Category Archives: Drug Pipeline

CROI 2017 by Lucinda K. Porter, RN

CROI 2017 by Lucinda K. Porter, RNLucinda K. Porter

This is a collection of blog posts written by Lucinda K. Porter, RN, a hepatitis C writer who attended this year’s Conference on Retroviruses and Opportunistic Infections (CROI). The blog posts below highlight hepatitis C studies presented at the conference that stood out to her.

Please scroll down and click on the blog tittles that interest you.

Sampling of CROI 2017 Meeting Highlights Written by Lucinda K. Porter, RN

CROI 2017

The Conference on Retroviruses and Opportunistic Infections (CROI), an annual preeminent HIV research meeting, was held in Seattle, Washington, February 13-16 this year. CROI gathers scientists researching epidemiology and biology of human retroviruses and associated diseases to discuss their findings.

More information about the CROI and the studies that were presented there can also be found in our blog post CROI 2017 Hep C Highlights Part I.

“Creating a world free from hepatitis C one step at a time” -Lucinda Porter

CROI 2017 Hep C Highlights Part II

CROI 2017 Hep C (HCV) HighlightsCROI 2017

The Conference on Retroviruses and Opportunistic Infections (CROI), an annual preeminent HIV research meeting, was held in Seattle, Washington, February 13-16 this year. CROI gathers scientists researching epidemiology and biology of human retroviruses and associated diseases to discuss their findings.

This blog post is a collection of HIV/HCV highlights that were presented at CROI 2017. Please scroll down and click on the subjects that interest you.

More Interesting CROI 2017 Abstracts about HIV/HCV Coinfection

More information about The Conference on Retroviruses and Opportunistic Infections (CROI), or these and other studies can be found in our blog post CROI 2017 Hep C Highlights Part I or on the conference’s website.

CROI 2017 Hep C Highlights Part I

CROI 2017 Hep C Highlights Part ICROI 2017

The Conference on Retroviruses and Opportunistic Infections (CROI), an annual preeminent HIV research meeting, was held in Seattle, Washington, February 13-16 this year. CROI gathers scientists researching epidemiology and biology of human retroviruses and associated diseases to discuss their findings.

This blog post is a collection of HIV/HCV highlights that were presented. Please scroll down and click on the subjects that interest you.

Interesting Meeting Abstracts about HIV/HCV Coinfection

More information about The Conference on Retroviruses and Opportunistic Infections (CROI), or these and other studies can be found in our blog post CROI 2017 Hep C Highlights Part II or on the conference’s website.

PHCN’s Statement about the Successful Negotiations for 3 New Hepatitis C Treatments

PHCN's Statement about the Successful Negotiations for 3 New Hepatitis C Treatments‘No One Left Behind!’

Pacific Hepatitis C Network (PHCN) is very happy to learn that effective March 21, an extensive list of hepatitis C treatments will be available through BC PharmaCare – at far better prices than they previously had been. The high cost of hepatitis C treatment has effectively restricted the numbers of people living with hepatitis C who could access treatment.

Even with lower prices, those restrictions will remain in place until next year. Come March 2018, those restrictions (requiring a liver fibrosis stage of F2 or greater) will be lifted and hepatitis C treatment will be available to any person living with hepatitis C in BC, “regardless of the type and severity of their disease”.

The Province, via the Ministry of Health, co-led the negotiations for new, affordable prices and we at PHCN are both proud of that fact and sincerely grateful. We hope the same for new, hep C drugs that are currently in development and that improve even more on cure rates, tolerability, length of treatment, and treating more than one HCV genotype.

And with these new developments, our work continues! Now is the time to identify and address the barriers still in place that keep those living with hep C from accessing care and treatment: low levels of primary care provider awareness of hep C and treatments; believes about who deserves treatment and who doesn’t; patient education and outreach to those who were diagnosed years ago but are not engaged in care for their hep C. Stigma can and does underlay many of those barriers and must be addressed.

PHCN applauds the ushering in of the first critical step by BC’s Ministry of Health and we urge continued vigilance and collective planning and action to ensure ’No One Left Behind!’ when it comes to hepatitis C care and treatment in BC.

More information can be found here.

Successful Negotiations for Three New Hepatitis C Treatments

Successful Negotiations for Three New Hepatitis C TreatmentsDirectly copied statement from the pan-Canadian Pharmaceutical Alliance

TORONTO, Feb. 21, 2017 /CNW/ – On behalf of participating federal, provincial and territorial public drug plans, the pan-Canadian Pharmaceutical Alliance (pCPA) has concluded successful negotiations with three drug manufacturers to help jurisdictions expand access to publicly funded medications for the treatment of chronic hepatitis C.

Hepatitis C is a communicable liver disease that is caused by an infection with the hepatitis C virus. Seventy-five per cent of people who have contracted hepatitis C cannot spontaneously clear the virus. This leads to chronic hepatitis C infection. Although many of the estimated 250,000 infected Canadians may have no symptoms for decades, if left untreated, chronic hepatitis C can lead to serious complications such as liver failure and liver cancer.

Just a few years ago, hepatitis C patients took a combination of pills and injections for almost a year and these earlier drugs had lower rates of treatment success. Today’s newer therapies are more effective, available in oral form and require substantially shorter durations of treatment.

These benefits, however, come at a substantial cost. Depending on the drug and disease progression, the list cost for hepatitis C treatments ranged from $45,000 to over $100,000 per patient. Although these costs were made more affordable with previous agreements, the funding of hepatitis C treatments has resulted in significant cost pressures.

Recently, multiple products have become available, creating a more competitive environment for hepatitis C treatment price negotiations.

The pCPA’s approach to hepatitis C treatment negotiations was guided by the following:

  • goal of providing treatment for patients regardless of genotype and disease severity
  • financial affordability and sustainability
  • a fair approach in negotiating value among multiple drugs and manufacturers.

Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada were able to reach an agreement through the pCPA to provide hepatitis C drugs at an improved cost. These agreements will help increase publicly funded access for most patients with hepatitis C.

As with all pCPA drug negotiations, individual participating jurisdictions will be responsible for implementing changes under their respective public drug plans.

SOURCE Pan Canadian Pharmaceutical Alliance (pCPA)

For further information: For more information (media): David Jensen, Ministry of Health and Long-Term Care, 416-314-6197

Glecaprevir/Pibrentasvir Granted Priority Review

Glecaprevir/Pibrentasvir Priority Review GrantedAbbVie, the developer of glecaprevir (ABT-493) / pibrentasvir (ABT-530), has submitted a New Drug Submission to Health Canada for the treatment of chronic hepatitis C and has been granted a priority review for it. This means that it will receive a priority review from Health Canada.*

A couple of weeks ago, the same hepatitis C treatment received a Breakthrough Therapy Designation (BTD) from the FDA for the treatment of patients with hep C genotype 1 who were not cured with prior DAA therapies.

Glecaprevir/Pibrentasvir

Glecaprevir/pibrentasvir was submitted to Health Canada as a short term, eight week, treatment, made up of a once-daily three pill regimen. The treatment is for patients with chronic hepatitis C virus (HCV) genotypes 1-6, all major genotypes, without liver cirrhosis or with compensated liver cirrhosis (Child-Pugh A).

Glecaprevir/pibrentasvir is intended to address the unmet medical needs of patients with specific treatment challenges, including those with severe chronic kidney disease and those not cured with previous direct acting antiviral treatment.

Additional information and AbbVie’s press release about their New Drug Submission to Health Canada can be found here.

Sampling of Phase III Clinical Trials for Glecaprevir / Pibrentasvir:

Clinical Trial Patients Treatment Duration Treatment Regimen SVR12*
ENDURANCE-1 GT1 without cirrhosis, new to treatment or not cured with previous treatment 8 weeks Glecaprevir / Pibrentasvir (G/P) once daily 99%
12 weeks
ENDURANCE-2 GT2 without cirrhosis, new to treatment or not cured with previous treatment 12 weeks G/P vs Placebo 99%
ENDURANCE-3 GT3 without cirrhosis (NC), new to treatment (TN), treatment experienced (TE) 12 weeks G/P Ongoing
12 weeks SOF + DCV
8 weeks G/P 95%
ENDURANCE-4 GT4-6 NC, TN, TE 12 weeks G/P GT4 99%, GT5 100%, GT6 100%
SURVEYOR-2 (Part 3) GT3 TN, TE 12 weeks G/P 91%
Compensated cirrhosis (CC), TE 16 weeks 96%
GT3 TN 12 weeks G/P 98%
GT3 TE 16 weeks 96%
SURVEYOR-2 (Part 4) GT2, GT4-6 NC, TN, TE 8 weeks G/P GT2 98%, GT4 93%, GT5 100%, GT6 90%
EXPEDITION-4 CKD4/5, GT1-6, +/- CC 12 weeks G/P 98%
EXPEDITION-1 GT1, 2, 4-6 CC, TN, and TE 12 weeks G/P Ongoing
CERTAIN-1 GT1 without cirrhosis, some with the resistance-associated Y93H virus variant 8 weeks G/P 99%
12 weeks Technivie 100%
MAGELLAN-1 (Part 2) GT1, 4, 6 +/- liver cirrhosis, DAA treatment experienced 12 weeks G/P + RBV Ongoing
16 weeks G/P – RBV
*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped. A SVR12 is an HCV viral load that has remained undetectable for 12 weeks after treatment, indicating a cure.
**Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon.

Common Side Effects Reported in Clinical Trials:

  • Headache
  • Tiredness (fatigue)

“HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat. This is particularly true in those with genotype 2 and 3 infection, and those with cirrhosis,” said Dr. Curtis Cooper, Director of the Regional Hepatitis Program at the Ottawa Hospital. “Recent clinical trial results are a positive development in AbbVie’s investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options.”

*For more information about the drug approval system in Canada please see Approval Process.

Glecaprevir/Pibrentasvir Submitted to the US FDA

Glecaprevir/Pibrentasvir Submission to the FDAA New Drug Application was submitted to the U.S. Food and Drug Administration (FDA) late last year for glecaprevir/pibrentasvir, a hepatitis C treatment against all of the virus’s major genotypes. This application was submitted after the FDA grated glecaprevir/pibrentasvir a Breakthrough Therapy Designation (BTD) for the treatment of patients with hep C genotype 1 who were not cured with prior DAA therapies last September. It also came just weeks after a New Drug Application was submitted for sofosbuvir/velpatasvir/voxilaprevir, another hep C treatment.

There has been no word as to when glecaprevir/pibrentasvir will be submitted for approval in Canada.

Glecaprevir/Pibrentasvir

Glecaprevir/pibrentasvir was submitted to the FDA as a once-daily three pill regimen for the treatment of patients with chronic hepatitis C virus (HCV). The treatment is taken without pegylated interferon or ribavirin. It has achieved high SVR/cure rates in patients with health concerns that limit hep C treatment options, such as those with severe chronic kidney disease. In as little as 12 weeks, it has also been effective for those historically difficult to treat, such as those not cured by other direct-acting antiviral treatment.

Additional information and AbbVie’s press release about their New Drug Application to the U.S. FDA can be found here.

Sampling of Phase III Clinical Trials

Clinical Trial Patients Treatment Duration Treatment Regimen SVR12*
ENDURANCE-1 GT1 without cirrhosis, new to treatment or not cured with previous IFN-based treatments (pegIFN +/- RBV or SOF/RBV +/- pegIFN) , and patients co-infected with HIV-1 8 weeks Glecaprevir / Pibrentasvir (G/P) once daily 99%
ENDURANCE-3 GT3 without cirrhosis, never been treated G/P 95%
SURVEYOR-2 (Part 4) GT2, 4, 5, 6 without cirrhosis, new to treatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV or pegIFN/SOF) G/P 97%
*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped. A SVR12 is an HCV viral load that has remained undetectable for 12 weeks after treatment, indicating a cure.
**Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon.

Common Side Effects Reported in Clinical Trials:

  • Headache
  • Tiredness (fatigue)

“The results we announced today bring us closer to providing a potential pan-genotypic, once-daily treatment option with 8 weeks of therapy for people living without cirrhosis and who are new to treatment,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

Grazoprevir and Elbasvir at the Liver Meeting 2016

Grazoprevir and Elbasvir at the Liver Meeting 2016As we begin to look back on 2016, this post highlights some of the presentations that took place at the Liver Meeting 2016 about the hep C treatments grazoprevir and elbasvir.

Grazoprevir and Elbasvir

  • #74C-ISLE: Grazoprevir/Elbasvir plus Sofosbuvir in Treatment- naïve and Treatment-experienced HCV GT3 Cirrhotic Patients Treated for 8, 12 or 16 weeks
Treatment Naive Treatment Experienced
Arm 1, 8 weeks + RBV Arm 2, 12 weeks without RBV Arm 3, 12 weeks without RBV Arm 4, 12 weeks with RBV Arm 5, 16 weeks without RBV
Treatment Week 4 87% 74% 71% 88% 71%
Treatment Week 8 100% 100% 100% 100% 100%
  • #76Efficacy 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

Summary: Hepatitis C contributes significantly to the overall liver disease burden in the Asia Pacific region and Russia where the seroprevalence rates vary from 1-5% and genotype (GT) 1b accounts for about half of infections. Conclusion: A 12-week regimen of EBR/GZR is effective and well-tolerated in GT1 and GT4-infected, treatment-naive patients in the Asia Pacific/Russia region.

Genotype SVR12 Rate
Overall (232/250) 92.8%
GT1a (23/26) 88.5%
GT1b (185/187) 98.9%
GT4 (2/2) 100%
GT6 (22/35) 62.9%
  • #110Safety 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)

Summary: Treatment was generally well tolerated, with no cardiac or renal safety signals seen. One GT1-infected patient died due to a study drug-unrelated bacterial sepsis The most common side effects, in >5% of all patients, were fatigue, headache, and nausea.

Patients SVR8/12 Rate
126 GT1-infected patients who recieved 8 or 12 weeks of treatment 100%
85 patients (46 GT1a/39 GT1b) who received 12 weeks of therapy 100%
  • #112High 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)

Summary: To evaluate a retreatment regimen for patients who had failed therapy with a 3-drug direct-acting antiviral (DAA) combination: MK-3682, an NS5B polymerase inhibitor, grazoprevir, an NS3/4A protease inhibitor, and either elbasvir or MK-8408, which are NS5A inhibitors. All of the patients achieved SVR. The most common (>10%) side effects were headache, fatigue, nausea, rash, pruritus, insomnia, decreased hemoglobin, and cough.

  • #193Safety 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)

Summary: Patients who have failed an NS5A-containing DAA treatment regimen (Harvoni or Zepatier) are an unmet medical need because there isn’t enough data to guide physicians in their management. This study found that the treatment MK-3682/Grazoprevir/MK-8408 did well.

Arm Proportion of Patients with HCV RNA <15 IU/mL
Treatment Week 4 Treatment Week 8
16 weeks + RBV 39/42 (93%) 35/35 (100%)
24 weeks without RBV 44/49 (90%) 38/38 (100%)

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.

Possible Softening of Liver Fibrosis Stage F1> Treatment Requirement

Possible Softening of Liver Fibrosis Stage F1> Treatment RequirementThe Pacific Hepatitis C Network has received reports that at least one Canadian assistance program offered by a pharmaceutical company is working with patients, on a case-by-case basis, to treat those with liver fibrosis stage F1. The status quo, requiring a liver fibrosis stage F2 or higher to access hep C treatment, in Canada may be changing and the Pacific Hepatitis C Network applauds this possible change.

If you have hepatitis C and are interested in treatment, please talk to your healthcare provider about it and keep regular tabs on your liver’s health.

Liver Fibrosis

Liver fibrosis is the early stage of liver scarring. It happens when a liver tries to heal itself and in the process creates scar tissue that can’t do the work of normal liver cells. Fibrosis doesn’t cause symptoms but can lead to portal hypertension or liver cirrhosis. A liver biopsy is used to diagnosis it. Fibrosis can be stopped and some of the changes reversed if the underlying condition is treated.

Liver Fibrosis Stages

There are five stages of liver fibrosis, stage 0 to stage 4 (stage F1-F4). Stage 0 means a liver is normal and doesn’t have fibrosis. Stage 4 is liver cirrhosis. Currently, BC PharmaCare requires a patient to have liver fibrosis stage 2 or higher in order to possibly qualify for hep C treatment coverage. At stage 2, one may still not know that their liver is damaged and may not experience liver failure symptoms such as yellow skin or eyes or abdominal pain.

More information about liver fibrosis and liver cirrhosis can be found in Understanding Cirrhosis of the Liver: First steps for the newly diagnosed, an easy-to-read resource that was put together by CATIE and the Canadian Association of Hepatology Nurses.

New Drug Application Submitted for Sofosbuvir/Velpatasvir/Voxilaprevir

New Drug Application Submitted to FDA for Sofosbuvir/Velpatasvir/Voxilaprevir~ A New Drug Application has been submitted to the FDA. If Approved, Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Would Be the First Once-Daily Single Tablet Regimen Available as a Treatment Resorted to when Preferred Therapies have been Tried, or a Salvage Treatment,  for Patients with Hep C Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors ~

The creator of the hepatitis C treatment SOF/VEL/VOX, Gilead, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the hep C treatment. SOF/VEL/VOX has been submitted as an once-daily single pill regimen for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients.

The Data Submitted in the New Drug Application (NDA)

The data submitted in the NDA, see below, supports the use of the regimen for 12 weeks in DAA treatment experienced patients with genotype 1 to 6 hep C who have or don’t have liver cirrhosis.

Clinical Trial Patients Genotype Duration Treatment SVR12
POLARIS-1 455 patients, including those who failed prior treatment with an NS5A-containing regimen, 41 percent (172/415) had cirrhosis 1-6 12 weeks SOF/VEL/VOX 96%
Placebo 0%
POLARIS-4 DAA-experienced (No NS5A inhibitor), 46 percent (153/333) had cirrhosis 1-4 12 weeks SOF/VEL/VOX 97%
SOF/VEL 90%
POLARIS-2 DAA-naive, 18 percent (174/941) had cirrhosis 1-6 8 weeks SOF/VEL/VOX 95%
12 weeks SOF/VEL 98%
POLARIS-3 DAA-naive, All had cirrhosis 3 8 weeks SOF/VEL/VOX 96%
12 weeks SOF/VEL 96%

Patients treated with SOF/VEL/VOX for 12 or 8 weeks experienced side effects similar to those treated with placebos. The most common side effects from SOF/VEL/VOX were headache, fatigue, diarrhea and nausea.

No news on or how the treatment may be submitted to Health Canada.

More Information

“The remaining clinical need to treat HCV patients is a safe and effective cure for patients who have failed previous therapy with DAA regimens, including those with NS5A inhibitors,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead.