1. 2014 Chronic Hepatitis C: Treat Now or wait? Presented by: Hepatitis C New Drug Research And Liver Health Hepatitis C New Drug Research And Liver Health The Dawn Of Multiple New Treatments For Hepatitis C With rapid advancements of new HCV agents offering potential improvements in cure rates, shorter treatment durations, and less side effects, patients must stay informed of the evolving data in order to make an informed decision rather to treat now versus waiting for future therapies.

2. The Diagnosis As once a patient myself, I understand the shock and fear of being diagnosed with hepatitis C. In 1999, hepatitis C was a highly stigmatized disease, sadly, my well meaning family and friends had no idea how to address my diagnosis. For them, hepatitis C, referred to as my “health dilemma” was easier to ignore. My diagnosis grew into this non-existent entity - one we didn’t talk about. Slowly, I suppose like most of us, I began my decent into a world of unfamiliar medical terms, appointments, statistics, blood tests, and overwhelming medical decisions. Eventually, only because of an online website; HCV Advocate, I gained enough momentum to move forward and acquire the knowledge needed to participate with confidence in managing and treating my disease.HCV Advocate

3. Be Your Own Health Advocate Today, as patients, we must be a diligent advocate, and carefully scrutinize our own medical care. The final decision on everything from invasive procedures, testing, and any future treatment options is ours to make, which isn’t easy when you're treating hepatitis C. Gone are those lovely Normal Rockwell days of house calls and handholding. However, not everyone is comfortable with making their own medical decisions, some people find having too much knowledge is very stressful, and (for them) it may make things more difficult. If this describes you, possibly a loved one or friend can act as your health advocate. Whether you’re newly diagnosed, a savvy patient or considering treatment, the purpose of this slide-set is to offer a strong starting point for anyone faced with treating HCV. So lets get started…………

4. The first set of slides include: How To Find A Specialist Reasons To Treat Hepatitis C Disease Progression Terminology Used To Determine Treatment Response

5. How To Find A Specialist To Treat HCV It is very important to find a health practitioner who is familiar with this disease, a hepatologist is far more likely to be on top of the latest information concerning the treatment of hepatitis C. The study of gastroenterology and hepatology are often related to each other, most hepatologists, although not all, are also gastroenterologists. A hepatologist specializes in treating liver disease, a gastroenterologist is an internist who has completed specialty training in the treatment of digestive disorders. Digestive disorders include disorders of the esophagus, stomach, small and large intestines, pancreas, gallbladder, and liver.

6. Finding A Specialist Use your primary care physician as a source of referral, attend a hepatitis C support group, click here for a list of U.S. locations, click here, for groups in Canada and here for more information.click here Canadahere Search online at Health US News for major hospitals in your area, simply enter your zip code, consider the hospital ranking as only a guide. If you find a doctor in the field of gastroenterology and hepatology call their office and ask if they have experience in treating patients with HCV, also inquire if they have been involved in HCV research.Health US News

7. Finding A Specialist Finally, find a hepatitis C trial in your area, find out where it is and who is running it. If the trial is at a teaching hospital, call the facility and ask for the practice associated with the research team, or physician in charge. Click here, for additional information on choosing an academic teaching or university hospital.Click here Searching For A Clinical Trial To find a clinical trial in your area, click here, or to review a list of trials updated over the last thirty days click here.click herehere.

8. Disease Progression FACT - Out of 100 people that contract the infection, 75–85 people will develop chronic infection,60–70 people will develop chronic liver disease, five to 20 people will develop cirrhosis over the course of their chronic infection and one to five people will die of complications including hepatocellular carcinoma (HCC). FACT - HCV increased risk for dying prematurely Adults with hepatitis C had an increased risk for dying and for dying prematurely compared with the general population, according to findings from a study conducted in New York.HCV increased risk for dying prematurelystudy

9. Why Treat HCV? Because we can not look into a crystal ball to determine who will develop serious complications over the course of the disease, we turn to data collected from large cohorts/groups of people living with the virus. Benefits of HCV eradication: As an example, in this observational cohort study researchers examined clinical records of 128,769 patients who were enrolled in a database through the US Veterans Health Administration from 1999-2010. The aim was to determine risk for late-stage liver complications and the benefits of eradicating the virus, the conclusion: Benefits of HCV eradication For patients with chronic HCV infection, achieving an undetectable viral load reduces the risk for death by 45% and the risk for liver-related adverse events by 27%.

10. Other Conditions Related To HCV The Hepatitis C virus is associated with a broad range of clinical conditions outside the liver, referred to as extrahepatic manifestations, approximately 30 reported extrahepatic manifestations, such as mixed cryoglobulinemia, glomerulonephritis, polyarteritis nodosa, rashes, renal disease, neuropathy and lymphoma is well documented, while others are still being investigated and have not been proven. extrahepatic manifestations

11. Other Conditions Related To HCV In addition to an increased risk of death from hepatocellular carcinoma, chronic hepatitis C virus (HCV)-infected patients also have a higher mortality rate from non-Hodgkin lymphoma and pancreatic, rectal, and oral and pharyngeal cancers, according to a new study. Hepatitis C Infection and Higher Risk of Death From Non-liver Cancers Hepatitis C Infection and Higher Risk of Death From Non-liver Cancers The findings were presented February 20 at the annual meeting of the American College of Preventive Medicine in New Orleans, Louisiana. Cancer-related mortality was analyzed for 12,126 chronic HCV-infected patients in the Centers for Disease Control and Prevention's (CDC) Chronic Hepatitis Cohort Study and compared to Multiple Cause-of-Death mortality data for 2006 to 2010 from the National Center for Health Statistics after age adjustment. Twelve percent (1496) of the HCV patients died during the five-year period, 25% (372) of them from cancer. Compared to the general population, the HCV group was more likely to die from non-Hodgkin lymphoma (RR, 2.27) and rectal (RR, 2.60), pancreatic (RR, 1.63), and oral cavity or pharyngeal cancers (RR, 5.22). As expected, the risk of dying from liver cancer was elevated among HCV-infected patients - nearly 30 times higher than among non-infected individuals. Study author Dr. Robert D. Allison from Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, said it is important to point out that "chronic hepatitis C infection is a known risk factor for developing non-Hodgkin lymphoma (NHL). But to our knowledge, this is the first U.S. study to investigate and show that persons with chronic hepatitis C have a higher risk of death from NHL." He said there are multiple possible explanations for the other cancers. "The HCV group had a higher rate of smoking and alcohol use than the general population. So, it's hard to say for sure if the increased risk of death from the three smoking-related cancers (oral, pancreatic, and rectal) was related to HCV infection. However, NHL is not associated with either smoking or alcohol use."

12. Hepatitis C treatment terminology: Response to hepatitis C treatment is measured by change in HCV viral load at different time points. Since it is a common practice to release interim data from HCV treatment trials, it is important to understand what these terms mean, so that interim results can be properly interpreted. Federal Drug Administration (FDA) and the European Medical Agency (EMA) have shortened the post-treatment follow-up period necessary to define an SVR by introducing the so called SVR12, defined as HCV RNA undetectability 12 weeks after treatment is completed. Federal Drug Administration (FDA) and the European Medical Agency (EMA) RVR (Rapid Virological Response): RVR means that there is no detectable hepatitis C virus in the blood after 4 weeks of treatment. An RVR is a good indication of SVR, but it is not as accurate for predicting who is unlikely to have SVR. Therefore, HCV treatment should not be discontinued if there is no RVR. RVR is mainly used in research. EVR (Early Virological Response): EVR means that hepatitis C viral load has dropped by 99% (2 logs), or is undetectable after 12 weeks of HCV treatment. An EVR is a good predictor of the ultimate response to HCV treatment. If a person does not have an EVR, their chance of SVR is very low (1-4%). Usually, HCV treatment is discontinued in people who do not have an EVR. ETR (End-of-Treatment Response) ETR means that there is no detectable hepatitis C virus in the blood at completion of HCV treatment. The ETR is usually higher than the SVR rate, because the hepatitis C virus may reappear in a person’s blood after completion of HCV treatment.

13. Hepatitis C treatment terminology continued SVR (Sustained Virological Response): SVR means that there is no hepatitis C virus detectable in the blood six months after a person completes HCV treatment. Many experts regard SVR as a cure, and it is an indication of long-term remission. SVR rates are always lower than response rates from earlier time points. SVR-12: SVR-12 means that there is no hepatitis C virus detectable in the blood 12 weeks after completion of HCV treatment. Although it has not been prospectively validated, many experts agree that relapse (meaning the emergence of detectable hepatitis C virus in blood after completion of treatment) is most likely to occur within 12 weeks. However, FDA and other regulatory agencies require 24 weeks of post-treatment follow-up before a person is considered to have achieved an SVR, read more, here.here. Null Responder: A null responder is someone who achieves little or no decrease in hepatitis C viral load during HCV treatment. Null responders are highly unlikely to respond to re- treatment with an interferon-based regimen. Non-responder: Often referred to as a "treatment failure," a non-responder is someone who does not have an EVR or, if they stay on treatment for 24 weeks, does not ever have a 2-log (99%) drop in hepatitis C viral load or undetectable HCV RNA during hepatitis C treatment.

14. Hepatitis C treatment terminology continued Partial Responder: A partial responder is someone who experiences at least a 2-log decrease in hepatitis C viral load during HCV treatment. Partial responders are more likely to respond to re-treatment than non-responders or null responders. What Is A 2 log drop? Example: 2 log drop = 15,000,000 IU/Ml to 150,000 IU/mL; a viral load that starts at 15,000,000 IU/mL and does not decrease to 150,000 IU/mL or lower. Relapser: The term relapser refers to someone who has had an EVR or ETR, but whose virus rebounded after they completed HCV treatment. People who had a relapse after completing HCV treatment are more likely to achieve SVR after re-treatment than partial responders, non-responders, or null responders. From Treatment Action Group, also see: Hepatitis C - Is SVR12 As Good As SVR24?Treatment Action Group Hepatitis C - Is SVR12 As Good As SVR24?

15. Hepatitis C Treatment According To Genotypes: Treatment options for HCV genotypes 1-6 The second group of slides will include treatment for HCV genotypes 1-6, topics include; off-label use, SVR (cure) rates for both FDA approved and investigational agents currently in clinical trials, and finally, links to relevant information. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, and research manuscripts.

16. Genotype 1 2011 - FDA Approved Protease Inhibitors Boceprevir and Telaprevir In 2011 NS3/4A protease inhibitors boceprevir and telaprevir were approved for the treatment of patients infected with HCV genotype 1 used in combination with peginterferon alfa and ribavirin, in adult patients (older then 18 years of age) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. Therapy is 24-48 weeks in duration and results in a sustained viral response (SVR) in 67%-75% of patients. Patients with extended rapid viral response (eRVR) associated with a marked reduction in viral titer by 4 weeks of therapy and HCV absence at 12 weeks may require only 24 weeks of total treatment. Side effects, such as anemia, are frequent, as are drug interactions and medication intolerance. The combination of a protease inhibitor plus pegylated interferon and ribavirin results in more anemia and drug interactions then pegylated interferon and ribavirin alone.

17. First-generation Direct-acting Antiviral Therapy: Moving forward to all oral combinations Triple therapy with boceprevir and telaprevir was found to improve response rates and treatment durations for many patients with genotype 1 disease, however, in phase 3 clinical trials it was shown that many people still did not achieve SVR. In addition, drug– drug interactions limited the use of both protease inhibitors and high pill burden made compliance difficult. Side-effects were intolerable, new rashes and anorectal symptoms were experienced in people treating with telaprevir and moderate-to-severe anemia is common in both regimens. In December 2012, in light of some rashes resulting in death a black box warning was added to telaprevir labeling. black box warning Today, ongoing research has shown new all oral regimens in devolvement such as; daclatasvir and asunaprevir (which was recently granted FDA breakthrough designation), daclatasvir and sofosbuvir, ledipasvir and sofosbuvir (submitted for FDA approval), coupled with newly approved regimens and other agents in various stages of clinical trials will offer patients a high barrier to resistance, some will be pan-genotypic, favorable pill burden, shorter treatment duration, and fewer drug interactions. Treating people successfully with advanced liver disease; cirrhosis or awaiting a liver transplant and coinfected with HIV - is now, more then ever, a realistic goal, the dream is alive.which was recently granted FDA breakthrough designation daclatasvir and sofosbuvir(submitted for FDA approval

18. Genotypes 1, 2, 3, and 4 In 2013 The U.S. Food and Administration Approved Solvadi (sofosbuvir) In Combination With and Without Interferon Solvadi (sofosbuvir) is a polymerase inhibitor approved for genotypes 1 and 4, in combination with interferon and ribavirin and for people with genotypes 2 and 3 with ribavirin alone, making it the first interferon free combination approved to treat HCV. Solvadi (sofosbuvir) Overall cure rates are at 80%, response rates and treatment duration varies, depending on genotype, viral and host factors. *Gilead states Sovaldi in combination with ribavirin alone for 24 weeks can be considered for patients with genotype 1 infection who are interferon ineligible. Additionally, Sovaldi should be used in combination with ribavirin for treatment of HCV patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation to prevent post-transplant hepatitis C infection. View The Next Slide For Response Rates

19. SOVALDI (Sofosbuvir) Response Rates: The safety and efficacy of SOVALDI was evaluated in a total of five Phase 3 trials, response rates from four trials are provided below. The SVR rates on this table differ slightly in comparison to the table provided in Sovaldi’s full prescribing informationfull prescribing information

20. Genotype 1 - OLYSIO/simeprevir In 2013, The U.S. Food and Administration approved Johnson & Johnson's protease inhibitor Simeprevir for the treatment of genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non ‑ pegylated) with ribavirin. Before starting simeprevir patients with HCV genotype 1a should be screened for a genetic mutation called Q80K polymorphism. Alternative therapy should be considered for people with the mutation according to Prescribing Information. Additional information can be found, here. Prescribing Informationhere. The results from three phase III studies used to determine the FDA approval of simeprevir were QUEST-1 and QUEST-2, both made up of treatment-naïve patients. In the PROMISE trial participants relapsed after prior interferon-based treatment – and finally in the Phase 2b ASPIRE study, participants were prior non- responders. QUEST-1 and QUEST-2 *80% Achieved SVR12phase III studies QUEST-1 and QUEST-2, of 785 treatment-naive patients, 80 percent treated with simeprevir achieved sustained virologic response 12 weeks after the end of treatment, called SVR12, compared with 50 percent in the placebo groups. PROMISE *79% Achieved SVR12 In the third study called PROMISE of 393 prior-relapsers, 79 percent in the simeprevir group achieved SVR12 compared with 37 percent of patients in the placebo group. ASPIRE *65% Achieved SVR24 Results from ASPIRE led to sustained virologic response 24 weeks after the end of treatment (SVR24) in 65 percent of prior partial-responder patients and 53 percent of prior-null responder patients compared with 9 percent and 19 percent of prior partial- and null-responder patients in the placebo groups, respectively.

21. Genotypes 1, 2, 3, and 4 FDA APPROVED DRUGS Review: The Old And The New Interferon-free Genotype 2 and 3 - In December 2013 Sovaldi (Sofosbuvir) was FDA approved as the first IFN free therapy for people with HCV genotypes 2 and 3, which account for about 20% to 25% of hepatitis C cases in the US. Sovaldi plus ribavirin is highly effective in genotype 2 patients, treatment duration is 12 weeks. Although in genotype 3 patients cure rates appear to be similar to that achieved with pegintereron and ribavirin, treat duration is 24 weeks. Feb 2014 TORONTO-Sofosbuvir/Ribavirin Cures Over 90% of Treatment-Naive Patients With Genotype 3 Sovaldi (Sofosbuvir) - Genotype 1 and 4 - Genotype 1 accounts for more than 70% of cases in the US. For both genotype 1 and 4, Sovaldi is used in combination with ribavirin and pegylated interferon alpha (peg-IFN)), treatment duration is 12 weeks OLYSIO (Simeprevir) Genotype 1 Triple Therapy - OLYSIO (Simeprevir) is approved for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naive or who have failed previous interferon therapy with ribavirin. FDA approved TORONTO-Sofosbuvir/Ribavirin Cures Over 90% of Treatment-Naive Patients With Genotype 3OLYSIO (Simeprevir) Incivek and Victrelis Genotype 1 Triple Therapy - Incivek and Victrelis is approved for genotype 1 patients used in combination with peginterferon alfa and ribavirin, in adults (older then 18 years of age) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

22. Treating HCV Genotypes 1-6 - Link To Expert Advice In a recent collaboration, AASLD/IDSA launched an up-to-date guidance for the treatment of hepatitis C. The new guidelines will have a complex treatment algorithm for practitioners to follow allowing them to see "what's the right treatment, for the right patients, for the right about of time." The living document includes both newly FDA approved drugs sofosbuvir and simeprevir, as well as off-label use for specific HCV combinations. The AASLD/IDSA table provided in the “next slide “ offers recommended guidance for treating HCV according to genotype; for people starting treatment, or have achieved an undetectable level of virus during a prior treatment course of PEG/RBV and relapsed (relapsers). new guidelines AASLD/IDSA

23. Summary of Recommendations for Patients Who are Initiating Therapy for HCV Infection or Who Experienced Relapse after Prior PEG/RBV Therapy, by HCV Genotype Summary of Recommendations for Patients Who are Initiating Therapy for HCV Infection or Who Experienced Relapse after Prior PEG/RBV Therapy, by HCV Genotype Note - Recommended off-label use of both FDA approved drugs: SOF=Sovaldi/sofosbuvir plus SMV=OLYSIO/simeprevir with ribavirin for persons who are "IFN ineligible" or unable to tolerate interferon

24. Genotype 1 Off-label use of both FDA approved drugs: Sovaldi/sofosbuvir plus OLYSIO/simeprevir and ribavirin As noted in the previous slide, off-label use of both FDA approved drugs: Sovaldi/sofosbuvir plus OLYSIO/simeprevir and ribavirin is recommended for people with genotype 1 who are "IFN ineligible" or unable to tolerate interferon. In a clinical trial deemed COSMOS, both drugs were studied with and without ribavirin in cirrhotic and non-cirrhotic genotype 1 patients, the response rates are shown in the table provided below, to read full background information, click here.click here

25. HCV Treatments - Off-Label Use Sovaldi (Sofosbuvir) Off-Label Genotype 5 and 6 Sovaldi is not approved for genotypes 5 and 6, however according to reports it's likely some hepatologists will use sofosbuvir-based therapy off-label citing SVR rates seen in Gilead's Phase 3 NEUTRINO trial. The study size was very small; one subject with genotype 5 and six with genotype 6, all participants achieved SVR12. Efficacy in HCV Genotype1, 4, 5 and 6 treatment naïve population (NEUTRINO) View background information here....... View background information here.......

26. NOT APPROVED - Interferon Free: Genotype 1 A Once-Daily Fixed-Dose Combination Pill of Sofosbuvir and Ledipasvir is currently in clinical trials. On Feb 12 2014 - Gilead Filed for U.S. Approval of Ledipasvir/Sofosbuvir Fixed- Dose Combo For Genotype 1 Hepatitis CGilead Filed for U.S. Approval of Ledipasvir/Sofosbuvir Fixed- Dose Combo For Genotype 1 Hepatitis C Gilead's FDA approved drug Sovaldi (sofosbuvir) is a nucleotide analog polymerase inhibitor that works by blocking an enzyme the hepatitis C virus needs to copy itself, the drug has potent antiviral activity against HCV genotypes 1-6 and Ledipasvir, an NS5A inhibitor (not yet FDA approved,) has potency against genotypes 1a and 1b. Gilead tested its combo pill at a variety of treatment durations both with and without ribavirin. In three clinical trials deemed ION-1, ION-2 and ION3, initial results after 8 weeks of treatment demonstrated cure rates over 90 percent for some patients. View the December press release, here. Sovaldihere

27. NOT APPROVED – Interferon-Free: Genotypes 1, 2, and 3 Daclatasvir and Sofosbuvir In the January 16 issue of the "New England Journal of Medicine" researchers reported that patients with genotypes 1, 2, or 3 who were given daclatasvir plus sofosbuvir, with or without ribavirin, for 12 or 24 weeks achieved cure rates from 89% to 100%. (View Full Text @ NATAP) - Download PDF, here.New England Journal of MedicineNATAPhere. Excerpt From: MedPage Today: In the trial, patients with genotypes 1, 2, or 3 of the virus were given daclatasvir/sofosbuvir, with or without ribavirin, for 12 or 24 weeksExcerpt From: MedPage Today: The primary endpoint -- reached by 201 of 211 patients -- was a sustained virologic response 12 weeks after the end of therapy, or SVR12. SVR12 rates were: 98% in previously untreated genotype 1 patients and the same in genotype 1 patients who had failed previous therapy with interferon, ribavirin, and HCV protease inhibitors 92% of patients with genotype 2, and 89% of those with genotype 3 infection 98% and 100%, respectively, among patients with HCV subtypes 1a and 1b 93% and 98%, respectively, for those with CC and non-CC IL28B genotypes, where the non- CC genotypes are regarded as predicting poor response 94% among those who also got ribavirin, and 98% among those who did not According to Paul Pockros, MD, of the Scripps Clinic in La Jolla, Calif., who was not part of the study - if daclatasvir is approved on its own, it's likely some doctors at least will prescribe it with sofosbuvir off label. Bristol-Myers recently announced daclatasvir will get an accelerated review by European regulators, in addition the EMA allows for compassionate use of daclatasvir-sofosbuvir.Paul Pockros, MDdaclatasvir will get an accelerated review by European regulators,

28. NOT APPROVED – Interferon-Free: Genotype 1 Daclatasvir, Asunaprevir, and BMS-791325 Published in the February issue of Gastroenterology, a phase 2b study of investigational agents Daclatasvir, Asunaprevir, and BMS-791325 (without interferon or ribavirin) achieved SVR 12 in up to 94% treatment-naive genotype 1 participants, according to lead author Dr. Gregory T. Everson and colleagues.February issue of Gastroenterology Currently Phase III clinical trials are underway which included treatment- experienced, naive and patients with cirrhosis. Phase III clinical trials Watch this video presentation with Dr. Gregory T. Everson discussing his manuscript; "Efficacy of an Interferon- and Ribavirin-Free Regimen of Daclatasvir, Asunaprevir, and BMS-791325 in Treatment-Naive Patients With HCV Genotype 1 Infection." "Efficacy of an Interferon- and Ribavirin-Free Regimen of Daclatasvir, Asunaprevir, and BMS-791325 in Treatment-Naive Patients With HCV Genotype 1 Infection."

29. NOT APPROVED – Interferon-Free: Genotype 1 Daclatasvir/Asunaprevir An interferon - and ribavirin - free oral regimen of daclatasvir plus asunaprevir taken for 24 weeks led to sustained virological response in 85% of Japanese patients with HCV genotype 1b, according to findings presented at the 64th AASLD 2013 Liver Meeting in Washington, DC.64th AASLD 2013 Related: Nov 2013: No Interferon, No Ribavirin, No ProblemNo Interferon, No Ribavirin, No Problem February 2014: Bristol-Myers Squibb Receives U.S. FDA Breakthrough Therapy Designation For All-Oral Daclatasvir Dual Investigational Regimen for Chronic Hepatitis C

30. NOT APPROVED – Interferon-Free: Genotype 1 ABT-450 with ritonavir (ABT-450/r) and ABT-333 In AbbVie's Interferon-free late-stage studies of 6 phase 3 studies most HCV genotype 1 participants achieved an impressive 99% cure rates in 12 weeks, AbbVie said it will file for FDA regulatory approval early in the second quarter, expecting to launch in late 2014. Full Text @ NATAP / New England Journal Abstract, AbbVie December 2013 press release - 96 percent SVR(12) Phase III Treatment-Experienced Patients with Geno 1NATAPAbstract96 percent SVR(12) Phase III Treatment-Experienced Patients with Geno 1 Jan 31, 2014 -AbbVie Completes Largest Phase III Program of an All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1AbbVie Completes Largest Phase III Program of an All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1

31. Following Your Own Path To Wellness The decision to begin treatment is never an easy one, especially when you’re feeling fine, right? However, hepatitis C symptoms manifest very slowly, it's easy to dismiss treatment because it appears that there is nothing to be treated. What ensues, for some people, is a lack of urgency to seek treatment. In the past, the thought treatment was frightening, injecting interferon is a huge undertaking, and the side effects were seen as much more detrimental then the disease itself, and they were! However, now we have interferon-free regimens for genotypes 2 and 3, and multiple interferon-free regimens in late stage clinical trials, with promising high SVR rates to treat genotype 1.

32. Stay Updated If you are considering therapy, stay on top of all the new data for both FDA approved and investigational agents used to treat your genotype. The last few slides will provide relevant links to that information. Whatever path you decide to follow may you have a successful and safe journey With great passion always, Tina Banwart

33. Links: News, Research And Clinical Trials See **Clinical Trials @ HCV Advocate For Enrollment Information AbbVie is a new, independent biopharmaceutical company composed of Abbott’s former proprietary pharmaceutical business News and Research ABT-450/R/ ABT-267/ABT-333 no ribavirin, ABT-450/r - ABT-267 - ABT- 333-non- nucleoside r = ritonavir ABT-450/R/ ABT-267/ABT-333 no ribavirinABT-450/rABT-267ABT- 333-non- nucleoside **Clinical Trials @ HCV Advocate- AbbVie Achillion News and Research Sovaprevir ACH-3102 Sovaprevir (ACH-3102) AbbVie Sovaprevir ACH-3102 Sovaprevir **Clinical Trials @ HCV Advocate- Achillion Achillion Boehringer Ingelheim News and Research Faldaprevir w-PPI- 668/deleobuvir(BI207127) Faldaprevir Faldaprevir/ (BI 201335) Faldaprevir w-PPI- 668/deleobuvir(BI207127) Faldaprevir Faldaprevir/ (BI 201335) **Clinical Trials @ HCV Advocate- Boehringer Ingelheim Bristol-Myers Squibb News and Research GS-7977 now Sofosbuvir/BMS- 790052 now Daclatasvir, Daclatasvir/asunaprevir/BMS- 791325 Boehringer Ingelheim GS-7977 now Sofosbuvir/BMS- 790052 now Daclatasvir Daclatasvir/asunaprevir/BMS- 791325 **Clinical Trials @ HCV Advocate- Bristol-Myers Squibb (BMS) Bristol-Myers Squibb (BMS)

34. Links: News, Research And Clinical Trials See **Clinical Trials @ HCV Advocate For Enrollment InformationHCV Advocate Idenix News and Research IDX719 Simeprevir/Samatasvir (IDX719) IDX719 Simeprevir/Samatasvir (IDX719) **Clinical Trials @ HCV Advocate- Idenix Idenix J&J/Janssen News and Research Simeprevir now Olysio Simeprevir Simeprevir (TMC435) Simeprevir now Olysio Simeprevir **Clinical Trials @ HCV Advocate- Tibotec / JanssenAdvocate- Tibotec / Janssen Gilead News and Research (Sofosbuvir) now Sovaldi GS-7977 sofosbuvir /GS- 5885 ledipasvir, Sofosbuvir (GS- 7977) Ledipasvir (GS-5885) GS-0938 and Sofosbuvir (Sofosbuvir) now SovaldiGS-7977 sofosbuvir /GS- 5885 ledipasvirSofosbuvir Ledipasvir GS-0938 and Sofosbuvir **Clinical Trials @ HCV Advocate- Gilead Gilead

35. Clinical Trials To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here. ClinicalTrials.gov: updated in the last 30 daysclick here. ClinicalTrials.gov: updated in the last 30 days Merck News and Research MK-5172 Victrelis (Boceprevir) MK-5172 Victrelis **Clinical Trials @ HCV Advocate- Merck Merck Roche News and Research Danoprevir Danoprevir **ClinicalTrials.gov - DanoprevirDanoprevir Santaris Pharma News and Research Miravirsen Miravirsen **ClinicalTrials.gov - Miravirsen Vertex News and Research Incivek (Telaprevir) Daclatasvir/VX-135 As a reminder (VX-135) is still on partial clinical hold by the FDA in the U.S. Miravirsen Incivek Daclatasvir/VX-135 **Clinical Trials @ HCV Advocate- Vertex Vertex

36. Links Financial Support Assistance Programs Many companies offer patient assistance programs which give medications free of charge to physicians whose patients might not otherwise have access to necessary medicines Financial Support Assistance Programs NATAP HIV and Hepatitis Clinical Care Options CCO ViralEd Live Internet eSymposia. ViralEd regularly broadcasts live updates from major scientific conferences featuring experts in the field ViralEd

37. Our Favorite HCV Advocate Hepatitis C Treatment One Step at a Time Lucinda K. Porter, RN, the author of "Free from Hepatitis C" has graced the HCV community with a second book "Hepatitis C Treatment One Step at a Time" available now on Amazon. A must read for anyone starting HCV therapy. Blog Hepatitis C Treatment One Step at a Time Hepatitis C Treatment One Step at a TimeAmazon Lucinda K. Porter, RN Shares A Personal Experience: 12 weeks of sofosbuvir, GS-5885, and ribavirin Best Links These links will take you to the premier hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences and more These links will take you to the premier hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences and more