Tag: glp-1

The present economic downturn, coupled with 20 states and counting, pulling back their government funding for HIV/AIDs assistance programs could not have been untimelier. Economic pressures and potential budgeting shortfalls are forcing states to revise their spending. As a direct result, life-saving medications and preventative care for many living with HIV/AIDs has become more costly than ever. For instance, from 2012-2018, the first-line treatment options for Antiretroviral Therapy (ART) increased by a whopping 30%, which outpaced the inflation rate by 3.5 times,^[1] and have only continued to rise.  

In an effort to ensure accessibility to comprehensive treatment and support, the Ryan White Care Act was enacted. It is the largest, federally funded program for people with HIV/AIDS in the US. Since its inception, the program has helped over 600,000 people get access to life sustaining care, which is more than half the U.S population living with AIDs. The Act dispenses funds to state programs for uninsured, underinsured, and low-income people living with HIV and higher risk individuals. The funds cover inpatient services, ART medication assistance, counseling and mental health services, case management services and more.^[2]

Part B of the program: AIDS Drug Assistance Programs (ADAPs), are responsible for providing HIV treatment and Pre-exposure Prophylaxis (PrEP) to those at the lower income level, or with limited or no health insurance at a significantly less or no cost. ADAPs can also purchase insurance for those who qualify, and provide services to ensure the safety of drug treatments.^[3]

What does less funding look like?

Funding has been at stagnant at around $900 million since 2014^[4], yet we have seen an increase in enrollments by 30% from 2022-2024. The irrefutable truth of the matter is that thousands will lose access to their life-saving medications and treatment interventions if states continue to cut ADAP funding.

The relationship between poverty levels and HIV diagnoses has always existed— the further someone is below the poverty level, the higher incidence of HIV cases. One the most aggressive cuts so far have come from the state of Florida’s Department of Health. Despite insurance premiums rising nationwide, the Department lowered participant’s income eligibility from 400% to 130% of the federal poverty level. Meaning, only individuals earning $20,345 yearly, or less would be eligible to receive program benefits. Previously, those making $63,840 yearly or less were eligible. This change alone would result in approximately 16,000 individuals losing access to their HIV medications.^[5]

Though ADAPs are federally funded, each state determines: how funds are allocated, which medications are part of the program, waitlists for specific medications, and the program eligibility requirements. 

Ironically, state cuts in this department don’t actually correlate to money saved in the long run. HIV transmission would rise, as would hospitalizations, emergencies, and complex treatment cases, all of which are more expensive than maintenance medications. Pre-Exposure Prophylaxis (PrEP) medications are used to prevent the transmission of HIV, and are 99% effective when used correctly in those who don’t inject drugs. An economic evaluation study concluded with a modest 3% decline in PrEP coverage yearly, about 8,618 new infections would have failed to be prevented, and would account for $3.6 billion in lifetime costs.^[6]

The soaring costs of ART alone is enough to pose a significant barrier for people living with HIV/AIDs to receive life-saving treatment. If these state-implemented cuts continue, much needed resources will be out of reach for the disadvantaged, posing a great risk to several communities. The state-sanctioned rollbacks only add fuel to the fire, and threatens decades of progress that has been made to combat the virus. 

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How to best navigate these uncertain times?

• Brief yourself with different insurance plans in the market place, and enrollment periods
• Familiarize yourself with your state’s HIV Care and Services
• Ask your healthcare providers and local HIV organizations for assistance programs and resources

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^[1] https://pubmed.ncbi.nlm.nih.gov/32011622/

^[2] https://www.ncbi.nlm.nih.gov/books/NBK216136/

^[3] https://ryanwhite.hrsa.gov/about/parts-and-initiatives/part-b-adap

^[4] https://stateline.org/2026/03/10/states-are-limiting-hiv-drug-assistance-programs/

^[5] https://www.aidshealth.org/2026/02/florida-health-dept-proposes-new-formal-rule-to-slash-hiv-drug-access-for-thousands/

^[6] https://pmc.ncbi.nlm.nih.gov/articles/PMC12426795/

What’s new in the GLP-1 market? You guessed it: the second oral GLP-1 therapy is here. On April 1, 2026, Fundayo (orforglipron) received FDA approval for weight reduction and maintenance in adults with obesity or overweight adults with one comorbid condition related to their weight. Importantly, the medication is to be used in combination with an increase in physical activity and a reduced calorie diet.^[1] This announcement comes just three months after oral Wegovy started to occupy pharmacy shelves. 

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How does Fundayo compare to oral Wegovy?

With full adherence, oral Wegovy resulted in a 16.6% mean weight loss^[2], while Foundayo yielded just a 12.4% mean weight loss reduction.^[3] Despite the significant variance in performance, Fundayo does have unique advantages. It can be taken without any dietary restrictions, at any time of the day. Unlike Wegovy, which must be taken in the morning, on an empty stomach, with a full glass of water followed by 30 minutes of fasting. 

The dosing flexibility Fundayo offers would be beneficial for those who are may not want to use injectables, have less regimented schedules, or struggle with adherence. The added convenience of the oral dosage form, combined with the freedom from special storage requirements is another incentive for consumers. 

Another advantage is in its chemical structure. Foundayo is a small molecule weighing 902g/mol about 4 times less than that of oral Wegovy.^[4] The significance here is that due to the cyclical supply and demand shortage with GLP-1s, it may be cheaper, and easier to manufacture Foundayo which could ensure constant supply. Eli Lilly’s CEO even boasted, “We can make basically as much as we need”, suggesting that the company would be able to meet high demand. For providers, initiating a patient on a readily accessible therapy could provide better outcomes as it would be easier to maintain adherence. 

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What about the Disadvantages?

Because Foundayo is metabolized by the CYP3A4 enzyme, it is advised to not be used with any strong CYP3A4 inhibitors or inducers due to clinically significant drug-drug interactions. CYP3A4 inhibitors include several commonly prescribed drugs, such as Clarithromycin, Verapamil, and Carbamazepine.

Foundayo may also interact with certain statin drugs, which would require a thorough risk-benefit analysis. For example, if Foundayo was taken with Simvastatin, it would lead to a 2—2.5-fold increase in drug exposure, which would greatly heighten the chances of rhabdomyolysis (a painful, potentially life-threatening condition where one could experience sever muscle pains, weakness and dark colored urine).^[5] Despite this interaction, Simvastatin was not listed as a contraindication. Should a patient be on  both medications, the max Foundayo dose would be 9mg, rather than the regular max dose (17.2mg) that yields the largest weight loss.^[6]

Foundayo also stimulates insulin release, and can cause hypoglycemia in those using insulin and/or insulin secretagogues like sulfonylureas and metaglinides. For these patients, they would need to consistently monitor their blood sugar and understand the manifestations of low blood sugar. 

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How Well is Foundayo Tolerated?

During the clinical trials, about 7% of participants who received Foundayo had to discontinue the therapy due to adverse events.^[7]The most common side effects are consistent with what we’ve observed with the injectable GLP-1s: gastrointestinal effects such as nausea, constipation, diarrhea, and dyspepsia ranging from mild to moderate. 

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Eli Lilly plans to launch Fundayo this Monday April, 6^th. Having already anticipated insurance formulary restrictions, Eli Lilly offers a self-pay program, LillyDirect, which mirrors NovoNordisks self-pay program for oral Wegovy. Both programs price the lowest doses at $149 per month and the highest doses at $299 per month. 

Foundayo was reviewed through the Commissioner’s National Priority Voucher (CNPV) program which is aimed at accelerating the drug approval process in order to provide therapeutic options to Americans in a timely manner. The FDA’s to approval of Foundayo just 50 days after Lilly filed for approval, makes history as the fastest drug approval in the over 2 decades. Yet, in the ever-growing wake of class action suits against GLP-1 medications, one has to wonder if 50 days was adequate to ensure patient safety. 

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^[1] https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program

^[2] https://www.appliedclinicaltrialsonline.com/view/fda-approves-oral-wegovy-positive-oasis-trial-results?utm_source=copilot.com

^[3] https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill

^[4] https://www.managedhealthcareexecutive.com/view/foundayo-vs-oral-wegovy-the-similarities-the-differences-and-what-you-need-to-know

^[5] https://www.uptodate.com/contents/rhabdomyolysis-clinical-manifestations-and-diagnosis

^[6] https://pi.lilly.com/us/foundayo-uspi.pdf

^[7] https://www.nejm.org/doi/full/10.1056/NEJMoa2511774

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