced Use of Mail-Order Pharmacies Is Highly Detrimental to People Living with HIV/AIDS, and
  3. That Coercing People Living with HIV/AIDS to Use Mail-Order Pharmacies Is a Disability-Rights Violation, by Both Intent and Impact.

“CVS said to people living with HIV that they can only go to a few of its selected pharmacies and/or be compelled to utilize its PBM’s mail order pharmacies. Patients asserted they weren’t getting full service there, which discriminated against them. They wanted to keep their current pharmacies which provide more comprehensive and specialty services,” said Tom Myers, Chief of Public Affairs and General Counsel for AHF. “We filed this amicus brief to support HIV/AIDS patients’ legal arguments in the case before the Supreme Court and to defend patients’ rights and choice in their pharmacy services.”

The December 2020 9th Circuit Court ruling validated AHF’s earlier warning of the CVS threat to the HIV response back in 2018. See AHF press statement (Nov. 28, 2018) “CVS-Aetna Merger is Bad for HIV Patients.”

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million individuals in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us @aidshealthcare.

Contacts

MEDIA CONTACTS:

Jonathan M. Eisenberg, Deputy General Counsel–Litigation for AHF +1.323.860.5361 w Jonathan.esienberg@ahf.org
Ged Kenslea, Senior Director, Communications, AHF +1.323.791.5526 [cell] +.323.308.1833 [work] gedk@aidshealth.org
John Hassell, National Director of Advocacy, AHF +1.202.774.4854 [cell] John.hassell@aidshealth.org

Clinical and Patient-Reported Outcomes in People Living With HIV on Biktarvy in Observational BICSTaR Study Demonstrate Consistent Efficac OutBuro lgbt professional entreprenuer networking community

Clinical and Patient-Reported Outcomes in People Living With HIV on Biktarvy® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting

– Clinical Data Across a Diverse Range of People Living With HIV on Biktarvy Treatment in the International BICSTaR Study Showed High Effectiveness and High Levels of Adherence –

– Long-Term Switch Data Presented at EACS 2021 Further Establish the Robust and Durable Efficacy Profile of Biktarvy –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim results from the ongoing, multinational, observational single-arm, non-comparative real-world cohort BICSTaR study, which is designed to evaluate the antiviral effectiveness and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in 1,135 people living with HIV. The BICSTaR study also collected patient-reported outcomes in routine clinical practice to better understand the impact of treatment on health-related quality of life in people living with HIV. These data were presented at the 18th European AIDS Conference (EACS 2021).

Gilead presented an analysis of patient-reported outcomes after 12 months of treatment with Biktarvy from the BICSTaR study. During the study, conducted at sites in Europe, Canada and Israel, people living with HIV who initiated treatment with Biktarvy between June 2018 and September 2020 completed questionnaires at baseline and 12 months. The questionnaires assessed patient-reported outcomes covering a range of measures. The results underline the importance of collecting patient-reported outcomes in order to understand the impact on mental health status, health-related quality of life and treatment satisfaction of people living with HIV.

“Despite advances in antiretroviral therapy, people living with HIV experience burdensome multidimensional symptoms and concerns requiring person-centered care,” said Fernando Bognar, MD, Vice President, Medical Affairs, HIV at Gilead Sciences. “The patient-reported outcomes observed in the BICSTaR study provide a first-hand assessment of the impact of HIV treatment and care on the quality of life that people living with HIV experience. As physicians and people living with HIV look to understand what long-term treatment means to them individually, these data presented at EACS also reinforce that Biktarvy can meet the specific treatment needs of diverse groups of people, including men and women aging with HIV and those with existing comorbid conditions.”

In a second analysis of the BICSTaR study, 97% (n=149/154) of treatment-naïve adults and 96% (n=771/800) of treatment-experienced adults achieved and maintained virologic suppression (HIV-1 RNA <50 copies/mL) after one year of treatment. Participants included adults 50 years of age or older, cisgender women, and late presenters (CD4 <200 cells/μl and/or ≥1 AIDS-defining event at baseline). Both treatment-naïve and treatment-experienced participants had high persistence with Biktarvy (91%, n=1032/1135) across both groups, Biktarvy was generally well-tolerated and no resistance to the components of Biktarvy emerged. 148 (13%) participants had any adverse event and 2 (<1%) had a serious adverse event. The most common drug-related adverse events observed to date in the BICSTaR study were weight increase (3%), nausea (1%), depression (1%), headache (1%), fatigue (1%), diarrhoea (1%) and sleep disorder (1%). These large cohort findings continue to reinforce the real-world effectiveness of Biktarvy across populations and are consistent with evidence from randomized clinical trials.

Additional Biktarvy data presented at EACS 2021 include a Phase 3 trial (Study 1878) that demonstrated the durable efficacy of Biktarvy. In the study, 99% of people living with HIV who switched to Biktarvy from a boosted protease inhibitor-based regimen maintained and achieved long-term viral suppression through a median of 101 weeks (n=525/532), including 98% of participants with pre-existing resistance (n=212/217; median of 108 weeks) and 98% of participants with viral blips (n=39/40; median of 109 weeks), with no treatment-emergent resistance to Biktarvy. A pooled analysis of five Phase 3 studies (1844, 1878, 4030, 4449, 4580) also found that regardless of pre-existing TAMS (thymidine analog-associated mutations M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E), a high proportion of those on Biktarvy were able to maintain virologic suppression and had an absence of treatment-emergent resistance. These data support the continued evaluation of Biktarvy as a potential option for virologically suppressed people living with HIV with known resistance. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

Please see below for the U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy.

There is currently no cure for HIV or AIDS.

About BICSTaR

The Bictegravir Single Tablet Regimen (BICSTaR) Study is an ongoing, multinational, observational single-arm, non-comparative real-world cohort study, which aims to evaluate the effectiveness, safety, tolerability, and patient-reported outcomes of treatment with Biktarvy in treatment‐naïve and treatment‐experienced people living with HIV. Among the people living with HIV enrolled in the BICSTaR study, there is a high baseline prevalence of comorbidities.

About Biktarvy

Biktarvy is a complete HIV-1 treatment that combines three powerful medicines to form the smallest integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete single-tablet regimen and should not be taken with other HIV-1 medicines.

In February 2018, the U.S. Food and Drug Administration (FDA) approved Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a once-daily single-tablet regimen for the treatment of HIV-1 infection in adults. In June 2019, the FDA approved labeling revisions to Biktarvy, expanding the patient population to include pediatric patients weighing at least 25 kg. In October 2021, the FDA approved a new low-dose tablet formulation of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg. For all patient populations, Biktarvy is only indicated for the treatment of HIV-1 infection in people who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

U.S. Important Safety Information for Biktarvy

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

  • Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

Warnings and precautions

  • Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
  • New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.

    Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
  • Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Dosage and administration

  • Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
  • Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.
  • Prior to or when initiating: Test patients for HBV infection.
  • Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

Pregnancy and lactation

  • Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed eleven HIV medications, including the first single tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving Biktarvy; the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy; Gilead’s ability to receive FDA and other regulatory approvals for additional indications for Biktarvy, and the risk that any such approvals, if granted, may have significant limitations on its use; the risk that physicians may not see the benefits of prescribing Biktarvy; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

U.S. full Prescribing Information for Biktarvy and Descovy, including BOXED WARNINGS, are available at www.gilead.com.

Biktarvy, Descovy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s).

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contacts

Jacquie Ross, Investors

(408) 656-8793

Brian Plummer, Media

(202) 309-5207

Out of the Closet Designer Wins HBO Max Craftopia Episode OutBuro lgbt professional entreprenuer networking online community gay lesbian transgender queer bisexual nonbinary

‘Out of the Closet’ Designer Wins HBO Max ‘Craftopia’ Episode

Edgar Eiotown, a respected artist and the longtime and award-winning visual display coordinator for AIDS Healthcare Foundation’s ‘Out of the Closet’ thrift store chain, lands first place on HBO Max’s ‘Craftopia’ program, Season 2, Episode 2 (“Bow-Wow Ween”)

LOS ANGELES–(BUSINESS WIRE)–#OTC–The longtime and award-winning visual display coordinator for AIDS Healthcare Foundation’s (AHF) Out of the Closet thrift store chain, has won first place in a crafting and design competition in a special episode of HBO Max’s innovative reality program, “Craftopia.”


Edgar Eiotown, a respected artist who has designed windows and other visual displays for AHF’s 21 ‘Out of the Closet’ stores for over 20 years, triumphed over two other “Craftopia” contestants in a special Halloween-themed design competition that was the focus of Episode 2, Season 2 of the HBO Max program titled “Bow-Wow Ween.” Eiotown learned of his victory just prior to HBO Max’s streaming of the episode, which began streaming last week (October 7).

“For over twenty years, Edgar has worked his special magic with our Out of the Closet windows and visual displays harnessing his keen artistic sensibility and real-world practical design skills in his work helping to raise funds and awareness about AHF and our mission delivering HIV/AIDS prevention, care and services,” said Jonathan Kreuyer, General Manager of AHF’s Out of the Closet Store chain. “I am thrilled to learn of his win here, a well-deserved recognition of his unique talent and vision.”

In the “Bow-Wow Ween” episode of “Craftopia,” Eiotown went up against two other artists, all of whom were given two crafting assignments. The first was to create a Halloween costume for a dog (which another contestant prevailed at), and second, to create a piece of wearable art representing the concept of ‘split personality.’ Eiotown handily won this portion of the competition, creating an elaborate black, red, yellow and white costume featuring a Venetian- or Kabuki-style face mask designed with two intricately painted and distinct halves. To underscore the concept of split personality and heighten the impact of his artistic vision in his presentation to the judges, Eiotown’s mask also opened at one point right down the middle, top-to-bottom across the nose line, to reveal that he had made his face up and painted it identically as the mask—however, each half of his painted face was now the reverse of the beautifully handcrafted mask.

“Edgar: on behalf of all your Out of the Closet and AHF colleagues, we offer our congratulations and are so proud of you for your spectacular work on HBO Max’s Craftopia,” said AHF President Michael Weinstein. “Out of the Closet remains a powerhouse brand and not-so-secret weapon for AHF. Your visual artistry over the years on our behalf has been equally remarkable, adding fun to the shopping experience while helping us honor our mission of service. It is particularly amazing that you could do that much beautiful and intricate work under that kind of time pressure on your Craftopia episode. You are much more than a craftsman you are an artist. Bravo!”

In addition to his work for Out of the Closet, Eiotown is indeed also an artist whose work can be viewed at his eponymous website: www.eiotown.com. Eiotown marked his 20th year working for Out of the Closet this past April. AHF’s Out of the Closet thrift store chain celebrated its 30th anniversary last October. The OTC stores—all of which Eiotown oversees for visual display—consists of 21 stores in seven states (with another outlet set to open in San Diego at the end of October).

Over the years Eiotown’s design work for Out of the Closet has been officially honored with awards and recognitions in Los Angeles, Chicago and Dallas.

Out of the Closet Thrift stores provide people a fun, cause-worthy place to shop and donate gently used goods in support of the fight against HIV/AIDS. Many Out of the Closet Thrift Stores make HIV testing easy with fixed-site testing in stores. Many Out of the Closet sites are also connected to an AHF Pharmacy, providing a convenient one-stop experience for clients to shop and pick up their medications.

HBO Max

Instagram: @HBOMax

Twitter: @HBOMax

Facebook: facebook.com/HBOMax
www.hbomax.com
#Craftopia

#CraftopiaOnMax

Edgar Eiotown

Instagram: @eiotown

www.eiotown.com
#eiotown

Out of the Closet Thrift Stores

Instagram: @outofthecloset

Twitter: @outofthecloset

Facebook: facebook.com/OutoftheClosetThriftStores
www.outofthecloset.org
#outofthecloset

#OTC

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million individuals in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us @aidshealthcare.

Contacts

Ged Kenslea, Senior Director, Communications, AHF

+1.323.791.5526 [cell] gedk@aidshealth.org

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AHF Praises President Biden’s Pick for New PEPFAR Chief

LOS ANGELES–(BUSINESS WIRE)–AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS care provider operating in 45 countries, praised today President Biden’s decision to nominate John Nkengasong to lead the US President’s Emergency Plan for AIDS Relief (PEPFAR).

Nkengasong currently serves as the Director of the Africa Centres for Disease Control and Prevention (ACDC). Before joining ACDC as its inaugural director, he served as an acting deputy director at the US CDC Center for Global Health. Nkengasong is a virologist by training and holds a dual US and Cameroonian citizenship.

“We believe Dr. Nkengasong is well suited to lead PEPFAR because his tireless efforts in fighting COVID-19 as the head of ACDC are widely praised across Africa. As a virologist, he understands both the HIV and the COVID-19 pandemics, and has the requisite managerial and scientific credentials to successfully lead PEPFAR,” said AHF Africa Bureau Chief Dr. Penninah Iutung. “We hope the US Senate will fully support Dr. Nkengasong’s nomination and move quickly to confirm his appointment. To-date PEPFAR has saved millions of lives, most of them across Africa, and during the ongoing pandemic it is also providing indispensable COVID-19 relief. With Dr. Nkengasong at the helm, PEPFAR will continue its legacy of lifesaving humanitarian work funded by the generosity of the American people.”

Congress will soon consider whether to reauthorize PEPFAR for another five years. AHF has always been a strong supporter of PEPFAR and has repeatedly advocated for its reauthorization in previous rounds.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million clients in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare

Contacts

US MEDIA CONTACT:

Ged Kenslea, Senior Director, Communications, AHF

+1.323.308.1833 work +1.323.791.5526 mobile

gedk@aidshealth.org

Denys Nazarov, Director of Global Policy &

Communications, AHF

+1 323.308.1829

denys.nazarov@ahf.org

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Statement from the Board of Directors: The Black AIDS Institute Announces Interim CEO

Interim CEO will serve alongside new Managing Director and Expert Consultants

NEW YORK, Sept. 23, 2021 /PRNewswire/ — The Board of Directors of the Black AIDS Institute (BAI) is pleased to announce the appointment of Toni Newman as its Interim Chief Executive Officer and Dr. Kemal M. Atkins as Managing Director to help fortify BAI’s infrastructure and round out the organization’s stellar leadership team.

In addition, BAI has engaged Ms. Pat Bass and Mr. Chris Bates – two internationally recognized experts who pioneered HIV/AIDS prevention, education, and treatment programs – to assess BAI’s current capabilities and mission.

Ms. Newman is currently the Interim Executive Director at LYRIC – a non-profit in San Francisco, California that focuses on advancing the community and creating social change for lesbian, gay, bisexual, transgender, queer, and questioning (LGBTQQ) youth through education, career training, and health advocacy. She oversees the budget, programs, and community outreach for LYRIC. Ms. Newman is a distinguished Faculty Member at the Transgender Strategy Center in Los Angeles, where she advises non-profit organizations on engagement with transgender and non-conforming communities. In addition, she is the Chair of the Board of Directors for TransCanWork based in Los Angeles. Ms. Newman has a wealth of knowledge in non-profit management, budget and finance, and human resources and operations. We’re excited that she has agreed to serve as our Interim CEO as we continue implementing our transition plan to find a permanent, innovative executive staff leader.

Dr. Atkins has been engaged to help further build infrastructure and management processes at BAI. Dr. Atkins, who will serve as a consultant on a temporary basis, has an extensive background in higher education and non-profit leadership where his expertise in crisis management, such as leading institutional responses to the COVID-19 pandemic, and expertise in building national wellness health models will provide much-needed program direction for BAI.

Ms. Bass’s work in the field of HIV/AIDS prevention truly extraordinary. As one of the architects of the Ryan White CARES Act – the largest federally funded program for people living with HIV/AIDS, she helped pave the way for modern treatments to prevent the spread and contraction of the virus. Mr. Bates also has a distinguished career in HIV prevention policy – having served as the Executive Director on the Presidential Advisory Council on AIDS and Director of the Office of AIDS Policy under President Barack Obama. Together they will oversee a comprehensive review of BAI’s program efficacy, contributions, and impact in the field of HIV/AIDS prevention and provide data that informs BAI’s mission as the organization continues to refine.

Ms. Newman, Dr. Atkins, Ms. Bass and Mr. Bates will work alongside Jami Cox and Wendell Miller as we continue to deploy our substantial resources, forward-looking vision, and human capital in the fight to end the HIV epidemic in Black communities and improve the health and quality of life for Black people living with and vulnerable to acquiring HIV/AIDS across the country.

The work of BAI is as important today as it ever has been, and we’re so proud of our incredibly talented and dedicated team that understands what is at stake for the Black community impacted by HIV and committed to ending this epidemic. Please join us in welcoming these accomplished leaders to our team. And thank you for continuing to support BAI and our entire staff across our networks.

Contact:
Tori Campbell
(332) 207-1473
319716@email4pr.com

SOURCE Black AIDS Institute

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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

zvuong@coh.org

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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, ackleyl@magellanhealth.com, (860) 507-1923

Investor: Darren Lehrich, lehrichd@magellanhealth.com, (860) 507-1814

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AHF Dumbfounded by Gilead’s Claim of No AIDS Stigma Today

In recent legal filing in lawsuits over one of its HIV/AIDS medications that causes permanent and potentially deadly damage to the kidneys and bones, Gilead’s white shoe law firm, Sidley Austin, stumbles as it claims “…there is no shame or stigma …” associated with the disease today

At the same time its lawyers deny AIDS stigma, NBC News reported that Gilead itself funded a newly released study that found half of Americans “… said they’d feel uncomfortable with a HIV-positive medical professional, 42 percent were uncomfortable with a hair stylist or a barber living with the virus, and a third (34 percent) said they were uncomfortable with an HIV-positive teacher.”

LOS ANGELES–(BUSINESS WIRE)–Today, AIDS Healthcare Foundation announced that in a recent legal filing in personal injury lawsuits against Gilead Sciences Inc. seeking to hold the Bay Area drug maker accountable over one of its HIV/AIDS medications that allegedly causes permanent damage to the kidneys and bones, lawyers for Gilead claimed that “no shame or stigma” remains associated with HIV/AIDS today as they sought to reverse a judicial order denying Gilead access to AHF’s patient and client mailing lists.

In an August 9, 2021 filing in the Superior Court of California County of San Francisco (Case No. CJC-19-005043) seeking reconsideration of the Court’s Recommended Order No. 19 (Motions to Quash, and to Modify, Deposition Subpoena For Production of Business Records to AIDS Healthcare Foundation), lawyers for Sidley Austin, Gilead’s law firm, twice asserted there is no longer stigma associated with HIV or AIDS today, writing:

  • “Support for the HIV/AIDS community is not even stigmatized in today’s society,” (pleading, P #5, lines 19 & 20), and
  • “Further, there is no shame or stigma associated with supporting those affected by HIV/AIDS…” (pleading, P #9, lines 17 & 18).

At nearly the same time Gilead’s lawyers dubiously claimed that no HIV/AIDS stigma remains today, a new study undertaken by the LGBTQ advocacy group GLAAD and the Southern AIDS Coalition found that half of Americans “… said they’d feel uncomfortable with a HIV-positive medical professional, 42 percent were uncomfortable with a hair stylist or a barber living with the virus, and a third (34 percent) said they were uncomfortable with an HIV-positive teacher.” According to NBC News, the study, “The State of HIV Stigma 2021”, was published and widely reported on August 26, 2021.

NBC News also reported that Gilead funded the study.

Gilead’s assertions denying the existence of stigma surrounding HIV/AIDS today came about in its response to multiple personal injury lawsuits by patients taking Gilead medications. The lawsuits focus on Gilead’s failure to rectify a known defect in its tenofovir disoproxil fumarate (TDF) drug formulation, knowing that a safer alternate, tenofovir alafenamide (TAF) existed—in Gilead’s own laboratories—and for its failure to warn patients of the damaging side effects of TDF as well as Gilead’s active misrepresentation of TDF’s efficacy and risks. AHF supported many of the plaintiffs’ lawsuits, which likely led to Gilead’s discovery requests for its mailing lists.

Gilead’s zeal to maintain and maximize its corporate profits came at the expense of the health and wellbeing of its customers who were prescribed and taking TDF. According to earlier pleadings in the cases, the company knew as far back as 2001 from its own studies and other research that TDF was, ‘…highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.’

“It’s official, according to Gilead: there is no longer any stigma around AIDS today,” said Michael Weinstein, president of AHF. “I suppose that means Gilead wasted a lot of money on its recent—and disheartening—GLAAD/Southern AIDS Coalition study documenting the ongoing and severe stigma around HIV and AIDS. Perhaps Gilead should instead spend its energy developing a drug to treat the willful blindness associated with its overwhelming greed. They make billions of dollars harming HIV/AIDS patients when they knew they had a better, less toxic drug sitting on the shelf. Now, they declare AIDS stigma no longer exists. Gilead, what astounding arrogance—and greed!”

About AHF

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million individuals in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare

Contacts

Ged Kenslea, Senior Director, Communications, AHF

+1.323.791.5526 mobile

gedk@aidshealth.org

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AHF: ‘Providence Journal’ Rejects Ad Skewering CVS’s PBM Abuse

AIDS organization’s ‘Corporate Vampires Suck’ advocacy ad had already run in nearly half-a-dozen print and online new outlets nationwide, but was rejected last week by CVS’s home state newspaper, the ‘Providence Journal’

AHF ad targets CVS, the sixth largest corporation in the world, for its anti-competitive behavior, notably, buying up health plans like Aetna, and then forcing patients—including HIV patients, who often rely on specialty services from their pharmacists—to obtain their lifesaving medications by mail order or drop shipment

LOS ANGELES–(BUSINESS WIRE)–#StopCVSNow–After AIDS Healthcare Foundation (AHF) launched a new national advocacy and ad campaign to take on health and pharmacy giant CVS over its anti-competitive business model and practices, it learned late last week that the ‘Providence Journal’—CVS’s home state daily newspaper—was rejecting AHF’s ad. CVS, the sixth largest corporation in the world, is headquartered in nearby Woonsocket, RI. A version of the ad ran in today’s Boston Sunday Globe on page A3.


The advocacy campaign and ad, ‘CVS: Corporate Vampires Suck’ (https://ahf.org/stop-cvs), targets CVS over its fierce anti-competitive behavior, specifically regarding its refusal to allow patients any choice in their pharmacy services. CVS’s currently forces most of its health plan patients from providers like Aetna—which CVS purchased for $69 billion in cash and stock in 2018—to obtain their lifesaving medications by mail order or drop shipment.

AHF’s ‘CVS: Corporate Vampires Suck’ campaign kicked off last month, with a full-page, full-color ad that ran in daily and weekly newspapers across the country with most ads landing Sunday, July 11. The ad also ran in the weekly ‘Houston Defender’ (Thursday, July 8). The Sunday papers include the Ft. Lauderdale ‘Sun Sentinel,’ ‘Houston Chronicle,’ and the ‘Chicago Defender’ (online). The ads are being complemented by a radio campaign, social media and a legislative call-to-action urging viewers and readers to contact their legislators asking them to help fight back against CVS’s monopolistic and anti-competitive behavior.

AHF intended to run the ad this week in the ‘Providence Journal’ and had been communicating back and forth with the paper’s advertising department regarding suggested possible changes or edits to the ad. Some changes were incorporated by AHF: a change to the parody CVS logo and some softening of the ad copy. However, after making some initial changes suggested by the ‘Providence Journal,’ the paper’s ad reps then advised AHF the ad could not run. They also refused to inform AHF what else might need to be changed or altered to clear the ad for publication. The ‘Providence Journal’ is the oldest continuously published daily newspaper in the United States.

“While we are disappointed that the ‘Providence Journal’ will not run our ‘Corporate Vampires Suck’ advocacy ad, we are not entirely surprised. It’s the hometown paper of CVS, which also runs multipage ad circulars dozens of Sundays every year in the paper and in most major newspapers across the country,” said Michael Weinstein president of AHF. “But make no bones about it. CVS remains a major threat to public health. It has been buying up health plans for billions and forcing clients—including HIV/AIDS patients—to use CVS’s mail order services, harming patients and fragmenting their care in the process. Patients are suffering and small pharmacies are being squeezed, with many, being put out of business. That’s why we put some real fangs into this advocacy campaign—we need the public’s help to fight back against CVS’s ‘corporate vampires.’”

AHF’s ‘CVS: Corporate Vampires Suck’ campaign will run until September. For more information about this campaign to fight back against CVS and pharmacy benefit managers (PBMs) who are putting their profit ahead of patient health, please visit: https://ahf.org/stop-cvs

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.5 million individuals in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us @aidshealthcare.

Contacts

Ged Kenslea, Senior Director, Communications, AHF +1.323.791.5526 [cell] gedk@aidshealth.org
John Hassell, National Director of Advocacy, AHF +1.202.774.4854 [cell] John.hassell@aidshealth.org

AHF Commends the Resumption of HIV Treatment in Kenya – But More Is Needed

NAIROBI, Kenya–(BUSINESS WIRE)–AIDS Healthcare Foundation (AHF) welcomes the decision reached by the US Embassy in Kenya and the National AIDS Control Council (NACC) to end the stalemate between the Kenya Ministry of Health and the US Agency for International Development (USAID). As a result, distribution of lifesaving HIV/AIDS prevention and treatment medications has resumed as of July 14, according to the US Embassy.

Civil society organisations, communities of people living with HIV and other stakeholders have been advocating for an end to the deadlock to ensure a continued flow of antiretroviral medicines and other essential HIV supplies.

“The uncertainty that was experienced by nearly a million adults and thousands of children who missed their most essential treatment for months was preventable and should never have been allowed to happen in the first place,” said Dr. Samuel Kinyanjui, Country Program Director for AHF Kenya. “The damage done to people’s lives and wellbeing—particularly children’s lives—is irreversible and must never be repeated.”

Despite encouraging negotiations between the Ministry of Health and USAID, the resolution of the impasse only directly addresses the consignment of medicines currently at the port of entry in Kenya. The newly reached agreement merely provides a temporary solution and does not substantively address any future stalemates or the broader issue of taxes being levied on medical products and technologies donated to Kenya for free distribution.

While AHF recognizes that the resumption of treatment will help alleviate the immediate danger to people living with HIV in Kenya, the government should promptly take the following actions to maintain progress toward fulfilling its commitments on ending AIDS and curbing new HIV infections:

  1. Ensure that normal operations are re-established at all HIV clinics across the country and that the Differentiated Service Delivery (DSD) model is restarted. DSD is well embraced by all stakeholders and has been proven to work very well.
  2. Find a permanent solution to address the taxation of donated medical products. This can be achieved by waiving taxes or implementing an exemption on all medical products received as donations.
  3. Improve communications among all relevant stakeholders by implementing consultation and feedback mechanisms. Insufficient communication with communities leads to mistrust and undermines the achievement of positive results.
  4. Strengthen the Health Commodities Security Technical Working Group by including representatives from communities of people living with HIV and civil society organizations.
  5. Ensure that HIV management is implemented holistically by taking into consideration prevention and diagnosis, care and treatment, and related essential commodities, including medications. This is urgently needed to address current shortages of paediatric HIV treatment, viral load testing reagents, and HIV test kits.

The COVID-19 pandemic has deeply affected all aspects of Kenya’s healthcare system with a particularly strong negative impact on communities of people living with HIV and those at risk of contracting HIV. Despite the challenging situation, by adopting the above-mentioned actions, the Kenyan government can preserve progress achieved through national AIDS control efforts to date, and it can ensure predictable access to HIV treatment and services for its citizens even in these difficult times.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.5 million clients in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare

Contacts

KENYA MEDIA CONTACT:

Dr. Samuel Kinyanjui
Country Program Director
AHF Kenya

3rd Parklands Avenue, AHF Plaza

P.O. Box 103363-00101 Nairobi

Office Main: (254) 722 293 960

Samuel.Kinyanjui@ahf.org

Faith Ndungu Mwenda
Program Development and Advocacy Manager
AHF Kenya

3rd Parklands Avenue, AHF Plaza

P.O. Box 103363-00101 Nairobi

Office Main : (254) 722 293 960

Wamae.Maranga@ahf.org

US MEDIA CONTACT:

Ged Kenslea,
Senior Director,

Communications, AHF

+1.323.791.5526 cell

ged.kenslea@ahf.org

Denys Nazarov
Director of Global Policy &

Communications, AHF

+1.323.308.1829

denys.nazarov@ahf.org