Coronavirus-Related Blood Shortages Lead to Blood Donor Reforms, But Discrimination Remains

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Since the outbreak of Coronavirus, decisions have been made within the government on many topics including financial relief for students, unemployment and others. One of these decisions involves blood donations. On April 2, the U.S. Food and Drug Administration ("FDA") revised their guidelines which previously banned gay men from donating blood for a year after sexual intercourse with another man.

In these new guidelines, the FDA has instead recommended a three month wait period for these men. This will remain in place throughout the course of COVID-19 or within 60 days of the emergency being lifted, according to The Hill.

The national blood supply has been critically low, according to The Red Cross. Pleas for donations from healthy donors have been made within the past years, but with the recent outbreak of COVID-19, the need is much greater now.

According to their website, the American Red Cross provides roughly 40% of the nation’s blood and blood components, all volunteer based. Group O- blood is the most highly sought-after blood group, because it is universally accepted by other blood types.

The recent change in FDA guidelines to allow men who have sex with men to donate blood after 3 months may seem as better than the previous guidelines, which it is. However, this recent guideline change has revealed many issues with the blood donation program in America.

It was only in December of 2015 that the FDA moved their lifetime ban on gay and bisexual men donating blood to a one year wait period.

“Blood centers nationwide screen potential donors by asking a set of questions written to determine risk factors that could indicate possible infection with a transmissible disease, such as HIV or hepatitis. According to the FDA, this pre-screening eliminates up to 90% of donors who may be carrying a blood-borne disease,” the Human Rights Campaign said.

This raises the question: if screening donors is already a universal concept in blood donation, why should gay men have to wait a period of time to donate blood? Even if a gay man had sexual encounter with an HIV positive person, if they went through the pre-screening process for blood donation and reported either they had sex with another man who they were unsure of their sexual history and/or they had sex with a man who they are sure is HIV positive, wouldn’t that eliminate the risk there?

The American Red Cross tests all donated blood after donations for infectious diseases, but it may not be 100% effective in donors who may have been infected with a blood-borne pathogen recently.

However, if a gay man has taken the necessary precautions to protect against transmission of blood-borne diseases such as HIV or hepatitis, I see no reason as to why they cannot safely donate blood- especially in a time of crisis and a national shortage.

In an article written for USA Today, David Oliver spoke on issues he’s faced as a gay man attempting to donate blood amid Coronavirus.

“The first and only time I donated blood; I hadn't had sexual contact with another man. Heck, I hadn’t yet come out. I was 21 years old and passed out shortly after doing it. Over the six years since then, it has been too easy for me to throw my hands up and say: "Well, I can't even donate anyway." But during this time of crisis, I would give anything to help,” Oliver said.

This narrative is all too common among LGBTQ+ men. The need for blood is greater than ever, and if screening processes are taken and donors are open about their past possible exposure to pathogens, I see no reason as to why this blood shortage could not be addressed by all Americans.

Photo Source: Change.org

“The American Red Cross believes blood donation eligibility should not be determined by methods that are based upon sexual orientation. We are committed to working toward achieving this goal,” The American Red Cross said.

The goal of blood donation eligibility not being based upon sexual orientation is an achievable one. Americans must look past their ignorance and outdated ideas of LGBTQ+ men and blood donation to help the greater good.

References:

• Blood Needs & Blood Supply. (n.d.). Retrieved from https://www.redcrossblood.org/donate-blood/how-to-donate/how-blood-donations-help/blood-needs-blood-supply.html
• Human Rights Campaign. (n.d.). Blood Donations and the LGBTQ Community. Retrieved from https://www.hrc.org/resources/blood-donations
• LGBTQ Donors. (n.d.). Retrieved from https://www.redcrossblood.org/donate-blood/how-to-donate/eligibility-requirements/lgbtq-donors.html
• Oliver, D. (2020, March 30). Red Cross is asking for blood donations amid coronavirus. Because I'm gay, I'm excluded. Retrieved from https://www.usatoday.com/story/opinion/voices/2020/03/20/coronavirus-let-lgbtq-men-donate-blood-amid-shortage-column/2876677001/
• Weixel, N. (2020, April 2). FDA loosens restrictions on gay men donating blood amid pandemic. Retrieved from https://thehill.com/homenews/administration/490824-fda-loosens-restrictions-on-gay-men-donating-blood-amid-coronavirus#.XoYgEQB4AkA.twitter

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.

Despite Coronavirus, Trump Administration Proposes 15 Percent Cut To HOPWA Funding

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor 

UPDATE: This piece was authored prior to the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, on March 30th, 2020. This Act included $65 million in additional funding for the HOPWA program. As a result of these additional funds, the “$80 million” cut to the HOPWA program proposed by the Trump Administration will be temporarily abated (assuming that the proposed cut makes it into the annual budget bill).

It should be noted that this $65m is a one-time infusion of funds included only in the CARES Act, and is unlikely to be a permanent fixture in future budgets. The Trump Administration is still proposing the $85m cut to the overall budget.

There are currently efforts underway by HIV advocates and activists to include an additional $65 million in funds in the forthcoming fourth stimulus bill related to COVID-19.

The Trump Administration is, once again, demonstrating its attempt to end social safety nets via deaths by 1,000 cuts. In its latest budget proposal, the Trump Administration is proposing $8.6 billion in funding cuts for the HUD (Housing and Urban Development) program, including $80 million cut from the Housing Opportunities for People With AIDS (HOPWA).

Photo Source: New York Magazine

HOPWA was created in the AIDS Housing Opportunities Act, as part of the Cranston-Gonzales National Affordable Housing Act of 1990, and has consistently been one of the best-intentioned, but worst funded, managed, and disbursed elements of the various HIV-specific social safety net programs. Plagued by mismanagement at both the federal and state levels, in no small part because of the way the program is administered.

Unlike the overall Ryan White Program, which applies to virtually anyone in a state living with HIV, so long as they meet income verification and upper limit requirements, the HOPWA program operates through the HUD program via a series of grants and relies upon the availability of Section 8 low-income housing.

For example, when I lived in Los Angeles and was in need of a new housing situation when I was separating from my partner, I attempted to sign up for HOPWA via my Ryan White caseworker, only to find that there was, at the time, a waiting list of several years in order to qualify for a Section 8 voucher. What this meant was that, in effect, there were no available Section 8-eligible units available, and I would have to enter my name on a wait list. Should a unit become available, a call would go out, and whomever got there first and qualified was the lucky recipient of a place to live.

This is just on the front-end of HOPWA, however; on the back-end, where the program is administered by state and local governments, inefficiencies, personal and local politics, and failures to may payments to programs on time have created huge issues for people whose housing depends upon the program. There are few places where this is truer than Atlanta, GA:

The City of Atlanta failed to spend $41 million since 2014 meant for the HOPWA program in a dispute involving unpaid contractors, unspent development funds, and a multi-year failure to properly allocate and disburse funds. As a result, in the summer of 2019, hundreds of People Living with HIV/AIDS (PLWHA) were facing eviction as Living Room, the non-profit contractor with whom the City of Atlanta had contracted with to connect PLWHA with low incomes to safe, affordable housing, declared bankruptcy and closed.

Living Room announced in June 2019 that it was unable to pay the rents for roughly 250 clients because the City of Atlanta was several months late in disbursing $500,000 in reimbursement funds for expenses. As a result, those clients’ landlords filed for eviction, resulting in the Atlanta Legal Aid Society being swamped with requests for assistance to the point where they set up a special team just to address the issue. The city responded by paying $371,600 (Mariano, 2019), but those funds arrived too late for Living Room to continue operating.

The problems did not, however, originate with the current administration (Mayor Keisha Lance Bottoms); even when she stood for election in 2017, payments from the City of Atlanta to nonprofit contractors ran so late that many had to borrow against lines of credit and stop taking on new clients (Mariano). Bottoms, who vowed to get to the bottom (as it were) of why these programs were shutting down due to unpaid reimbursement requests has largely failed to live up to the promises she’s made over the past three years, in no small part because her administration has fundamentally failed to properly propose, explain, and implement changes in a timely manner, or to satisfaction of HUD, which has repeatedly expressed public concerns about the administration of Atlanta’s HUD grant.

The problems also do not stop in Atlanta. The HOPWA program has consistently been underfunded and unable to address the needs of PLWHA. The original language in the program focused primarily on people living in urban areas, but changes began, in 2015, to address the needs of PLWHA living in suburban and rural areas. Unfortunately, none of those changes have effectively increased the amount of funding needed, nor increased the availability of housing units.

Where other countries address low-income housing by building government-owned/operated council flats or apartment buildings, the U.S. has stubbornly (and stupidly, in my opinion) insisted upon “public/private partnerships” to address Section 8 housing, relying upon individual property companies and landlords to supply housing and qualify for/accept Section 8 vouchers. This is, no doubt, an artifact of the “Socialism Scare” of the 1950s and beyond, where any sort of social safety net or housing program was deemed “Creeping Socialism” that would doom the U.S. to become a Communist hellhole with never ending breadlines and (shudder) paying to support the Poors.

This decades-long failure on the part of federal and state governments to purchase land and build public housing sufficient to meet the needs of lower-income individuals and families (because, why that just wouldn’t generate a profit, you Pinko Commie bastard!) has resulted in an affordable housing crunch exacerbated by municipalities’ [stupid] desire to approve and build only “luxury” housing units that are, in actuality, little different from the medium-range housing units that were built in the late-90s and early-00s, but have the word “luxury” slapped on the development so that they can increase property values and rents.

In rural states, HOPWA funds are largely allocated in the more densely populated regions, where housing is already overpriced and affordable housing is unavailable. This means that people who could find housing outside of these areas are unable to do so, because the HUD grant for HOPWA only covers people if they live inside of those areas…where housing is over-priced and unavailable, creating waiting lists, backlogs, and people struggling to figure where to live and work, all while attempting to manage their HIV and achieve and maintain viral suppression.

In short, even before the proposed budget cuts for HOPWA (for the second consecutive year), HOPWA is a mess of an operation that is in desperate need of nationalization, centralization, and a massive increase in funds to continue to exist.

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.

Preventing Rx Medications from becoming the next toilet paper during the Coronavirus Pandemic

By: William E. Arnold, President & CEO, Community Access National Network (CANN)
       Shabbir J. Safdar, Executive Director of the Partnership for Safe Medicines
       Brandon M. Macsata, CEO, ADAP Advocacy Association

If you are taking a life-saving HIV medication right now, or any kind of life saving medication, you probably have two big concerns: “Can I afford my medicine if my economic status changes?” and “Will my medicine be in short supply? Will people do to medicines what they have done to toilet paper?”

Photo Source: USA Today

If you are concerned about affording medication, we strongly suggest exploring the tips in our COVID-19 one pager [English PDF, Spanish PDF] where we talk about the options offered by NeedyMeds, RXOutreach, and MedicationAssistanceTool.

If you are concerned about supply, don't turn to the wild west of foreign web pharmacies. That's more dangerous now than ever. Online scammers pretending to be Canadian, or in some cases actual Canadian criminals, have been perfecting their perfect-looking counterfeits and their fake-but-real looking web pharmacies for twenty years. You can find safe, U.S.-licensed online pharmacies at www.safe.pharmacy. No foreign pharmacy (even if it’s licensed in a trustworthy foreign country, like Canada) is safe for Americans to buy from.

But the good news is that you probably won’t have to. The American Medical Association has warned physicians against non-medically necessary prescribing to enable panic-buying. And pharmacy boards like those in Idaho, Texas, Nevada, West Virginia, and Ohio are tightening rules around prescriptions of medications, especially medicines like chloroquine, which may or may not be effective treatments for COVID-19. (For your reference, the National Alliance of State Pharmacy Associations is keeping a continuously updated list of state actions affecting Hydroxychloroquine, Chloroquine, and Azithromycin).

In the HIV space, ADAP Advocacy Association has published statements from nearly all the major manufacturers explaining that their supply is secure for the next twelve months, so panic-buying your medication is not advised, and if we all did it, would create a shortage where one does not exist today.

Photo Source:  master control.com

Ok, but what if I’m still concerned about making sure I’ve got enough medication for myself?

Talk to your pharmacist (and if you don’t do that often, go meet your pharmacist)
Call your pharmacist. If you can’t get them on the phone, you can go see them, but in this time of social distancing they would probably prefer a phone call. If you don’t have a relationship with your pharmacist this is a great time to begin one.

Let your pharmacist know about your medication needs for the next three to six months. If everyone orders a year’s supply of medication at once, the rush could create shortages. If your pharmacist knows about your needs, they can take them into account when they are ordering stock.

Plan to refill your prescription a ten-days ahead of time
If there is a shortage, your pharmacist has options to secure enough medicine for you, but they will need enough time to work it out. If you go in ten days ahead of time, that will give your pharmacist enough notice. If your insurance doesn’t allow you to refill ten days out, then call your pharmacist ten days out to let them know you’ll be coming in for a refill.

Ask your prescriber and pharmacist about a 90-day prescription
If you want to minimize trips to the pharmacy during this time, ask your prescriber about writing you a prescription for a 90-day supply instead of 30 days. Your pharmacist can tell you in advance if your insurance will cover a 90-day prescription before you even contact your physician.

Pharmacists and pharmacy techs may be the healthcare professionals you see the most often, and they know a great deal about medicine, the supply chain, and the best way to help you afford your medications. But they are working long stressful hours right now instead of sheltering at home---and they may need a little bit of planning to be your best ally.

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.

Surprise Medical Bills in the Age of the Coronavirus

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Many of America’s citizens consider their country one of the most advanced in the world. Despite this advancement, healthcare in the U.S. has sunk to 27th in the world (Business Insider). Unexpected medical bills for many families in the U.S. are problematic because they have no way to address them. The ongoing novel Coronavirus ("COVID-19") pandemic only exacerbates it.

Recent statistics revealed 35% of adults in America are worried about unexpected medical bills, with 22% worried about both health insurance and prescription drug costs (KFF).

Photo Source: Center for Public Policy Priorities

Out of network providers are often the culprit of these surprise medical bills for insured citizens. According to KFF Health Tracking Polls, 65% of the public say they are somewhat worried about unexpected medical bills. 35% say they are extremely worried.

With the recent spread of COVID-19 to Europe and America, questions have been raised about the affordability of testing and treatment of the virus.

Families who work hourly for family income are extremely susceptible to surprise medical bills in relation to COVID-19. With quarantines, restaurant shutdowns and other businesses suspending operations in light of the pandemic, many are left without work, and subsequently without an income.

Most all U.S. insurance companies have agreed to cover costs of COVID-19 testing and treatment, but those who are uninsured and in a high-risk category such as HIV positive persons are at the mercy of the healthcare system.

One Miami resident checked himself into the hospital after a work trip to China, for fear of possible exposure to the virus.

“He asked to be first tested for the flu before getting a CT scan to screen for coronavirus because of his limited insurance plan. He did have the flu, which meant no further testing for coronavirus, but he told us that the whole hospital visit cost $3,270, according to a notice from his insurance company,” (Business Insider).

A trip for the flu is upwards of $3,000 for the average person. A person who visits the ER with moderate severity to high severity of COVID-19 could face hospital bills ranging from $441-$1,151. A bill this high and unexpected could set back the average American citizen for months.

For insured persons, out of network costs could cripple even the most financially secure families. Jennifer Finney Boylan is a contributing opinion writer for the New York Times recently wrote on her $145,000 surprise medical bill, due to an out of network provider. (New York Times)

“I contacted our doctor the day after we got our $145,000 bill and he very kindly told me not to worry. “Doctor’s orders!” he added, which I thought was nice. Later, another doctor in the practice told me that even when procedures are pre-authorized (as my child’s was) insurers often deny them anyway. His understanding was that insurance companies often respond to preapproved claims with denial and delay, hoping that consumers will somehow just give up,” Boylan said.

While surprise medical bills may knock American citizens off their financial track for a while, Boylan’s story proves that some are repairable. With the inevitable spread of COVID-19 through the U.S. in the upcoming months, hopes of many are that out of network costs will be waived to fight the virus and help the more financially fragile of us all.

References:

• Bendix, A. (2018, September 27). The US was once a leader for healthcare and education - now it ranks 27th in the world. Retrieved from https://www.businessinsider.com/us-ranks-27th-for-healthcare-and-education-2018-9
• Boylan, J. F. (2020, February 19). My $145,000 Surprise Medical Bill. Retrieved from https://www.nytimes.com/2020/02/19/opinion/surprise-medical-bill.html
• Hoffower, H. (2020, February 29). Coronavirus testing is free, but the hospital trip may set you back thousands. One graphic breaks down potential costs. Retrieved from https://www.businessinsider.com/how-much-does-coronavirus-treatment-cost-cdc-health-insurance-2020-2
• Lopes, L., Kearney, A., Hamel, L., & Brodie, M. (2020, February 28). Data Note: Public Worries About And Experience With Surprise Medical Bills. Retrieved from https://www.kff.org/health-costs/poll-finding/data-note-public-worries-about-and-experience-with-surprise-medical-bills/?utm_campaign=KFF-2020-Health-Costs&utm_source=hs_email&utm_medium=email&utm_content=84040903&_hsenc=p2ANqtz-9QXfClhIkboujL5y5GF7evYHuGhjVSsvRW9KkkIH0tEGYuc7-VaNrvabHd3r-GyjNBOLUJOKsL8fDWEhhoQxixWSJ9DQ

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.

Ryan White & HOPWA Funding Increases in Coronavirus Stimulus Package

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor 

The Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law by sitting president, Donald J. Trump, on March 27th, 2020, and in this act, two HIV-specific programs – the Ryan White Program (RW) and the Housing Opportunities for Persons With AIDS (HOPWA) – received a combined total of $155m (Johnson, 2020). While the funds have been allocated for these programs, there is little guidance on how those funds will be disbursed or distributed once they are received.

Photo Source: cpabr.com

RW received $90m for “existing contracts” under the law and the Public Health Service Act (Johnson). These funds come at a time when many People Living With HIV/AIDS (PLWHA) are at risk of losing health insurance coverage as a result of job losses or financial hardship during the Coronavirus (COVID-19) outbreak. Loss of hours or employment may end up disqualifying many PLWHA from receiving employer-provided health insurance coverage, and loss of those wages may result in losing coverage purchased on the Affordable Care Act Health Insurance Exchange market. These losses in coverage will, inevitably, lead to more people turning to RW as their payor of last resort to cover the costs of medications and doctor visits.

A bigger question, however, is how are the $65m allocated to the HOPWA program going to be distributed to the states? Because of the way the HOPWA program is administered, using a series of grant awards that are then administered by states and metro regions, who then often contract out the management of those funds’ disbursal for rent payments. This relies on a lot of moving parts, not all of which consistently work. In a blog that will be posted to aaa+, later this month, we will take a look at one such situation, where the city government of Atlanta has consistently failed over nearly a decade to properly reimburse funds to a contracted organization, resulting in several hundred HOPWA recipients being evicted from their homes and the closure of the organization that was so far in debt from Atlanta’s failure to remit payment, they were forced to declare bankruptcy.

Both of these funding inclusions are fantastic, especially during a time when it is clear that these services will be vitally important for PLWHA. We will continue to monitor the situation as more news emerges.

References:

• Johnson, C. (2020, March 26). HIV programs get big money in stimulus deal to fight coronavirus. Washington, DC: Washington Blade. Retrieved from: https://www.washingtonblade.com/2020/03/26/hiv-programs-get-big-money-in-stimulus-deal-to-fight-coronavirus/

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.

Nation's HIV Drug Supply Secure Despite Coronavirus Pandemic

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

****UPDATED APRIL 24, 2020 - 5:22 P.M. EST*****

The ADAP Advocacy Association has fielded countless inquiries from people living with HIV/AIDS expressing concerns over the novel Coronavirus ("COVID-19") and its impact on the nation's drug supply chain. Namely, their concerns have centered around potential drug shortages of the anti-retroviral medications for the treatment of HIV/AIDS. No such drug shortages are foreseen for these medications over the coming year, thanks to the assurances extended by the drug manufacturers AbbVie, Janssen Pharmaceuticals, Gilead Sciences, Merck. Theratechnologies, and ViiV Healthcare.

Photo Source: master control.com

The ADAP Advocacy Association contacted each company about the patient community concerns, and the respective drug manufacturers provided the following statements.

• ABBVIE STATEMENT:

"AbbVie is closely monitoring product demand and supply levels throughout our global network to ensure adequate and effective distribution. While helping respond to the COVID-19 crisis is a high priority, AbbVie is committed to protecting the supply of Kaletra/Aluvia for HIV patients. AbbVie is actively assessing the increased demand for Kaletra/Aluvia and has taken steps to increase supply for COVID-19 patients without impacting treatment supply for HIV patients. Our priority is to ensure uninterrupted supply for HIV patients around the world."

Read the AbbVie statement online.

• GILEAD SCIENCES STATEMENT:

"Over the last several weeks, we know you have heard from many of your constituents who are concerned the novel coronavirus pandemic could impact their ability to obtain HIV medication. We wanted to reach out to assure you there are currently no manufacturing concerns or supply shortages with any Gilead products, including our HIV portfolio.

Gilead’s global commercial supply chain is robust and resilient with the right processes in place, geographic diversity in our supply chain and enough of the materials required to make our medicines. We have done this purposefully and carefully to enable continued supply of Gilead’s medicines in a challenging situation like the one we face today. As a result, we are not seeing, and we do not anticipate, shortages of Gilead marketed products, including our HIV medicines, in the foreseeable future.

Our supply network provides both flexibility and redundancy, and our inventory levels are robust, with no immediate or foreseeable risk to our supply chain. For more information, please see this article on Gilead.com. We are also working closely with our partners to monitor travel restrictions and border closings. There are currently no restrictions or delays limiting the transport of goods, including medications.

Some wholesalers have proactively implemented allocation limits on several pharmaceutical products, including HIV medications. In the event that pharmacies experience a temporary lack of inventory, they should contact their wholesaler to request an exception to these limits. When necessary and approved by the wholesaler, Gilead is able to drop-ship directly to a pharmacy. A complete list of authorized distributors can be found here.

Additionally, while we have paused enrollment for some clinical studies, we have made important exceptions for studies where patient outcomes are critically impacted. This includes studies of our investigational HIV capsid inhibitor GS-6207 in people who have multi-drug resistant HIV and therefore have limited treatment options. We will also continue to prepare for new study initiations in the face of temporary delays to most study enrollments.

During this uncertain time, it is more important than ever that we stay in close communication. We do not see any potential disruption to our supply chain now or in the foreseeable future. Gilead is committed to ensuring you have up-to-date information on our efforts to help the HIV community respond to the novel coronavirus pandemic and will keep you apprised of any changes."

Read the Gilead Sciences statement online.

• JANSSEN PHARMACEUTICALS STATEMENT:

"In our role as a global health leader, Johnson & Johnson is closely monitoring the COVID-19 (coronavirus) situation and taking steps to help prevent the spread of the virus as well as exploring the potential for a vaccine.

We have robust business continuity plans in place across our global supply chain network to prepare for unforeseen events and to meet the needs of the patients, customers and consumers who depend on our products.  These steps include maintaining critical inventory at major distribution centers away from high-risk areas and working with external suppliers to support our preparedness plans.

We are closely monitoring product demand and supply levels across our global network to ensure adequate and effective distribution, and working diligently to meet patient, customer and consumer need.

Below is a summary by sector:

​​​​​​​- Pharmaceutical: While this remains a dynamic situation, we do not foresee pharmaceutical supply interruptions related to COVID-19 at this time.

- Medical Devices: While this remains a dynamic situation, the vast majority of our global medical device manufacturing is running at or near normal capacity, and we are not experiencing product supply interruptions at this time.

- Consumer: We are experiencing increased consumer-driven demand with certain products and markets, which we are currently meeting in a controlled manner. We are taking all possible measures to maximize product availability.

As a leader in global health, our top priority remains our patients, customers and employees. We are partnering with global and local health authorities to address immediate and long-term health care needs, to ensure sustainable supply of our critical medicines, as well as to research potential vaccines and therapeutics.

We will remain on the front lines of this health crisis, bringing our full resources and minds to combat it."

• MERCK STATEMENT:

"We continue to track the COVID-19 outbreak closely and are focused on the safety of our employees and their families, continuity of supply and clinical trials, and supporting communities affected by this outbreak. Our thoughts are with the people of all affected areas. We would also like to extend our sincere appreciation to the many health care providers and volunteers who are doing so much to help affected patients and communities.

While supply and demand vary by product, we are not aware of any significant near-term impacts from COVID-19 on the production and supply of Merck's medicines and vaccines.  We have also assessed potential longer-term impacts of the outbreak. The situation is fluid, but at this point we do not anticipate impacts to our supply chain unless the outbreak were to continue for an extended period of time."

Read the full Merck statement online.

Read the supplemental Merck statement online.

• THERATECHNOLOGIES STATEMENT:

"At Theratechnologies, we presently have enough inventory, here in the U.S., for our 3 products and expect to be able to provide Trogarzo®, EGRIFTA SV™ or EGRIFTA® to all currently prescribed and new patients during the next 12 months. In addition, the production for all of our products is not affected at this stage by the COVID19 situation."

• ViiV HEALTHCARE STATEMENT:

"In these uncertain times, the safety and well-being of our employees, customers, partners, and people living with HIV remains ViiV Healthcare’s top priority. As the coronavirus (COVID-19) continues to affect communities in the US and around the world, our hearts go out to those impacted, and we want to share our response to the evolving situation.

We have been closely monitoring the COVID-19 pandemic and its impact. We believe it is our responsibility to prioritize two things:

- our commitment to supporting the health and safety of our employees, customers, partners, and people living with HIV;

- protecting our ability to manufacture and supply medicines

Consistent with our values and role as the only global healthcare company solely focused on HIV, we will continue to make decisions informed by the latest science and in consultation with leading health authorities.

In-line with these principles, we have implemented a variety of measures to help prevent spread of disease and minimize disruption to our operations.

- Ensuring medicine supply and patient access. At this time, even with loosened restrictions on early and various quantity refills by US government and private payers, there is no impact to supply of our medicines in the US as a result of the COVID-19 pandemic. We are continuing to closely monitor the situation and will keep you updated on any changes. We have supply chain planning in place for our products, which includes measures to secure reliable supply, such as holding strategic stock as well as working with our wholesalers, pharmacies and direct purchasers to ensure they are responding to the demand for our medicines from providers and people living with HIV.

- Caring for our people and communities. We have taken several temporary measures to protect the well-being of our employees and the communities in which we operate. We have directed our field teams to suspend all face-to-face interactions and refrain from visits to clinical offices, healthcare centers and other customer offices. Virtual interactions will be implemented to ensure we continue to provide support and ensure adequate supply and access to resources and our medicines.

- Contributing to the fight against COVID-19. We are conducting some exploratory research to see if our medicines may have the potential to demonstrate impact, although it is too early to speculate on any benefit. We are pleased that our major shareholder, GSK, is contributing its science and expertise where they can have most impact on the outbreak. They recently announced a research collaboration with Clover Biopharmaceuticals, providing their pandemic vaccine adjuvant technology to scientists at Clover who will use their cutting-edge research to evaluate the combination of GSK’s adjuvant with its promising vaccine candidate, S-Trimer.

Patient focus is one of our core values and we are proud of our employees and their commitment to people living with HIV during these challenging times.

The situation is changing rapidly, and we are closely monitoring this as we seek to safeguard the health and well-being of our employees, limit the spread of the disease, and continue to make our products available to all who need them. We will continue our vigilance in assessing the situation."

Read the ViiV Healthcare statement online.

The U.S. Food & Drug Administration (“FDA”) has made available information on the current drug shortages online at https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages.

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.

HIV Medications and the Treatment of Coronavirus

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor 

Over the past few months, numerous theories have been bandied about regarding the efficacy of certain HIV-centric drugs being potentially effective in treating novel coronavirus (SARS-CoV-2, or COVID-19). Moreover, stories continue to be published claiming that three drugs, in particular – ritonavir, lopinavir, and darunavir – may be used to “cure” COVID-19, a popular, yet untested idea because of the drugs’ effectiveness in treating certain other SARS (Severe Acute Respiratory Syndrome) strains (Journal of the American Medical Association, 2020). Again, these theories are untested.

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Whenever a new pandemic arises, questions about why existing drugs aren’t being used to treat novel infections arise. Why, after over a century of medical innovations that, before the 19th Century, would’ve been labeled “Witchcraft,” are these pandemics catching us so frequently by surprise? The answer is that each virus is different; each straight of each virus family is different; not every drug that treats one strain of a virus will prove effective in another.

When I was first tasked with writing this piece, my prompt was:

There are lots of stories about coronavirus and the impact on HIV-positive folks. Yet, there are also lots of updates about HIV antiretrovirals being used to treat (and even cure) folks with the virus. So, does it stand to reason an HIV-positive person adherent to their therapy might be more protected?

So, I got down to some research. Sadly, the answer I’ve gotten from my own Infectious Disease doctor is:

There’s no real evidence to suggest that those specific HIV medications are 100% effective in treating COVID-19; there’s also no real evidence to suggest that people who are taking those medications and thus have them in their system are any more protected than anyone else.

The problem with novel viruses is that they often surface and retreat before any real, definitive testing can be completed. When a new one comes along, scientists rely upon things that have worked in the past to try to cobble together a workable solution in a short amount of time. Moreover, Janssen, maker of darunavir, released a statement on Monday, March 16th stating that there is “…insufficient evidence to suggest that…darunavir can effectively treat COVID-19,” and that “…HIV drugs are being considered as possible treatment options largely due to limited and ‘unpublished virological and clinical data’ that demonstrated they were effective in treating the SARS coronavirus” (Jagielski, 2020).

What is clear is that people living with HIV who have achieved viral suppression through adherence to a treatment regimen are shown to be generally healthier than people with higher levels of the HIV virus detectable in their blood. That doesn’t mean, however, that we are any more or less susceptible to opportunistic infections. Respiratory ailments, in particular, have historically been bad news for people living with HIV.

So, the verdict at this point is: “We don’t know what we don’t know, and therefore, should act with an abundance of caution.”

References:

• Jagielski, D. (2020, March 16). Johnson & Johnson Says There's Insufficient Evidence Its HIV Drug Can Treat COVID-19. Alexandria, VA: The Motley Fool: Investing. Retrieved from: https://www.fool.com/amp/investing/2020/03/16/johnson-johnson-says-theres-insufficient-evidence.aspx
• Young, B. E., Ong, S. W. X., Kalimuddin, S., et al. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. Published online March 03, 2020. doi:10.1001/jama.2020.3204 Retrieved from: https://jamanetwork.com/journals/jama/fullarticle/2762688

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.