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