When You’re Still Sick: Living with Long-COVID and HIV

By: Marcus J. Hopkins, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)

Recently release research in The Lancet has found that, in addition to Long COVID, other respiratory ailments (Acute Respiratory Infections, or ARIs), such as colds, flus, and pneumonias, are associated with a wide range of long-term symptoms more than four weeks after the acute infection (Vivaldi, Pfeffer, Talaei, Basera, Shaheen, & Martineau, 2023).

This article was sent to me by Brandon M. Macsata, CEO of ADAP Advocacy, after graciously allowing me to cancel my attendance at the most recent Health Fireside Chat in Philadelphia due to a respiratory ailment.

“I read this article and said, ‘Hmmm…sounds like Marcus.’”

And it did.

On July 14th, 2023, I attended an outdoor ABBA tribute band concert with my mother and stepfather, but left early because I was feeling sick. I got home, and within twelve hours, I could barely breathe and moving was a chore. The following Monday, I tested myself for COVID, and got a negative result, so I thought, “Okay…must just be a summer cold.”

And then, it lingered.

By August, I’d spent most of July sleeping ~12 hours a day, between sleeping at night and intermittent naps throughout the day. My waking hours were spent coughing for so long I would literally lose consciousness from the lack of oxygen and come to a few moments later to find myself slumped over in bed and disoriented.

I had to push back several deadlines with clients, and when I reached out to my Primary Care Physician (PCP, who is also my Infectious Disease, ID, doctor), they recommended I go to Urgent Care for testing, where I was given a breathing treatment while they tested me for fourteen different respiratory ailments, from multiple strains of COVID to flu to tuberculosis, took X-Rays of my lungs, and sent me home with an inhaler, a strong antibiotic, and instructions to rest.

Another week went by, and there were no changes. Finally, my ID doc agreed to see me, where I was put through another battery of tests to see if non-ARI issues were to blame for my symptoms, including thyroid function, testosterone levels, prostate-specific antigen (PSA) levels, lung function, toxoplasmosis (from my eight cats), and virtually every other disorder or disease that are common for People Living with HIV/AIDS (PLWHA). After several hours, I left with a steroidal inhaler, a new statin drug, and additional orders to rest.

Another month went by, and my symptoms continued. 

It’s been three months since my initial illness, and still, I find myself regularly out of breath, physically exhausted from simple tasks such as walking down the stairs or into the kitchen, and suffering from neverending bouts of intestinal issues. Ultimately, they determined I must have initially had a negative reaction to receiving a second Shingrix vaccine on July 12th—a claim that seemed plausible, but still unlikely.

And then, Brandon sent me The Lancet article.

These symptoms I am still experiencing align perfectly with those described in The Lancet. Patients who had Non-COVID ARIs were more likely than COVID patients to report certain symptoms, including diarrhea, sleep problems, and coughing. They were also likely to report muscle or joint pain, difficulty concentrating, and lightheadedness or dizziness (Figure 1):

Figure 1.

Regularly Reported Symptoms by Patients Dependent Upon Infection Status

Photo Source: The Lancet

While this research does not definitively answer the underlying question, “What the Hell is Wrong with Typhoid Marcus,” it does provide me with another piece of information to send to my ID specialist for consideration.

One of the most humiliating parts of living with a chronic condition, like HIV/AIDS, is having to navigate the various conversations we must have with any number of parties to explain our health issues without opening ourselves up to unwanted or undue levels of scrutiny. Some of the conversational barriers we must overcome include:

1. How do we communicate our symptoms to our healthcare providers without coming across as a hypochondriac?
• Will our providers believe us? (This concern is particularly felt by persons of color or of trans experience)
• Will additional tests or examinations provide us with definitive answers?
2. How do we communicate our health issues with our employers or clients without risking our employment or incomes?
• Will our employers or clients be understanding of our health challenges and willing to extend deadlines so that we are able to meet them?
• Will our employers or clients consider these delays unacceptable and terminate our employment or contracts? If so, is there any recourse?
3. How do we communicate our health issues to friends and loved ones?
• Will our friends understand that we may not have the capacity or ability to respond to their inquiries about our health?
• Will our family members understand that we may not have the energy or ability to live up to familial obligations?
• Will anyone be able or willing to help us pick up the slack, in terms of chores, daily tasks, or caring for dependents?

When it comes to our incomes, how will we navigate the very real possibility that our incomes will suffer if we’re physically unable to work? Will we be able to make rent? For PLWHA, is there an immediate support system in place that can quickly respond to our needs as they relate to utility and housing costs, given the dysfunction that typifies the Housing Opportunities for Persons with HIV/AIDS (HOPWA) program?

Luckily, my clients have been largely understanding and accommodating, in no small part because I, personally, am an open book when it comes to my health. Other PLWHA may have neither the luxury of being open about their health issues nor the interest in telling others about their health. This is another area where PLWHA must navigate what level of disclosure is right for them, if any at all.

So, here we are.

I am slated to fly to Washington, DC, next week to attend an in-person meeting, and…if I’m being honest, I’m not certain whether or not I will have the energy to do so.

This places me in the very frustrating position of having to explain to the organizer that I will have to attend virtually, even though I confirmed my in-person attendance in July…before all of this started.

Hopefully, I’ll be able to return to some semblance of normal health sooner, rather than later. In the meantime, I’ll keep using my inhaler and resting.

References:

Vivaldi, G., Pfeffer, P.E., Talaei, M., Basera, T.J., Shaheen, S.O., & Martineau, A.R. (2023, October 06). Long-term symptom profiles after COVID-19 vs other acute respiratory infections: an analysis of data from the COVIDENCE UK study. The Lancet. https://doi.org/10.1016/j.eclinm.2023.102251.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Intersection between Intimate Partner Violence & HIV

By: Ranier Simons, ADAP Blog Guest Contributor

As with any chronic disease, quality of life and effective disease management requires consideration of the whole person, not just the disease. Regarding HIV, many different social determinants of health affect treatment, outcomes, and disease acquisition. The social, cultural, and physical environment of people living with HIV can be a crucial positive or negative factor. A recent study investigates the intersection of domestic violence and HIV. The Lancet published a retrospective study in December 2022 exploring the relationship between intimate partner violence (IPV) and women’s acquisition of HIV and experiences in the HIV treatment and care cascade (Stillman, 2023).

Photo Source: Fighter Law

Globally, more than one in four women experience IPV in their lifetime (McGill University, 2023). IPV is a subset of domestic violence and is not limited to physical abuse. Its forms include sexual, psychological, and even economic abuse. IPV is defined as violence that happens between people in an ongoing or former intimate or romantic relationship (Cerulli, 2022). Men experience it as well. Nearly one in ten men has experienced it in their lifetime. The Lancet study focuses on women in Sub-Saharan Africa, the regions of Africa south of the Sahara. This includes West Africa, East Africa, Central Africa, and Southern Africa (Wikipedia, 2022).

The study is a retrospective pooled analysis of cross-sectional surveys encompassing 280,259 women across 30 countries administered between January 1, 2000, and December 31, 2020. Ages ranged from 15-64 years old, and all the women were currently or formerly married or cohabitating. Sub-Saharan Africa was chosen because, in global comparison, the region has a very high prevalence of IPV and HIV (Cerulli, 2022). For the purposes of the study, IPV was limited to physical and sexual abuse. The study estimated the effects of past-year physical, sexual IPV, or a combination of both. Four outcomes were the focus of the study: recent HIV infection, HIV testing in the past year, antiretroviral regimen adherence, and viral load suppression (Kuchukhidze, 2022).

Photo Source: Loma Linda University 

Overall, 21.2% of the women self-reported having experienced physical or sexual IPV in the past year, and 29.1% had experienced it at some point in their lifetime. Self-reporting of HIV testing was very similar between the groups of women who did and did not experience past-year physical or sexual IPV, and more than a quarter of both groups had been tested in the past year. 

Regarding the women in the study who are living with HIV, there were differences in antiretroviral adherence. The ones who reported past-year physical or sexual IPV had lower uptake of ART (64.2%) than those who did not report any past-year IPV (71.3%) (Kuchukhidze, 2022).Those who had experienced physical or sexual IPV had missed 2-3 times as many pills in the past month as those who had not experienced past-year IPV. Additionally, women on antiretroviral therapy who had experienced past-year physical or sexual IPV were 5% less likely to be virally suppressed than those who had not. Regarding infection, women who had experienced physical or sexual IPV in the past year were 3.22 times as likely to acquire a recent HIV infection as those who had not experienced it in the past year (Kuchukhidze, 2022).

The mechanisms by which IPV can affect HIV acquisition are layered. One major pathway is infection through sexual violence, and another is the culture of the men who are abusers. Many may have multiple concurrent sexual partners coupled with a lack of condom use which would increase HIV transmission if they live with HIV. Knowledge of HIV status is an essential initial factor in reducing the adverse effects of IPV on HIV. Another barrier caused by IPV is antiretroviral adherence. Some women may fear being tested, dreading the possible reactions from their abusers if the test is positive. Treatment adherence is negatively impacted due to women not disclosing their status out of fear of abuse from their partners, making it hard to get them into consistent care.

Photo Source: Harvard Health Publishing

The study highlights the need for more research into the effects of IPV on HIV and systemic change to help the women involved. The researchers suggest that healthcare providers need to be trained on how to have patients safely disclose their instances of living with IPV. Additionally, there need to be innovative ways to safely deliver consistent antiretroviral and HIV care to those living with HIV in IPV situations. Creating patient-focused safe service delivery platforms, such as safe medication pick-up points, are policies to be considered (Kuchukhidze, 2022).

The Lancet study is further confirmation that there are many levels of barriers to overcome in the fight against HIV. Networks that span locally to globally are necessary to manipulate the mesh of life factors that complicate the transmission and treatment of HIV.

[1] Stillman, A. (2023, January 9). The link between HIV and domestic violence. Retrieved from https://news.yahoo.com/between-hiv-domestic-violence-213422389.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

[2] McGill University. (2023, January 6). Women experiencing intimate partner violence three times more likely to contract HIV

[3] University of Rochester, Cerulli, C. (2022, March 23). What is intimate partner violence? It’s not just physical abuse. Retrieved from https://www.rochester.edu/newscenter/what-is-intimate-partner-violence-domestic-violence-516342/

[4] Sub-Saharan Africa. (2023, January 9). In Wikipedia. https://en.wikipedia.org/wiki/Sub-Saharan_Africa

[5] Kuchukhidze, S. et al. (2022, December 01). The effects of intimate partner violence on women's risk of HIV acquisition and engagement in the HIV treatment and care cascade: a pooled analysis of nationally representative surveys in sub-Saharan Africa. Lancet.Retrieved from https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00305-8/fulltext DOI:https://doi.org/10.1016/S2352-3018(22)00305-8

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Understanding Breakthrough COVID-19 Infections

By: Richard Moscicki, M.D., Executive Vice President, Science and Regulatory Advocacy & Chief Medical Officer with the Pharmaceutical Research and Manufacturers of America (PhRMA)

****Reprinted with permission from the Pharmaceutical Research and Manufacturers of America****

The biopharmaceutical industry continues to work around the clock to research, develop and manufacture vaccines and therapeutics to prevent and treat COVID-19. Already, we’ve made unprecedented progress, and COVID-19 vaccines have protected hundreds of millions of people in the United States and billions around the globe.

Progress in a pandemic is not linear, unfortunately. Breakthrough infections, an infection with a virus after you have been vaccinated, are possible for some individuals even after vaccination. No vaccine – for COVID-19 or any other disease – is 100% effective in preventing infection in every person who receives it. Still, overwhelmingly, vaccines are preventing or mitigating infection, and continue to be our best tool in fighting COVID-19.

Here are a few common questions about breakthrough COVID-19 infections.

How likely am I to get a breakthrough COVID infection?

• In a recent Lancet study, less than 0.2% of the vaccinated individuals reported a breakthrough infection. And those who did suffer a breakthrough infection were older or had underlying illnesses that may make them more susceptible to infection. This study is part of a growing body of research, including from the CDC, showing the significant protections vaccines provide.
• There are preventative health interventions that can significantly boost protection against COVID-19 even when you’re vaccinated, like wearing masks, social distancing and avoiding crowds.
• Overall, the risk of severe illness from breakthrough infection remains very rare.

Source: PhRMA

What is the chance I get hospitalized if I do get a breakthrough case? 

• According to the CDC, if you are vaccinated and develop COVID-19, you will likely experience less severe symptoms than unvaccinated people and are at a greatly reduced risk of hospitalization.
• Another Lancet study found that elderly people with underlying conditions accounted for most severe breakthrough cases and were more likely to need hospitalization as compared to their vaccinated, younger counterparts. This underscores the need for more people to get vaccinated or receive a booster if eligible to reduce the chance of breakthrough infections.
• An Oxford University study confirmed that overall, people who are fully vaccinated and develop a COVID-19 breakthrough infection had lower risks for death and serious complications such as need for mechanical ventilation, ICU admission, life-threatening blood clots and other issues.

If vaccines don’t prevent me from getting and/or spreading COVID-19, why do I need a vaccine?

• People who are vaccinated are less likely to be infected by COVID-19 and less likely therefore to spread the infection and if a breakthrough infection does occur, the symptoms are typically less severe.

The COVID-19 vaccines are safe, effective, and to date, more than 416 million doses of vaccines have been administered in the U.S. But we know our work isn’t done. Protect yourself and your community by getting vaccinated, receive a booster if eligible, and take appropriate precautions based on your personal risk and the level of transmission in your community. Learn more at PhRMA.org/Coronavirus.

Richard Moscicki, M.D. - Dr. Moscicki serves as executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA. He joined the organization in 2017 after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as the senior vice president and head of Clinical Development at Sanofi-Genzyme from 2011-2013.

This opinion piece was also published in the November 11th edition of the Catalyst.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Making U=U Foundational in Our Efforts to End the HIV Epidemic

By: Murray Penner, U.S, Executive Director, Prevention Access Campaign/U=U

Undetectable = Untransmittable, or U=U, was created in July 2016, BY people living with HIV (along with leading researchers and other advocates), FOR people with HIV. The U=U campaign is approaching the fifth anniversary of its launch. As such, it is the perfect time to expand the U=U message with an advocacy focus on how U=U contributes to ending the HIV epidemic. 

Photo Source: Prevention Access Campaign

The medications people with HIV take to stay healthy also make it impossible for them to pass on HIV. That’s because when people are on effective HIV treatment, their HIV is suppressed in the body to such low levels that it’s undetectable by most lab tests. And when one’s viral load is undetectable, HIV also is not transmitted through sex. 

The U=U message is revolutionary and has a positive impact on people’s lives and on ending the epidemic:  

• U=U improves the well-being of people with HIV, transforming their social, sexual, and reproductive lives.
• U=U reduces the anxiety associated with HIV testing and adds an incentive for people with HIV to start and stay on treatment and in care. 
• U=U dismantles stigma on individual and community levels. 
• U=U provides a strong public health rationale for universal access to treatment, care, and support services. We refer to this as the U=U public health strategy.   

The U=U public health strategy is important to use in advocacy efforts. It works like this: When people with HIV have the treatment, care, and support services they need to stay undetectable, they remain healthy, and they cannot transmit HIV through sex. In other words, care and treatment is good for the personal health of people with HIV and good for the public health of the community. 

Photo Source: The Lancet

In a recent article in The Lancet, prominent U.S. leaders called for action to end the HIV epidemic. Among other strategies, it prioritizes the inclusion of U=U in efforts to end the HIV epidemic. 

One strategy in The Lancet article states that “Advocates should be equipped to use the so-called public health argument from U=U in advocacy to increase access and remove barriers to quality health care; ensuring people with HIV have the treatment and services they need to achieve and maintain an undetectable viral load. This not only saves lives, but also is an effective way to prevent new transmissions.” In keeping with this recommendation, PAC has created this U=U resource for use in advocacy efforts.As we continue our focus on ending the epidemic, advocacy is critical to make U=U a foundational strategy of our efforts. U=U is essential for the well-being and health of people with HIV. And it’s also critical for ending the epidemic, because U=U also prevents transmission. 

Dr. Anthony Fauci, Director of NIAID at the NIH and chief medical advisor to President Joe Biden, says it best, stating that “U=U is the foundation of being able to end the HIV epidemic.”

Photo Source: NBC

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

New Study Demonstrates Value of Tesamorelin for Non-Alcoholic Fatty Liver Disease

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association since its inception has advocated for more open drug formularies under the AIDS Drug Assistance Program ("ADAP") because they promote greater access to care and treatment for people living with HIV/AIDS. By omitting therapies that are approved by the U.S. Food & Drug Administration ("FDA") for the treatment of HIV-infection and related co-morbidities, some State ADAPs are being counter-productive to the needs of the people they're intended to serve. One example is the unfair limitation often put on the drug tesamorelin for the treatment of lipodystrophy. A new study published online in The Lancet shows promise for non-alcoholic fatty liver disease, and as such it might finally change some opinions about adding it to drug formularies.

Photo Source: Drugs.com

Current restrictions on the use of tesamorelin do a disservice to the needs of people living with HIV/AIDS, and diagnosed with HIV-related abnormal accumulation of visceral adipose tissue (VAT) by concluding that the potential discontinued use of tesamorelin and its “expense” is limited its use. Yet, research has shown that between 20% and 30% of HIV-positive patients are experiencing excess VAT. For years, there's been a common misconception that this belly fat is just a physical cosmetic issue that is a side effect of earlier HIV treatments - something that must be accepted as a reality of now living longer with HIV-infection. Recent research dispels that myth so that even with newer anti-retro viral regimens this condition continues to exist.

Some states, such as Massachusetts, have long recognized the value of tesamorelin - not only within its ADAP drug formulary, but by also mandating treatment for HIV-related lipodystrophy for private insurance. The Massachusetts model was largely based on the FDA's findings: “The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy. The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”[1]

The new study - "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial" - yielded positive results, such as demonstrating tesamorelin can reduce liver fat and prevent scarring of the liver.[2]

According to the study, "Non-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD."[3]

The study's findings concluded:

"61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received placebo. Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of −4·1% (95% CI −7·6 to −0·7, p=0·018), corresponding to a −37% (95% CI −67 to −7, p=0·016) relative reduction from baseline. After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069). Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months. Individuals in the tesamorelin group experienced more localized injection site complaints than those in the placebo group, though none were judged to be serious."[4]

These findings bode well for people living with HIV/AIDS, especially as it relates to co-morbidities such as cardiovascular and type 2 diabetes risks. Now it is time for more State ADAPs to take notice.



__________
[1] U.S. Food & Drug Administration (2010, November 10). FDA approves Egrifta to treat Lipodystrophy in HIV patients. U.S. Department of Health & Human Services. Retrieved online at https://aidsinfo.nih.gov/news/889/fda-approves-egrifta-to-treat-lipodystrophy-in-hiv-patients---november-10--2010.
[2] Brokaw, Sommer (2019, October 15). NIH: Drug reverses liver fat, slows fibrosis in HIV-positive people. UPI. Retrieved online at https://www.upi.com/Health_News/2019/10/15/NIH-Drug-reverses-liver-fat-slows-fibrosis-in-HIV-positive-people/8621571156412/?sl=3.
[3] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.
[4] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.