Earlier this month, pharmaceutical company Gilead Sciences announced that it will donate enough HIV prevention drug Truvada to the Centers for Disease Control and Prevention (CDC) to benefit 200,000 people at risk for HIV.

While news of the announcement was met positively, it also came ahead of some other negative headlines surrounding the drugmaker, coupled with cautions from the medical community.

Health experts warn that better access to medications is just one piece in the very large puzzle of stopping HIV transmission in the United States.

It all underscores just how complex tackling HIV has been in the past and continues to be in the present.

The promise for better PrEP access
“We are proud to partner with CDC to dramatically expand access to medication that can help prevent new HIV infections,” Gregg Alton, chief patient officer of Gilead Sciences, said in the company’s statement in early May.

“We believe today’s donation, combined with efforts to address the root causes of the epidemic, such as racism, violence against women, stigma, homophobia, and transphobia, can play an important role in ending the HIV epidemic in the United States, particularly in parts of the country with the highest burden of disease.”

The goal is to expand access of the high-cost drug — central to pre-exposure prophylaxis (PrEP) treatment for HIV prevention — to people who are low-income, either uninsured or underinsured, and are at risk for contracting HIV.

The deal between the company and the U.S. government will last through the end of 2025 and could potentially extend to 2030, according to a statement from Health and Human Services Secretary, Alex Azar.

The medical community has long been proponents of PrEP as the highly effective face of treatment to prevent HIV.

The drug regimen actually consists of two medications in one pill, prescribed for daily use by people who are HIV-negative and at risk for contracting HIV.

The drug isn’t cheap, with a list price of up to $2,000 for a 30-day supply. Gilead has touted a co-pay coupon assistance program to help people who are commercially insured.

The Trump administration heralded the announcement as a key part of realizing its pledge to eradicate HIV from the United States by 2030.

As part of its four-pronged approach to hit this goal, the government zeroed in on the need to provide PrEP to at-risk populations, according to the CDCTrusted Source.

Just weeks after this initiative was first highlighted in the president’s State of the Union address, the CDC revealed that the annual decline in new HIV numbers has stalled, further highlighting the need for more aggressive measures.

That being said, some medical professionals say we have to wait and see how impactful this will be.

Dr. Hyman Scott, MPH, the clinical research medical director at Bridge HIV and an assistant clinical professor of medicine at the University of California San Francisco (UCSF), told Healthline that it isn’t exactly clear if this impacts the company’s current voucher program and assistance efforts for people who are low income.

He said, as with many drug manufacturers, there’s no publicly available data on how many people benefit from Gilead’s existing efforts and it’s unclear if these initiatives will be discontinued once this partnership with the CDC goes into effect.

“I think that is still an open question in terms of what advantage the donation has over the existing infrastructure,” Scott said.

“One thing is that we will have more transparency. We will be able to see — if it’s run by the CDC and administered by the CDC — who is using the program, who is accessing it, who is staying on [the drug regimen],” he said. “Because, right now, we don’t have any data on the people currently using this patient assistance program from Gilead.”

Scott said that as a healthcare provider it’s frustrating to see how the high cost of the drug can make necessary, life-saving treatment out of reach for those who might need it most.

“The cost of Truvada has been a significant barrier for expanding PrEP use in the U.S.,” he added.

“I saw a patient a couple of months ago who previously tried to get on PrEP, had a $1,600 bill to access it for just one month [and] found it very discouraging for him. Subsequently, he was diagnosed with HIV.”

Scott stressed that for PrEP to work on society at large, “barriers need to be removed” and the cost of medications is a “big barrier for those who have no insurance or gaps in insurance or the underinsured who have high co-pays and deductibles.”

Dr. Kristin Englund, an infectious disease expert at Cleveland Clinic, told Healthline that just offering free medications is not enough for people.

She said that people who receive the treatment still need to go in every three months for evaluations, which include meeting a provider, getting lab tests done, and doing an HIV screening to make sure they’re still HIV-negative.

None of this is free and the costs of these regular visits alone — even without paying for PrEP — can be cost prohibitive.

“This presents big barriers to getting PrEP to appropriate populations who need it. To at-risk populations, which include adolescents, young adults, people of color, and other at-risk groups like men who have sex with men (MSM), bisexuals, transgender people,” she stressed.

“We need to have a better ability to reach those populations and provide them with continuity of healthcare regardless of insurance.”

Englund said the new donation of drugs from Gilead to 200,000 people is going to “go a long way toward helping with at least the medication portion” of their care, but beyond that, more needs to be done to make sure the healthcare system benefits those in need.

Not everyone thinks this corporate donation is praiseworthy.

The New York Times Editorial Board issued and editorial that said while laudable on the surface, these kinds of donations “have a long history of doing more for drugmakers than for patients.”

They highlighted the fact that a month’s supply of Truvada costs roughly $6 to make and sells for more than $1,600 in the United States, according to the PrEP4All Collaboration, an advocacy group.

“Owing partly to those prices, only about 18 percent of the million or so at-risk Americans who need the drug have access to it,” the New York Times editorial board wrote.

“Gilead’s donation could double that percentage, but only if it’s reserved for patients who aren’t already receiving Truvada through the company’s existing financial aid programs. The deal, which Mr. Trump is said to have negotiated himself, contains no such guarantee.”

A generic hits the market
Complementing this news, Gilead announced that a generic form of the drug will be made available in 2020, which is a full year earlier than previously stated.

The company reached a deal with Israel-based Teva Pharmaceuticals to release a generic version of Truvada to the market. Gilead included information on the generic of Truvada in the company’s recent SEC filing.

In the past, Gilead has come under fire from HIV advocacy groups for seemingly holding onto the patent for the drug, preventing competition, and keeping prices at their sky high rates.

“While Gilead’s announcement that generic Truvada will be made available in the United States a year early is a victory for the LGBTQ+ community, for HIV activists, and for U.S. taxpayers, this should only be the beginning. Even their announcement today leaves Gilead with exclusive rights to Truvada as PrEP for another 15 months and Teva as the only generic manufacturer on the U.S. market,” wrote Dr. Aaron S. Lord of PrEP4All, in a blog post.

“This will do little to reduce the price in a way that will increase access and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement. I have to ask, what’s to stop them — other than a desire for profit margins — from releasing the rights now?”

As with the news of the donation, Englund cautioned that we have to wait and see how this plays out.

She said that we’ll have to see what the price point for a generic form of the drug will be once it hits the market.

“For folks who don’t have insurance, I anticipate it’s going to be exceedingly expensive — prohibitive for them — to be on PrEP,” Englund said.

She added that it’s unclear what insurance companies will be willing to cover and what will be left for consumers to pay.

It’s been a mixed bag of news headlines for Gilead. Separate from this, the Washington Post reported that the company engaged in deals to block generic drug competition for the HIV therapies it puts out to market.

This occurred even after the company’s patents on medications expired. The news was revealed through a civil antitrust lawsuit brought to the U.S. District Court in San Francisco by HIV and AIDS activists.

The Gilead spokeswoman responded to the Post: “We have entered into partnerships with other companies with the goal of bringing life-saving therapies to patients in need… Any assertion that we worked to delay availability of life-saving medication to patients is absolutely false.”

Reaching at-risk communities
“I think in the larger picture, we should not have any uninsured people in the United States. I’m just thinking in the broader context of ‘we shouldn’t have to have a program for uninsured. We shouldn’t have anyone not on insurance,'” Scott said. “Everyone should have access to care.”

Scott was speaking to the fact that fights over making PrEP more accessible touch on aspects of the healthcare system that make it incredibly hard for people — especially those of lower income levels and who are part of marginalized populations — to get the care they need to stay healthy and, in some cases, alive.

“PrEP is not just the pills. You require a visit with a clinician, your healthcare provider, laboratory testing — all those are not covered by the access to medications. Access to the drug is not all you need for PrEP treatment,” he said.

“We can’t lose sight of that. In California, we have a state-funded and supported PrEP assistance program. It came based on a lot of advocacy from people,” he added.

Englund added that treating HIV is complex. It involves an understanding of cultural and socioeconomic barriers that prevent people from accessing treatment and avoiding HIV.

She also said it’s important to reach all at-risk populations — from transgender people to those who are IV-drug users. It involves education programs, treatment as prevention, as well as addressing systemic problems in healthcare that fuel disparities in care.

“I think the easiest part of providing PrEP is writing the prescription. That’s simple. But, making sure that your patient is in a position to get it, to maintain it, to practice other harm-reduction practices — that gets complex,” Englund said.

“I appreciate the overarching initiative of eradicating new diagnoses by 2030, but it’s a lot more involved than simply writing prescriptions.”

Source: www.healthline.com