Monitoring Treatment and Confirming the Cure of HCV

Transcript

Anthony Martinez, MD: Mark, in the old days when we started a patient on therapy, we had to do a million different labs while they were on treatment to monitor blood counts and this and that. You’ve done extensive work in terms of minimal monitoring. Is there anything that we need to do with these newer regimens once they’re on treatment?

Mark Sulkowski, MD: It’s a great question. A few years back, we started to use these, at the time, new therapies, and we were bringing people in for labs and once a month, we were checking closely. And after about 6 months of that, we realized that it was pretty boring. Everything looked about the same and the results were about the same. So we started to peel back our practice to do less, but then you’re troubled by guidelines that say you’re supposed to measure. So we designed a trial in that we did some of the basic workup. In fact, it was exactly what people described up front, and then we gave the patients the entire treatment course all at once. Then we asked them, “We’re going to check in with you. How do you want to be contacted?”

Anthony Martinez, MD: And you had some high-risk patients in that study?

Mark Sulkowski, MD: We did. We did this in 5 different countries including the United States, including people under the age of 30. And all we said was, look, how do you want us to reach you? Some people said what’s that, some people said text message, older people said email. What we did was checked in with them at 4 weeks and then we said, we want you to come back in 24 weeks. We’re going to check for cure. And we contacted them and said come on in [to assess] cure, and that’s all we did. The overall response was a cure rate above 95%. What we realized is that, we talked about task shifting, you can task shift clinicians right out of the picture and just have someone keep track of people, so you don’t lose them. We’ll talk a bit more about keeping track of them, getting them back for that cure visit. But what we learned was that this is really something where we need to empower our patients to get cured now, giving them medicines, letting them cure.

Anthony Martinez, MD: This is a good segue in terms of cure and the definition of what that means. So we obviously finish out our 8- or 12-week regimen. We need to check a viral load 12 weeks thereafter. If it’s negative, it’s defined as SVR [sustained virologic response], synonymous with cure. A lot of programs, Tipu, have trouble with this. For programs that are not co-localized, that maybe aren’t seeing those patients every month or every few weeks, a lot of times they lose track of them, and it’s hard to get them back to get that SVR assessment. What do you do in your practice, and have you been successful with this?

Tipu V. Khan, MD: That’s a really good point. It’s still tough. We struggle with this every day. We do a lot of task shifting like we’ve all talked about here in that we empower our nurses or a case manager to follow up to get that lab drawn, and it pops up in my inbox and I can follow up on it. But, realistically, I think dialing down real-world data with high-risk patients, a lot of them aren’t coming back. But I think what’s reassuring for us as treatment providers is all the data that we’ve talked about so far, knowing that adherence is high even in high-risk patients and the cure rates are high, that knowing that even if they don’t [get] to the SVR, they’ve probably taken their medications. That’s what our real-world data is telling us, and they’re probably cured. So it’s an issue we struggle with in our clinic all the time. We still have a lot of patients we can’t get into SVR, but I think what has helped has been empowering our nonprescribing providers, so our nurses, our case managers, to get that blood work done, but also making sure that patients know they need that test. So even if they don’t come back to me or to my clinic, but they follow up with their primary care doctor to go to another treatment center somewhere else, they can let them know, “Hey, I had hepatitis C. I was treated. I never got a test of cure.” So we kind of ingrain that in them so they can have someone pull that lab at some point.

Anthony Martinez, MD: Peer navigators may be also very helpful in facilitating getting that done. Mark, do you envision a day where we don’t need that 12-week viral load to confirm cure? Could we potentially do it in 4 weeks?

Mark Sulkowski, MD: Well, I think we could potentially get rid of it. And what I mean by that is that treatment is highly predictable. In other words, if someone’s taken their medications, we can predict very high cure rates. And it is not typical for many infections to actually prove someone’s cured. We don’t do that, for example, with pneumonia. We give them 7 days of antibiotics or less, and they get better. So this idea that we have to prove they’re cured is probably antiquated. And there are some guidelines, the WHO [World Health Organization], the European guidelines, that are saying, “You know what, if you can, definitely measure. We want you to measure, but if you can’t, that should not be a barrier to treating them.” So I think we’re working our way away from that concept. But I think the other point that’s so important is, patients will engage the health care system again. In fact, I just had a guy—talk about popping [into] my inbox—[I] treated him about a year ago, active substance use disorder, a few other problems, [and he] ended up in the hospital. We were able to ask the team to go ahead and measure HCV. I hadn’t seen the guy for a year and a half. I didn’t really know if he finished his medication because he missed the last couple of check-ins. He’s cured.

Anthony Martinez, MD: This is something that we see frequently too. Even when patients separate, they at some point do seem to cycle back into the system. And it may be a year later, it may be a couple of years later, but when we do check that, viral load, [which] typically is negative. So to Tipu’s point, they had the medication, they had access to the medication, which is really the key. And, ultimately, you can get where you want to be.

Transcript was AI-generated and edited for clarity.