Tag Archives: hepatitis c

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.

What do you think about The Vancouver Sun article?

The Vancouver SunAn article, entitled ‘Hepatitis C treatment skyrocket after pill-based drugs covered by B.C. plan’ and published by The Vancouver Sun on July 29, 2015, highlighted not only the cost and marketing around hepatitis C treatments, but also the demand for those treatments in BC.

The article began with: “About 1,400 British Columbians have been treated for hepatitis C in the first four months since new anti-viral medications were covered by the province’s public drug plan — far above predictions. The Ministry of Health expected 1,500 patients in the first full year for the pill-based medication.”

The Pacific Hepatitis C Network is ecstatic to hear that so many British Columbians are seeking treatment. However, do we still need a clear strategic plan in BC to ensure that those who need treatment now get it as soon as possible and those waiting for treatment get excellent care and support? We think so!

What about you? What do you think?

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!

PharmaCare Drug Coverage Review for Holkira Pak

Holkira PakThe Hepatitis C Treatment Information Project received an advance notification from BC’s Ministry of Health that Holkira Pak (generic name: ombitasvir/paritaprevir/ritonavir and dasabuvir) will soon be considered for PharmaCare coverage. The tentative dates for input into this process are from Wednesday, April 22nd, to Wednesday, May 20th.

If you are a BC resident and answer yes to any of the following questions for Holkira Pak, you can give your input:

  1. Do you have hep C?
  2. Are you a caregiver to someone who has hep C?
  3. Does your patient group represent patients who have hep C AND have you registered with PharmaCare to give input?  (Learn more about registering your organization).

Please note that PharmaCare’s questionnaire for Holkira Pak may not be available for another couple of weeks.

For more information, please contact  Your Voice or the Hepatitis C Treatment Information Project.

Response to Treatment by Prevention Article

sq_trialsThe Globe and Mail article: B.C. medical researchers offer treatment by prevention for hepatitis C

PHCN recognizes treatment as prevention (TasP) as the strategy of choice for people who use injection/inhalation drugs, who, as a group, have the highest rate of new HCV infections. Treatment as prevention is an approach tailored to meet their specific health needs and we both support and advocate for that approach in all communities of the province.

That idea – specific approaches designed to meet the needs of specific populations – is what is critical in the drive to cure individuals and eradicate hepatitis C in BC.

The gap right now is a clearly thought-out and articulated strategy for reaching out to baby boomers, immigrant populations, and Aboriginal people, and engaging them in care, treatment, and support for hepatitis C. The other half of this picture is the health care system and providers within it. What is the strategy to build capacity – system and providers – to meet this urgent and acute population health demand?