This feature is not a substitute for advice or care provided by a licensed medical or health care professional.
The year was 2019, and Louisiana was lurking then—as it is now—near the bottom of the country for health outcomes. An estimated 40,000 Louisianans were living with the hepatitis C virus (HCV), and that summer the Louisiana Department of Health (LDH) began a new initiative to eliminate HCV in the state. Where Louisiana’s Medicaid recipients and incarcerated patients had been subject to intense barriers to treatment before the deal, the state planned to lift the restrictions and cover treatment for everyone who tested positive for HCV. The goal was to treat 10,000 people in the first year, and cure at least 31,000 cases of HCV over the five-year plan.
The year is now 2023, and thus far only about 13,000 people have been treated since the rollout. Beyond 2024, it is uncertain whether the state will continue to provide this level of care—at press time, officials at LDH themselves do not yet know the future of this program.
“Before the HCV elimination plan, we were really only able to test people for hepatitis C. And then we didn’t really have anywhere to refer those people to,” said Alex Stallings, the director of health, education, and wellness at CLASS (formerly Central Louisiana AIDS Support Services) in Alexandria. CLASS serves people living with or at risk for HIV and also provides counseling, HCV and other sexually transmitted infection (STI) screenings, linkage to health care support, and runs a syringe service program (SSP) to distribute safe injection supplies to community members.
Before mid-2019, Louisiana Medicaid required patients to be sober for months prior to HCV treatment, capped treatment coverage at once per lifetime (though reinfection is possible), required a specialist to prescribe the HCV medication, and required the patient to have severe liver fibrosis before greenlighting treatment. The State was spending roughly $60 million annually to treat patients who were incarcerated or on Medicaid—which included only those who cleared the formidable hurdles placed in their path. As of July 2019, all those restrictions have been removed.
To understand just how we got here, it’s worth taking a look at the history of HCV. First documented in the 1970s in blood transfusion patients, the virus went by “Non-A Non-B Hepatitis” before researchers coined the admittedly catchier “hepatitis C.” A bloodborne virus, it can spread through sharing personal items that contain trace amounts of blood, from a pregnant person to a fetus, through sex, or, most commonly, transmitted through sharing syringes or other equipment used for intravenous drug use. In some cases, the immune system “clears” the infection; in others, it becomes a chronic condition. In chronic HCV, the virus can remain outwardly asymptomatic for years as the virus gradually damages the liver. Over decades, chronic HCV causes liver inflammation, fibrous webs of scarring, and eventually can lead to liver cancer and liver failure. Despite its slow progression, it is one of the deadliest infectious diseases in the country.
Treatment began in the ‘80s and ‘90s with an antiviral called interferon, but cured only about 40 to 60% of patients. Interferon was administered via injection and caused flu-like symptoms and other side effects in many recipients, which could last the entire year-long course of treatment.
Enter direct-acting antivirals (DAAs), which hit the market in 2013. DAAs work by inhibiting the virus’ ability to reproduce, and have few known drug interactions. Some are up to 99% effective, and some, like Gilead Sciences’ Epclusa (generic name sofosbuvir/velpatasvir), work on several different strains of HCV. Unlike interferon, these drugs are available in pills that can cure people infected with HCV in a matter of months, with drastically fewer side effects. With the introduction of DAAs, HCV went from a potentially deadly and highly transmissible infection that was very difficult to treat, to one that could be easily cured with oral medication.
Despite the advances in treatment, patients on Medicaid and in Department of Corrections (DOC) custody were largely unable to get on DAAs. DAAs come with an intense price tag—without insurance, the full course of treatment costs between $24,000 and $99,000. In 2018, less than 3% of Medicaid recipients and people in DOC custody could access treatment after testing positive.
By some reckoning, the draconian limitations on medication before the elimination plan (sobriety, advanced fibrosis, the “lifetime limit”) were meant to limit state spending on a prohibitively expensive drug. But by LDH’s estimation, this was a failing strategy: New infections were outpacing those that were cured, and very few could access treatment. In 2019, the four treatment requirements—sobriety, the so-called “lifetime limit” on treatment, the need for a gastroenterologist or hepatologist to prescribe medication, and the condition that the patient be suffering late-stage fibrosis—were all removed.
What made this polaric shift possible was the keystone of the elimination plan: a five-year subscription arrangement between the state of Louisiana and pharmaceutical juggernaut Gilead Sciences. For a cool $38 million per year, for five years Gilead Sciences subsidiary Asegua Therapeutics would provide as much of the generic version of their HCV drug Epclusa as was prescribed through Medicaid and the DOC. If everyone in those systems, or none of them, took the drug, the cost to the state would be the same.
“The elimination plan/subscription model completely changed access to medications,” said Dr. Lorna Seybolt in an email interview. She first began working with HCV back in 2004 during a fellowship in infectious diseases, and has worked at CrescentCare in New Orleans since early 2014.
“Prior to [the elimination plan] for patients on Medicaid, only those with advanced liver disease could access medications. We spent time trying to get meds for patients with little or no liver disease and were never successful,” said Seybolt.
“As someone who worked with patients at the very beginning of the rollout, people were over the fucking moon,” said River1River wished to use a pseudonym due to professional constraints., who worked in HCV testing and linkage care before and after the implementation of the elimination plan. When we communicated over text, he said he wanted to underscore just how radical, how exciting the change was. “To get to tell people that they were now eligible for treatment (Easy treatment! Free treatment!) for a deadly virus they were told would kill them is one of the greatest gifts of my life,” he said.
“People were fucking pumped,” he added.
After the rollout of the elimination plan and subscription deal, CrescentCare workers developed their “rapid start” HepC clinic. “With Medicaid, the full three-month dose can be prescribed and picked up in one visit,” said Naomi Langlois, the CrescentCare HCV Linkage to Care Coordinator.
“As soon as someone has a positive test for HCV, they can access care and treatment. If they are enrolled in LA Medicaid they can get medication on the day they have their test/appointment,” said Dr. Seybolt. In other words, someone can walk into CrescentCare, get tested, and pick up the full course of medications at their on-site pharmacy all in one visit. This was simply impossible before the rollout of the elimination plan.
With the intimate connection between HCV transmission and injection drug use, syringe service programs (SSPs) are a critical part of reaching people who are at a high risk of HCV infection and transmission. There are seven SSPs in Louisiana, located in Shreveport, Alexandria, Baton Rouge, and New Orleans.
CrescentCare and CLASS both run SSPs where participants can get free safe injection supplies. They both also conduct HCV and other STI screenings. “We do testing on everyone who walks through the door, it’s kind of an opt-out thing,” said Alex Stallings. When participants test positive, CLASS works closely with the LDH HCV Linkage to Cure team to connect people to treatment. The linkage team also arranges transportation, and otherwise provides support and tracks patients’ progress so they can successfully finish their full course of medication (and in most cases, achieve cure).
In Shreveport, the Philadelphia Center runs a similar program. In connection with their SSP, they provide rapid and confirmatory testing for HCV. Hershey Krippendorf, who runs the SSP, said, “If [participants] are positive, we will take the opportunity right then and there to try to link them into either supportive services for HCV or to say, ‘Hey, are you ready for medical care?’”
If the answer is “yes,” then the Philadelphia Center is prepared with a sequence of operations to get the patient’s confirmatory labs and treatment at nearby Ochsner LSU Health Shreveport.
But because the virus can be spread through intravenous drug use, stigma is the specter that haunts HCV treatment and elimination. “The general population thinks that people who use drugs are all bad people, and they’re not bad people,” said Krippendorf. “This is a community that has been forgotten for years because the war on drugs had just done nothing but harm,” she added.
“You know, we still see medical providers not wanting to treat people who are actively using,” said Stallings. One of the things that CLASS helps participants with who want to get treatment is coaching them on how to engage with providers, as patients don’t need to disclose their drug use if they don’t want to. Langlois mentioned that stigma from providers and health care workers becomes a barrier for clients extending beyond HCV treatment.
Deepa Panchang, who works with CrescentCare as a nurse practitioner providing primary care, noted: “Removing the sobriety requirement has been so, so important. For people desiring sobriety, achieving it can still be a long and difficult road, and often the treatment modalities are insufficient. For many people, sobriety is not a goal, or not a goal they feel is realistic for them. This group also deserves access to treatment for a chronic infection when that treatment is available.”
“Evidence shows that people who are using substances can be treated successfully,” said Dr. Seybolt. “There is no reason to deny treatment to people with active substance use. HCV treatment can effectively engage them in care and lead to treatment for substance use disorders,” she added.
Meanwhile, community memory of the old landscape of HCV treatment—the malaise of interferon regimens, the sobriety requirement, and fibrosis requirement for treatment—has persisted. “The misconception is that you have to have insurance or you have to pay out of pocket. That’s the point of view of our participants, that they’re going to have to spend their money on it,” said Krippendorf. Stallings has heard interferon treatment compared to chemotherapy in terms of its side effects.
Krippendorf told me that the day before we spoke, a participant had gotten a positive test from a plasma center. A positive HCV test, but no education or connection to care.
With the limited number of SSPs in Louisiana (of the seven, four are in New Orleans), Philadelphia Center sees more people each week coming from rural areas. In one case, Krippendorf told me someone who tested positive for HCV at the Philadelphia Center would have needed a 45-minute ride to and from Ochsner for treatment. Though the cost for the ride was covered by LDH, geographic access was still a problem.
While Krippendorf spoke highly of the HCV elimination plan, she worried what would happen if the funding for medication was not renewed. And, while LDH has worked to promote the elimination plan, a more intensive push seems needed to make sure as many people as possible are aware that they can get access to treatment for hep C for free—with the new DAA treatment, that they don’t need to be in stage 3 or 4 fibrosis for, that they don’t need to be arbitrarily sober for, that they can get even if they have started treatment for HCV in the past.
“The shadow of the lifetime limit weighed heavily on [patients]—the unlimited treatment over five years is a key part of this,” said River. “You can’t build a tolerance to Epclusa,” he continued. “So we aren’t just offering people a cure, we are offering them a whole future of care that can meet them where they are until their HCV is gone. So if you missed appointments, fell off, were going through it… HCV care would be there for you because you deserve it.”
Dr. Seybolt also brought up “treatment as prevention.” That is to say, treating one person can reduce community transmission. And as Deepa Panchang pointed out, if we have the technology and resources to cure someone of a deadly disease, shouldn’t we?
The Linkage to Cure team at LDH has access to the list of Medicaid recipients who have tested positive for HCV, and was tasked with contacting them and connecting them to care—a daunting task given the thousands of people who applied, even if the state had working addresses and phone numbers for everyone. They didn’t. For instance, Krippendorf said that some participants at the Philadelphia Center lack permanent addresses, or don’t always have working phones.
In those cases SSP’s regular contact with participants, as well as mutual trust, is essential. “We know who needs to be re-linked to medical care and if we see them at a drop-in we can just have a little conversation with them and say, ‘Hey, what’s going on? Is this something that you’re still interested in?’” said Krippendorf.
When asked how LDH is supporting on-the-ground medical providers, CrescentCare’s Director of Communications Joe Hui responded, “There are some funds from the state that go toward participation incentives and other indirect support for our own outreach,” while Krippendorf said, “At the beginning of the elimination plan, there was a campaign that circulated via social media but haven’t seen it in a while,” and that she was unaware of any current resources from LDH to promote HCV screenings and access to treatment.
After the elimination plan’s rollout, Louisiana went from being one of the most restrictive states to get treatment under Medicaid, to offering one of the best access plans in the country. And initially, the amount of patients getting treatment for HCV in Louisiana increased—in the first reporting quarter, those getting treatment more than quintupled, from 288 patients to over 1,500. If that initial number—about 1,500 people cured per reporting quarter—had continued or increased, the state could have met its goal and eliminated HCV by WHO definitions within the five-year timeline.
But after less than a year, a new virus emerged for which there was no vaccine or treatment, which radically changed how people could interact with SSPs and health care providers. In 2019, HCV had killed an estimated 14,282 Americans, one of the deadliest infectious diseases in the country at the time. The following year, SARS-CoV-2 killed over 350,000 people in the United States.
It is impossible to overstate the astronomical impact of COVID-19, which eclipsed other public health initiatives when it swept through the country in 2020—but even before COVID-19 emerged and changed history, LDH needed to overcome intense barriers to ensure that the rollout cured the ambitious number of HCV patients that it set out to.
To reach their goal, LDH would have needed to provide intensive outreach and training so that providers understood that the former prerequisites for treatment were removed, push anti-stigma trainings for providers to improve outcomes in patients who inject drugs, provide massive outreach campaigns for the public to get out the word that treatment was now fully covered without sobriety or advanced liver disease, and inform patients that the treatment for HCV no longer made you seriously ill. Finally, LDH would have needed a more comprehensive way of reaching rural patients. While there was some investment in both provider-side trainings and public education campaigns, these efforts have clearly fallen short.
And though these logistical challenges may seem insurmountable, consider that Egypt, with a population 22 times larger than Louisiana’s, has rolled out an elimination plan of its own, with their own deal with Gilead to purchase HCV medications. From having one of the highest rates of HCV in the world, Egypt is now close to eliminating HCV nationwide. The Egyptian elimination plan combined newfound access to medication with free screenings for the population, which included public outreach and teams with mobile testing units (1,079 vans total) that set out to screen rural residents and connect them to treatment. The success of the program is undeniable: Egypt’s HCV elimination initiative screened 60 million people and cured four million people of HCV since 2014.
While the potential for Louisiana’s HCV elimination plan is clear, the future remains murky. After mid-2024, when the subscription deal for Epclusa ends, it is not known how or if the state will continue to offer the access to DAAs that it has for the past four years. Requests for information from Gilead yielded a polite but unilluminating response and a link to a statement reaffirming Gilead is “steadfast in support for hepatitis C elimination efforts” without any information about continuing the subscription deal for Louisiana (or anywhere else). Providers across the state do not know what the protocol will be in the future, nor do those working at LDH. And to lose the ability to treat an easily curable, potentially deadly disease—when the technology to treat it is available—would be nothing short of shameful.
“This project has already impacted a lot of people’s lives in a positive way,” said Stallings. “At the end of the day, there’s no reason not to get tested for hepatitis C… You don’t have to be a person who uses drugs to get hepatitis C, it can affect anybody. If you do test positive, reach out to a medical provider, don’t take no for an answer. If someone turns you down, if there’s something you feel you can’t navigate, don’t stop there. You can get treated.”
“The subscription model has really changed the landscape of HCV medical care,” said Krippendorf. With patients at the Philadelphia Center (such as the woman who tested positive for HCV at the plasma center), Krippendorf provides reassurance that treatment is easy and free. She says within a week participants can expect an appointment at the clinic, which has a designated day for HCV patients. Yet she worries about what comes next for patients when the subscription deal ends—whether the pre-2019 restrictions will come crashing back down onto those who need medication. “What happens to the requirements for sobriety? Does that go away too?” she asked.
Despite the gains in the last four years, the state has a long way to go before HCV is eliminated. In 2021, Louisiana reported over 4,000 new cases of chronic HCV and about 300 new cases of acute HCV. And the rise of fentanyl in the drug supply—a drug which has a shorter duration than heroin—has increased the need for widely available sterile syringes. However, federal HIV and HCV funding cannot be spent on syringes and “cookers” for intravenous drug use, which makes it much harder for SSPs to afford the syringes needed for participants to have adequate supplies and avoid sharing needles or cookers.
As the light of a potential for an HCV-free world crests the horizon, it is clouded by the cost of medication. While the case of Egypt’s eradication efforts show that a concerted effort—and not medication alone—is needed to stop the virus, getting DAAs to patients is still needed to cure HCV. Epclusa is cheap to produce. But it is expensive to buy. When Gilead first brought DAAs to the market in December 2013, the company made a mind-boggling $2.23 billion in profits during the first quarter of 2014.
Pharmaceutical manufacturers’ rationale for charging tens of thousands of dollars for a potentially life-saving treatment that costs about $60 to make goes something like this: Yes, making this drug is not costly. But the price is reflective of the demand, not to mention the years of research and development that it took to make a drug that can stop this disease in its tracks, a process so specialized, so enshrined in the halls of prestigious research that follows years of study, that it may as well be sorcery, and we’ll thank you to pay us the cost of a miracle.
But should we? After all, the precursor to Epclusa (sofosbuvir/velpatasvir) was Sovaldi (sofosbuvir), which was developed by a start-up called Pharmasset. Pharmasset was subsequently acquired by Gilead for $11.2 billion in 2012. A U.S. Senate investigation found that Pharmasset spent $62.4 million developing Sovaldi; an independent study tracked about $60 million in support from the federally-funded National Institutes of Health to Pharmasset to develop the drug that would become Sovaldi.
So should we pay the full cost of a miracle, some of which is to help Gilead recoup the cost of buying Pharmasset, or have we already paid for it when the public funding bankrolled its development?
While we don’t know what the future holds for Louisiana’s deal with Gilead, we do know that Louisianians need to have access to affordable, curative HCV treatment. It is time for LDH to pursue every available avenue to continue to provide DAAs to all Louisianans who need them. All the same, there are no guarantees what happens next. If you have gotten this far, understand: The time to get tested for HCV—and to get treated if that test is positive—is now.
For more info on HCV testing and treatment, visit crescentcare.org/service/sti-testing and louisianahealthhub.org/testing-treatment.
Illustrations by Kate Lacour
