Tag Archives: hep c

To treat or to wait? That may be the question with hep C treatment.

To treat or to wait? That may be the question with hep C treatment.To treat or to wait? Only you and your doctor–and possibly BC PharmaCare–can decide whether you should begin hepatitis C treatment now or wait. However, there are resources that may be able to help you answer that question or to think about the factors one may want to think about when considering treatment for hepatitis C. For example, current state of health, virus genotype, work and family circumstances, as well as financial considerations, may all be factors that can influence if, and when, a person decides to try to treat their hepatitis C.

Basic Facts about Hep C Treatment to Consider

Historically, treatment for hepatitis C has been difficult and long – up to a year. However, even now, when newer treatments boost shorter treatment times (8 – 24 weeks) and much less side effects, patients may still face treatment difficulties. A few patients still find that the new treatments are impossible to complete health-wise or find that treatment is too disruptive, given their current life circumstance or health situation. Therefore, patients still decide, or are advised by their healthcare providers, to delay treatment, even when new treatments are available.

Also–and this one is a big one–one should be aware that even newer, possibly better, hep C treatments are on their way.

Resources Weighing the Risks and Benefits of Treating or Waiting to Treat Hepatitis C

Resources Designed to Help You Talk to Your Doctor

Peer Supports

There are a number of support groups and hotlines available to support you and to answer your questions. Going online is a great way to find local groups and connect to communities through social media, especially on Facebook.

However, one of your best resource when considering whether to treat on not to treat will always be your own healthcare provider or a healthcare provider. They can talk to you about your different health concerns and weigh in on whether they think treatment is right for you while knowing you and your medical history.

To treat or not to treat? That is still a question asked and still one that should be asked.

Please contact us at hepctip@pacifichepc.org or check out our Considering Treatment page for more information.

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.

Liver Meeting 2015 Highlights

Liver Meeting 2015 HighlightsThe 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. The below is some of what they discussed and some of what has gone viral.

Hepatitis C Highlights from the 2015 Liver Meeting

AASLD issued a statement about hepatitis C that:

  • Endorsed treating patients with hep C as the standard of care instead of waiting for liver disease to develop;
  • Endorsed hepatitis C treatment that can prevent the progression of liver disease;

And argued that:

  • Inaction is harmful to patients;
  • Failure to treat leads to other health problems;
  • Access to treatment is the most effective way to eliminate the virus.

The full AASLD news release can be found at Leading Liver Doctors: Hepatitis C Patients Must Be Treated.

Hepatitis C Subjects Garnering Attention

Advocacy
Prevention
Treatment

Clinical Trial Results Garnering Attention

Clinical trial results were presented by researchers working to understand hep C and help treat a wider range of patients easier and faster. Our blog post covering some of these clinical trials results in more detail has been posted and can be found at Liver Meeting 2015 Clinical Trial Highlights.

The Liver Meeting 2015 Abstracts and Other Resources

The AASLD’s Liver Meeting 2016 will be in Boston.

Information presented at The Liver Meeting can be found online in easy-to-use versions 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 for direction.

References:

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.

Thank you for Your Input

grazoprevir / elbasvirThank you to all of you who completed PHCN’s grazoprevir / elbasvir patient input survey and the earlier Technivie  patient input survey. Thank you also for sharing them with others. It was truly an honour to read your responses and to use them to write the patient group input report for the Canadian Agency for Drugs and Technologies in Health (CADTH) on your behalf.

The patient group input reports requested by CADTH are an important step towards getting new treatments for hep C more widely available in Canada and BC.

The patient input about grazoprevir / elbasvir was sent in this morning. We now wait to hear the outcome of the treatment submissions.

The Hepatitis C Treatment Information Project will keep you apprised of any news and is here to answer any questions you may have.

Thank you for taking the time to voice your opinion and help advocate for a better tomorrow.

SVR is Not a Treatment’s Survival Rate

The Basic Hep C Treatment Terms pageAwhile back, I read an article published by a business magazine that defined a hep C treatment’s SVR as the treatment’s survival rate. Fortunately, this is not the correct definition of SVR. However, the incorrect definition–and probably all of the snickers that have followed at its expense–has led to the Hepatitis C Treatment Information Project putting together a Basic Hep C Treatment Terms page.

The Basic Hep C Treatment Terms page is filled with terms one may encounter while researching hep C treatments. The page’s terms have also been linked throughout the Hep C Treatment Information Project so that when a reader comes across one of the terms, they can click on it and a new window will open with the word’s definition.

As you may have already guessed, SVR is one of the term defined on the new page. SVR stands for sustained viral response. There is a time period, right after treatment has been completed, when HCV RNA, or the hep C virus, isn’t detectable in one’s blood. If the virus remains consistently undetectable over time, the chances of it coming back, or relapsing, are extremely low (less than 1%). When this happens, a SVR is thought to have been achieved.

Achieving SVR is the goal of hep C treatments. It is considered to be an hep C infection cure, a successful treatment. When it is achieved, the hep C virus can’t be detected in the blood, can’t be spread, and liver cirrhosis from it has stopped.

Currently, hep C treatments in clinical trials are usually listed with SVR12s or SVR24s. The numbers after ‘SVR’ are the number of weeks that the virus must remain undetectable for the treatment to be declared successful. For example, if SVR24 95% is listed for a treatment, it means that 24 weeks after that treatment has been completed, 95% of patients had such low levels of HCV RNA within them that they were declared cured. If SVR12 95% is listed, it means the same thing but after only 12 weeks of testing for the virus instead of 24 weeks.

Other hep C treatment terms defined on the new page are:
Hep C Antibody Test Hep C Genotype Liver Cirrhosis
Liver Fibrosis Liver Fibrosis Stages PCR Test/HCV RNA
PharmaCare Limited Coverage Drugs PharmaCare Special Authority Relapse
Treatment-Experienced / Previously Treated Patients Treatment-Naive Patients / Patients who have never tried treatment Viral Load
Viral Load Test

The Basic Hep C Treatment Terms page is a project in progress, like the Hepatitis C Treatment Information Project itself, and will probably be frequently updated with new terms.

If there are other terms that should be defined on this page, please let the Hepatitis C Treatment Information Project know and we’ll gladly add them!

Yellow People in Vienna

European Association for the Study of the LiverThe European Association for the Study of the Liver’s 50th International Liver Congress

The European Association for the Study of the Liver (EASL)’s International Liver Congress 2015 took place in Vienna last week. Founded in 1966, the European Association for the Study of the Liver is the leading liver association in Europe. Its annual congresses unite up to 11,000 participants.

This year, new European Association for the Study of the Liver treatment guidelines were issued, presentations were made, clinical trial results were announced for a variety of new hep C DAA treatment combinations, and tweets were sent out—many, many tweets.

As a result, the Treatment Information Project’s Clinical Trial Results page was updated with more information about trial results for treatment combinations targeting hard to treat patients and trying to achieve shorter SVRs.

Clinical Care Options covered the EASL’s Liver Congress and has also published capsule summaries covering presentations about emerging hep C treatments. Their downloadable set of slides is coming soon. Some of their summaries include information on:

  • High SVR12 rates in patients with genotype 4 or 5 after 12 weeks of Harvoni (ledipasvir and sofosbuvir)
  • Trial results for grazoprevir/elbasvir
  • High reinfection rates following SVR among patients who use injection drugs
  • Sovaldi (sofosbuvir) plus Daklinza (daclatasvir) +/- RBV

Posts by Hep Magazine also cover the meeting’s highlights. Some of their listed highlights are:

  • Emerging liver diseases on the rise
  • Hep C and cancer rates
  • Advanced liver disease success
  • High cure rate with kidney disease

For Twitter users, some of the meeting’s tags were: #EASL2015#ILC2015, #LiverHome, @ILCpress, @EASLnews. Some of the tweets that can still be found via these tags led to pretty interesting slides and articles.

Lastly, while reading through the pharmaceutical press releases, articles, and tweets, one of the random things that was interesting was that some of the clinical trial control groups weren’t listed as having been treated with placebos of ribavirin or interferon, but were treated with DAAs, the treatments that have recently become the standard of care—the treatments that have become the drugs to beat and so, at times, are showing how quickly treatments seem to be improving.