Atea Pharmaceuticals, Inc. (AVIR) Earnings Call Transcript & Summary

Good morning, and welcome to the Atea Pharmaceuticals Virtual KOL Event. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Atea website following the conclusion of the event. I'd now like to turn the call over to Dr. J.P. Sommadossi, Founder, Chairman and Chief Executive Officer of Atea Pharmaceuticals. Please go ahead, J.P.

Thank you, and good morning, everyone. Thank you for joining us today for this HCV KOL event. This event includes a panel of the foremost leaders in pathology, gastroenterology and infectious disease with expertise in HCV treatments in the U.S., Canada and Europe. We are very pleased to have the following KOL experts with us today. Dr. Eric Lawitz from the University of Texas Health San Antonio will review the Phase II final results, which we have presented last week at EASL; Dr. Anthony Martinez from the University of Buffalo, Erie County Medical Center; Dr. David Wyles from the University of Colorado, Denver Health Medical Center; Dr. Tarik Asselah from Hôpital Beaujon, University of Paris-Cité, France; Dr. Joaquin Cabezas, Marques de Valdecilla University Hospital in Santander, Spain; and Dr. Jordan Feld from the University of Toronto and Toronto General Hospital in Canada. Also with us today from Atea, John Vavricka, our Chief Commercial Officer, who will review the HCV commercial market opportunity; Dr. Janet Hammond, Chief Development Officer; and Dr. Arantxa Horga, our Chief Medical Officer, will review the profile of our regimen and the ongoing Phase III program; Janet and Arantxa will also moderate the fireside chat without distinguished KOL panel. At the end of today's event, there will be the Q&A session. So before we begin, Slide 3 shows our forward-looking statements and further information can be found in our most recent regulatory filing. I will now hand the meeting over to Dr. Janet Hammond. Janet?

Good morning, everyone. On Slide 5, our regimen for hepatitis C is a next-generation pan-genotypic fixed-dose regimen. It consists of Benfostelier, the most potent nucleotide polymerase inhibitor for HCV yet to have been developed and which has been shown in in vitro studies to be approximately at least tenfold more potent than sofosbuvir. It also includes Ruzasvir which is a highly potent HCV NS5A inhibitor with pan-genotypic activity in the picomolar range. I'd like to note that both compounds have already been studied in a large number of individuals with favorable safety and tolerability profiles. The targeted indication is the treatment of adult patients, 18 and above with chronic hepatitis C infection with and without compensated psoriasis. The treatment duration of 8 weeks for noncirrhotic patients in 12 weeks were those with compensated cirrhosis. The regimen is differentiated from the currently approved treatment and that it offers a highly prudent pan-genotypic therapy but importantly, with a short treatment duration, a low potential for drug-drug interactions and can be taken with or without food. These are attributes which will closely meet the needs of both the prescriber and the patient. Moving to Slide 6. This illustrates that our regimen has a favorable drug interaction profile. Since in 2025 approximately 80% of HCV patients are taking concomitant medications, the drug-drug interaction profile of HC therapies is of particular importance to both patients and prescribers for ease of use. As you can see on this slide, our Phase I drug interaction studies in healthy volunteers have confirmed that the regimen of bemnifosbuvir and ruzasvir has a benign drug interaction profile with commonly prescribed medications, such as oral contraceptives, statins and proton pump inhibitors. I'll now hand the meeting over to Dr. Arantxa Horga who will review the Phase III clinical design. Arantxa?

Good morning, everyone. On Slide 8, there is an overview of Atea's HCV Phase III program that includes 2 open-label Phase III trials C-BEYOND in the U.S. and Canada and C-FORWARD, a global trial outside of North America. Each Phase III trial will involve approximately 880 treatment-naive patients, including those with and without compensated cirrhosis. The trial will compare the fixed-dose combination regimen of bemnifosbuvir and ruzasvir to a fixed-dose regimen of sofosbuvir and velpatasvir, also known as Epclusa. Our 2-pill regimen will be administered orally once daily for 8 weeks in non-cirrhotic patients or 12 weeks in patients with compensated cirrhosis. While sofosbuvir and velpatasvir will be administered orally once daily for 12 weeks to all patients with or without compensated cirrhosis. The primary endpoint measures cure by using HCV RNA less than the lower limit of quantification at 24 weeks from the start of treatment and encompasses sustained biological response 12 weeks posttreatment or SVR12 in each arm. Measurement at 24 weeks from the start of treatment is to ensure that the primary end point occurs at the same relative time points from the start of treatment in all patients. Patient enrollment in the C-BEYOND trial is ongoing and enrollment in the C-FORWARD trial is expected to begin in mid-2025. Slide 9 shows the geographic footprint for C-BEYOND with 120 clinical sites in the U.S. and Canada and for C-FORWARD, we are targeting approximately 120 clinical sites in 16 countries. And now I would like to hand the meeting over to Dr. Eric Lawitz, who was an investigator in the Phase II trial, and will review the Phase II results that were presented at EASL last week. Dr. Lawitz?

Thanks, Arantxa. Pleasure to review the data. And as we all know, this was recently presented in Amsterdam last week at EASL. As you remember, this was a Phase II open-label study of bemnifosbuvir and ruzasvir in hepatitis C infected patients. There were 275 treatment-naive patients who were treated. Patients were treated across all genotypes and across all stages of fibrosis, including those with compensated cirrhosis. So all patients were treated with 8 weeks of an open-label regimen of bemnifosbuvir 550 milligrams daily and ruzasvir 180 milligrams daily. At the end of 8 weeks, all therapy was discontinued and patients were followed up for 24 weeks. The primary endpoint of this trial was SVR12, which was defined as those who had evaluable follow-up week-12 results in addition to treatment adherences defined by the protocol. The other primary endpoint was safety, looking at the secondary and exploratory endpoints SVR12 in patients who had evaluable follow-up week 12 results, but regardless adherence to the treatment. So for the presence or absence of adherence SVR24, which represents patients for the follow-up week 24 results to ensure concordance between SVR12 and 24, which has been historically seen with antivirals for hepatitis C. Looking at rates of virologic failure and finally looking at resistance. If we turn our attention to the circles on the left, we can see the patient disposition. There were a total of 275 patients enrolled. Of these, 259 had an evaluable follow-up week-12 results. And of those 259, 44 did not have treatment adherences defined by the protocol and thus, we have a primary endpoint population of 215 patients. Next slide, please. So let's turn our attention to the demographics. On the left, you can see the primary endpoint population demographics and on the right, you can see all the 275 patients enrolled. The first thing to notice is there's no difference between the per protocol or primary endpoint population compared to the total enrolled. So let's focus all the way to the right on the total enrolled. We can see that the mean age is under 50 and I have to note this is the first time I presented a hepatitis C population under the age of 50 in a decade plus. There was an equal distribution between males and females. As typical, this was a Caucasian predominant trial, but it is noteworthy that 20% of the patients were Asian. Again, all genotypes were enrolled and genotypes 1 through 4 were represented in the trial, 2/3 of patients were genotype 1. But again, there was a good representation, genotype 3 with 28% of the population. And then finally, looking at cirrhosis, there was low rates of cirrhosis at 13.5% and it's noteworthy that there was no upper restriction on the number of cirrhotics to be included and the inclusion/exclusion criteria were actually very favorable to allow cirrhotics to enroll in the study. Next slide, please. So let's turn to the good information on efficacy. So this is the primary endpoint population efficacy slide and on the left, you can remember the total end for the primary endpoint population was 215 and 210 of those patients had SVR12, representing an SVR12 in the primary endpoint population of 98%. The bar to the right, I add back the 44 patients were not compliant and didn't meet the requirements for the primary endpoint population. But if I add them back, we now have an end that goes from 215 to 259 and an overall SVR12 of 95%, suggesting a nice redundancy in this regimen. Next slide, please. So to me, this is the most important slide and graph on the left because in 2025, when I'm treating patients in clinic, I see lots of young people who have recent infections, are noncirrhotic and just need treatment and effective antiviral cures. So what -- how did the patients who are noncirrhotic in the Phase II trial do as you can see on the left and the overall bar, 181 patients were noncirrhotic, and of those 181, 180 were cured. So there was 1 virologic failure out of 181 patients, which represents 99%. And if you carry the vessels even further, it's 99.44%. So we're approaching 99.5% in this noncirrhotic population. The bars to the right represent each of the genotypes so you can find 1 failure was in the genotype 1 bar and importantly, if you turn your attention to the genotype 3 bar, all 53 noncirrhotic genotype 3 patients achieved an SVR12 and were cured. Now let's look at the bars to the right going through the same exercise as I went through with the primary endpoint of adding the non-adherent patients back to the population. So the adherent SVR12 was an end of 181. Here, it increases in the blue bars to the right to 222, which represents a valuable follow-up with 12 patients, but also includes the non-adherent patients and we can see the overall SVR12 and that population with 222 patients was 97%. And then finally, a focus on genotype 3, historically, some regimens have had troubles with genotype 3. So again, there were 53 patients in the primary endpoint population of genotype 3. If you add the 11 non-adherent patients back to the primary endpoint population, we now have an end of 64. And as you can see, 63 of 64. So one of the 11 nonadherent patients did not achieve SVR12 and ultimately, the genotype 3 noncirrhotic SVR12, irrespective of the presence or absence of adherence was 98%, again, showing some redundancy in this regimen. Next slide. So let's look at the virologic failures. I already told you there were 5 virologic failures. I showed you the 1 non-cirrhotic, the other 4 were cirrhotic biologic failures. So the rate of virologic failure was 0.6% in the noncirrhotics and 12% in the cirrhotics. If we look at the genotype distribution of the virologic failures, the 1 noncirrhotic failure was a genotype 1. Looking at the 4 virologic cirrhotic failures, there was no single genotype overly represented. There was a mixture across the population. There are 2 genotype 1a cirrhotic failures, one 1b and one 3a. It's important to note there was no virologic breakthrough. There was no positivity on therapy and all the relapses occurred at the follow-up week for visit. And when you do an analysis of the virokinetics compared to the plasma drug exposed across the whole study population, it does give you a sense that a lot of the virologic failures were due to treatment adherence issues. And finally, the SVR12 and SVR24 were universally maintained. So there was no late relapse. And this regimen performed just as all previous antiviral regimens with concordance between SVR12 and SVR24. Next slide. So the question is, is there anything in the cirrhotics that might be seen that might give us a lesson on why there were 4 virologic failures in the cirrhotics and the one thing that came to attention is the delay in the viral decay curves and the slower rate of viral clearance in some cirrhotics. So this is a slide that shows rates of HCV RNA below the limit of quantification at week 4 and at the end of treatment at week 8. And you can see at week 4, 29 of the 34 were below the limit of quantification. So there were 5 patients who did not become below the limit of quantification by week 4. However, they did become below the limit of quantification by week 8. So this delay in some cirrhotics in the viral decay curve suggest potentially longer duration therapy may convert some of these cirrhotic relapsers test the R patients. So in an effort to leave no patient behind, the Phase III program was designed to increase the duration of 12 weeks to ensure we could capture the cirrhotic population. Next slide. So let's turn our attention to safety, all good news here. Bemnifosbuvir and ruzasvir was generally well tolerated. There was a minority of treatment-emergent adverse events in about 43% of the population. Most events were mild to moderate in severity. There were no adverse events more than 10%, which would be typically seen on an adverse event table. The 2 most frequent adverse events were below 10%, and were headache at 9% and nausea at 8%. There were no serious adverse events that were related to the study drug. There were treatment adverse serious adverse events that were unrelated to the study drug in 3% of the population, including 1 death from esophageal squamous cell carcinoma. In the follow-up period if the patients were followed for 24 weeks post therapy, there were 4% of the patients who had, again, unrelated serious adverse events, including 4 deaths. Finally, there was no drug early discontinuation due to adverse events, and there was no clinically relevant trends in laboratory data or ETG parameters. Next slide, so in conclusion, we have a study, an open-label study of 8 weeks of bemnifosbuvir and ruzasvir in treatment-naive patients that showed a primary endpoint population SVR12 of 98%. In the noncirrhotics, the SVR12 rate was 99%, in the noncirrhotic population 88%. As I discussed, the slowing of the viral decay curve suggest increasing the duration in the cirrhotics may leave no cirrhotic behind in achieving an SVR12. Thus the Phase III program is maintained at 8 weeks in noncirrhotics and extended to 12 weeks in cirrhotics. Rates of virologic failure were low. There was no impact to baseline resistance-associated substitutions in SVR12. Bemnifosbuvir and ruzasvir was well tolerated. There were no study related serious adverse events and no early discontinuations. So I would suggest that this data strongly supports the ongoing Phase III program. So thanks for the opportunity to review that data with you. And now I'd like to turn it over to John Vavricka, the Chief Commercial Officer, who is going to discuss the hepatitis C market in general and some new market research that I understand is hot off the press. John take it away.

Thank you. Good morning, everyone. On Slide 20, ACV continues to be a significant global health care issue. Despite the availability of direct-acting antivirals for the past decade, the unrelenting high rate of HCV infections which is outpacing the stagnant number of patients being treated underscores the need for new, differentiated and optimized therapy. I'd like to point out that we still have a large number of untreated HCV patients of between 2.4 million and 4 million in the U.S. And in the U.S., 70% of liver cancer is a consequence of HCV disease progression. Therefore, the lack of treatment of these HCV patients has a profound impact on patients' lives and the associated health care hospitalization cost. Moving to Slide 21. The large burden of untreated HCV disease translates into a large untapped commercial market opportunity. Currently, in the U.S., out of 160,000 new infections only approximately 100,000 patients are treated annually. Last year, these U.S. treated patients resulted in approximately $1.5 billion in net sales and globally, the market is approximately $3 billion in net sales. We believe that the best-in-class profile of our regimen together with the anticipated removal of access barriers and future government initiatives can dramatically expand the number of patients cured from the severe viral disease. On Slide 22, as the doctor just talked about, I'd like to share with you that we're currently conducting new qualitative and quantitative market research to evaluate the Phase II data with high-volume DAA prescribing U.S. health care providers. And we recently just completed the U.S. qualitative market research. The research was conducted by IQVIA. The purpose was to evaluate health care providers current HCP treatment practices, assess their reaction to the Phase II data and to understand how our regimen, if approved, would impact their prescribing to patients. It is important to note that the selection of the HCPs and the interviews were conducted independently by IQVIA. And I'd like to highlight the top line findings for you today. It's not surprising to learn that HCPs have a high level of satisfaction with the current treatments of Mavyret and Epclusa. Go back 1 slide, please. So HCVs had an average satisfaction of 6 with 7 being extremely satisfied. And when we ask them for their perspective, most HCV HCPs stated that DAAs are a major improvement compared to what the previous treatments they had such as interferon, et cetera. So it's not surprising that there level of satisfaction was 6 out of 7. Going on to Slide 23. HCPs also reviewed the BEM/RZR Phase II clinical data. The data was presented in a similar way to what has been presented today. And it's important to note that the HCP read these slides without any moderator interactions. And what you see up there is the 5 slides that these health care providers did read and so what did they think of the data? So after they just read it, we asked them their initial impressions. And if you go to Slide 24, these are verbatim comments. I'm not going to read all of them. What I can tell you is that they are overwhelmingly positive reactions. And just some of them, these are verbatim comments, all the advantages of Epclusa and Mavyret without the disadvantages, ideal drug makes selection of drug therapy easier. An internal medicine doctor said, Cleaner profile. You made it better. Don't have to worry about drug-drug interactions. We had some funny ones as well. Sounds great compared to Epclusa and Mavyret. I don't see any downsides. What is the catch? And I'll read one more. Excellent combines the best of both products. Looks like next generation. Seems like an improvement over Epclusa. So going on to Slide 25. Following the Phase II data slides, the HCPs then were asked to rate how likely they were to prescribe BEM/RZR approved. And the HCPs had an average score of 7 with 7 being extremely satisfied. Now what this research confirms -- confirmed is that without any new improved DAA to treat HCV, HCPs are satisfied with the current treatment options. However, with BEM/RZRs improved profile, such as short duration -- treatment duration, protease inhibitor free, low potential for drug-drug interactions and convenience with no food effect, HCPs are likely to have a high preference for BEM/RZR. This is because it combines the best attributes of Mavyret and Epclusa. And Slide 26. In closing, from a U.S. payor standpoint, the BEM/RZR profile was also viewed favorably as they are receptive to inclusion of the regimen on their formulary. In fact, 2/3 of payors representing over 130 million lives rated the BEM/RZR profile either superior or comparable to Epclusa and Mavyret. It's also important to note that the U.S. -- that in the U.S., HCV prescriber base is highly concentrated with approximately 6,000 prescribers writing 80% of all the DAA prescriptions, making it an optimal scenario for efficient commercialization. Ultimately, we believe this provider feedback reflects how our product profile targets today's HCV patient. And combined with the support of payor access for HCV antivirals, our regimen should achieve substantial market share. Now let's move on to the KOL panel discussions that will be moderated by Janet and Arantxa.

Thanks, John. So -- it's a great pleasure and an honor to have the 6 people participating today in our panel discussion. And I thought, perhaps it would be a good way to start to have each of you introduce yourselves perhaps in a little more detail to the audience and perhaps concentrating on few things, in particular, the nature of your practice. For example, is it an academic center or community practice, the composition of your patients in terms of age, race, gender, insurance, et cetera, and perhaps the challenges you find in identifying patients and then in treating them. And perhaps Tony, could we start with you?

Sure. So I'm Tony Martinez, I'm the Director of Hepatology here at the University of Buffalo. I've been involved in the hepatitis C space now for about 23 years. Since the before times with interferon. This is a very dynamic market. And the only thing that hep C today has in common with the hep C of the before times is the 3 letters, HCV. It's a completely different animal when a lot of us started, it was primarily baby boomers. It was interferon driven. That all changed with the DAAs around 2015. But at that same time, the market changed. The thing about the baby boomers is that they tend not to perpetuate spread. And I think that's where we've seen this huge shift in the market into young individuals who inject drugs. This is a problem that is only getting worse. So in my own practice, we did the baby boomer part. I'm also trained in addiction medicine in addition to hepatology. So I've spent a long time treating within both spaces. And I can tell you now in 2025, I work in an academic medical center, it's urban-based. We still see what we see more than ever, a lot of young kids using drugs, the hepatitis C business where we're at has not slowed down. I've been in Buffalo about 10, 11 years now. And I think we've treated roughly 8,000 patients for hepatitis C, and it just does not slow down. Unfortunately, this is a market that doesn't lose. You see the numbers, it's a $3 billion a year industry. It could be even more, but we're not reaching these high-risk young individuals in the way that we need to. When you look at the prevalence numbers, if you go back in time to 2015, there were 2.5 million people in the U.S. with hepatitis C, if you look at the more updated prevalence estimates today in 2025, it's $4.5 million. So I mean, that tells you everything about the market. The market is growing. We've had curative therapies for a long, long time. And we've had 2 highly efficacious, safe, easy-to-use regimen since at least 2015 and the prevalence is going up. So I think that there is definitely space for this, but that's kind of the overview of the quick and dirty outlook around that.

Thank you. Thank you so much. David, David Wyles from University of Colorado, would you like to introduce yourself next?

Sure. Thanks, Janet. David Wyles, I'm an infectious disease's physician at the University of Colorado and Denver Health Medical Center. Very much like Tony, I started treating hepatitis C over 20 years ago when we were using interferon and have seen the entire evolution of the space and the treatments. Just to go specifically into a little bit more about my practice in the patients I see, so being at Denver Health Medical Center, which is kind of an integrated system of community health centers combined with kind of more typical academic training, hospital and subspecialty clinic setting. Also very much like Tony, the patients we see have undergone an evolution. Our patients are also younger now a lot with substance use disorder. And the main factors are engagement and getting the treatment to where those patients are. So we have a number of programs to work in the community, in syringe service programs with community testing and even availability of treatment there. As well as trying to better embed treatments in our primary care clinics that are throughout the community. The population in general is about 80% Medicaid for us. with maybe 15% to 16% of Medicare and then a few percent of private insurance. And again, just to reemphasize, like Tony, we're seeing a younger population now that we're primarily treating.

Thank you so much. So moving across the world to France, Tarik, would you like to introduce your situation to us, please?

Yes, of course. Thank you, Janet. So I am Tarik Asselah. I'm a Professor of Medicine at the University of Paris, Hôpital Beaujon. I'm the Head of the Viral hepatitis group. It's a very large university academic hospitals and also with the research academic group. So as you know, in France, screening, testing, casual treatment is all paid by the national health insurance, it's the government. So we implement more systematic screening, in treating the patients. But now we see that there are still many new infection like a plateau with many patients that we treat each year -- we are now more going outside the hospitals to go where the patients are. So we are going also to present to drug centers to community patient to try to treat. So the patient population is very large because it's the north of Paris, around 5 million people. And it's very heterogeneous. We are drug users. We have people with past blood transfusions. We have young patient, old patients. So we still -- and it's still a very big issue. And I think that we need maybe more treatment option to go to elimination of hep C.

Thank you very much. Jordan in Toronto, could we have you next, perhaps.

Thanks, Janet. I'm Jordan Feld, I'm a Professor of Medicine and a hepatologist at the University of Toronto and getting over a cold as you can hear, but still seeing a lot of hepatitis C. So spend -- and like the others, I started in the bad old interferon days, spent a lot of my time doing clinical and translational research to figure out how to make interferon work better and was thrilled that, that line of research ended completely, and we moved into the DAA era. So as an academic center and we're really sort of a tertiary retardant care hepatology program, a lot of the people I see are more of the complicated folks, people with decompensated cirrhosis, people who have failed treatment multiple times. And those are the people I'm seeing in clinic, but what I'm spending actually most of my time doing is figuring out how to move care out of specialty practices into community centers to try to drive treatment in locations where people are being seen. So I do a lot of work with the government and sort of thinking about policy strategies to try to develop really low barrier models to care, often modeled after models like Tony's model in Buffalo to try to ensure that we can reach people with substance use disorders, people that are really marginalized. Also in Toronto, we have a huge newcomer population people from all over the world, so figuring out how to get the message out to providers that speak the languages, that are relevant to the populations and make sure that they can provide care and then really supporting them more than actually doing the direct treatment. So unlike Tony, I have seen a huge reduction in the number of people I'm actually treating, but a complete leveling off or actually increase in the total number of people that we are treating at a more provincial or national level, and we're trying to support that in an academic setting.

Thanks very much. Joaquin from Spain, would you like to introduce yourself next, please.

Thank you, Janet. My name is Joaquin Cabezas. I work as gastroenterologists and hepatologist in academic center in the north of Spain. I'm based on a region in the north which encompasses like 500,000 inhabitants. We are the reference Hospital for our region. We were the first region in Spain with a plan, a strategic plan to deal with hepatitis C to promote macro and micro elimination in our region. So we were first in management hepatitis C in the patient where we were able to eliminate hepatitis C in that patient with a test and treat Strategy. And also we were able to deal with the tele consultation or telemedicine tool to strengthen communication to care within this setting. We have to know that in Spain, the test and treatment is completely reimbursing with our health system. Spain is one of the few countries that are on the track of the elimination of hepatitis C because the hepatitis C do not have a vaccine. So we have to lay on a test and treat strategy to deal with this issue and keep the line of treating hepatitis C. And now I think within our region, or at least in Spain there are still like 10,000 people that do not know that they are infected. So there is still people that need to be treated -- tested and treated, I must say, and also to reach those high risk population easy treatments with no drug-drug interaction and few treatments are the key to achieve the elimination in every setting. So I think there is still too much to do and strength go below after our capital situation within the hospital. Now we are moving to addiction centers, the patients I said, people living with some sentence that are not [ in patient ], where we are have experiences where we test these kind of people with point of care test and then deliver the treatment with telemedicine, telepharmacy, which also helps to deal with issue. I must say that in Spain, unfortunately, we are still dealing with the prescription by the specialist. So have strengthen the treatment delivery with these tools like telemedicine or telepharmacy to make it easy for patients to reach their treatment. So that's my opinion. Thank you, Janet.

Thank you. Thank you, that's very helpful. And last, but not least, Eric, would you like to tell us a bit about what you're seeing, how you practice?

Sure. Eric Lawitz, University of Texas Health and Texas Liver Institute. So I have a blended practice, both university and community-based. And I guess, I'm pushing 30 years doing hepatitis C over the long haul here. And we've really, of course, seen a change in wins just like everybody else. The population is younger and potentially a little more complicated but certainly have had very successful treatments. We recently, a couple of years ago, put out a poster at AASLD on our last 2,500 patients, which I can share some information on from the community standpoint. One of the interesting things is we've seen a very consistent flow in hepatitis C over the years really, really, really a consistent flow. And when we look at our carriers, which is -- I know Dr. Wyles, he primarily has a Medicaid population. Looking at the big practice in South Texas, we see 37% commercial, and 34% Medicare, so 71% of either commercial or Medicare population. We have a big footprint across South Texas. We're really the main liver institute and referral center for South Texas. And so we continue to get a very, very steady flow of hepatitis C patients in. And as I presented in -- when I presented the Phase II data, the slide I was most interested in is the noncirrhotic patient population who just need an effective regimen because they don't have a complicated liver disease. They really have a virus that needs a cure with very mild liver disease in a lot of parts, a lot of times, but -- and -- the important thing of getting these patients cured is preventing them from transmitting it to their peer group and ultimately helping the community. So -- we see -- we continue to see a lot of hepatitis C patients, and I echo a lot of what the other experts have said. And we hope to have some more options on the market because individualizing patient care is important. And if you have more options, you can individualize patient care more appropriately. It's hard to individualize patient care with limited options.

Thanks so much, Eric. So very consistent really in many ways in terms of the younger patient population and some of the other characteristics that define them. I'm going to turn it over to Arantxa, perhaps to talk -- little bit more into the treatment plan scape.

Yes. Thank you, Janet. I have 2 questions, and I'm going to start with the first question, which is regarding the treatment. So would you like more treatment options for hepatitis C than what is currently available. Would it make it easier for you why walk us through the process to determine the right treatment options for your patients. And I'm going to ask Dr. Asselah in Europe and also Dr. Lawitz to expand a little bit. So starting with Dr. Asselah.

Yes. Thank you. So all the patients that we see that have been diagnosed for hep C with RNA-positive are candidates for treatments. We treat almost all the patients. And then we discuss with the patients, it's informed consent, discussion, explain him the treatment option. So it's true that today, it's limited to these 2 treatment options, either Epclusa for 12 weeks or Mavyret for 8 weeks. And then for these 2 treatment options, sometimes patients would like 8 weeks. But there are some DDAs which will not allow the available treatment. Sometimes they go for 12 weeks. So I think when you look for personalized medicine, you would like more frequent option, you would like a short treatment duration with less DDAs with high efficacy regardless of compliance forgiveness. And so sometimes, we feel uncomfortable with some patients not having the possibility to have the short treatment duration because of the [indiscernible] or other issue. So I think that was also very interesting is also forgiveness. Sometimes you get the treatment and the forgiveness you achieve is very high, excellent efficacy. We have more young patients with [ direct drug ] use, which would like short treatments. And sometimes because of DDAs, it's not possible. So I think that with personalized medicine, we need a third treatment option.

And Dr. Lawitz, would you like to add something you touched on it a little bit before, but maybe to expand...

For sure. Yes. No, I think the patient journey is very simple. They have a virus. We want to cure it. And ultimately, we currently have 2 options, and those options are obviously very effective. As Tarik points out, sometimes patients would be more advantageous to have a shorter regimen, but that's not possible due to concurrent medications or other concerns that require us to use the 12-week therapy. So I think having the opportunity to have more regimens on the market where we can actually look at the patient, look at their concurrent medications. Look, look at their past medical history and ultimately optimize the regimen to the patient profile would only help us take care of patients. Obviously, we've had effective therapies that have done a good job, but there are sometimes -- you wish you had another option that would potentially fill a hole. And I think -- if this Phase III trial is successful, it gives us another tool in the tool belt and potentially another way to personalized medicine for the patients. Obviously, as Tarik said, every patient that comes into my office, I'm going to treat and cure or try to and I think the concept of personalized medicine is important.

Thank you. And my second question is something that we get asked a lot. Based in your experience, why is HCV infection still such a persistent issue? Why is it still a problem and despite of the curative therapies. And I know you have touched a little bit some of you on this point, but we would like to hear maybe from Dr. Wyles and then Dr. Martinez, what is your opinion? Why is this still a big problem? Dr. Wyles?

Yes. sorry, I was muted there. Thanks. Yes, I think at the most basic level, it comes down to we're not effectively reaching key populations that are being infected and then facilitating ongoing transmission. And currently, at least in my practice, that population is a younger population with maybe not the medical complexity surrounding their liver disease and their hepatitis C as kind of Eric alluded to, a simpler population from that standpoint, but that has very complicated social determinants of health and social situations. And so doing whatever we can to facilitate treatment as quickly as possible, improving diagnosis and having low barrier ways to facilitate treatment including drug approval or not having prior authorizations. We are fortunate here in Colorado, at least for folks under Colorado Medicaid and even kind of branded Medicaid like Denver Health Medicaid, where we no longer have prior authorizations. So that helps, but our system is still not effective enough to get those vulnerable populations into care quickly and treat them quickly so we can prevent ongoing transmission. I know, Tony, I'm sure we'll talk about some of their unique programs. But the way a new regimen can help is if it's a short duration, 8 weeks where you don't have to modify the duration at least for a noncirrhotic population. And then the lack of drug interactions, I think that could help maybe non-expert providers take up hepatitis C therapy more quickly.

Dr. Martinez.

Yes. I mean I think hep C remains such a big problem because of the mode of viral acquisition. I mean at the end of the day, right now, the primary route of transmission is via injection drug use. And that stigma will always be there. And that's been a huge barrier to hep C elimination efforts. And I think that, that's probably the biggest hold back. And then like David mentioned, this is a whole different market. This is a whole different group of patients with a whole different group of social determinants of health. We've long relied on a patient readiness model for hep C elimination and is the patient ready to be treated? And to deal with the hep C patient of today, we need to get past that. We need more of a provider readiness model. How do we get to that? You need a regimen that is close to perfect as you can get. We haven't gotten where we need to be despite 2 highly effective regimens because neither one is perfect. So if we can get to something that's closer to perfect, it enables you to deploy a true test and treat model of care. You see that a patient's viremic, you can give them something for short duration that has almost no DDAs and it's as close to perfect is that you can get. I can tell you in my clinic, and we published this data about a year ago, when we see patients. We operate on a rapid start model of care. So we've been using Cepheid's point-of-care machine. I poke your finger, your viremic. I literally have the medications on the shelf. Where I am here in New York, the patients have a true choice of what regimen. It's no longer payer-driven. I have primarily Medicaid as well. overwhelmingly, patients choose a shorter duration. I mean it's just logical, right? It's intuitive, shorter is better. You want it over with as quickly as you can do it. So we've seen a clear preference for 8 weeks. Part of it, though, to expand the market is that we need to eliminate any barriers, including like prior authorization, things like that, where patients can get fast access to the medications. So there's ways to do this, and it's being done right now. But I think that this regimen actually pushes things even closer to being able to deploy a true test and treat model of care. And that's something that we kind of don't have right now. We have one that's too long, one that has a protease that we can do it, but this just gives us an even easier option.

Thank you. I'm going to pass it to Janet back to talk about the drug profile of the treatments.

I think, obviously, what we're hearing is simple is better, but adherence, obviously, on the behalf of the patient is one of the key aspects to getting them across the finishing line. And hopefully, a regimen with forgiveness and short duration can allow them to do that. But what is the profile, Joaquin, in particular is going to ask you in Jordan about this? That you would see that the patient would find most appealing. I mean how do you see your interactions with them in that regard? And what do you think could help them with adherence and finding something that they really would want to take.

Thank you, Janet for the question. Yes, thank you. I think I have 2 different profile, those that come from the communities. Sometimes those are young people or with few comorbid medications, so no problem there. And then the main issue I have those in prison, for example, we have a lot of experience and those that are serving sentences are outside the prison that are similar to those in prison with substitution therapy or severe mental disease, treatment with tons of medications. So sometimes it's difficult to deal with DAAs. There, the main thing we have in place at least in Spain is that paper from the direct drug therapy in prison with comorbid medication, but also with the treatment with the DAA. So we guarantee the [ adherence ]. So there deal with the interaction, it's very important to realize there is no issue with them. So that's the main, I think, population I handle with.

Thank you.

And then I would just really second what Joaquin said about the issues around some duration is key for some of the more marginalized populations, prison being a really important setting, where we're all doing work and people that are there. And ideally, you want it to be as simple as possible because this is the scenario where you really want to do the work up as quickly as possible now that we have point of care testing options, we can really get people diagnosed basically at admission to prison. And ideally, now with short -- many people are in for a short time. And if you can try to get their treatment started and then complete it before they leave and that means simplicity is important. So making sure not that the providers in the prison who may not be as familiar with the drugs don't have to worry about complicated drug interactions is really important. They don't have to send someone out of the prison, which is incredibly complicated, but they can provide the care there and don't even have to reach out to a specialist to get oversight. That really makes it easier. And I would -- again, I've done a lot of work with the mental health population, Joaquin, mentioned this as well, but this is a group where drug interactions become a major issue with the current therapies and trying to have, again shorter regimens also pill burden is not -- the fewer the better. So even though, Epclusa only 1 pill, it's longer. Mavyret is 3 pills a day. This would be 2. So it's getting -- that's an improvement as well. And I think it's just, again, having options where we're getting shorter and really simplified risk of drug interactions and complicating existing medical problems is really quite important for both providers. I think for patients, they care mostly about the pill burden and the duration, but the providers care about simplicity that they're not going to make a mistake. They're not going to put someone on the treatment and then find out there was a drug interaction we didn't recognize or that there was an underlying medical condition that they were going to worsen. And the data here look really promising. And also the forgiveness is reassuring that at least in the population with imperfect adherence, we still saw extremely high SVR rates. Especially in the population without cirrhosis, which Tony made the point, I think, or someone else did that really in the community practice, it's under 5% of people who have cirrhosis now, which -- so we're really looking at a predominantly non-cirrhotic population.

Thanks, Jordan. Just quickly, I think moving from Goldilocks to the pain points. Tony, just wanted a quick comment from you on that as to what you experience from the patient perspective, what are the pain points for them that you see the most. Just...

I mean, in my current model, in fairness, we don't have a lot of pain points. But the reasons for that because here in New York, we have robust Medicaid program. So a lot of these folks, almost universally have some form of coverage. That's key. We know that we can get the meds covered. We have no need for a prior authorization. That's huge. And we have a very robust state hep C elimination plan. That eliminates a lot of the pain points for the patients. In general, before even that, before any of those 3 key things took place for the patients, they just need access to the medication. They need somebody who's willing to prescribe it to them and ideally provide them with the full 8- or 12-week regimen upfront to have that option. That's not for everybody, but that needs to be on the table. But the pain points are the usual things. Do they have health insurance? Do they have the ability to get to a specialist, Jordan mentioned that he focuses on decentralizing care into other disciplines. I think that's critically important. If they have to wait to get to see a hepatologist or an infectious disease specialist, it's just lost time. This really needs to be a true test and treat model of care. And right now, it can be done by anybody. The baseline work up, it's minimal. Interpretation of data, it's minimal. This is a younger population that once we diagnose and we simply need to get them access to medication. So I think the pain points, at least in the U.S., are the usual things that you might suspect, but they centralize around access to care and access to the meds.

Thanks so much. So just in wrapping up and probably we're saying the same thing a few times, but I think these are clearly key points in caring for these patients -- and David and Tarik, I think what I'd draw on you here, anything else that you want to add in terms of attributes that you would consider to be the most important, although we've missed perhaps...

Sure. I'll just hone in on maybe one. I agree with really everything that's been said and just removing all barriers possible, whatever that means. I think forgiveness is one that I really think a lot about with the regimen. I'm using for patient populations, particularly if they have a lot of other things going on and I have some concerns. It doesn't stop me from prescribing hepatitis C treatment, I really offer it to everybody. But I do have some worries. So seeing forgiveness, we've all had patients that have been cured with very short duration. So knowing a little bit more about this, Jordan alluded to it, the population that had less than perfect adherence, let's say, in the Phase II study still did very well. And I would really love to see more data on that as we get into the Phase III program about what level of forgiveness we can expect.

Thank you. Tarik, anything from you?

Yes. No. I agree with my colleagues, but just to reinforce key attributes of the future treatments, I think we need and this treatment has very high antiviral potency efficacy regardless of adherence. So forgiveness, I agree with David. It's very important. Then the short treatment duration is the preference for many patients for 8 weeks, and also finally, few DDAs because of no protease inhibitors. So I think there's 3 attributes, make it a very important new treatment option to achieve this hep c elimination worldwide. So I see that it's very similar in Europe and in North America.

Janet you are on mute, I'm sorry.

Sorry, I didn't get. I was just going to say, perhaps you wanted to ask a little about the clinical trials, as you know.

Yes. I think maybe to wrap up this section, it will be very nice if we hear from the ones that are investigators in our trial what makes them excited about the C-BEYOND or the C-FORWARD study. And maybe I will turn it to Dr. Feld, who was also in the Phase II Dr. Cabezas, who will join us for the Phase III and Dr. Lawitz, who was also in the Phase II. So what is so exciting about our Phase III trial design in particular?

Yes, we're really excited about it. We had a great experience with the Phase II trial, and we have people waiting for the Phase III to get approved. And we're just waiting for final approval, but we actually have people end up waiting. And it's actually interesting talking to some of the potential study participants is that they're quite excited about the idea of being part of sort of moving the field forward and seeing a new regimen, and they do see advantages to this. So when we talk to them about most of the people that are sort of waiting right now are people without cirrhosis. So they see the advantage of a shorter regimen or at least the potential for a shorter regimen being a real benefit. And Interestingly, we still have small holdouts to people that maybe it's an old history of interferon days and things, but they were saying like, "Oh, I still a little -- I want better treatment for hep C still." So they're still holding out for this "better stuff." It's hard to get too much better, but being able to offer them, again, shorter duration, smaller pill burden, fewer drug interactions, is something that is attractive to people. And so I think we're excited to participate in the Phase III and see how this rolls out, and we're confident that it's going to look good.

Joaquin?

Thank you, Arantxa. Yes, it's exciting to be able to try another short-term treatment and with a few interactions. Here, the main encouraging thing is that in the community, we treat patients and they're left for the treatment by others. So within their trial, we can follow up closing the patients to realize the security and the effectiveness of this new treatment. And to be compared with a real competitor that's not been done before, which encourage the non-inferiority of these treatment will make it very, very, very interesting.

Thank you. And Eric can you add?

Sure. Yes. I can tell you the patients in the Phase II trial were very happy. They were cured and really didn't have anything remarkable in the way of adverse events. And so the patients were very, very satisfied with their experience and even more happy that they were successfully cured across our population in the Phase II trial. Phase III, it's a great design. I'm very enthusiastic. It reminds me back to the '90s when we did the IDEAL trial of the two interferons against each other. We haven't looked at the direct comparison in a controlled trial since then. So the opportunity to look at sofosbuvir, velpatasvir compared to ruzasvir, bemnifosbuvir is very exciting to me for the opportunity to be able to actually describe the impact in a single trial in a controlled manner. So I think the nice thing for patients, obviously, is that there is no placebo when all the previous antivirals were coming through, we had the placebo-controlled trials which is disappointing to patients. So here, everybody gets active therapy, which is very, very motivating to the patients because their goal is trying to get cured. And so I think there's a lot of positives and ultimately, the opportunity for short duration of 8 weeks in these non-cirrhotic populations, the limited drug-drug interactions, and the ease of administration looks to be a step forward in my mind in the hepatitis C field.

Thanks so much, Eric. It's a nice summary. I think that really is going to conclude our panel discussion, but I'm going to hand the microphone over to J.P. And I think we're going to get some external questions now. So, over to you.

Thank you Janet. Yes. Let's go over the Q&A session if -- among the participants. Janet, do you coordinate or...

Yes, J.P., I'll take it from here. [Operator Instructions] So our first question comes from Andy Hsieh at William Blair.

Great. Well, I really appreciate the Atea team for holding the event and also all the physicians for sharing and educating us about the HCV landscape. So my question has to do was really the patient complexion, obviously, from the outside world, we don't get the benefit of using patients on a daily basis. So just maybe out of let's say, 10 patients that goes into your care, how would you kind of bucket them into various different parameters. For example, treatment naive, treatment experience, what's kind of the breakdown between those two population. Anything that has to do with like metabolic syndrome coming in and whether that would change your choice of therapy, taking other drugs, what are the breakdown between patients with other concurrent medication or just completely nothing on the other side. So I'm curious if you can share something about that.

Thank you, Andy, for your question. So I'm going to ask Janet and Arantxa to have two KOL panelists to address the question based on geography. So maybe Dr. Martinez and Dr. Asselah. So to have a view from the North America and the view from Europe. So Dr. Martinez?

So I would say, to answer the question out of every 10 people that I see, these are patients who are primarily under age 40. They're treatment naive as they're newly infected. They're non-cirrhotic. Concomitant medications tend to be psychiatric medications. And then there's definitely a component of illicit street drug use. So things like cocaine, fentanyl, whatever the case may be, or medications that we use for opioid replacement therapy like methadone or buprenorphine. So that's kind of like what the typical person that I see every now and again, I'll get an individual over age 50, who slipped through the cracks. Those individuals take multiple medications, all the things that you might expect, whether it's hypertension, diabetes, hyperlipidemia. They also have a component of metabolic steatosis, but it doesn't really impact the regimen that I pick, given what regimens we have available, it doesn't really impact things. You pay attention to the potential DDIs, of course, but there's no real impact there. Hopefully, that gives a little bit of clarity on the U.S. side.

Thank you, Tony Martinez. Dr. Asselah?

Yes. In the European side, it's very similar. The majority of our patients are naive. They are young. There's many comorbidities with the steatosis, obesity, sometime alcohol. Maybe a specificity in my side since we have also a liver transplant, we have also patient to fail cirrhotic patients. And I think the driver sometimes of the selection of the treatment option is co-medications. It's DDI that will allow you to say, should I go for this treatment or this treatment. So I think that we treat all the patients as Tony said, any patient to come with RNA detectable. We want to cure and to treat him. So it's not about to select who to treat, we treat everyone. But what is a treatment option, we love for comorbidities for DDI. So if we have a new treatment option, it will give us maybe more patients who could go for 8-week treatment. With only 2 pills instead of 3 per day and also with less DDI. Sometimes, we -- it's mandatory to go for 12 weeks because in the 8-week regimen, there's some DDI.

I also ask a follow-up question. I think Dr. Martinez, you talked about having the drug available, so you can basically put the patient on therapy immediately. And I'm curious about the protocol for determining cirrhosis, obviously, for patients who are treatment naive, the cirrhotic status is not known, and that actually determines whether it's an 8-week treatment or a 12-week treatment. So can you kind of go over that quickly.

Yes. Do you have another piece to that?

No, that's basically just kind of determining the cirrhotic status.

Okay. So I assume when you're saying about the 8 or 12 weeks, you're referring to the molecule that we're talking about today because the existing regimens they're both indicated for cirrhosis. You have an 8-week option that is indicated for cirrhosis. Just to be clear with that, just can't use it in decompensated cirrhosis. All that said, we have a ton of data that demonstrates that if you're under age 45, 99% of these patients do not have cirrhosis. We've gotten to the point where we don't even stage you if you're -- at least in my group in a large piece of the country. And we don't even stage you if you're under age 45. You can tell based on basic labs that everyone has had. All of these folks have had labs at some point in their life. There's a few red flag lab parameters that you can look at, and you can know if they have cirrhosis or not. If this molecule is on the market today, I would use this all the time. I mean, I would use this in every individual under age 45 without thinking twice. I would even use it in the older ones. It would not inhibit the treatment start with it. It's just if you were of advanced stage at some point, I would do that staging to determine if I have to give you the extra month. But it would not change a single thing in how I practice in a test and treat model of care.

Dr. Asselah, do you want to also add?

Thank you, Jean-Pierre. A very short comment. I agree with Tony. I think that just there is the APRI, which is easily available worldwide which is just transaminase ratio, AST to platelets. So it gives you with a threshold if the patient has a cirrhosis or no cirrhosis. So sometimes if you want to go also for screening for portal hypertension for viruses, screening for hepatocellular carcinoma, because if the patient have a cirrhosis, even if it's treat and cure for hep C, you will need also to screen for hepatocellular carcinoma with ultrasound in 6 months. So I completely agree with Tony that if your age lower than 45, if you have normal platelets, normal protomic times, there is no need to stage the patient. But in some case, if you need, it's very easy with APRI. We use also elasticity with Echosens, with a FibroScan. We can use if available some other tests but something that is universal and very easy to get is just the APRI, the ratio of ATS and platelets. Thank you.

Thank you, Asselah. So if you can move to the next question, please.

So our next question comes from Maxwell Skor at Morgan Stanley.

I appreciate the team holding this KOL event. So can you remind us just that the relapse rates observed with currently approved HCV therapies, real-world adherence rates and any commentary around reinfection prevalence? And also for the KOL panel, can you elaborate a bit more on how you individualize care for hep C patients? Kind of what is the most important factor guiding your treatment decision?

Maybe I ask Dr. Lawitz and Dr. Feld. Dr. Lawitz?

Sure. Relapse rates are generally very low as long as patients are adherent to the regimen. There is some variation in relapse rates based on duration. So there is some patients that can be treated with very short durations of therapy and they are currently available and achieve SVR. But as the duration of exposure decreases the rate of relapse increases. So we know based on Phase III trials that we're sitting above 95% in the general population. But the important thing is, as you have a longer treatment duration, you have a tendency to have decreased adherence. And ultimately, as you decrease adherence, you're going to have an increased rate of relapse. So who's the -- how do you decide what treatment for what patients? I mean I think -- as I think was alluded by some of my colleagues here is to me, it's really is drug-drug interactions, what is their concurrent medications? Are they on proton-pump inhibitors twice a day? Are they on birth control pills? I mean, some of the bread-and-butter stuff we've been talking about in from clinical hepatology for hepatitis C for the last 10 years. And I think that really plays a big role in my treatment selection. The ideal regimen to me is short duration to encourage adherence, limited drug-drug interactions and a small pill burden, which has kind of been the message I think you've heard from most of us. So I think that's the profile that we're looking for. And it would be nice not to have to go to the drug-drug interactions site and figure out which DDIs you're worried about. A lot of us know them because we do them every day, but for people that don't necessarily have the experience that we have in this call that they use online DDI calculators or DDI interventions to be able to help them decide which regimen is right. It would be nice not to have to worry about that as much and be able to just test and treat.

Dr. Feld?

Yes. I don't have a lot to add to what Eric has said. The relapse really -- fortunately, the relapse rates are low with the current regimens, especially in people without cirrhosis, they creep up a bit and people with cirrhosis, but adherence is certainly the driver in people without cirrhosis. And I think what we've seen is the current regimens do have pretty good forgiveness. So we -- that's good as long as people are able to finish the regimen, even if it takes them a little longer than prescribed period. So they tend to achieve SVR. And I think the data from the Phase II trial suggests that's the same with this regimen. It will be obviously, important to really nail that down in the Phase III, but I think we're confident that sort of forgiveness will be there and that relapse will be an infrequent event. And I think it's also reassuring to see that the SVR4 data are really tell us that you probably don't need SVR12 data, someone's negative probably even at the end of therapy. It's basically reflection that they took the pills. And if they took the pills, they're very unlikely to relapse. That's really the message. So that's very reassuring. And just I would say in terms of the drug selection, I always sort of go through it as are the reasons that I would choose the regimen and those are going to be really DDIs or medical comorbidities, relatively uncommon with the current regimen, but there definitely are a few stickler drug interactions, which are quite relevant. And then after that, I'm just asking person what they prefer, and they're going to choose on different things about pill burden, pill size, duration, food effect, all of those things. So this is nice fewer pills than the current 8-week regimen, no food effect and only 8 weeks. So that's going to be, I would think, attractive to many people who are just choosing, which is at least 95% of the people, it's a small proportion where I'm choosing.

Thank you. Max do we have a follow-up question?

I think a piece of that question that was asked had to do with the reinfection and I don't think we answered it.

So, go ahead. Dr. Martinez.

Reinfection rates across the board around 5%. And it really -- reinfection is truly a mechanism of a failure of harm reduction. It's really the only way that you're going to get it again. If you maintain your opiate substitution therapy, the rates of reinfection go down to about 1.5%. So they can be kept extraordinarily low. Treatment failure, we have a lot of real-world data. I mean, we've referenced the two other regimens in clinical trials. But when we look at real-world data, even with variable adherence with both regimens that are available those cure rates still exceed 95%. So both very forgiving, and this molecule looks to be trending exactly the same way.

Anyone want to add. Go ahead Dr. Wyles. I was going to ask anyone to add on the rate of infection or any other question from Max. Go ahead, Dr. Wyles.

Echoing what Tony was addressing in terms of reinfection, certainly persons who have drug use and making sure we're providing comprehensive care for them. I just want to mention one other reinfection population. It's not a large one, but it is perhaps the most, I don't know, at least for me, difficult to tackle our persons living with HIV, particularly men who have sex with men. I have a couple of patients I've treated 3x now with reinfections and these are often sexual transmissions or at least that's what we believe. So that is one population where we still deal with reinfection that maybe is a little more challenging sometimes to address.

Dr. Cabezas from Europe. Anything you want to add or different view...

Yes. I was about to add something on reinfection, at least in the depression population. All the reinfection happens when the inmates are released. So something that Tony said is that depression, they are not linked to harm reduction or you weren't unable to treat the patient in prison or to finish the treatment. So you need short-term treatments to at least when the inmate is admitted, just treating at the time of admission and do not release the patient without treatment accomplishment. So I think the treatment within itself is a harm reduction tool that we should use as soon as the patient contacts harm reduction programs or health settings or depression setting. Yes. That's a...

Thank you, Dr. Cabezas. Any other questions?

So we have a question from Eric Joseph at JPMorgan. He's wondering if there's trial data with available TX point to less than 95% cure rates? And does your real-world experience differ from this meaningfully?

Dr. Martinez, do you want to address that?

Not sure that I follow that question. Can you repeated it or rephrase it...

Yes. I was struggling with it as well. Yes. Just can you restate the question?

I'm glad it's not just me, Jordan. I was feeling bad about myself.

Yes. He's wondering trial data with available TX point to less than 95% cure rates. And if your real-world experience differs from this meaningfully.

No. Look, in the real-world setting, it's 98%. I mean I treat primarily injection drug users over 8,000 treated, it's 98%. In the trial data, I'm not sure which trial you're referring to. But I mean, if you look at Gilead, you look at AbbVie, their regimens, it's the same. It's over 95%. It's 98% real-world, 99%. With this molecule here, I mean, we've seen the data. So no, I don't see any -- I mean, I haven't seen any dips real world with available regimens or from the data that we've seen so far with this product, I've seen no dips below 95%.

It's kind of amazing that this is one of the first areas of medicine that I'm aware of where the real-world experience mirrors the clinical trial data, you move from this very well-selected controlled model. And even when we moved into really hard-to-reach populations, we've been able to replicate the clinical trial data and sometimes even exceed it, which is really quite remarkable with the existing regimens and I would expect the same here. I mean we're seeing outstanding clinical trial results. There's no reason to believe that when we move outside of this, that we'll see that drop off.

Dr. Lawitz, do you want to comment?

No, I agree. We -- in our 2,500 patients experience, we are about 96%. Maybe not as good as Tony's data, but we sit about 96% in our real-world experience. And yes, in general, I mean, if you can get the patient through their therapy, they are very, very successful and the real-world experience mirrors clinical trials and this in newer generation DAAs is much different than the original DAAs, where the toxicity of the medications was more significant. And there, we had much better results in the clinical trials than we did in the real world. But with the emergence of current way of direct-acting antivirals, really, we do see very high rates of SVR, both in...

Dr. Wyles?

I generally agree, certainly with standard durations. I didn't know if maybe the question was referring to. There are some trials of ultra-short durations 4 weeks, 6 weeks with -- particularly with patients or participants that had earlier acute hep C infection. For instance, we just completed one with Mavyret, 4 weeks for acute or recent infection that had about a 85% SVR rate, but with only 4 weeks of therapy. But completely agree with what has been said. The standard durations 8, 12 weeks have completely translated from clinical trial data to community practice.

Thank you. Any other questions?

Yes. Eric Joseph is also wondering what approaches are implement to boost compliance rates, and how or where do these fail or fall short?

Dr. Asselah, do you want to address that? Or Dr. Cabezas. Dr. Asselah?

Can you repeat the question, because I didn't hear it thoroughly.

What approaches are implement to boost compliance rates? And how or where do these fail or fall short?

I'm not sure, if I understand correctly, the question.

Can I take a crack at that?

Yes.

Yes. I was just -- go ahead, Dr. Martinez.

I wouldn't get so hung up on the compliance thing. Even among -- and again, we have a lot of data about this when we're talking about high-risk populations, people who use drugs, homeless, adherence is an everybody issue. It's a regular people issue. It's a high-risk population issue. In general, when we look at the data, people who use drugs, for example, are those who are homeless, the adherence rates are actually in some of these cohorts higher than the general population. So there's an assumption that people who use drugs can't be adherent to a regimen. But if you understand drug use, it's something that they have to do on a regular basis on a schedule. They inherently know how to follow a regimen. So the adherence compliance thing isn't -- at least in the DAA era, it hasn't been such a huge factor. Both regimens that are on the market now have extensive data about variable adherence. There is minimal impact on the SVR rate. There's a number -- a whole litany of things that have been done to foster adherence and compliance from directly observed therapy, pill counts, blister packs, peer delivered medications. I mean there's a whole bunch of ways that you can do this, but honestly the adherence compliance piece since the release of the DAA, at least in our experience, hasn't been a major issue. The bigger issue is getting them access to -- once they have...

Yes. Dr. Asselah, do you have a different view?

Yes. No, I can add a comment. I said that I agree that many studies, trials, real life. So that even with forgiveness, with noncompliance, we can achieve high rates. And also in IV drug users. However, we should improve adherence. We should not promote noncompliance. And I think from the beginning, in the trials or in real life, we should explain to the patient that it's very important to adhere to the treatment. So I think that what also Tony was telling is that we should not exclude the patient because we have a suspicion of non-adherence because IV drug -- we should not make discrimination. IV drug user are also having excellent compliance. But I think we should always make educational and promote adherence. And just one very short comment, very short about the pervious question about the goals is to have SVR -- to have no RNA. Now since several years, we have treatment available, we have shown also robust endpoint, less cancer, less transplantation, better survival. So I think we know that if we clear the virus, there's a global increase in survival. So it was the two short comments I wanted to do.

Thank you. Dr. Cabezas, do you want to say something?

Yes. I want to add -- thank you to Tony clarification regarding that. In Spain, the treatment is delivered from the hospital. So pharmacies are involved in this patient journey. So they are trained with motivational interview, and also the instructions of the drug delivery. So they also help the physicians to help patients to be adherent and to keep on treatment. So we have like secure network under our pharmacies to make it easy for patients to be adherent.

Just last one. Dr. Wyles, so you treat a difficult populations, maybe can we have your view as a final, please.

There are a lot of pressure there. I ultimately want to echo again what Tony said, the concerns over potential for non-adherence should not be a barrier, and we really operate on the approach to prescribe everybody that we come into contact with that needs treatment. I do -- I would also say there are also for those populations that need extra assistance, it's not going to be one answer for everybody. I think one of the things Tony hit on, though, was being able to give the entire course if that fits with somebody's lifestyle. But on the flip side, having opportunities for them to have a safe place to store their medications if they don't have a home. And so we work with partners to have lockers and things where they can store medication or only dispensing it once a week. So it really depends and it almost comes down to an individual patient level, the steps you need to take to improve adherence.

So Dr. Wyles, thank you, I think we are way over past the time that we were going to spend with you guys. First, really, I would like to thank all the KOL participants, as you can tell it is a very productive and very actually interactive. And that's exactly what we were trying to do at Atea. I don't think that anyone was shy on the panel. So we hope that our regimen, if approved, would provide, as mentioned many times now by these expert and additional important options for doctors and patients interacted with HCV. We hope -- and for someone that have been involved in HCV for almost 30 to 40 years. We hope that this regimen, if approved, will play an important role in the eradication of this serious viral disease. That's really especially in the United States, in Europe. I think they are much closer, but in U.S. as we all know, we are far away. And hopefully, this regimen will help to this eradication. So thank you again. Thank you all for joining Atea HCV KOL Event today. Thank you.