UrSure

Adherence Startup UrSure Could Prevent 11K+ HIV Infections

UrSure helps reduce the spread of HIV in at-risk populations. The company produces a urine test to check if patients are taking their pre-exposure prohylaxis (PrEP) medication.

PrEP has been around since 2012 and is a groundbreaking way to prevent HIV negative people from becoming infected. Similar to birth control, it is taken once daily as a pill and prevents patients from contracting HIV.

However, adherence to the once-a-day pill averages only 43%, leading to thousands of new infections each year. The UrSure test boosts aherence and — after a successful trial at the FIGHT clinic in Philadelphia — is being introduced to health systems across the United States.

For his efforts, co-founder Giffin Daughtridge was recently named to Forbes’ 30 under 30. I sat down with him to better understand the UrSure story and the team’s goal to tackle the HIV infection epidemic in the United States and abroad.

Context

2013 was an exciting time for HIV prevention.

In 2012, Truvada — the pioneer PrEP drug manufactured by GILEAD — had been approved by the FDA. The initial data showed that PrEP, in fact, was effective at preventing HIV. Specifically, if the drug was taken once a day as prescribed, PrEP would prevent the contraction of HIV with near 100% effectiveness.

Giffin Daughtridge, then a medical student at UPenn, and Helen Koenig, a professor of infectious diseases at UPenn’s medical school, were excited about the possibility to prevent the spread of HIV with PrEP. They began working with Philadelphia FIGHT to create an HIV-prevention clinic, where they helped give at-risk populations access to PrEP.

Adherence: The Major Sticking Point

Daughtridge and Koenig quickly realized that adherence would be one of the most difficult challenges they would face in preventing new HIV cases in Philadelphia.

Co-Founder, Dr. Helen Koenig

Research indicated that 43% of PrEP patients adhere to their once-a-day regimen — and it quickly became clear that it would be difficult to bring that number up. Even among those who reported that they were abiding by their once daily regimen, many weren’t actually doing so.

“The gap between self-reported and actual adherence to a pill regimen is not uncommon. We needed to develop a test to make sure patients were taking their PrEP,” said Daughtridge.

That’s how UrSure, a urine test for PrEP patients, came to be.

A Case Study: Catching it Before it Kills

When Daughtridge and Koenig began using urine tests, they learned firsthand how different self-reported and actual adherence can be.

One patient reported that he took the drug every day. However, when his urine sample indicated that he hadn’t, he confessed that he had stopped taking the drug due to a family situation.

As it turns out, the 17-year old gay black male’s mother had discovered the pills. After looking up what the pills were, she became irate. She associated the drug with HIV, homosexuality, and sex work and demanded that he stop taking the pills.

Because of the UrSure urine test, the prescribing physician knew that the patient was no longer adhering to his regimen.

Daughtridge reported that “the physician began providing the PrEP pills in an Altoids can upon learning what had happened. That way, the patient’s mother wouldn’t suspect anything about his sexuality.”

Since then, the patient has adhered to his regimen and — likely as a result — has not contracted HIV.

“The physician began providing the PrEP pills in an Altoids can upon learning what had happened. That way, the patient’s mother wouldn’t suspect anything about his sexuality.” Giffin Daughtridge, UrSure Co-Founder and CEO

In the overall study, UrSure was able to boost adherence to 70%, as opposed to the typical 43%.

Co-Founder Giffin Daughtridge after winning Harvard’s Innovation Challenge

“If we applied this adherence boost across at-risk populations in the United States, we would prevent 11,500 new infections and save $425 million in healthcare costs each year,” says Daughtridge.

Obstacles: The HIV Stigma, Insurance Coverage, and Competing Tests

Why was the patient’s mother so unhappy that her son was taking a drug that — in fact — was potentially saving his life?

The adoption of PrEP and UrSure is complicated by the stigma associated with HIV. The virus is often associated with what many perceive to be undesirable lifestyles: homosexuality, drug use, and sex work.

Unfortunately, this makes many patients weary of taking PrEP.

This helps explain why only 140,000 patients currently take PrEP in the United States, while the Center for Disease Control (CDC) recommends the drug for 1.2 million at-risk Americans. Resolving the disparity between these two numbers will help both PrEP and UrSure reach their full potential.

Two other obstacles for UrSure will be proving that its product should be insurance reimbursable and that it should be the de facto test for PrEP adherence.

For healthcare startups, becoming insurance reimbursable is often a longer and more difficult path that getting FDA approval. However, UrSure is exploring several options for becoming insurance reimbursable, which include joint ventures or licensing agreements with larger companies like GILEAD.

The final obstacle will be showing healthcare providers that UrSure is the best way to test patient adherence to PrEP. There are several medical research groups looking at blood and hair samples.

“Blood and hair tests are significantly more expensive, invasive, and time-consuming than a urine test. That is why we believe UrSure is the best solution,” says Daughtridge.

An Opportunity to Save Lives

At full scale in the United States, UrSure estimates that the urine test for PrEP adherence is a $120 million annual opportunity. If it expands internationally, that number expands to a whopping $7 billion.

But those aren’t the most important metrics to UrSure. The product is designed to save lives — and that is why UrSure chooses to focus on the 11,500 new HIV infections it believes that it can prevent each year in the United States alone.

And there are even more lives to save.

Beyond international markets, the UrSure team believes that a similar urine test could be used for patients at risk of contracting Hepatitis C and Tuberculosis.

Despite this long-term vision, UrSure will be focused on getting its existing product to as many at-risk HIV patients as possible for the foreseeable future.