Today, NMAC Launches “Save Our Services,” an innovative campaign created to empower Americans across the country in fighting the proposed federal budget cuts that would cause severe harm to vital HIV treatment and prevention services.
SOS will enlist the advocacy of community volunteers to contact their representatives in Congress both in their home offices during the August recess and on Capitol Hill for the official “HIV/STD Action Day” on Sept. 6. This Day of Action will precede the opening of NMAC’s annual U.S. Conference on AIDS, which will run from Sept. 7 – 10. More information about “Save Our Services” can be found at nmac.org/sos.“We are at a critical point in the fight against HIV/AIDS. The real possibility of ending the epidemic is in sight but only if we continue to use and fund the current tools we already have.,” said Paul Kawata, Executive Director of NMAC. “Through methods like Treatment as Prevention and Pre-Exposure Prophylaxis, we have seen drastic reductions in new infections around the country. But that progress is threatened by the cuts proposed by this Administration to HIV/AIDS services. These cuts could lead to a resurgence of HIV in America just as we have found a path to potentially end it.
If passed, the president’s budget would:
Eliminate the Secretary Minority AIDS Initiative FUND (SMAIF), a program that provides over $50 million in funding that helps get and keep people of color in care.
Decrease funding to the Ryan White HIV/AIDS Program by $59 million thereby eliminating AIDS Education and Training Centers which would make it all but impossible for clients seeking HIV-related services to do so.
Cut $610 billion from Medicaid – one of the largest payers of insurance for people living with HIV.
Result in over one million fewer HIV tests each year, meaning thousands of people will be unaware of their status leading to over 30,000 more people becoming HIV-positive.
“These cuts would deprive communities of color – which are more greatly impacted by HIV – from vital treatment and prevention services,” said Kawata. “Make no mistake: these proposed cuts would lead to more people becoming sick, becoming HIV-positive, or even dying. We absolutely cannot back down in the fight against HIV/AIDS now that we are so close to a final victory in this decades-long fight.”
Theratechnologies Inc. (Theratechnologies) (TSX: TH) announced Friday that it has been notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing.
“We are excited to be one step closer to potentially bringing an important new treatment, with a new mechanism of action, to patients whose virus has become resistant to therapies in multiple classes and have limited treatment options for the long-term management of their condition,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. “The granting of Priority Review status is important since it confirms that, if approved, ibalizumab would represent a significant improvement in the treatment of this serious condition,” added Mr. Tanguay.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2018, for the ibalizumab application. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance. In addition, ibalizumab received Breakthrough Therapy designation from the FDA in 2015, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted Orphan Drug designation in 2014.
The BLA, submitted on May 3, 2017, is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients who had high pre-existing levels of drug resistance and advanced clinical disease.
As HIV multiplies in the body, the virus may mutate to produce drug-resistant strains. Viral mutations may mean that HIV medicines that previously controlled a person’s virus are no longer effective, causing treatment to fail. There are approximately 20,000 to 25,000 Americans with HIV-1 that are resistant to at least one drug out of the three different classes of antiretroviral therapies. Up to 12,000 of these patients experience a virological failure over a period of 48 weeks of treatment, requiring their physician to modify their treatment.
About ibalizumab
Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of MDR HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function.
Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents.
In a community-created consensus statement released today, AIDS United provides critical guidance for clinical providers, funders and social service providers to strengthen their understanding of how best to engage and support transgender communities. The statement provides concrete and measurable steps organizations can take to improve their approach to HIV work in transgender communities and was drafted by 12 transgender leaders at a think tank convened by AIDS United and generously supported by Janssen Therapeutics, Division of Janssen Products, LP.
The transgender community is critically affected by HIV and faces unique challenges accessing HIV care. A landmark 2013 study estimates that 22 percent of transgender women in the United States are living with HIV. This makes transgender women the most heavily affected group in the United States, relative to their population size. This disproportionate risk is fueled by pervasive violence and discrimination faced by transgender and gender non-conforming individuals in areas such as housing, education and when accessing health care.
“Our recent survey shows 41 percent of the respondents reported lapses in health care for longer than six months. This speaks to the need to meaningfully involve trans people living with HIV in cultural competency training and program designs. Trans people are experts of their experiences and this consensus statement puts the expertise of trans people front and center,” said nationally recognized leader in civil rights and trans equality Cecilia Chung.
“Twelve trans leaders from across the country came together to create concrete recommendations so that funders, health care providers and social services organizations can serve our communities with the dignity and respect we deserve. There is power in this—and the best practices we outlined are critical for improving trans health and justice in this country,” said Chung.
Due to these factors, it is critical that clinics and support services are welcoming, inclusive and competent in serving transgender people. Additionally, funders must ensure that funding strategies and decisions are community informed to yield the greatest impact.
“We can no longer ignore the needs of the transgender and gender-nonbinary community. Our consciousness of their presence has been raised, but our services have not stepped up to meet their unique needs,” said AIDS United President & CEO Jesse Milan, Jr. “We cannot allow transgender people to be left out or left behind or we will not fully achieve our national goals.”
The Consensus Statement and the newly launched Transgender Leadership Initiative, also funded by Janssen Therapeutics, are programmatic efforts by AIDS United to better partner with transgender leaders to address the dire HIV epidemic in transgender communities, to improve transgender health outcomes and to solidify transgender power in our society. Proposals for support from the Transgender Leadership Initiative are due by Jun 14, 2017 at www.aidsunited.org.
“This statement is a foundational tool that every provider and HIV advocate can use. It is the newest tool in our toolbox for ending the HIV epidemic in this country and AIDS United is proud to release it to everyone,” said Milan.
HIVE (hiveonline.org) and Project Inform (projectinform.org) are pleased to announce the hiring of three key positions for supporting PrEP services within California and nationally through expanded navigation services at PleasePrEPMe.org (PPM). The launch date of these free new services is being planned for early April.
“HIVE launched PleasePrEPMe.org in 2015 to provide consumers a search engine to find PrEP-friendly clinicians within California,” stated Shannon Weber, Director at HIVE. “This year, with a grant from the state department of health, we’re excited to be expanding the original site to include an online chat function as well as provide navigation assistance by phone, email and text services in English and Spanish.”
Charlie Romero comes to the program as PleasePrEPMe’s State PrEP Navigator from Children’s Hospital Los Angeles where he supported adolescents’ access to care and prevention, including PrEP, for the last four years. He brings incredible compassion and commitment to people of diverse backgrounds along with his real-world clinic experience to support individuals in accessing the care they need. Charlie is based in Los Angeles and is eager to help bring a true state-wide vision and network to PPM efforts.
Laura Lazar very recently started as PleasePrEPMe Coordinator and is based in San Francisco. Laura joins PPM from AVAC (avac.org) where she was Program Coordinator of Research and Data Analytics, reporting on HIV prevention R&D investments and managing their HIV prevention study database. She previously worked at the HPV and Anal Cancer Foundation running the database that matched applicants for peer-to-peer support. With her strong organizational skills, analytical mind and ability to connect, Laura will assure our work processes and communications make PPM a product that is maximally useful for all.
Reilly O’Neal recently joined PleasePrEPMe as State Resources Coordinator. Previously, Reilly was the editor of San Francisco AIDS Foundation’s BETA Blog and more recently has been a freelance writer and editor for UCSF and Gilead. Reilly will work with us to develop state-specific resource pages, helping us develop a sustainable infrastructure to support states in PrEP rollout nationally.
Although additional strategies are in clinical study, currently PrEP is taken as a daily pill by HIV-negative individuals at risk for the virus. The State Department of Health estimates that between 221,528 and 238,628 Californians are eligible for PrEP, though far fewer than that are currently on PrEP. In contrast to these figures nationally, only 80,000 prescriptions have been written since the FDA approval in July 2012.
“PleasePrEPMe is looking forward to further help Californians understand PrEP and how to find and maintain their prescriptions,” remarked Alan McCord, Director of Education at Project Inform. “It’s exciting for us to help enhance individuals’ sexual and general health, and our new star staff are eager to begin this journey throughout the state.”
The Human Rights Campaign (HRC) Foundation announced the selection of ten outstanding, young leaders for the second year of its fellowship program focused on elevating the work of young people on the front lines of the HIV and AIDS epidemic.
The HRC Foundation’s HIV 360° Fellowship Program, made possible with the generous support of the Elton John AIDS Foundation (EJAF), provides individualized training and support to innovative young professionals and nonprofit leaders as they tackle the challenges facing communities hit hardest by HIV, including Black and Latino gay and bisexual men, transgender women of color, and LGBTQ people living in the U.S. South.
“We are honored to welcome ten talented young leaders to the second class of HRC’s HIV 360° Fellowship Program,” said Mary Beth Maxwell, HRC Senior Vice President for Programs, Research and Training. “Through their dedication, creativity, and hard work, these activists are changing lives, expanding opportunity, and combatting the stigma and discrimination facing so many people living with and affected by HIV in the U.S. We look forward to working with them over the coming year and into the future as they continue to speak out, act up, and bring an end the HIV and AIDS epidemic once and for all.”
“The Elton John AIDS Foundation is proud to support HRC’s second class of HIV 360° Fellows,” said Scott Campbell, EJAF Executive Director. “This impressive, diverse group of leaders has a vast amount of professional and real world experience and represents viewpoints from across the country. The future of LGBTQ rights and HIV activism is brighter because of their commitment and dedication.”
The new class reflects a diverse cross-section of the activists and advocates working tirelessly to combat both the stigma and spread of HIV across the country:
Ashley Young of Little Rock is an experienced public health professional whose work is aimed at the improvement of health systems and health outcomes for underserved communities specifically geared towards women and children. Ashley currently serves as the project manager for the Passion Project, a SAMHSA funded initiative designed to expand and enhance substance use disorder treatment, behavioral health, HIV & AIDS, and viral hepatitis services to high risk African-American women who have substance use or co-occurring substance use issues and mental health disorders.
Charlie Ferrusi of New York City is an impassioned social justice activist, seeking to eliminate the health disparities faced by LGBTQ people as well as people living with and affected by HIV. Charlie received his MPH in Community Health from New York University College of Global Public Health. He currently serves as a Contract Manager at the NYS Department of Health, AIDS Institute in the LGBT Health Services Unit. Charlie works closely with both the Columbia County Young Democrats and Hudson Pride Foundation.
Damon Johnson of Atlanta is a rising public health leader dedicated to transformational social change. Damon currently serves as the Associate Director of Programs at NAESM, Inc., a community-based organization focused on the impact of HIV on communities of color in the South. Damon and his team take a multidisciplinary approach to developing comprehensive programs and initiatives that address the complex needs of people from marginalized communities.
Daniel Downer of Orlando is a budding community advocate who firmly believes in fostering unity for everyone regardless of their ethnicity, gender identity, race, or sexual orientation. He currently works as an Early Intervention Specialist for the Hope and Help Center of Central Florida, Inc. Daniel is a well-respected leader in his community for his ability to captivate, empower, inspire, and mobilize others to erase the stigmas not only surrounding HIV, but also ethnic and gender identity, homelessness, mental health and substance abuse, race, and sexual orientation.
Daniel Szymczyk of New York City is a graduate of Appalachian State University and a rising, nonprofit professional. He is the founder and Executive Director of The HIV League, the nation’s only scholarship-granting organization for students living with HIV. Daniel began focusing his efforts on HIV-related issues once he grew comfortable with his own HIV-positive diagnosis.
Erika Usui of New York City is a graduate of the State University of New York Downstate Medical Center’s School of Public Health. Erika currently serves as Health Services Coordinator at The Ali Forney Center, a community-based organization whose mission includes protecting LGBTQ youths from the harms of homelessness. Erika is committed to providing LGBTQ youth with the HIV prevention and treatment tools they need and deserve.
Francisco Cortes of Philadelphia is the Youth Program Coordinator at Galaei, a queer Latinx social justice organization based in Philadelphia. Francisco currently serves on the Board of Directors for Juntos, and he is the youngest appointed Commissioner to the Office of LGBT Affairs in the city of Philadelphia.
Jalenzski Brown of Dallas seeks to find peace, love, happiness, and understanding in every moment of his human experience and help those around him do the same. Jalenzski studies the world around him, seeking new truths in an effort to create a greater tomorrow. He currently works at Resource Center – North Texas’ primary LGBT and AIDS service organization – as the MPowerment Programs Manager, where co-manages HIV and STD prevention and treatment services.
Socorro Moreland of Oakland is a Puerto Rican, classically trained chef who was born in 1985 to a revolutionary family committed to social justice liberation and the Black power movement. Socorro found his calling within the HIV prevention field 11 years ago and coordinates programming and support services for transgender people of color within the Bay Area. Socorro currently works for APEB, a community-based, nonprofit organization.
William Campillo Terrazas of Little Rock was born in Nogales, Sonora, Mexico and migrated to the United States at the age of 6. Upon receiving Deferred Action for Childhood Arrivals, William took a job as a Disease Intervention Specialist within the Arkansas Department of Health. In 2015, William helped co-found Latinxs Revolucion LGBTQ, a queer- and trans-led, community-based organization in Little Rock that focuses on the health and well-being of Latinx immigrants.
The new class of fellows will receive leadership and organizational development training, mentorship, as well as coaching in communications, leadership, fundraising, and other aspects of successful nonprofit management – all focused on strengthening their own community-based organizations and initiatives.
Members of last year’s inaugural fellowship class developed their non-profit management and leadership skills, and received a grant of up to $9,000 to design, implement, and evaluate innovative approaches to addressing the HIV and AIDS epidemic in their local communities. You can read more about their projects here. To date, the 2016 cohort’s efforts have helped more than 1000 LGBTQ people and allies access HIV-related programs and services in some of the nation’s hardest hit communities.
Since its founding, HRC has worked to end the dual epidemics of HIV and HIV-related stigma through federal, state and local advocacy as well as public education and outreach. By educating LGBTQ people and allies about the current realities of HIV, HRC has been able to mobilize its members and supporters to take action to support critical public health programs like the Ryan White Care Program, and to expand access to vital health care, treatment, and nondiscrimination protections made possible by the Affordable Care Act.
HRC has also worked with various public health organizations to raise awareness of and increase access to Pre-Exposure Prophylaxis (PrEP) in communities across the nation hardest hit by HIV. HRC also regularly trains healthcare providers, front line workers, and community advocates on how to best provide LGBTQ-competent, HIV-inclusive care to the people most in need, especially those living throughout the Deep South.
For more information about the program, please visit: www.hrc.org/hiv360.
Today, NASTAD (National Alliance of State & Territorial AIDS Directors), a leading non-partisan non-profit association that represents public health officials who administer HIV and hepatitis programs in the U.S. and around the world, published a new statement affirming that durably virally suppressed people living with HIV on antiretroviral therapy (ART) do not sexually transmit the virus. The statement accelerates NASTAD’s longstanding work to end HIV and promote policies and public health practice grounded in science.
”The science is clear that people living with HIV with a sustained undetectable viral load do not transmit the virus to others. What’s also clear is that we have the tools to end the HIV epidemic and HIV-related stigma and make new infections a thing of the past. Today, we tackle a major part of this work by raising awareness about the latest science of HIV transmission risk,” remarked NASTAD Executive Director Murray Penner.
“Until now, there hasn’t been anyone ensuring this life-changing information is communicated clearly and meaningfully to people living with HIV,” said Bruce Richman, Executive Director of Prevention Access Campaign and the Undetectable = Untransmittable Initiative. “NASTAD was the first non-profit to endorse the Prevention Access Campaign’s Consensus Statement last year representing a bold step toward sharing a message that will improve the social, sexual, and reproductive lives of millions of people living with HIV in the U.S. and around the world.”
The conclusive evidence about the highly effective preventative benefits of ART provides an unprecedented opportunity to improve the lives of people living with HIV, improve treatment uptake and adherence, and advocate for expanded access to treatment and care.
People living with HIV who are on ART and are durably virally suppressed are not only less likely to develop HIV-related complications, they also do not transmit the virus to others. This new evidence will help ameliorate decades of HIV-related stigma, discrimination, and criminalization by confirming that treatment is a powerful preventive intervention.
Zero new linked transmissions in the PARTNER study based on new findings and zero transmissions from virally suppressed partners in HPTN 052 trial studying whether ART can prevent sexual transmission of HIV equates to there being effectively no chance of sexual HIV transmission from people living with HIV who are on ART and durably virally suppressed.
An FAQ on the PARTNER study notes that STIs and likely small short-lived increases in viral load or ‘blips’ did not increase HIV transmission risk during sex in this study. STIs and viral blips have not been shown to increase transmission risk from an HIV positive person who is on ART and virally suppressed in any study or empirical evidence to date.
While viral suppression prevents the transmission of HIV, consistent and correct condom use and pre-exposure prophylaxis (PrEP) also prevent the transmission of HIV, and condoms provide additional protection for other sexually transmitted infections (STIs) and pregnancy.
These findings have been embraced by leading experts in the field, including:
“People living with HIV who achieve viral suppression are a fundamental part of ending new HIV infections in the United States and around the world in our lifetime. History will judge us by how well we respond to this unprecedented opportunity,” noted Dr. Demetre Daskalakis.
In conjunction with new and existing partners, NASTAD will continue to advocate at the national level to raise awareness about the latest science of HIV transmission risk and implement policies and practices grounded in our best science void of stigma and discrimination. Finally, NASTAD will continue to monitor the scientific landscape for advances that will enhance our understanding of how to reduce new HIV infections and optimize the quality of life for people living with HIV.
The first large-scale clinical trial of a long-acting injectable drug for HIV prevention began today. The study, sponsored by the National Institutes of Health, will examine whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every 8 weeks can safely protect men and transgender women from HIV infection at least as well as the anti-HIV medication Truvada taken daily as an oral tablet. If injectable cabotegravir is found to be effective for HIV pre-exposure prophylaxis, also known as PrEP, it may be easier for some people to adhere to than daily oral Truvada, the only licensed PrEP regimen. Truvada consists of the two anti-HIV drugs emtricitabine and tenofovir disoproxil fumarate.
“We urgently need more HIV prevention tools that fit easily into people’s lives,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. “Although daily oral Truvada clearly works for HIV prevention, taking a daily pill while feeling healthy can be difficult for some people. If proven effective, injectable cabotegravir has the potential to become an acceptable, discreet and convenient alternative for HIV prevention.”
NIAID is collaborating on the Phase 3 clinical trial of injectable cabotegravir with ViiV Healthcare, Gilead Sciences, Inc., and the NIH-funded HIV Prevention Trials Network (HPTN). In a novel funding structure for an NIH HIV prevention study, NIAID and ViiV Healthcare are co-funding the trial. NIAID is sponsoring the study, called HPTN 083, and ViiV Healthcare and Gilead Sciences are providing the study medications.
The study will enroll 4,500 men who have sex with men and transgender women who have sex with men at 45 sites in eight countries in the Americas, Asia and Africa. Participants will be aged 18 years or older and at high risk for HIV infection. Results are expected in 2021.
“The annual number of new HIV infections among young people, especially young men who have sex with men and transgender women who have sex with men, has been on the rise despite nearly flat HIV incidence among adults worldwide,” said HPTN 083 Protocol Chair Raphael J. Landovitz, M.D., M.Sc. “It is essential to develop multiple effective HIV prevention modalities so the most vulnerable populations have a choice of preventive options. We hope injectable cabotegravir will become one such modality.” Dr. Landovitz is an associate professor of medicine at the David Geffen School of Medicine at University of California, Los Angeles, and associate director of the UCLA Center for Clinical AIDS Research & Education.
HPTN 083 study participants will be randomly assigned to either the cabotegravir group or the Truvada group. Neither the participants nor the study team will know who is in which group until the end of the trial.
Participants will be in the study for an average of 4.5 years. During their first five weeks after enrollment, they will receive two daily oral tablets: either cabotegravir or Truvada, and a placebo pill. Beginning in the sixth week, participants in the cabotegravir group will receive injections of cabotegravir and placebo tablets to be taken orally daily, while participants in the Truvada group will receive placebo injections and Truvada tablets to be taken orally daily. Injections will be administered by study staff. The first two injections will be four weeks apart, then once every 8 weeks for an average of nearly 3.5 years. After completing the injections, all participants will be offered 48 weeks of PrEP with daily oral Truvada.
HPTN 083 study participants will receive HIV prevention counseling, condoms and lubricant, as well as counseling to encourage and support adherence to the daily oral pill. Participants will be tested for sexually transmitted infections (STIs) throughout the study and referred for appropriate treatment if an STI is diagnosed. Study participants who become HIV-infected during the trial will stop receiving the study products and be referred to local medical providers for HIV care and treatment.
“The HPTN 083 study has the potential to provide game changing data as the first large-scale test of a long-acting injectable drug for HIV prevention,” said Protocol Co-Chair Beatriz Grinsztejn, M.D., Ph.D. Dr. Grinsztejn directs the Instituto de Pesquisa Clinica Evandro Chagas HIV/AIDS Clinical Research Centre of the Oswaldo Cruz Foundation-Fiocruz in Rio de Janeiro, Brazil.
A related study called HPTN 084 will test the safety and efficacy of injectable cabotegravir for HIV prevention in young women in sub-Saharan Africa beginning in 2017.
PrEP stands for Pre-exposure Prophylaxis, protection before exposure to HIV. It’s a once a day pill called Truvada for people who are HIV negative to protect them from getting HIV. PrEP was approved by the FDA in 2012, and by the U.S. Centers for Disease Control for use in HIV prevention.
I recently attended the National PrEP Summit with other HIV prevention professionals from around the country. The two-part take away for me could not have been any clearer: PrEP works, and there are so many more people who should be using it. Throughout the country, PrEP is disproportionally underutilized by women, African Americans, and Latinos. There are many challenges in getting the word out about PrEP, especially in these populations.
I have said before, if you had told us in the 1980s and 90s that there was a pill that could have prevented HIV, people would have been falling all over each other to get it. So, why not now? Although a growing number of people are beginning to use PrEP as part of their personal HIV prevention strategy, it has not taken off as quickly as one would think. There are a variety of reasons for this, the first clinical trials showed that PrEP was only 44% effective, not all that exciting. However, when they dug deeper into the data it showed to be up to 99% effective for those in the study who actually took the medicine every day as prescribed. Now we’re talking!
Many people, especially in certain populations have still not heard of PrEP, or have not heard how effective it is in preventing HIV. There has also been some stigma related to taking PrEP (similar to birth control when it first came out in the 60s). Early PrEP users were often referred to as “Truvada Whores”. Fortunately, this has begun to wane in the Gay community, where it is now being viewed as a positive thing that a potential sexual partner has been protecting themselves from HIV. Other barriers in getting people on the PrEP bandwagon include the high cost, and medical providers who are not comfortable prescribing it.
While PrEP is very expensive, $1,300 a month, it’s covered by most health plans including Medi-Cal. There are also patient assistance programs that can help with co-payments. Although many non-HIV specific doctors are not knowledgeable, and therefore uncomfortable, prescribing PrEP (or even talking to their patient about sex), we are fortunate here in Sonoma County to have several local health centers that are eager to talk to their patients about starting PrEP. California just passed a law requiring HIV test counselors to tell every person who tests negative about PrEP.
Face to Face does the majority of HIV testing in the county. We’ve been handing out PrEP brochures, and referring people to PrEP providers for quite a while. We are strong advocates for using every tool out there to end HIV transmissions in Sonoma County, and believe PrEP is our most powerful prevention tool yet. Each time we deliver the news that someone is HIV positive, I wonder if this person had heard of PrEP, considered it, thought they didn’t need it, or couldn’t afford it. A person does not need to be at high risk for getting HIV, they just have to be at risk.
The PrEP vs condoms controversy: Can’t people just use condoms? Sure, and many people do and feel comfortable with that level of protection. However, condoms don’t work at all if they’re left in the bedside drawer, just like PrEP doesn’t work if you don’t take it. Many people have a hard time (pun intended) with condoms, and therefore don’t use them regularly. Most see PrEP as an extra layer of protection and use them in conjunction with condoms. Some choose to use PrEP only, and do not use condoms. Yes, public health folks are concerned about increases in other sexually transmitted diseases. And, while there is currently a significant spike in Chlamydia, Syphilis, and Gonorrhea in California and in Sonoma County, it has not been shown that PrEP is to blame. And remember, these sexually transmitted infections are all curable, whereas there is still no cure for HIV.
So, PrEP is effective. There has been only one known case of someone contracting HIV while on PrEP, owing to a rare Truvada-resistant strain of HIV.
And, PrEP is safe. Most people experience no side effects and those who do say they are mild and last less than a month.
And, PrEP is available locally, and in most cases, affordable.
The enthusiasm and hope of ending HIV at the National PrEP Summit got me thinking about myself. I’m a single Gay man. I’m 62, and not quite as “popular” as I was in my 20’s, but couldn’t I use another layer of protection? Why not take PrEP myself? I called my doctor, got labs done to make sure I’m HIV negative, a full STD screening, checked my kidney function and bone density (all good tests I haven’t had in a long time), and now I’m ready to start my once a day pill. Who knows, maybe I’ll become more “popular” because of it, lol.
If you, or someone you know is curious about PrEP, come in and talk to one of our HIV Test Counselors. Get more information, have your questions answered, and if you’re ready, get a referral to a local provider. Test Counselors are available on a drop-in basis, Tuesday through Friday from 9:00 am to 4:30 pm at the Face to Face office at 873 Second Street, Santa Rosa.
In 2017, the patents for two antiretroviral drugs for HIV that continue to be widely used will likely expire in the United States and generic alternatives at lower market prices could be introduced. Some have long awaited this occurrence, hoping for increased competition and a drive to lower prices for all HIV medications. However, it is an open question whether generic competition, at least in the short term, will actually materialize or if it does, lead to reduced prices. If savings are realized, there is also no guarantee they will be funneled back into other critical HIV services. To explore the possibilities of wider generic availability in the United States, Project Inform co-hosted a meeting with the National Association of State and Territorial AIDS Directors (NASTAD) and the Treatment Action Group (TAG) in Washington, D.C. on September 29 and 30, 2016.
The two drugs going off patent soon are efavirenz – marketed as Sustiva – and tenofovir disoproxil fumarate (TDF) – marketed as Viread. Both efavirenz and TDF are available in combination with other antiretroviral drugs as single tablet regimens (STRs), and some of the other drugs contained in those STRs will not be going off patent. This could have significant consequences, such as the need to break up prescribed regimens into multiple pills with multiple insurance copayments.
Co-sponsors invited a diverse set of stakeholders, including providers, activists, policy makers, health economists and generic manufacturers to the meeting to ensure a broad and lively discussion. The primary segments of the discussion were:
an analysis of current drug costs across multiple payers (e.g. private insurance, Medicaid, The VA, etc.);
the potential (if any) to redirect any savings to other HIV services; and,
what the positive, neutral or negative outcomes might be for people living with HIV and front-line providers when generic HIV drugs become available.
As became clear through early discussions, the drug purchasing systems in the United States are incredibly convoluted, vary significantly by payer source, and are fairly opaque to those seeking to understand or reform purchasing systems.. Appearances can be deceiving. The price actually paid by private and public payers is almost never publicly available as negotiations are protected by privacy agreements. Because of certain purchasing mechanisms , public programs such as Medicaid or public health clinics or hospitals may be paying very little and generating program income on some older brand drugs before they go off patent. This income could significantly decrease with the introduction of generics, depending on a number of factors, including how the generics were priced and whether or not supplemental rebates were negotiated.
Examination of the generic market and payer purchasing systems raised real questions about how much money could actually be saved within a system on generic versions of HIV drugs, certainly in the near future. It is unclear where savings might be possible and how much savings would be generated by the entry of generic HIV drugs into various health care settings. Generic manufacturers and some academic studies have previously stated that significant savings could be generated but a closer examination of generic competition and health care systems made it clear that more analysis is necessary. This is not to say that generic competition is inherently bad or unuseful as a bargaining chip to lower health care costs, but that the system is so complex and everchanging that it will take considerable effort to unravel the potential outcomes of different possible scenarios.
In most cases, there are no mechanisms for savings on drug costs within most health systems to accrue back to other HIV services. Some experimental comprehensive care programs in one state are being attempted, but there is no guarantee that such programs will continue or be could be adopted in other states.
Finally, there is the fear among some advocates and providers that more aggressive cost containment measures, such as the need for a provider to get prior authorization from an insurer in order to prescribe brand name or single tablet regimens drugs, could result in some people with HIV having to take less tolerable or simple regimens and an increase in the time spent by providers and their staff dealing with the ever-changing rules and policies put in place by payers.
Though the participants agreed that the hopes once expressed about the potential for generics to usher in lower drug prices for all HIV medications in the United States are perhaps not grounded in our current reality, the activists and providers who gathered on the second day were determined to identify actions that could be taken now to ensure that benefits might be achieved. In addition, it was decided to further explore what protections might be necessary for patients and their providers to ensure access to standard of care HIV treatment in all health care systems with the entry of generic HIV drugs.
These actions have been prioritized and are being refined by the co-sponsors. They will be outlined in in more detail in recommendations put forward by the co-sponsors and we will work on implementation of some of the prioritized suggestions, which include a modelling project that would help to better understand potential cost savings and/or program income loss with the entry of generic HIV drugs. Project Inform will provide updates on these important efforts as they become available.
The ultimate impediment to a cure for HIV infection is the presence of latent, HIV-infected cells, which can reawaken and produce new virus when antiretroviral drug therapy is stopped. These latent, HIV-infected cells are untouched by antiretroviral therapy and are unseen by the immune system. Moving medicine closer to a cure for HIV, scientists at Blood Systems Research Institute (BSRI), the University of California at San Francisco (UCSF), and the University of Hawaii have discovered that the human sugar-binding protein galectin-9 potently forces latent HIV out of hiding, and poisons the virus on its way out.
Building off of their earlier studies that identified key human genes involved in maintaining the latent, hidden state of HIV-infected cells, the paper’s lead author, Dr. Mohamed Abdel-Mohsen, Scientist at BSRI and UCSF School of Medicine, and colleagues used cutting-edge technologies to demonstrate that galectin-9, a beta-galactoside-binding lectin, reactivates latent HIV and renders infected cells visible to the immune system. This concept of therapeutically forcing latent HIV out of hiding as a curative approach is known as the “shock and kill” HIV eradication strategy.
Dr. Satish Pillai, lead researcher on the study, Associate Investigator at BSRI and Associate Director of the UCSF-Gladstone Institute of Virology & Immunology Center for AIDS Research, explains, “For nearly two decades, antiretroviral therapy has demonstrated efficacy in suppressing HIV replication, but these drugs do not completely clear viral infection or fully restore health. We need a means to draw out the virus from its hidden reservoirs within the body and allow the body’s own immune system to eliminate it.”
Beyond subjecting latent HIV-infected cells to destruction by the immune system, the team found that galectin-9 strongly increases levels of an antiviral protein called “APOBEC3G” in infected cells. APOBEC3G is a lethal mutagen that destroys the genetic code of viruses including HIV. This ensures that virus that comes out of hiding at the hands of galectin-9 will be sterilized on its way out of the cell, preventing any further infection. These findings reveal that galectin-9 is a new weapon in the HIV cure arsenal, promoting eradication of the latent HIV reservoir in infected individuals on antiretroviral therapy.
The research was published in PLoS Pathogens and is an open access manuscript.
An additional revelation in the authors’ study is that galectin-9 works by manipulating sugars on the surface of HIV-infected cells to deliver the signals that force latent HIV out of hiding. “Galectin-9 binds to certain classes of sugars on the surface of cells to start a chain reaction that forces HIV out of hiding. There’s been very little attention paid to how the sugar coating on the surface of human cells affects the fate of the virus that lies inside. This sugar coating may hold the key to new therapeutics that can be harnessed to cure HIV and possibly a range of other infectious diseases.” says Abdel-Mohsen.
Pillai and Abdel-Mohsen also see the potential for galectin-9 to alter the current course of treatment for HIV, which involves life-long adherence to antiretroviral therapies to prevent latent stores of the virus in the body from reactivating and infecting new cells. “Our findings make us optimistic that future HIV treatments can eliminate all traces of the virus from the body,” says Pillai. “Ultimately, we hope that galectin-9 gets us one big step closer to a cure.” says Abdel-Mohsen.
The study was funded in large part by the amfAR Institute for HIV Cure Research and by the National Institutes of Health (NIH), with additional support from the University of California and the San Francisco-Gladstone Institute of Virology & Immunology Center for AIDS Research. The findings are among the first to be generated by researchers supported by the amfAR Institute, which was announced in December 2015. The centerpiece of amfAR’s Countdown to a Cure for AIDS initiative, the Institute brings together leading HIV researchers working collaboratively to address the scientific challenges that stand in the way of a cure.
