Tag Archives: clinical trial results

Two BC based Clinical Trials Examined at the Liver Meeting

Two BC based Clinical Trials Examined at the Liver MeetingThis post examines two BC based clinical trials BC for hep C treatments that were presented at the Liver Meeting 2016 earlier this month.

Clinical Trial Abstract #60 – Impact of drug use and opioid substitution therapy on hepatitis C reinfection: The BC Hepatitis Testers Cohort by Nazrul Islam, et al.

Summary: This clinical trial identified the risk factors that may lead to hep C reinfection by looking at those tested for the virus in BC between 1990-2013. It looked at data about their medical visits, hospitalizations, and prescription drugs.  Those who were able to clear the virus on their own were included in this study. The study’s results showed that 11.8% of those who cleared the virus on their own were reinfected within the study’s 19 year time period. This rate was higher in this group than in those who had cleared the virus through treatment. However, this group also had a higher proportion of people who recently injected drugs. Using injected drugs made the risk of reinfection higher, where as, using opioid substitution therapy (OST) reduced the hep C reinfection risk. Also, being younger was seen to increase one’s of reinfection risk, as well as, being co-infected with HIV.  Whereas, being female and being infected with hep B lowered one’s chances of reinfection. From these findings, the study concluded that treatment should be combined with harm reduction programs.

Clinical Trial Abstract #175 – The impact of sustained virological response to HCV infection on long term risk of hepatocellular carcinoma: The BC Hepatitis Testers Cohort by Naveed Z. Janjua, et al.

Summary: The risk of hepatocellular carcinoma (HCC), the most common type of liver cancer, after being cured of hep C in North America hasn’t been looked at in depth. This study assessed the effect of sustained virologic response (hep C cure) on the risk of HCC among a large Canadian population base, by examining the same patient database as the above clinical trial. RESULTS: It found that the risk of HCC was higher in those who weren’t cured than those who were (1.1/1000 person-yr(PY) in the SVR group and 7.2/1000 PY in the no-SVR group). It found that the risk of developing HCC was higher in those with liver cirrhosis, who were older, male, had hep C genotype 3 vs 1, and drank alcohol. The HCC incidence post treatment increase was steeper in the no-SVR vs the SVR group, but that SVR (cure) doesn’t eliminate the risk of HCC.

 The Liver Meeting 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, was held November 11th – 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, hosted the meeting and, as always, it was exciting.

More information about The Liver Meeting 2016 or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part2) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

The Liver Meeting 2016 by Hep C Treatments

The Liver Meeting 2016 by Hep C TreatmentsThis post lists all of the topics around hep C treatments presented at the Liver Meeting 2016 by treatment as well as their abstract numbers so that one can easily browse the titles and look them up in the meeting’s online abstracts list, Plenary and Parallel Sessions (Abstracts 1–258).

Treatment: Glecaprevir / Pibrentasvir

  • #73 – ENDURANCE-2: Safety and Efficacy of ABT-493/ABT-530 in Hepatitis C Virus Genotype 2-infected Patients without Cirrhosis, a Randomized, Double-Blind, Placebo-Controlled Study
  • #113 – SURVEYOR-II, Part 3: Efficacy and Safety of ABT-493/ ABT-530 in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis
  • #114 – ENDURANCE-4: Efficacy and Safety of ABT-493/ABT- 530 Treatment in Patients with Chronic HCV Genotype 4, 5, or 6 Infection
  • #253 – ENDURANCE-1: Efficacy and Safety of 8- versus 12-week Treatment with ABT-493/ABT-530 in patients with Chronic HCV Genotype 1 Infection

Treatment: Daclatasvir and Asunaprevir

  • #197 – Complex Pattern of Resistance-Associated Substitutions of Hepatitis C Virus after Treatment failure of Interferon-Free Daclatasvir plus Asunaprevir regimen

Treatment: Sovaldi (Sofosbuvir) and Sovaldi Combos (Included Harvoni and Epclusa)

  • #21 – Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir and Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir-Based Antiviral Regimens for Hepatitis C in 17,847 patients in the Veterans Affairs National Healthcare System
  • #23 – Sofosbuvir/Velpatasvir (SOF/VEL)-Based Regimens are Associated with Excellent Efficacy and a Significant Improvement of Patients-Reported Outcomes (PROs) across Patient Populations: From Non-Cirrhotics to Compensated Cirrhotics to Decompensated Cirrhotics
  • #75 – Integrated Analysis of SOF+RBV, LDV/SOF or SOF/VEL for the Treatment of Genotype 4 Chronic HCV Infection
  • #109 – A Randomized, Controlled, Phase 3 Trial of Sofosbuvir/ Velpatasvir/Voxilaprevir or Sofosbuvir/Velpatasvir for 12 Weeks in Direct Acting Antiviral-Experienced Patients with Genotype 1-6 HCV Infection: The POLARIS-4 Study
  • #194 – Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients with Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study
  • #212 – Successful pre- and post liver transplant Sofosbuvir based anti HCV treatment in persons living with HIV infection
  • #213 – Efficacy and safety treating the recurrent hepatitis C post-liver transplantation with simeprevir and sofosbuvir: The Spanish experience (SETH)

Treatment: Zepatier (Grazoprevir/Elbasvir)

  • #74 – C-ISLE: Grazoprevir/Elbasvir plus Sofosbuvir in Treatment- naïve and Treatment-experienced HCV GT3 Cirrhotic Patients Treated for 8, 12 or 16 weeks
  • #76 – Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naive Subjects with Chronic HCV GT 1, GT 4 and GT 6 Infection (C-CORAL): A Phase III Randomized Multinational Clinical Trial
  • #110 – Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 With or Without Ribavirin in Non-cirrhotic or Cirrhotic Patients with Chronic HCV GT1, 2 or 3 Infection (Part B of C-CREST-1 & 2)
  • #112 – High Sustained Virologic Response (SVR) Rates in Patients with Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/MK-8408 Plus Ribavirin After Failure of 8 Weeks of Therapy (Part C of C-CREST-1 & 2)
  • #193 – Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 in Cirrhotic or Non-cirrhotic Patients with Chronic HCV GT1 Infection who Previously Failed a Direct-acting Antiviral Regimen (C-SURGE)

Treatment: Elbasvir

  • #195 – Distinct Evolutionary Pathways of NS5A Inhibitor Resistance in Patients With Genotype 1a Versus 1b Infection During Monotherapy With MK-8742 (Elbasvir)

Treatment: RG-101

  • #111 – RG-101 in Combination with 4 Weeks of Oral Direct Acting Antiviral Therapy Achieves High SVR Rates in Treatment Naïve Genotype 1 and 4 Chronic Hepatitis C Patients

The Liver Meeting 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, was held November 11th – 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, hosted the meeting and, as always, it was exciting.

More information about The Liver Meeting 2016 or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part2) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

The 2016 Liver Meeting by 2 Attending Blog Writers

2016 Liver Meeting via Attending Blog WritersAttending the Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, this year are not only researchers and physicians, but also a number of different blog writers.  The below is some of what these writers have been hearing and writing about.

2016 Liver Meeting Highlights being Written about by Two Attending Blog Writers

By Lucinda K. Porter, RN

Summary: A general description of the Liver Meeting 2016. “There were quite a few presentations on fatty liver diseases (FLD) such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). FLDs are rapidly overtaking hepatitis C as the most prevalent liver threat.”

Summary: A post about two of Porter’s favorite conference posters, Abstract #868 Safety and Tolerability of Direct Acting Antiviral Agents (DAAs) Used in Usual Clinical Practice: HCV-TARGET International Consortium, by Michael W. Fried, et al., and Abstract #911 Alcohol Use and Hepatitis C Virus Treatment Outcomes Among 15,151 Patients Receiving Direct Antiviral Agents, by Judith Tsui, et al. Editorial comments included.

Summary: A post highlighting Abstract # LB-15 Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients With HCV Genotype 2, 4, 5, or 6 Infection Without Cirrhosis Following an 8-Week Treatment Duration(SURVEYOR-II, Part 4), by Tarek Hassanein, et al., and Abstract #831 Hepatitis C (HCV) Virologic Outcomes in Veterans Taking Ledipasvir/Sofosbuvir With Concomitant Acid Suppressing Medication – Austin Chan, et al. Editorial comments included.

By HIVandHepatitis.com

Summary: The hep C treatment Zepatier (grazoprevir/elbasvir) and Sovaldi (sofosbuvir) without ribavirin cured 96% of previously untreated and 97% of treatment-experienced people with hep C genotype 3 and liver cirrhosis, matching rates seen in easier-to-treat patient groups.

Summary: Direct-acting antiviral treatments have real-world rates similarly found in clinical trials, without major differences between treatment regimens.

Summary: Being cured of hepatitis C with direct-acting antiviral treatment doesn’t increase one’s risk of developing hepatocellular carcinoma (HCC) and may reduce it. (Canadian Study)

More information about the Liver Meeting or information about these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part1), on the American Association for the Study of Liver Diseases (AASLD)’s website, or by clicking the links listed above.

Live Stream Sessions from The Liver Meeting 2016

Three Live Stream Sessions from The Liver Meeting 2016Three Live Stream Sessions on Tuesday, November 15, 2016 @ 11:30 am to 1:00 pm ET (8:30 am to 10 am PT)

Can’t make it to The Liver Meeting this year? Get the latest updates on hepatitis treatment and clinical hepatology from the meeting in Boston, from your home or office.

The live stream for The Liver Meeting sessions below can be viewed via the LiverLearning® website or the LiverLearning® app for Android and iOS devices. You must register in order to watch the live stream on Tuesday, November 15. There is no charge for registration.

Three Live Stream Sessions

Hepatitis Debrief
11:30 am -12:00 pm ET
Speaker: Robert S. Brown, MD, MPH, FAASLD

This session provides a synthesis of new data on the treatment of viral hepatitis presented at The Liver Meeting.

Schiff State-of-the-Art Lecture
12:00 pm -12:30 pm ET
Speaker: Anna S. Lok, MD, FAASLD

This lecture will provide a vision for the global elimination of hepatitis B and strategies to reach that goal by examining the burden of hepatitis B infection and the disparity in prevalence across different parts of the world. Programs preventing hepatitis B infection, available treatment options in chronic hepatitis B, their limitations and novel therapies will also be discussed.

Clinical Hepatology Debrief
12:30 pm -1:00 pm ET
Speaker: Arun J. Sanyal, MD, FAASLD

This newly added session is designed to complement the highly-regarded, Hepatitis Debrief, and will review key clinical highlights from the meeting.

Access the Live Stream Sessions after The Liver Meeting

In addition to watching the sessions live on Tuesday, November 15, as a registered attendee of the live stream you can access the session recording on demand through December 31, 2016. AASLD members have access to content on LiverLearning® all year round.

The Liver Meeting 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held November 11th to the 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.

*The content of this blog post was taken from AASLD’s http://www.aasld.org/events-professional-development/live-stream-sessions

The Liver Meeting 2016 Hep C Abstract Highlights (Part2)

Liver Meeting 2016 Hep C Abstract HighlightsThe Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held November 11th to the 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.

Hep C Abstract Highlights to be Presented at The Liver Meeting 2016 (Part 2)

  • Eight weeks treatment duration with Ledipasvir/Sofosbuvir (LDV/SOF) is effective for appropriately selected patients with genotype 1 Hepatitis C virus (HCV) infection: an analysis of multiple real world cohorts totaling >6,500 patients, by Vinay Sundaram, et al. (LB-16)

Summary: Current studies are limited by lack of uniform data regarding fibrosis stage or risk factors for relapse when it comes to 8 weeks of treatments with LDV/SOF (Harvoni).  Looking at past records, the research team determined the effectiveness of 8 weeks of treatment (SVR rates >95% in selected patients), examined variables associated with relapse, and compared the efficacy of 8 weeks with 12 weeks of therapy.  The results were in the 90s for those >65 years, HIV co-infected, Caucasian and African-American, fibrosis stages of 0-3, and genotype 1a and 1b.

  • Hepatitis B Reactivation Associated with Direct Acting Antiviral Therapy for Hepatitis C: A Review of Spontaneous Post-Marketing Cases, by Susan J. Bersoff-Matcha, et al. (LB-17)

Summary: There have been recent published cases of hepatitis B virus reactivation (HBV-R) in patients with HCV/HBV coinfection. Before DAAs, this is often seen with immunosuppression, although, DAAs don’t suppress immune response. Therefore, the purpose of this evaluation was to assess spontaneous reports of HBV-R with DAA treatment. The conclusion was that it does happen and that further study is needed into the reasons for it and how to stop it from occurring.

  • Retreatment with sofosbuvir + grazoprevir + elbasvir + ribavirin of patients with Hepatitis C virus Genotype 1 or 4 with RASs at failure of a sofosbuvir + ledipasvir or + daclatasvir or + simeprevir regimen (ANRS HC34 REVENGE study), by Victor de Ledinghen, et al. (LB-18)

Summary: The best treatment regimen for such patients who have already tried but failed treatment is still unknown. This study evaluated sofosbuvir + grazoprevir + elbasvir + ribavirin, taken for 16 weeks vs 24 wks in patients with NS5A or NS3 resistance-associated substitutions (RASs), when treatment failed. SVR4 was achieved by 16/17 patients. The finding suggested that “…retreating patients who failed a DAA-based regimen with NS5A/NS3 RASs with the combination of SOF + GZR + EBV + RBV for 16 weeks is efficacious and represent an interesting option. Safety will need to be monitored cautiously for this combination.”

  • Reduction in Liver Transplant Wait-Listing in the Era of Direct Acting Anti-Viral Therapy, by Jennifer A. Flemming, et al. (LB-23)

Summary: The study analyzed trends in liver transplant wait-lists to explore the potential impact of effective medical therapy on wait-list registration. The findings found that wait-lists have reminded the same for those with hep B but the number of those waiting for livers due to hep C has decreased by over 30% in the era of DAA therapy. Further reductions of wait-lists may result from increased testing, linkage to care, and access to DAA treatment.

More information about this meeting or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part1) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

The Liver Meeting 2016 Hep C Abstract Highlights (Part1)

The Liver Meeting 2016 Hep C Abstract Highlights (Part1)The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held November 11th to the 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.

Hepatitis C Treatment Topics to be Presented at The Liver Meeting 2016 (Part I)

  • GS-4997, an Inhibitor of Apoptosis Signal-Regulating Kinase (ASK1), Alone or in Combination with Simtuzumab for the Treatment of Nonalcoholic Steatohepatitis (NASH): A Randomized, Phase 2 Trial, by Rohit Loomba, et al. (LB-3)

Summary: “ASK1 is a serine threonine kinase that promotes hepatic inflammation and fibrosis in the setting of oxidative stress. Our aim was to describe the preliminary efficacy of GS-4997, a selective inhibitor of ASK1, alone or in combination with simtuzumab (SIM), in patients with NASH and moderate to severe liver fibrosis.” (Loomba, et al.) This study found that a 24-week course of GS-4997 reduced liver fibrosis and lowered hepatic stiffness in patients with NASH and moderate to severe fibrosis.

  • EXPEDITION-IV: Safety and Efficacy of GLE/PIB in Adults with renal impairment and Chronic Hepatitis C Virus Genotype 1 – 6 Infection, by Edward J. Gane, et al. (LB-11)

Summary: Currently, severe renal impairment still limits treatment options for those with hepatitis C. This study showed that a fixed dose of GLE/PIB (glecaprevir/pibrentasvir) taken once  a day for 12 weeks was well tolerated by patients with severe renal impairment, without any serious side effects. 99% of patients achieving SVR4, hep C cure.

  • A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study, by Ira M. Jacobson, et al. (LB-12)

Summary: This study compared treatment with sofosbuvir/velpatasvir/voxilaprevir for 8 weeks with treatment with sofosbuvir/velpatasvir (brandname Epclusa) for 12 weeks in patients with genotype 1-6 hepatitis C, who had or didn’t have liver cirrhosis, and who hadn’t previously been treated with a direct-acting antiviral agent (DAA). The most common side effect were headache, fatigue, diarrhea and nausea while taking SOF/VEL, and diarrhea and nausea while taking SOF/VEL/VOX.
Clinical Trial Results:

SVR4 % Total GT1 GT2 GT3 GT4 GT5 GT6 Other
SOF/VEL/VOX 8 Weeks 96 (482/ 501) 95 (221/ 233) 97 (61/ 63) 100 (92/ 92) 94 (17/ 18) 94 100 (30/ 30) 100 (2/2)
SOF/VEL 12 Weeks 98 (432/ 440) 99 (229/ 232) 100 (53/ 53) 97 (86/ 89) 96 (55/ 57) 100 (9/9)
  • A Novel Single Daily Fixed Dose Combination of Sofosbuvir 400 mg + Ribavirin 1000mg + EGCG400 mg is Superior to the Standard of Care as an Anti-Viral and Safer Causing less Hemolysis in Patients with Chronic Hepatitis C, by Gamal Shiha, et al. (LB-14)

Summary: Sofosbuvir has improved hep C treatments and outcomes, however, it is extremely costly and there is a risk of selecting viral escape mutants so a new combination, focusing on other steps in the infection process, may be better. Therefore, EHCV (Catvira) formulation composed of sofosbuvir / ribavirin / epigallocatechin gallate 400 mg (EGCG) is being developed. SVR 12 and SVR 24 for EHCV (Catvira) show results similar to those reached by the current standard of care, but with a much faster rate of viral load decline, for both treatment experienced and treatment naive genotype 4 hep C patients.

  • Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients with HCV Genotype 2, 4, 5, or 6 Infection without Cirrhosis Following an 8-Week Treatment Duration (SURVEYOR-II, Part 4), by Tarek I. Hassanein, et al. (LB-15)

Summary: The hepatitis C virus genotypes (GTs) 2, 4, 5 and 6 are everywhere and together make up approximately 23% of global hep C infections. With these genotypes being so widespread, it is important to have treatments and improving treatments for them as well. In previous phase 2 studies, SVR12 rates of 98% and 100% were achieved following treatment with GLE/PIB for 8 weeks in GT2 infected patients or 12 weeks in GT 4-6 infected patients. This study, SURVEYOR-II Part 4, looked at the safety and efficacy of 8-week GLE/PIB treatment in patients with GT4-6 infection, and a larger group of GT2-infected patients.  The study’s results were as follows:

SVR4 % Total GT2 GT4 GT5 GT6
GLE/PIB 8 Weeks 98 97 (141/145) 98 (45/46) 100 (2/2) 100 (10/10)

Lastly, more information about The Liver Meeting 2016 or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part2) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

Digestive Disease Week 2016 in San Diego Part II

Digestive Disease Week 2016 in San Diego Part IIDigestive Disease Week 2016

Digestive Disease Week 2016 (DDW2016, #DDW16) took place in San Diego last month. According to its website, it is the world’s largest gathering of doctors and researchers in the fields of gastroenterology, hepatology, endoscopy, and geastrointestinal surgery. This blog post is a collection of just some of the research about hep C treatments discussed at the Digestive Disease Week 2016.

Research Presented at the Digestive Disease Week 2016 about Hepatitis C Treatment Topics

  • 100% Svr4 and Favorable Safety of Abt-493 + Abt-530 Administered for 12 Weeks in Non-Cirrhotic Patients With Genotypes 4, 5, or 6 Infection (Surveyor-I) by Edward Gane, et al.

Summary: The combination of the antivirals ABT-493 and ABT-530 was well tolerated and resulted in 100% SVR/”cure rate” when tested 4 weeks after treatment in non-cirrhotic patients with a genotype 4, 5, or 6 hep C infection.

  • Age No Bar With New Anti-HCV Directly Acting Anti-Viral Agents: Real World Experience at a Single Tertiary Care Center in Rural Pennsylvania by Amir N. Rezk, et al.

Summary: This study looked at hep C treatment results of patients 70 to 90 years of age, with a mean age of 75 years old. The study concluded that age doesn’t affect success rates of DAA treatments.

  • Clinical Benefits of Successful Treatment in HCV Infected Patients With Decompensated Cirrhosis Treated With Sofosbuvir/Velpatasvir (Sof/VEL) by Robert S Brown, et al.

Summary: Patients with decompensated cirrhosis achieved high SVR12 with sofosbuvir/velpatasvir. These patients “…had a higher probability of clinical improvement if they had a higher MELD score, lower (<30) BMI or the absence of ascites and encephalopathy at the time of enrollment.” (Robert S Brown, et al.)

  • Comparative Effectiveness of Ledipasvir/Sofosbuvir±Ribavirin and Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir±Ribavirin in 6,961 Genotype 1 Patients Treated in Routine Medical Practice by Lisa I Backus, et al.

Summary: A large real-world study looking at patients with hep C genotype 1 infections that had been treated. It concluded that SVR rates were similar to those found in clinical trials.

  • Daclatasvir Plus Sofosbuvir Plus Ribavirin for 12 or 16 Weeks in Treatment-Experienced Patients With HCV Genotype 3 Infection and Advanced Fibrosis or Cirrhosis by Christophe Hezode, et al.

Summary: Daclatasvir + sofosbuvir + ribavirin for 12 or 16 weeks resulted with SVR12 100% in patients with hep C genotype 3 infections and advanced fibrosis and  SVR12 87% in patients with liver cirrhosis who  failed previous interferon- or sofosbuvir-based therapies.

  • Genotype Subtype and Gender Influence SVR12 Rate With Directing Antiviral Therapy in Well Compensated Hepatitis C Related Cirrhosis by Amitkumar Patel, et al.

Summary: The study tried to evaluate cure rates in cirrhotic patients undergoing DAA therapy and identify predictors of response/non response to treatment. It concluded by finding that those with compensated cirrhosis were experiencing high cure rates when treated and that “Genotype 1a infection and male gender may be significant negative predictors of response to DAA in cirrhotic populations.” (Amitkumar Patel, et al.) Further investigation is required.

Additional information about the abstracts listed above or other abstracts that were part of Digestive Disease Week 2016 can be found in the Digestive Disease Week 2016’s online planner (click the abstracts tab and then the hepatitis C abstract category).

Digestive Disease Week 2016 in San Diego Part I

Digestive Disease Week 2016 in San Diego Part IDigestive Disease Week 2016

Digestive Disease Week 2016 (DDW2016, #DDW16) took place in San Diego last month. According to its website, it is the world’s largest gathering of doctors and researchers in the fields of gastroenterology, hepatology, endoscopy, and geastrointestinal surgery. This blog post is a collection of just some of the hep C topics discussed at the Digestive Disease Week 2016 that weren’t specifically about clinical trials for hep C treatment.

Hepatitis C Topics Presented at the Digestive Disease Week 2016

  • Access to Therapy in Era of All DAA Regimens: Real-World Experience From the TRIO Network by Douglas Dieterich, et al.

Summary: (American) The study looked at patients who  had been denied treatment access and found that more than 33% of them had stage 3 or 4 liver fibrosis and were at risk of liver related health issues. The study’s abstract didn’t list the reasons why treatment had been denied.

  • Caffeine is Associated with Decreased Risk of Advanced Hepatic Fibrosis in Patients with Chronic Hepatitis C: A Systematic Review and Meta-Analysis by Sikarin Upala, et al.

Summary: This review found that caffeine intake is significantly connected with a decreased risk of advanced fibrosis in hep C patients. This “…might be due to the antioxidant properties of caffeine and this substance also can reduce expression of expression of CYP1A2, which is correlated with fibrosis progression.” (Sikarin Upala, et al.) In conclusion, the review advised further study into this subject.

  • Chronic Hepatitis C and Increased Risk of Gastrointestinal Malignancies by Sulieman Abdal Raheem, et al.
  • HIV Coinfected Patients Have a Slow Regression of Fibrosis After Achieving SVR12 by Melinda S. Brown, et al.

Summary: The study found that in those co-infected with HIV/HCV liver fibrosis reversed at a slower rate after ‘curing’ hep C than it does in those who were only infected with hep C.

  • Renal Function Decline Is Frequent in Patients Undergoing Hepatitis C Treatment Post Kidney Transplant by Kalyan R. Bhamidimarri, et al.

Conclusions: “HCV treatment with DAAs is feasible and effective post KT even in those who received HCV + graft. Renal function decline was frequent requiring tacrolimus dose adjustments in two thirds of the patients and there was 20% biopsy proven antibody mediated rejection. Close monitoring of renal graft function is necessary post KT while patients undergo HCV treatment.” (Kalyan R. Bhamidimarri, et al.)

  • The Additional Impact of Hepatitis C Infection on Cardiovascular Outcomes and Death Among Patients With Chronic Kidney Disease by Sara Tartof, et al.

Summary: Hep C adds to health issues and some cardiovascular outcomes in those with chronic kidney disease. Future assessments into whether new hep C treatments change this should be done.

  • The Hepatitis C and HIV Co-Infected Patient: Time to Scale Up HCV Therapy at a Local Level by Alireza Meighan, et al.

Summary: (American) The study found that patients co-infected with HIV/HCV are under treated even after newer hep C treatments, able to treat patients co-infected demonstrated higher success rates, have been developed.

  • Trends in Health Care Utilization for Hepatitis C Virus Infection in the United States by Vaibhav Wadhwa, et al.

Summary: The number of inpatient discharges for hepatitis C grew between 1998 and 2012, but the mortality rate has decreased. This has increased hospital admissions due to hep C in the US.

Additional information about the abstracts listed above or other abstracts that were part of Digestive Disease Week 2016 can be found in the Digestive Disease Week 2016’s online planner (click the abstracts tab and then the hepatitis C abstract category).

Journal Articles Since the Liver Meeting

journalWriting about the hep C research presented at the Liver Meeting 2015 in November started us wondering about what has been published since the meeting. Thus, the following highlights some recent* journal articles and press releases about hep C.

Canadian Medical Association Journal (CMAJ) (December 2015)

Summary: Due to budget cuts, high hep C treatment costs, and an increasing inmate population, the number of inmates in treatment has declined.

Summary: Upcoming health decisions in Canada will center around: a new health accord to replace the lapsed 2004 Health Accord, PharmaCare, assisted death and marijuana, health promotion, indigenous health, foreign aid and refugee health. [This was included in this blog in hopes of helping hep C advocates.]

The Lancet (November 2015)

Summary: In 1992, the British Columbia Centre for Excellence in HIV/AIDS opened in Vancouver. It has worked against HIV/AIDS and now, with help from BC’s provincial government, will also work against HCV.

Summary: A review done to estimate the frequency of blood-borne viral infection in people with serious mental illness.

Hepatology (December 2015)

HCV: Direct-Acting Antiviral Agents Against Vertical Transmission by Tomi T Kanninen, et al.

Summary: Those pregnant can not be prescribed ribavirin and, although the risk is small (2%-10%), can pass HCV onto their babies. This article examines the possibility of  treating pregnant women to eliminate any chance of virus transmission, as recent literature has shown success for those with hep B, and states that more research in this should be collected.

Antibodies to an interfering epitope in hepatitis C virus E2 can mask vaccine-induced neutralizing activity by Alla Kachko, et al.

Summary: So far, a vaccine against HCV remains just a  goal. This article highlights one of the difficulties faced in developing a HCV vaccine and hypothesizes “…that the proximity of the two epitopes [epitopes 1 and 2] leads to physical interference among the antibodies. Epitopes selected for a vaccine should not be in close proximity.” (Dufour)

Summary: The research team compared cure rates of two hep C treatments, Sovaldi-based regimens and historical controls treated with pegylated interferon and ribavirin (PR), in those with mixed cryoglobulinemia syndrome (MCS). Conclusion: The Sovaldi-based regimens decreased the cryoglobulin levels in 89% of patients, 83% achieved SVR12 (cure). Only 10% of those treated with PR achieved SVR12 and 50% had to stop treatment due to side effects.

Liver International (December 2015)

CADTH (November 2015)

Press Releases by Pharmaceutical Companies (International)

*This post concentrated on literature published between November 18th and December 12th, 2015.

Liver Meeting 2015 Clinical Trial Highlights

The Liver MeetingThe American Association for the Study of Liver Diseases (AASLD) held its 66th annual meeting, The Liver Meeting 2015 (#Liver15), November 13th – November 17th. The meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases.

Some of the meeting’s highlights have been posted in our Liver Meeting 2015 Highlights blog post. In addition, some of the clinical trial results that were part of the meeting are presented below.

Some Clinical Trial Result Highlights that were Presented at the 2015 Liver Meeting

 

Patients
Treatment Regimen
Duration in Weeks
SVR
ASTRAL-1: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for
12 Weeks in Naïve and Experienced Genotype 1, 2, 4,
5, 6 HCV Infected Patients with and without cirrhosis (Abstract LB-2)
Genotype 1, 2, 4, 5, 6 Hepatitis C (GT 1, 2, 4, 5, 6 HCV); with and without cirrhosis; 740 patients Sofosbuvir/Velpatasvir 12 SVR12 99% Overall (GT1 98% GT2 100% GT4 100% GT5 97% GT6 100%)
Placebo Similar adverse effects
ASTRAL-2 and ASTRAL-3: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
GT 2, 3 HCV; treatment naive and treatment experienced; including patients with compensated cirrhosis GT2 Sofosbuvir/Velpatasvir 12 SVR12 99%
Sofosbuvir + ribavirin (RBV) SVR12 94%
GT3 Sofosbuvir/Velpatasvir 12 SVR12 95%
Sofosbuvir + RBV 24 SVR12 80%
ASTRAL-4: Sofosbuvir/Velpatasvir Fixed Dose Combination for the Treatment Of HCV in Patients with Decompensated Liver Disease
GT 1, 2,
3, 4, 6 HCV; with decompensated liver
disease; 267 patients (Patients with prior liver transplant or
hepatocellular carcinoma were excluded)
Sofosbuvir/Velpatasvir 12 SVR12 83% Overall (GT1 88% GT2 100% GT3 50% GT4 100%)
Sofosbuvir/Velpatasvir + RBV SVR12 94% Overall (GT1 95% GT2 100% GT3 84% GT4 100%)
Sofosbuvir/Velpatasvir 24 SVR24 85% Overall (GT1 91% GT2 75% GT3 50% GT4 100% GT6 100%)
SURVEYOR-I and SURVEYOR-II: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection (Ongoing Phase 2 clinical studies. Part 1 results of the SURVEYOR-II were presented at AASLD)
GT 1 HCV; without compensated cirrhosis; treatment naive or did not respond to pegylated interferon + RBV (PR) ABT-493 (200mg) + ABT-530 (120mg) 12 SVR12 100%
ABT-493 (200mg) + ABT-530 (40mg) SVR12 97%
ABT-493 (300mg) + ABT-530 (120mg) 8
GT 2 HCV; without compensated cirrhosis; treatment naive or did not respond to PR ABT-493 (300mg) + ABT-530 (120mg) 12 SVR12 96%
ABT-493 (200mg) + ABT-530 (120mg) SVR12 100%
ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily
GT 3 HCV; without compensated cirrhosis; treatment naive or did not respond to PR ABT-493 (300mg) + ABT-530 (120mg) 12 SVR12 93%
ABT-493 (200mg) + ABT-530 (120mg)
ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily SVR12 94%
ABT-493 (200mg) + ABT-530 (40mg) SVR12 83%
ALLY-3+ Phase 3 Study: All-Oral Treatment With Daclatasvir (DCV) Plus Sofosbuvir (SOF) Plus Ribavirin (RBV) for 12 or 16 Weeks in HCV Genotype (GT) 3-Infected Patients With Advanced Fibrosis or Cirrhosis (Abstract LB-3)
GT 3 HCV; treatment-naive or treatment-experienced with advanced fibrosis or cirrhosis. Patients were randomized 1:1 to receive 12 weeks vs 16 weeks of DCV + SOF + RBV DCV + SOF + RBV 12 SVR4 88% Overall (83% in those with cirrhosis, 100%
in those with advanced fibrosis)
16 SVR4* 96% (94% with cirrhosis, 100% in those with advanced fibrosis)
*The AASLD Abstracts states, “DCV+SOF+RBV for 12 or 16 weeks achieved high SVR4 rates of 88% and 96%, respectively…”.
An Integrated Analysis of 402 Compensated Cirrhotic Patients With HCV Genotype (GT) 1, 4 or 6 Infection Treated With Grazoprevir/Elbasvir (Abstract 42, pg 23)
GT 1, 4, 6 HCV; treatment-naive with compensated liver cirrhosis (Child-Pugh class A) Grazoprevir/Elbasvir 12 SVR12 90%
Grazoprevir/Elbasvir + RBV SVR12 98%
GT 1, 4, 6 HCV; treatment-experienced with compensated liver cirrhosis (Child-Pugh class A) Grazoprevir/Elbasvir SVR12 89%
Grazoprevir/Elbasvir + RBV SVR12 91%
GT 1, 4, 6 HCV; treatment-experienced Grazoprevir/Elbasvir 16 or 18 SVR12 94%
Grazoprevir/Elbasvir + RBV SVR12 100%
C-CREST-1 & 2, Part A: Phase 2, Randomized, Open-Label Clinical Trials of the Efficacy and Safety of Grazoprevir and MK-3682 (NS5B Polymerase Inhibitor) with Either Elbasvir or MK-8408 (NS5A Inhibitor) in Patients with Chronic HCV GT1, 2 or 3 Infection (Abstract LB-15)
Population* G+E + MK-3682 300mg Grazoprevir
+ Elbasvir (G+E)
+ MK-3682
450mg
Grazoprevir
+ MK-8408
+ MK-3682
300mg
Grazoprevir
+ MK-8408
+ MK-3682
450mg
GT 1 HCV 100%** 100% 100% 91%
GT 2 HCV 69% 60% 71% 94%
GT 3 HCV 90% 86% 95% 91%
*Treatment-naive without liver cirrhosis; **SVR12, following 8 weeks of treatment
Osiris: Simeprevir in Combination with Sofosbuvir in Genotype 4 Infected HCV Patients In Egypt
GT 4 HCV, without liver cirrhosis, treatment naïve and treatment experienced Simeprevir + Sofosbuvir 8 SVR12 75%
GT 4 HCV, with liver cirrhosis, treatment naïve and treatment experienced Simeprevir + Sofosbuvir 12 SVR12 100%

The American Association for the Study of Liver Diseases’ Liver Meeting 2016 will be in Boston.

Additional information presented at The Liver Meeting can be found online in easy-to-use versions and in our Liver Meeting 2015 Highlights blog post so that you can find the information that may become the meeting’s highlights for you. Explore on your own or use PHCN’s Hepatitis C Treatment Information Project / email us for direction.