The introduction of direct-acting antiviral (DAA) drugs in 2011 and continued advances have dramatically changed hepatitis C treatment, with fewer side effects, increased cure rates, and reduced treatment time, giving people with hep C the opportunity for a virologic cure, defined as an undetectable viral load after 8 to 12 weeks of treatment.
New York State Governor Andrew Cuomo, in addition to a plan to end the HIV/AIDS epidemic, also convened a task force to eliminate hepatitis C. This hepatitis C task force was convened to create recommendations in New York State, and advocates anticipate that these recommendations will be out in 2020 for the entire state to begin aggressively working on the elimination of hepatitis C.
The New York City Department of Health and Mental Hygiene reports that an estimated 116,000 New Yorkers, about 1.4% of New York City residents, are living with chronic hep C infection. This December, at the Ending the Epidemic Summit in Albany, New York, Ginny Shubert, JD, who is a cofounder of the New York City HIV services organization Housing Works and a senior advisor on policy and research, gave a poster presentation entitled, “Hep C TIP: Employing a Community-Based Treatment Incentive Program to Engage and Retain Vulnerable Persons in Curative Hepatitis C Treatment.”I interviewed her about her findings and insights.
Terri Wilder: This was actually one of the very few hepatitis C sessions at the Ending the Epidemic Summit. So, I was thrilled to see that you had this poster session. You worked with the University of Pennsylvania on this demonstration project and were funded through a grant through the Robin Hood Foundation. And so, I’m wondering if you can tell our readers a little bit about why this demonstration project was started and some of the details about it.
Ginny Shubert: Sure. And I should acknowledge that the folks that are implementing this intervention at Housing Works are our medical director, Vaty Poitevien, and two folks, in particular: Gillian Saunders and Brian Hennessey. They’re really the folks on the ground doing the intervention.
So, Housing Works serves a group of folks in our federally qualified health centers and our other programs that have a very high prevalence of hepatitis C. I think you mentioned that citywide prevalence is 1.4%, estimated. The prevalence that we’ve found in our 18-month demonstration project among clients tested at Housing Works was 18%.
In addition to a very high prevalence, many of the folks that we serve face a number of demonstrated barriers to hep C treatment, including experiences of homelessness, behavioral health issues, poverty, frankly, and other barriers. So, as part of the statewide plan to eliminate these kinds of things, Housing Works decided to take action to eliminate hepatitis C in its own communities. And so the key things that we felt were necessary were to, one, educate people on the new treatments with few side effects and much greater efficacy in a much shorter time, to engage folks in testing, and also, for those who tested positive for hepatitis C, to engage them in treatment.
And if you look at the literature, this seems to be the real problem in the treatment cascade—is engagement. Once folks are engaged in treatment, given the short period of treatment and the efficacy, what we found is that most folks succeed, although after the intervention was implemented, we did much better.
So, at Housing Works, they provide a model of integrated care, where primary care providers work in tandem with other care coordinations and case manager programs to coordinate care. And, of course, we were already doing hepatitis C treatment. But we weren’t achieving the levels—or, they weren’t achieving the levels—that they wanted in terms of treatment engagement or in terms of successful cures.
So, we decided to put together a toolkit in the space of intervention to support human engagement and success. Shall I continue to explain?
TW: Yah. Please explain what’s in the toolkit, because it’s really robust.
GS: We called the program the Hepatitis C Treatment Incentive Program.
So, the Hep C TIP toolkit included, as I mentioned, social marketing, outreach and education to increase understanding of hepatitis C, new treatments, and to engage both staff and clients in a campaign to end hep C in the community. As you may know, many folks in our community were familiar with the older treatments, the interferon-based treatments, which were very difficult, not always successful, and were injections. So, it took some education to familiarize people with the new treatment.
The toolkit also included—or, includes (it’s ongoing)—navigators to help with rapid testing, to get folks ready for treatment, to help obtain the prior approvals for the medications, and to monitor and support participants in the Hep C TIP program.
Case conferences are a part of it, that include the person being treated for hepatitis C, as well as their health care provider and their navigator, to agree on an individualized plan. And so, if you needed a behavioral health assessment or a referral to either harm reduction services or mental health services, that was part of it.
The program did weekly pill boxing nursing visits to help folks, as sort of a motivator, and also just as a regular check-in. So, folks would come in once a week and meet with the nurse during the course of treatment, and receive a pill box for the coming week.
The navigators stayed in touch with participants during the course of the treatment. There were adherence support groups if people found that helpful. And then, probably the most unusual part of the toolkit was that there were $100 gift card incentives available; up to five over a 12-month period. And folks enrolled in the program received a gift card at their first undetectable lab result, at the completion of their medication, and then each subsequent report of sustained viral response, undetectable viral load, and three months apart for—we were hoping to get folks back, not only at the three-month mark to be able to confirm sustained viral response, but at six months and nine months following treatment, because there is always a chance for relapse.
And then if folks wanted it and needed it, direct observational therapy was also available. I’m not aware of anyone who actually used that during the 18-month intervention.
TW: Can you talk about the social marketing piece? Maybe an example of something that you did to reach out to the community to let them know about this opportunity?
GS: Well, there’s a great marketing department at Housing Works. And they did a poster campaign. It started out as, “Let’s kick hep C’s ass.” But, actually, people didn’t like that too much. So, the [headline] was changed to, “Defeat hep C for good!” And the posters were engaging.
We did testing events at each program location, where there would be food or a party. And testing would be available, as well as treatment education. Every test member received training on hepatitis C, the treatments available, and on the availability of the hep C TIP program. So those are the main social marketing strategies.
There were also regular communications with staff and with clients that included information about the program and how to sign up.
TW: Can you talk about the evaluation piece of this, which I understand is still ongoing? But I’m just kind of curious about the methods and the measures that you came up with.
GS: Sure. Well, we started our program on April 1, 2016. And the demonstration project, in terms of the evaluation, looked at the 18 months following initiation, although it’s important to know the program is ongoing. And I think I failed to mention that participation was open to any person in primary care at Housing Works. Or if they were tested elsewhere, they could receive their hepatitis C treatment at Housing Works and continue with their primary care elsewhere. So, it was open to whoever wanted to participate.
For the evaluation, we were interested in seeing whether we could improve our hepatitis C treatment cascade. So, we were interested in seeing if we could improve the number of people with known hep C status. The known hep C status was defined as everyone who had a confirmed diagnosis at the start of a period, or who had a documented hepatitis C antibody test that was negative, or who had a positive antibody test during the program period that was confirmed with an RNA test.
We wanted to increase the percentage of folks in our primary care programs at the generally qualified health centers who knew their HCV status. And so, for the intervention demonstration, we wanted to look at a group of people who were not exposed to the TIP intervention, versus a group of people who were exposed.
So, the evaluation looked at folks that we considered were engaged in our primary care. We operationalized that as a certain number of primary care visits, at certain periods apart, over the 18 months pre- to the intervention, and the 18 months post. And then we looked at a group of people who were in our primary care, but who ended primary care before the intervention—so they had no exposure to the intervention—versus folks who were in primary care post-intervention.
The intervention group included about 2,900 clients. And the pre-intervention group, the folks who ended their primary care before the intervention started, were about 716 clients.
Our knowledge of HCV status, we were very pleased that we went from 60% with a known status prior to the intervention to 77% with a known status post-intervention.
Obviously, we were interested in seeing the prevalence of HCV among those with a known status, and as I mentioned before, we had a very high prevalence, 18% of folks during the post-intervention demonstration period. And, actually, the pre-demonstration period comparison group had an even higher prevalence, at 25%.
The next step in the cascade that we were interested in is: Who could we get engaged in treatment? And we operationalized that as folks with a confirmed HCV infection who received a drug at the interval, a medication prescription, and that that was a prescription that was followed up by at least one documented laboratory test to assess viral load, so that we knew that the client started medication and that they actually returned for a follow-up.
So, we were extremely pleased that we went from the 16% engagement in treatment in the 18 months prior to the intervention to 43% engaged in treatment post-intervention.
Finally, of course, we wanted to see what percentage of folks we could cure. That was operationalized as completing the course of medication and a sustained virologic response—which means that they were undetectable at the end of medication, and then also undetectable at a viral load test done at least three months after the end of medication.
So, there, we went from a 67% cure rate in the 18 months prior to the intervention to a 90% cure rate post-intervention. And I think that’s consistent with the literature that shows that if folks remain engaged in treatment, most people succeed. And just to put that 90% in perspective, this evaluation was an intense treating evaluation. So, we included everyone who was engaged in treatment, regardless of whether they subsequently died, were incarcerated, or otherwise lost to the intervention. And we had a 90% cure rate. So, we were very pleased with that.
TW: That’s kind of amazing data, to look at that intervention. Can you talk about the demographics of the post sample? I think it would be important for folks to know who is part of the sample.
GS: Well, what I can tell you about our basic demographics: A little over half of the people with the positive HCV status in our study group were HIV positive; 46% identified as African American; 35% as Latinx; 22% were female; and about 4% were transgender, identified as transgender.
Our hep C participants tracked the demographics of the overall positive group pretty closely; so, a little over half of the participants identified as African American; about 34% as Latinx; about 2% transgender; and just under 50% were HIV positive. This reflects our overall primary care group, as a whole.
We’re still continuing the evaluation and gathering other client characteristics, such as substance use, mental health status, experience of homelessness, etc. Because we know from experience—we believe from experience—that those factors actually didn’t impact their abilities to succeed with hep C treatment. But we want to look at that in a rigorous way.
TW: I’m a little curious about when an intervention ends. Because I’m assuming that at some point funding is not there for things like gift cards. And I’m wondering if you have any thoughts about people staying engaged in care if these interventions aren’t there anymore.
GS: Well, as you know, hepatitis C treatment is time-limited. The considerations are a little different from ongoing inherent intervention for, say, HIV viral suppression. We have been able to continue the hep C TIP program through general resources available in our primary care program. This isn’t the time to talk about 340B, but it is such an important program for federally qualified health centers to be able to provide the services that are needed for folks to succeed.
The other thing that I think is going to be important going forward are the implementation of value-based payment strategies and models, to incentivize performance or incentivize health behaviors in a way that makes sense to achieve outcomes. But [with] the greater focus on outcomes, there’s more freedom to address social drivers, which we all know affect outcomes, but it is difficult to address with the current Medicaid payment system.
TW: Great. And I’m just curious: To do a demonstration project like this—can you just give me a ballpark estimate? How much did this actually cost, in terms of funding?
GS: Well, of course, you always want to look at the incremental costs, when you’re adding services to existing care. And, in particular, obviously costs depend on the size of the program.
Based on standard costing analyses, we found that the total incremental cost per person per year for the intervention was about $1,500, or about $138 a month, which is well within the cost-effective threshold for HCV treatment support.
TW: And what are next steps for Housing Works, in terms of this intervention?
GS: We plan to continue the intervention. And we’re continuing, obviously, to monitor its effectiveness.
But for the moment, we are continuing to provide the intervention. We’re trying to, in particular, ramp up testing in all programs, and regular testing for folks that are at higher risk for acquiring hep C. And I can tell you it’s one of the—eliminating hep C in the Housing Works community is one of the key strategic objectives in that process of strategic planning.
TW: Right. And the unique thing about New York State is that there is a hepatitis C testing law, although it only encourages testing within baby boomers, which probably needs to be revised, considering who we actually see testing positive for hep C.
GS: Yes. If you look at the latest New York City hep C report, there is a real change in the age group most at risk, with younger people seemingly at even higher risk than baby boomers.
TW: Wondering if that might be something that’s going to be considered going forward, in terms of the work of the hepatitis C task force in implementing any of the recommendations that come out of the task force. It seems like it may be something that needs to be revised.
GS: Well, we’re really excited to see the task force’s recommendations get released so that we can all get going on hep C elimination. And I think that we’re going to have to have a lot of innovative strategies to deal with this pretty overwhelming epidemic, at this point. And I’m hoping including some innovative strategies for these financial incentives as part of integrating care.
TW: The other thing: My understanding is that activists are really pushing hard around safer consumption spaces. And I’m wondering if that’s going to somehow be tied into hepatitis C elimination.
GS: Well, I think harm reduction programs, in general, are really key to addressing the hepatitis C epidemic, and safe injections facilities, in particular—or, overdose prevention centers, as we’re referring to them in New York State. All the literature says that they are highly effective at providing HIV and HCV testing, engaging people in care—in addition to preventing overdose and preventing infections related to overdose.
So, I think that they’ll be key to our strategy.