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3 The Infectious Diseases Society of America (IDSA) Hepatitis C Knowledge Network offers monthly, 1 hour webinars to educate IDSA members on current recommended practices and treatments for patients infected with the hepatitis C virus (HCV). This is an opportunity for treaters to engage with experts and discuss issues related to complex patient care and effective treatment. The webinar series is provided with support from an unrestricted education grant from Vertex, Merck, and Gilead. Presentations are available in the archives of the IDSA website. 3

4 The question and answer session is not available after the live webinar. 4

5 Today we will cover important topics that you should be familiar with when managing patients co infected with HCV and human immunodeficiency virus (HIV), especially when using direct acting antivirals (DAAs). We will review currently available and appropriate therapies, focusing on pegylated interferon, ribavirin, sofosbuvir, and simeprevir. At this time, telaprevir and boceprevir do not have a role in treatment for these patients. We will discuss how to treat these patients with DAAs, focusing on drug interactions. We will review who to treat now with interferon based therapies or all oral therapies, and who should wait for therapies that will be available in the future. 5

6 First, let s review treatments of HCV. If you re familiar with HIV therapy, then you re familiar with HCV therapy, because many of the targets in the viral life cycle are the same. There are protease inhibitors and polymerase inhibitors that can be nucleoside inhibitors (NUCs) or non NUCs. There is another class NS5A inhibitors that is different from HIV therapies. This class targets a step that s part of HCV replication, and though it s not clear exactly how they work, they are important in inhibiting RNA replication. Here is a simple way to remember which drugs are of which class: Protease inhibitors all end in previr. If you see the P R for previr, it goes with the P R for protease inhibitor. Polymerase inhibitors all end in buvir. Remember this by thinking that base pairs are important in RNA replication, and base pair sounds like buvir. It s a loose association, but it works. These can by NUCs or non NUCs, and the only one currently approved is sofosbuvir, but others are coming. The NS5A inhibitors all end in asvir. Remember this by thinking that A S looks like 5A backwards. None of these have been approved yet. 6

7 In studies using DAAs in patients with HCV alone (light blue) compared with studies of patients with HCV and HIV co-infection (dark blue), patients with HIV do just as well with these drugs. There are differences in the ways these studies were conducted and in the study populations, but roughly lining them up, there isn t as big of a drop-off as was seen with interferon-based treatment for HIV co-infected patients. We can probably extrapolate results from studies of mono-infected patients to co-infected patients and use some of the same therapies, even if the therapies haven t been studied in co-infected patients yet. The main issue with doing this is the possible drug interactions.

8 Let s look at who to treat now versus who should wait for future treatment options. Patients with advanced fibrosis should be treated now. This slide shows data of how likely it is for a person with advanced liver disease to decompensate. Section A shows how, in people with fibrosis diagnosed by liver biopsy, about 15 20% will decompensate over 4 5 years. Section B shows people diagnosed by FibroScan (transient elastography), which is more common now for categorizing fibrosis by liver stiffness measurement (LSM). The top line shows people with intermediate fibrosis, whereas the bottom line shows people with advanced fibrosis (>14), where the decompensation rates were even higher. Patients with advanced fibrosis should have immediate initiation of treatment if possible. 8

9 These are the things you need to know prior to starting treatment: What are the genotype and subtype? The genotype and subtype will affect the treatment you give (we ll talk later about the different treatment recommendations based on genotype and subtype). What is the stage of liver fibrosis, and is cirrhosis present? If cirrhosis is present, is it compensated? Patients with decompensated cirrhosis should be treated differently and probably by an expert in managing patients with decompensated liver cirrhosis. Determining the fibrosis stage may be done by liver biopsy, but other methods are now available (such as FibroScan) and less invasive methods (such as FibroSURE, imaging, and physical exam). Has the patient received any prior HCV treatment? Did the patient receive interferon and tolerate it (or not)? Did the patient respond to treatment with a DAA, and if so, what class? What other medications is the patient taking? It s crucial to know what other medications are being taken by a patient co infected with HIV. We ll discuss drug interactions later. Is the patient able and willing to take interferon? Is the patient or patient s partner of child bearing potential? This is important if planning to use ribavirin, a known teratogen. 9

10 Here are the current treatment guidelines recommended by the American Association for the Study of Liver Disease (AASLD), the Infectious Disease Society of America (IDSA), and the International Antiviral Society USA (IAS USA). The goal of the committee that created these guidelines was to produce a live working document, updated in real time, that can inform you of current recommendations for testing and managing HCV. The guidelines are available at Soon there will be information at this website regarding for whom and when to initiate treatment, what type of monitoring is required when a patient is on treatment, and information about acute HCV. The information at this site may answer many of your questions related to HCV treatment. Today the focus is on patients co infected with HIV, and this information is located at report/unique patient populations. 10

11 These slides from John Faragon, PharmD, BCPS, AAHIV P, were made for the New York and New Jersey Aids Education Training Center webinar titled HIV and HCV Drug Interactions The archived webinar is available at This slide nicely summarizes the treatment guidelines. Genotype 2 is not the most common type (genotype 1 is most common in the United States), but it is the simplest to describe, so we will begin here. Genotype 2 treatment is straightforward: all patients, whether or not they have received prior HCV treatment, should receive sofosbuvir and ribavirin for 12 weeks. There is a caveat for prior non responders with cirrhosis: they might benefit from extension of treatment to 16 weeks, but the results of these studies are not final yet. If someone is slow to respond, extending to 16 weeks might be beneficial. In this slide, in yellow are alternative treatments and in red are treatments not recommended. In almost all cases, the preferred treatment in green should be used. The treatments listed as not recommended are as such because there is no efficacy, there are no data, or the treatment is more toxic than the other therapies. These treatments should be avoided. 11

12 The next simplest treatment guideline is for genotype 3. The recommendation is 24 weeks of sofosbuvir and weight based ribavirin (1000 mg per day if less than 75 kg or 1200 mg per day if greater than 75 kg, divided into twice per day dosing). In yellow is an alternative regimen of sofosbuvir with pegylated interferon and weight based ribavirin for 12 weeks. This recommendation is based on studies in patients with mono infection, but it may be a good regimen for treatmentexperienced patients or patients with cirrhosis. However, most people would prefer to avoid interferon, and sofosbuvir and ribavirin for 24 weeks allows you to do this and is the recommended regimen. 12

13 The data supporting the guidelines for genotype-2 and genotype-3 treatment recommendations for co-infected patients come from the PHOTON study, which included more than 200 patients. This study tried to have real-world criteria for eligibility, such as allowing patients with cirrhosis and no cutoff for platelet count. There were some restrictions for hemoglobin and creatinine clearance because a patient must have a creatinine clearance greater than 30 ml/min to use sofosbuvir. The study was not as limited as many others have been regarding antiretroviral therapy (ART) regimens. It allowed a wide range of antiretroviral drug (ARD) use. When using sofosbuvir, tipranavir is the only ARD you cannot use. Patients had to have undetectable HIV RNA if on ART, or could not be on ART if the CD4 count was greater than 500 cells/mm 3, though most patients in the study were on ART. 13

14 This slide shows the treatment response to this regimen for patients with genotypes 2 and 3. As seen on the previous slide, patients who were treatment naive received 12 weeks of therapy, and treatment experienced patients received 24 weeks (this varies a bit from current recommendations). Patients who were treatment naive (on the right) with genotype 2 had a sustained virologic response (SVR) rate of 88%, which is very similar to the SVR rate in patients with mono infection. In patients with genotype 3, the SVR rate of 67% at 12 weeks isn t bad, but it isn t as good as with 24 weeks of treatment in patients with mono infection, or with 24 weeks (on the left) in treatment experienced patients. This is why the guidelines indicate using 24 weeks of therapy for genotype 3 and 12 weeks for genotype 2. Note that the study was in treatment experienced patients receiving therapy for 24 weeks, but extrapolating from the results in patients with mono infection, the guidelines and the U.S. Food and Drug Administration (FDA) state that 12 weeks is likely enough for treatment experienced patients with genotype 2 (with the caveat of extending to 16 weeks if the patient is treatment experienced and has cirrhosis). 14

15 This slides refers to patients who were not successfully treated. There were not many, and most were in the genotype 3 group treated for 12 weeks. The red numbers highlight the outcomes. In genotype 3, treatment naive patients, the failures were relapses. This is typical with sofosbuvir and ribavirin. It s rare to have on treatment breakthrough. This is important because on treatment breakthrough is typically associated with development of resistance, whereas relapse is less likely to be associated with resistance. One of the strengths of using sofosbuvir and ribavirin is that there isn t much breakthrough and there are low rates of resistance. When the researchers looked carefully at the two patients with breakthrough, one had genotype 1 and the other genotype 2, and neither adhered to the sofosbuvir treatment regimen (as confirmed by pharmacokinetic (PK) analysis). The virus was undetectable in all patients who took the treatment correctly, and if the treatment didn t work, it was because of relapse. 15

16 Safety is much better than with interferon based therapies, though there were still many adverse events. Most were fatigue, but there was also some insomnia and irritability, which we used to attribute to interferon but may be caused by the ribavirin. In red are the more serious events, which were rare, and discontinuation of treatment was also rare. There was one death a suicide shortly after the patient entered the study. Overall, this treatment regimen appears to be safe. The main side effect was anemia, and most experts agree that the way to manage anemia due to ribavirin is to reduce the dose of ribavirin and give erythropoietin if necessary, but dose reduction of ribavirin is usually sufficient. 16

17 The main drug interactions you might encounter with sofosbuvir are with P glycoprotein (P gp) inducers such as St. John s wort, Dilantin, or carbamazepine. These medications can significantly decrease sofosbuvir levels because of the absorption of sofosbuvir in the gut. Tipranavir can also do this and is the only ARV you cannot use with sofosbuvir. There probably aren t many patients currently taking tipranavir, but if a patient is taking it, you should not co administer sofosbuvir. 17

18 These slides are also from John Faragon and summarize all of the ARVs and whether coadministration is recommended as well as the data behind the recommendation. 18

19 As you can see, most HIV medications may be administered with sofosbuvir. 19

20 Treatment of patients with genotype 1 is a little more complicated. For interferon eligible patients (at the top), you want to consider two types of patients: treatment naive or treatment experienced. Then, if treatment experienced, were they relapsers or non responders? Relapsers are often considered with the treatment naive patients because they are interferonsensitive; they have proven sensitivity to interferon (by having undetectable virus in the past when taking interferon). Then consider whether the patient is interferon eligible or not. We ll start with treatment naive patients who are interferon eligible. 20

21 Most of the data using the preferred regimen of sofosbuvir with pegylated interferon and weight based ribavirin for 12 weeks come from patients with mono infection. The results of the NEUTRINO study were published in the New England Journal of Medicine, included almost 300 patients with genotype 1, and showed cure rates approaching 90%. Just a note: If the patient had multiple bad prognostic factors (such as genotype 1, advanced fibrosis, or high viral load), the cure rates were not as high (almost 20% lower). This is something to keep in mind when deciding whether to treat a patient now or wait. 21

22 The study data in co-infected patients is limited to one small study of 23 patients that included genotype 1 and other genotypes (though most had genotype 1). The response rates were similar: about 90% achieved SVR and only two did not (one who relapsed and one who discontinued therapy early). Treatment responses in co-infected patients are similar. This was not a big study, but there were no indications of issues with using this regimen. For more information about this study (free membership required): /Comorbidities%20and%20Coinfection/Capsules/154lb.aspx. 22

23 This study of pegylated interferon, ribavirin, and simeprevir also had good response rates: 79% in treatment naive patients and 87% in patients who relapsed. However, having to use interferon for 24 or 48 weeks is not ideal when there is the option of using sofosbuvir with pegylated interferon and ribavirin for just 12 weeks. This is why this regimen is in the alternative therapy category instead of in the recommended category. 23

24 The reason for less use of interferon is that the people who need to be treated urgently (i.e., they can t wait for the newer, all oral therapies) tend to be the people who are not eligible for interferon, or who have some risk if interferon is used (such as being on the verge of liver decompensation, having advanced cirrhosis, or having other co morbidities, and interferon is just too toxic). It s becoming more difficult to find patients who are interferon eligible, with genotype 1, who cannot wait for the newer therapies. This slide lists some of the common, more important reasons why a patient may not be eligible for interferon. This is not an all inclusive list. Even in patients with cirrhosis who received interferon based therapies with a DAA, the patients with low albumin or low platelets tend to have more complications, and therefore interferon should be avoided. 24

25 If a patient is not eligible for interferon, the treatment options for treatment naive patients are sofosbuvir and weight based ribavirin for 24 weeks, or sofosbuvir and simeprevir with or without weight based ribavirin for 12 weeks. There are no data for co infected patients for this treatment, but there is some modeling from the FDA. For treatment experienced patients, the recommendation is sofosbuvir and simeprevir with or without weight based ribavirin for 12 weeks, regardless of interferon eligibility. Unfortunately, many patients ART is incompatible with simeprevir. If you can t give this and the patient is treatment experienced, alternative treatments are available. There are some data for the alternative treatment of treatment naive, co infected, interferon ineligible, genotype 1 patients. 25

26 These are the data supporting the recommendation for sofosbuvir and ribavirin for 24 weeks in co-infected patients with genotype 1. There were 114 treatment-naive patients with genotype 1 treated for 24 weeks. 26

27 The PHOTON study looked at a real world population. The cohort s average age was 48 years and was made up of mostly men, including a fair number of black or Hispanic patients. Most patients had genotype 1a and non CC, and a few had cirrhosis. Most were on ART and had good CD4 counts (above 600). 27

28 The overall response rate using sofosbuvir and ribavirin for 24 weeks in patients with genotype 1 was 75%. 28

29 Looking at this more closely, the virus was undetectable in almost everyone on treatment at week 4; the failures were due to relapse (22 out of 23 failures; one patient was not adherent to therapy). If this treatment doesn t work, resistance isn t a common downside. In other words, if patients fail, they fail by relapse and not because of resistance. 29

30 These interesting data for mono infected patients were recently presented at the European Association for the Study of the Liver (EASL) meeting. The multivariate regression analysis looked at all of the data and considered factors that might affect SVR rate. This analysis may or may not have included co infected patients. Six factors were found to be independently associated with relapse. The factors were not surprising and have been seen before, but you can add up how many you need to have to affect your SVR. You start to see the dip after three. These factors are things we commonly see in our patients who are being treated for co infection. This list can provide a way to predict who might not do as well on sofosbuvir and ribavirin for 24 weeks. If a patient has all of the factors, the SVR rate may be closer to 50%. For someone like this, you might consider simeprevir and sofosbuvir if planning an all oral therapy. 30

31 These are the data for SVR12 response broken down by subtype and the Q80K mutation. The Q80K mutation in the virus predicts patients who will not respond to pegylated interferon, ribavirin, and simeprevir, and probably has some impact on the sofosbuvir/simeprevir combination. If you look at the left under Cosmo Kramer, the SVR12 rates overall were 90 95% when looking at the intention to treat population. Looking at individual arms (some had ribavirin, some got 12 weeks, and some got 24 weeks), the lowest SVR rate was 79% and the highest was 100%. There were good responses in all of the arms, and it was not clear whether adding ribavirin made a difference in the response rates. This is why the guidelines specify with or without ribavirin. In practice, some practitioners will add ribavirin if the patient has the Q80K mutation, though there are no data to support this. Looking at the different categories, patients with genotype 1b do very well with this regimen. The cure rate was 100%, regardless of cohort. Cohort 1 had more treatment experienced patients, and cohort 2 had more patients with advanced fibrosis. Genotype 1a patients with no Q80K mutation did very well, and if the patient had the Q80K mutation, response rates were slightly lower but still good. The main issue with this regimen is that simeprevir has more drug interactions. 31

32 Drug interactions with simeprevir are due to the CYP3A pathway, and if you have any experience with treating HIV, you are familiar with these drug interactions. Simeprevir is more of a victim than a perpetrator; the levels of simeprevir are lowered, rather than simeprevir affecting other drug levels. Drugs like efavirenz that induce the CYP3A pathway will lower simeprevir levels; and drugs like ritonavir that inhibit CYP3A will increase simeprevir levels. The ARV options are listed on the slide. HIV protease inhibitors are not really options, which is unfortunate for some patients with advanced liver disease who have been through multiple HIV treatment regimens and may be taking a protease inhibitor. 32

33 These are summary slides showing what HIV medications are allowed with simeprevir and the reasons. The medications allowed with simeprevir are some of the newer agents that are in development. The best options now for avoiding drug interactions are giving a co infected patient two NUCs and rilpivirine, 33

34 two NUCs and dolutegravir, or two NUCs and raltegravir. You can supplement with maraviroc or enfuvirtide. In general, NUCs do not have a problem with simeprevir. 34

35 With all of these data, why would you wait to treat a patient with genotype 1 who does not have advanced disease? There are easier regimens that will soon be available. This is what HIV treatment looked like in Very complicated. Now we have three choices for one pill once per day. HCV treatment is going in the same direction. At its most complicated, as recently as 2013, there was telaprevir with ribavirin and interferon with the associated side effects. Now, we hope there will be approval later this year of a one pill, once per day regimen. This regimen is sofosbuvir and ledipasvir, and here is a summary of the phase 3 studies that include patients who are treatment naive, treatment experienced, with and without cirrhosis, and with resistance to or prior experience with protease inhibitors. In all groups, the response rate was greater than 90%. This is a great option for patients who can wait for treatment. 35

36 36

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