The Future of HIV: Novel Treatment Options & A Possible Cure

As the medical community and those it serves welcomed in a new year, it brought with it the hope of scientific advancements that will alter the course of certain disease states. These advancements include the use of stem cells to treat to treat macular degeneration, novel microscopic techniques to capture images of the brain, the continued observed effectiveness of the experimental Ebola vaccine, and countless other interventions aimed at creating a healthier global society. Included in these optimisms for 2019 is the possibility for novel treatment options and a possible cure for one of the world’s leading causes of death, HIV. The stories of Timothy Brown – the only individual ever to be cured of HIV, the Mississippi baby and Clark Hawley – both having an extended period of time with undetectable HIV viral load with an interruption of Antiretroviral Therapy (ART), and the Boston patients/Mayo Clinic patient – all three having undetectable HIV viral loads for an extended period of time after a stem cell transplant, have brought much sanguinity to health care professionals and patients alike. However, these exciting results have been unable to be replicated in the majority of the population suffering from HIV and remain unique in their respective occurrences. Although ART has been vital to the HIV community in terms of longevity and quality life, there are still certain populations that are seeking other mechanisms to treat this infectious disease – and, of course, always coveting the idea of a cure. The following is a brief glimpse at the vast pipeline that awaits 2019 and the anticipations of the global healthcare community.  

Combination Approaches

  1. The AIDS Clinical Trial Group (ACTG) is currently exploring the option of combining vorinostat, a HDAC inhibitor along with tamoxifen, which is an FDA approved medication the treatment of breast cancer for postmenopausal women. Utilizing this approach is thought to prevent the reactivation of HIV in CD4+ cells that are latent in addition to increasing the latency-reversal effect of vorinostat through tamoxifen.
  2. Researchers from the USA, France, Germany, Italy, Spain, Switzerland, and the UK are collaborating for a trial testing the combination of two HIV vaccine candidates alongside a monoclonal antibody called vedolizumab. This method of treatment is thought to target a certain protein in the body, α4β7 integrin, that plays a role in transmission of HIV into CD4+ cells. In a macaque model, this combination has shown the control of SIV (HIV but in simians) after discontinuing ART.
  3. At the University of Minnesota, researchers are testing infusions of natural killer (NK) cells with the administration of cytokine interleukin-2 (IL-2). The researchers are hoping to add to the evidence of NK cells being able to exhaust HIV reservoirs and to control virus replication.
  4. In a version of the “kick & kill” method of curing HIV, researchers in Oxford and Barcelona are using a medication to active the latent HIV reservoir while boosting the immune response 1000 times stronger than the usual to rid the body of the virus. Preliminary results showed that 5/15 patients had undetectable viral loads for seven months without ART.

Immunotherapy Approaches

  1. Immunocore, a company founded in Oxford with heavy investment by Bill Gates, has designed T cell receptors that seek out and bind with the HIV virus. These receptors then instruct immune T cells to eliminate any HIV-infected cells, even when the levels happen to be extremely low. Since levels can be rather low in the reservoir of HIV virus that exists in an infected individual, this is a promising lead to completely remove this retrovirus from the body. This immunotherapy has shown to be effective in human tissue samples, but no results being tested in humans have been released.
  2. In France, a company known as InnaVirVax has established a vaccine, VAC-3S, that allows the body to stimulate a production of antibodies against the HIV protein 3S. This, in turn, causes T cells to attack the virus. This is considered a novel approach because it encourages the immune system to recover while equipping it with the tools to continue fighting off the virus. VAC-3S has completed Phase 2a trials, and is partnered with a DNA-based vaccine from FIT Biotech, a Finnish company, that both parties believe can lead to a functional cure.  
  3. In a recently initiated trial, IMPAACT 2008, held in the USA, Botswana, Brazil, and Zimbabwe, a broadly neutralizing antibody termed VRC01 is being investigated for its effectiveness in infants with HIV who are also started on ART within 12 weeks of birth. Although the study aims at establishing the safety profile for VRC01, it is also observing the difference in the HIV reservoir compared with only ART.

Novel Antiretroviral Agents

  1. The manufacturer, ABIVAX, believes it has developed a compound that may help the immune system recognize cells infected with HIV by allowing an increased presentation of HIV antigens on the cell’s service. This would lead to an augmented immune response to abolish these infected cells. This compound has been labelled ABX464 and targets the HIV protein Rev, which is responsible for the transcription of HIV RNA. Reductions of measured HIV DNA have been reported from 25% to 50% in eight of the fifteen patients participating in the study; however, no delay in viral load rebound was found when compared with placebo.
  2. Gilead has created a novel mechanism of targeting the HIV virus through the capsid inhibitors class. Capsids are involved in protecting HIV RNA and related proteins, and capsids also breaks down to release the viral contents into CD4 cells which enable reverse transcription to take place. The novel agent by Gilead, GS-CA1, blocks both the assembly and disassembly of capsids that create non-infectious and defective viruses.

Gene Therapy

  1. Chimeric antigen receptor (CAR) T therapy has been re-initiated in the first cure related clinical trial of this approach in people living with HIV who are on ART. CAR T cell therapy involves the modification of an individual’s T cells that can target antigens of interest. The specific cells modified by the initiative in China, called VC-CAR-T cells, have been modified to target HIV gp120. These modified cells were able to induce the destruction of HIV-infected cells, including latently infected cells exposed to latency-reversing agents, in the laboratory setting.  
  2. With the knowledge of knowing that about 1% of the world’s population is immune to HIV due to a genetic mutation on the gene that encodes for CCR5, US-based Sangamo has begun to edit DNA to introduce the aforementioned mutation. The CCR5 protein is attached to the surface of CD4 cells that allows HIV to enter and infect the cell; with the mutation, it would be impossible for HIV to enter cells. This company extracts patient’s CD4 cells in order to use zinc finger nucleases to edit patient’s DNA to make them resistant to HIV.
  3. Although a highly controversial topic amid the recent publication of the use of CRISPER in twin daughters in China, scientists believe that this tool can lead to a cure for HIV as it is believed to be a much easier, faster, and effective approach than other gene-editing methods. However, the majority of the global health community is in agreement that years of laboratory research and ethical standards need to be established before human trials are properly started.

With the HIV virus adapting and mutating to evade treatments almost as rapidly as the world is producing novel approaches to treating this infectious disease, the drive for continued research and testing should be relentless. These aforementioned examples of novel treatments and possible cures display the creative and diverse thought processes the medical community has put forth to tackle one of the most stigmatized diseases on this earth. However, the ethics behind these trials need to be sound and forthcoming for all of humanity. The trials that occur need to ensure an assortment of demographics including individuals from both developed and developing nations – a subtle form of medical colonialism has no place in the global health community. In addition, trials that enroll patients who willingly accept the benefits and risks associated with the experimental therapy have the moral obligation to supply lifetime treatment if it happens to be effective. The researchers and medical professionals who monitor these participants need to take extreme caution in ART interruptions/discontinuations and certify that the patients realize what complications could transpire due to them. Finally, and most importantly, the interventions that show promise of novel ways to approach HIV or even a cure have to be accessible, affordable, and available to all humans who suffer from HIV. The health inequalities that plague this fragile planet have already been clearly highlighted in this ailment throughout history; the global health community is in debt to humanity for a cure for all when discovered.  

With the global health community’s commitment, the future of the HIV virus continues to transition from infectious disease to chronic disease. While the step that will advance the chronic disease to a cure is still thought to be unknown, the excitement behind the aforementioned gene editing therapy is substantial. The ability to safely, effectively and ethically modify human cells to prevent the entry of the virus into the immune system is certainly the most promising option recently and possibly from this disease’s initial appearance; although, health care professionals haven’t quite figured out how to combine these aspects yet. A cure or even functional cure may be years away, but the global health community needs to continue to accompany those inflicted by this chronic infectious disease to meet the hopes and expectations of alleviating the burdens of HIV.

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Empowering Women to Take Control of their Sexual Health

Two weeks ago, I attended a powerful and motivating summit hosted by Florida International University (FIU) Robert Stempel College of Public Health and Social Work on empowering women to take control of their sexual health through knowledge of biomedical HIV prevention methods, connecting to community resources, and mobilizing key community stakeholders and providers.

What was most unique about this summit was the rawness of the various conversations. These conversations included voices of state congresswoman Frederica Wilson and Ileana Ros-Lehtinen, community women and activists, a panel of diverse physicians and nurse practitioners, researchers, and LGBT and minority women working across different sectors in the HIV prevention field. When it comes to empowering women surrounding their sexual health, pre-exposure prophylaxis (PrEP) is viewed as the driving vehicle. The problem is that there is a lack of awareness among women particularly LGBT and minority women, and providers about PrEP and post-exposure prophylaxis (PEP). During the engaging providers panel comprised of various physicians working in South Florida, a Haitian physician expressed that before the conference he decided to call several of his provider friends that practice within the local Haitian community and asked them if they have heard of PrEP. How many do you think said, “Of course, I know about PrEP”? The answer is…0. Not one single doctor whom was asked said they have heard of PrEP. We have a lot left to do. The work has not yet been done!

Miami’s HIV Epidemic

So maybe you are wondering…well why host this conference? The county of Miami-Dade continues to lead the nation in new HIV infections. Not too far away is the neighboring county of Broward which continues to compete with Miami when it comes to high prevalence rates as well.

Due to the rising rates of HIV in Miami-Dade County, city officials have responded to the epidemic with the development of a “Getting to Zero” task force comprised of city commissioners and individuals representing various public health agencies throughout Miami-Dade County as well as the state of Florida. The task force devised a multi-pronged action plan with priority goals for the next two years. The plans include to (1) reduce the rates of reported AIDS cases, (2) reduce the percentage of newly diagnosed HIV cases among residents aged 13-19 (3) increase the percentage of newly identified HIV-infected persons who are linked to care within 90 days of diagnosis and are receiving appropriate preventive care and treatment services in Miami-Dade County and (4) reduce the number of newly reported HIV cases in Miami-Dade County (http://www.miamidade.gov/releases/2016-09-29-mayor-getting-to-zero.asp).

Prep around the globe

PrEP has served as a vehicle for prevention and is being used worldwide. Countries such as the United States has large scale PrEP programs while others are still in the stages of development and some have not implemented as of yet. There has been many PrEP initiatives enacted. The US Agency for International Development (USAID) is currently supporting 5 Microbicide Product Introduction Initiative (MPii) projects in Kenya, South Africa, Zimbabwe, Malawi, and Uganda from 2015-2020 focused on gender-based violence, drug resistance, creating demand, introducing new products, and models for delivering services. Another program is the DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored and Safe) initiative, a collaborative effort between US President’s Emergency Plan for AIDS Relief (PEPFAR), Bill & Melinda Gates Foundation, Girl Effect, Johnson & Johnson, Gilead Sciences and ViiV Healthcare. DREAMS aims to reduce the incidence of HIV by 40% among adolescent girls and young women by 2020 in the highest HIV burden countries including Kenya, Lesotho, Malawi, Mozambique, South Africa, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe. Of the 10 countries, 5 have included PrEP for adolescent girls and young women in their strategic plans to address HIV. Recent data from PEPFAR shows significant declines in new HIV diagnoses among adolescent girls and young women. In the 10 African countries implementing PEPFAR’s DREAMS partnership, the majority of the highest HIV-burden communities or districts achieved greater than a 25 percent–40 percent decline in new HIV diagnoses among young women (https://www.usaid.gov/what-we-do/global-health/hiv-and-aids/technical-areas/dreams). In other areas of the globe such as Latin America and the Caribbean, a combination of biomedical, structural, and behavioral interventions is greatly needed in order to reach target objectives and goals and ultimately increase HIV prevention efforts. I am excited to see the future of PrEP.

Women’s Perspectives

During the women’s perspectives breakout sessions, workshops were broken down into specific focus groups including African American, Latina and Haitian. Amongst the African American women breakout session, some key topics that were addressed included stigma, specifically communication between the medical provider and client such as clear language on how to ask questions during the appointment while also considering time constraints, policy, and the need for funding toward effective behavioral interventions for HIV negative black women in the community.

Sistas Organizing to Survive (SOS) is a grassroots mobilization of black women in the fight against HIV and AIDS. In Florida, one in 68 non-Hispanic black women are known to be living with HIV/AIDS and has been the leading cause of death among black women aged 25-44 years within the state. (http://www.floridahealth.gov/diseases-and-conditions/aids/administration/minority-initiatives.html)

Call to Action

Miami is the #1 city in the United States with new HIV infections. This is a huge public health issue. We have a call to action to advocate for ourselves and others when it comes to ending the epidemic. We have made significant strides, but the work has not yet been done. Sexual health including HIV prevention should be something that we freely discuss with our family, colleagues, peers, physicians, and anyone that we come in contact with that is willing to listen. It is these conversations that we can decrease stigma surrounding HIV. Women across the counties of Broward, Miami-Dade, and Palm Beach have answered the call to action by organizing and advocating for all women. We have accepted the call to action together that we can get Miami to Zero!

“A future where new HIV infections are rare, and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance will have unfettered access to high quality, life-extending care, free from stigma and discrimination.”

–Quote from the National HIV/AIDS Strategy Updated to 2020: Strategy Vision

For additional information, please visit http://www.who.int/hiv/topics/prep/en/ http://amp4health.org/ and http://getting2zeromiami.com/

Access to PrEP under NHS England: My trip to London

Pre-exposure prophylaxis (PrEP) is a way to prevent HIV infection for people who do not have HIV but who are at high risk of getting it by taking the pill everyday. When someone is exposed to HIV through sex or injection drug use, PrEP can work to keep the virus from establishing a permanent infection. Individuals who take 7 PrEP pills per week, have an estimated level of protection of 99%. It is a powerful prevention tool combined with condoms.

In the United States, PrEP became available in 2012 by the FDA and can be accessed in most clinics and hospitals and is free under most insurance plans. As of 2017, there are an estimated 136,000 people currently on the drug for HIV prevention. This is not the case in the United Kingdom. As a part of a research project for my MPH degree I traveled to London, England to meet with members from the LGBT community, advocates and public health professionals and to learn more about access to PrEP under the National Healthcare System (NHS) England. Currently, PrEP is not available under NHS England even though HIV continues to be a prevalent problem in England, namely among men who have sex with men (MSM) where approximately 54% of the total of MSM population were diagnosed in 2015. England is however enrolling 10,000 people over 3 years through the PrEP IMPACT trial.

Wales, Scotland, and Northern Ireland are also a component of the NHS. Wales has commenced their PrEPared Wales project, which provided information on where to access PrEP in the country. Scotland is currently the only country in the UK that offers a full PrEP provision through their NHS. Northern Ireland currently has no provision of PrEP.

The NHS is widely regarded as a remarkable system, allowing UK citizens to access certain free healthcare services. England has had some shortcomings however when it comes to preventing HIV and I was interested in learning more. I visited the Terrance Higgins Trust (THT), a British charity that campaigns on and provides services relating to HIV and sexual health. In particular, they aim to end the transmission of HIV in the UK, to support people living with HIV (PLWH), and decrease stigma around HIV. I met Greg Owen, the founder of iWantPrEPNow, a website that explains why it is important for HIV protection, who might consider PrEP, what you need to do before you start, where to buy it online, and how to take it. I also met with Will Nutland, who works alongside Greg and is the founder of Prepster, a guide and movement to safely buying PrEP. Both websites have experienced a lot of traffic since the IMPACT Trial began in October 2017. The trial seems like a step in the right direction when it comes to accessing PrEP, this is not the attitude for many and there continues to be a debate.  While there is significant evidence from other trials that demonstrates PrEP is an effective HIV prevention tool, many people believe that NHS will not endorse PrEP after the trial is complete.

I asked Liam Beattie, also a member of the THT team, why he believes NHS England did not endorse PrEP under its guidelines. He believed that it was because of 1. homophobia among the NHS and 2. the media. Liam was recently interviewed on BBC News. During the interview, PrEP was categorized as a “controversial drug,” which paints a negative light on the topic from the get-go.  While England is well-developed and progressive in so many ways, HIV is still known as the “middle-aged gay male virus.” THT and other organizations continue to develop new marketing tools and programs in order to target women, transgender persons, and people of color to visit a sexual health clinic and get tested. Taking PrEP is an advantage for not only the individuals health but the overall cost of healthcare. Many are hopeful that in the future, the NHS will work with organizations like THT to promote PrEP and other educational resources to prevent HIV.

Did you know condoms are considered immoral in some countries?

Condoms have been around since 1855. Crazy, right? Not so long ago, one of the main purposes of condoms was to protect soldiers in World War II against STI’s. Not a lot of things have changed since then. There’s actually more and more reasons now why condoms are useful- it is accessible, it does not have side effects, it lowers risk of STI’s and HIV, and does not change the menstrual cycle like birth control does. That being said, there are several countries in the world that believe condoms and contraceptives are immoral. The below countries and its leaders blast condom use as dangerous. Their anti-condom rhetoric is bringing down youth and many others and could ultimately hurt the world. Continue reading “Did you know condoms are considered immoral in some countries?”

Improving LGBT Health Education in South Africa: Addressing the Gap

I first became interested in the topic of lesbian, gay, bisexual, and transgender (LGBT) health care and health education while working as a country lead for the Presidential Emergency Plan for AIDS Relief (PEPFAR). During my time there I had the opportunity to travel to South Africa and understand their community and health care system a bit better, with an emphasis on their HIV/AIDS epidemic. This post focuses on the LGBT history in South Africa, recent developments, addressing that there is a gap between homophobia and non-judgmental care, and the importance of health care workers understanding LGBT health education.

More and more countries around the world are opening their arms to welcome and embrace LGBT pride. South Africa has one of the world’s more progressive constitutions which legally protects LGBT people from discrimination, although current research indicates that they continue to face discrimination and homophobia in many different facets of life. The most recent milestone occurred in 2006 when the country passed a law to recognize same-sex marriages. Nevertheless, LGBT South Africans particularly those outside of the major cities, continue to face some challenges including conservative attitudes, violence, and high rates of disease. As the country continues to grow there seems to be an increase in LGBT representation (with approximately 4,900,000 people identifying as LGBT) whether it is through activism, tourism, the media and society or support from religious groups. So, what about LGBT health education? Continue reading “Improving LGBT Health Education in South Africa: Addressing the Gap”