Tag Archives: AbbVie

Drug Pipeline

Viekira XR Received US FDA Approval

Viekira XR Received U.S. FDA ApprovalViekira XR has been FDA approved in America. Viekira XR is an extended-release version of the hepatitis C treatment Viekira Pak (American brand name Viekira Pak / Canadian brand name Holkira Pak). This extended-release version is for patients with chronic genotype 1 hepatitis C, including those with compensated cirrhosis (Child-Pugh A). The treatment includes 3 pills, taken daily with food, that may or may not be combined with ribavirin. It may be prescribed for 12 or 24 weeks of therapy.

An extended-release therapy is a treatment made up of pills that were created to slowly release over time. This slow release gives the drugs more time to work and may allow the levels of the drugs in the body to be more consistent than they may be with other treatment types. This may help lower side effects.

For more information about this FDA approval or about the hepatitis C treatment, please see the press release by AbbVie, the developer of Viekira Pak/Holkira Pak and Viekira XR.

Drug Pipeline

Press Releases from January and February 2016

Press Releases in January and February 2016The following highlights press releases about hepatitis C treatments posted in January and the beginning of February 2016.* Give the headlines a skim and find out what’s going on with hep C treatments according to current press releases posted by treatment developers.

2016 Press Releases by Pharmaceutical Companies (International)

U.S. FDA Approves Expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C (Bristol-Myers Squibb, Feb 5, 2016)

Merck Receives Approval of ZEPATIER™ (elbasvir/grazoprevir) in Canada for the Treatment of Chronic Hepatitis C for Patients with Genotype 1, 3, or 4 Infection Following Priority Review (Merck, Feb 3, 2016)

Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review (Merck, Jan 28, 2016)

European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV (Bristol-Myers Squibb, Jan 28, 2016)

AbbVie Initiates Enrollment of Six Global Phase 3 Clinical Studies for Once-Daily, Pan-Genotypic Hepatitis C Regimen (AbbVie, Jan 11, 2016)

FDA Grants Priority Review to AbbVie for Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Virus Patients with Compensated Cirrhosis (AbbVie, Jan 7, 2016)

Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection (Gilead, Jan 4, 2016)

* Time period was between January 1st and February 6th, 2016.

Drug Pipeline

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)

  • Federal inmates treated for hep C drop 29% by Paul Christopher Webster (Early release date: November 2, 2015)

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

  • What’s next for the Liberals on health? by Lauren Vogel

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)

  • Profile: British Columbia Centre for Excellence in HIV/AIDS by Tony Kirby

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.

  • Prevalence of HIV, hepatitis B, and hepatitis C in people with severe mental illness: a systematic review and meta-analysis by Elizabeth Hughes, et al.

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

Hepatology (December 2015)

  • Hepatology highlights by Jean-Francois Dufour The hepatitis C studies that were highlighted by Dufour are:

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)

  • Treatment of hepatitis C virus–associated mixed cryoglobulinemia with direct-acting antiviral agents by Meghan Sise, et al.

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)

  • Interferon-free regimens containing setrobuvir for patients with genotype 1 chronic hepatitis C: a randomized, multicenter study by Donald M. Jensen, et al.

    Summary: Study examined the combinations of setrobuvir (a DAA non-nucleoside inhibitor), danoprevir (a ritonavir-boosted protease inhibitor), and ribavirin, with or without the nucleoside inhibitor mericitabine in hep C genotype 1 patients. The 3 DAAs plus ribavirin combination was found to be safe and effective for hep C genotype 1 patients who have never tried treatment.

CADTH (November 2015)

  • CADTH Therapeutic Review, Drugs for Chronic Hepatitis C Infection: Recommendations Report

Press Releases by Pharmaceutical Companies (International)

  • AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection
  • European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C

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

Drug Pipeline

Holkira Pak and Technivie Health Canada Update

Health Canada*Please see AbbVie’s response to Health Canada’s Information Update below.

Health Canada’s Information Update

 

November 10, 2015
For immediate release

OTTAWA – In response to new international safety information, Health Canada is advising Canadians that it is working with the manufacturer of Holkira Pak and Technivie to update drug labels (product monographs) to include new information regarding serious liver injury.

Holkira Pak and Technivie are both used to treat chronic Hepatitis C viral infection that can lead to serious liver and health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing the virus from multiplying, which may slow down the disease.

International safety data has indicated that cases of serious liver injury (such as hepatic failure, including cases that resulted in liver transplantation or death) have been reported in patients treated with Holkira Pak or Technivie. Most patients with these serious outcomes had evidence of advanced liver disease (cirrhosis) prior to initiating therapy.

While Health Canada is working to update the product monographs, healthcare providers are reminded that Holkira Pak and Technivie should not be used in patients with severe hepatic impairment (Child-Pugh Class C) or moderate hepatic impairment (Child-Pugh Class B).

Patients should not stop taking these medications without first talking to their healthcare provider as stopping these medications early may result in drug resistance to other hepatitis C medicines.
Information for Patients and Caregivers

Immediately consult your healthcare provider if:

You experience fatigue, weakness, lack of appetite, nausea and vomiting, as well as yellowing of your skin or eyes, darkening of your urine or discolored feces while on treatment with Holkira Pak or Technivie.

Information for Health Care Professionals

Holkira Pak (fixed dose combination of ombitasvir/paritaprevir/ritonavir; and dasabuvir) and Technivie (fixed dose combination of ombitasvir/paritaprevir/ritonavir) are contraindicated in patients with severe hepatic impairment (Child-Pugh Class C) and should not be used in patients with moderate hepatic impairment (Child-Pugh Class B).

Closely monitor for signs and symptoms of worsening of liver disease such as ascites, hepatic encephalopathy, and/or increases in direct bilirubin in the blood.

Holkira Pak and Technivie should be discontinued if there are clinical signs of liver inflammation that are accompanied by persistent elevations in transaminases, direct bilirubin or international normalized ratio (INR).

Report health or safety concerns

Call toll-free at 1-866-234-2345
Visit MedEffect Canada’s web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
Media enquiries

Health Canada
613-957-2983
Public enquiries

613-957-2991
1-866-225-0709

AbbVie’s Response Issued November 11, 2015

AbbVie’s top priority is patient safety. We are committed to providing comprehensive information on the efficacy and safety of our medicines for health care professionals and patients to make informed treatment decisions.

On November 10, Health Canada issued an Information Update regarding HOLKIRA™ PAK and TECHNIVIE™. AbbVie is currently working closely with Health Canada to update the product monographs. As such, the Product Monographs for HOLKIRA PAK (date of revision: October 14, 2015) and TECHNIVIE (date of preparation: October 20, 2015) remain unchanged at this time.

As per the current product monographs, HOLKIRA PAK and TECHNIVIE should not be used in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C).

Patients should contact their health care provider if they have any concerns.

Advocacy

Advocating for those with Hep C Here and Abroad

AdvocatingThis fall, Daryl Luster, hep C advocate and president of PHCN, will be advocating for those with hepatitis C and their support networks here and abroad. The following is a list of the meetings that Daryl is looking forward to being a part of:

October 13-14 — Toronto, Ontario
Action Hepatitis Canada (AHC) Advocacy Meeting
Action Hepatitis Canada is a group that unites organizations and individuals to advocate for increased attention for hepatitis B and C–diseases that negatively affect the quality of life of up to 600,000 Canadians and support networks.
At the meeting Daryl and Cheryl Reitz, from HepC BC, will speak on hep C advocacy in BC.

October 20 — Windsor, England
Advocacy Meeting Sponsored by AbbVie
This meeting will bring together clinicians, policy, and NGO experts from around the world who are working for hepatitis policy change and development. The meeting will examine the World Health Organization’s HCV action plan and will be facilitated by Dr. Rafael Bengoa from the Health Policy program at the Duesto Business School in Spain. Dr. Bengoa develops strategies/action plans for fighting hepatitis and has successfully implemented them in both Spain and Israel.
At this meeting, Action Hepatitis Canada will be represented by two of its executives, Jeff Potts and Daryl Luster. Daryl may be the only person representing those with hep C who has had the disease.

October 21 — Ottawa, Ontario, via webcam
Canadian Institutes of Health Research (CIHR) Lecture
CIHR is the Government of Canada’s health research investment agency. Its mandate is to build scientific knowledge and to translation it into improved health, more effective health services and products, and a strong Canadian health care system.
Daryl has been invited to speak to CIHR about advocacy as a member of CanHepC, a new group formed to address hep C issues in Canada.

November 11 – 12 — Vancouver, BC
The Hepatitis Cure & Eradication Meeting
The Hepatitis Cure & Eradication Meeting will gather hepatitis experts from different disciplines to learn how science can influence public policy to work to cure and eliminate hepatitis.
Daryl will be one of the meeting’s speakers. He will talk about his role as a hep C advocate who has also been a patient.

“I’m not a lone voice, I’m many and our voices are our most powerful weapons.” Malala Yousafzai

Drug Pipeline, Uncategorized

PharmaCare Covers Holkira Pak

Holkira Pak and BC PharmaCareVancouver, B.C. – (July 28th, 2015) – On World Hepatitis Day, Pacific Hepatitis C Network (PHCN) welcomed the B.C. Ministry of Health’s announcement that it will provide coverage for a new hepatitis C virus (HCV) treatment, Holkira Pak.

The hepatitis C virus is considered one of the most serious public health issues facing Canadians, causing more years of life lost than any other infectious disease in the country. In B.C. alone, for example, there are about 80,000 people currently living with hepatitis C.

Therefore, “the Pacific Hepatitis C Network applauds the addition of new treatments like Holkira Pak to the PharmaCare formulary here in B.C.,” said Daryl Luster, president of the board of the Pacific Hepatitis C Network. “I can say with great certainty that lives will be saved, and the quality of life for thousands of people living with hepatitis C, and their families will be impacted in the most positive of ways due to this action by the Government of British Columbia.”

Holkira Pak is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).

Holkira Pak is the third new hepatitis C drug to be covered by BC’s PharmaCare this year. The other two treatments covered were Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir).

For more information about Holkira Pak, please visit PHCN’s Hepatitis C Treatment Information Project or email.

The B.C. Ministry of Health’s Holkira Pak Press Release can be found at: https://news.gov.bc.ca/releases/2015HLTH0053-001186

Holkira Pak

Advocacy

International Symposium on Viral Hepatitis and Liver Diseases

15th International Symposium on Viral Hepatitis and Liver DiseasesThe 15th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD) was held last weekend, June 26 – 28th, in Berlin, Germany. Symposium topics ranged from hep A to hep E treatments and cures  to the history of hepatitis to clinical trial results.

For example, AbbVie, creator of Holkira Pak (generic name: ombitasvir/paritaprevir/ritonavir and dasabuvir), announced that their clinical trial Turquoise-III, testing Holkira Pak without ribavirin, cured 100% of the trial’s 60 patients. The 60 patients all had chronic genotype 1b hep C and compensated liver cirrhosis and were either treatment-naïve (had never tried treatment) or treatment-experienced (failed previous treatment with pegylated interferon and ribavirin). None of the trial’s patients discontinued treatment due to side effects.

A quote from AbbVie’s press release stated: “Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens,” said Jordan J. Feld, M.D., MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada. “The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks.”

For more information about hep C treatments please visit PHCN’s Hepatitis C Treatment Information Project or email.

Drug Pipeline

Holkira Pak Recommendations

Holkira PakHolkira Pak (generic name: ombitasvir/paritaprevir/ritonavir and dasabuvir), developed by AbbVie, just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation.

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) compares the drug’s clinical and cost-effectiveness to those of other treatments. This assessment report is then sent to the provinces and territories to help them decide on coverage.

The CDEC’s Final Recommendation advocates for Holkira Pak to be listed as a treatment for adults with genotype 1 hep C if the following criteria is met:
Clinical Criteria
Conditions
  • Treatment should be started by physicians experienced with treating chronic hep C.
  • Drug plans should not pay more for Holkira Pak than they do for other hep C interferon-free treatments.
Reasons for the Holkira Pak Recommendations
  1. 6 randomized clinical trials (Sapphire I, Sapphira II, Pearl II, Pearl III, Pearl IV, and Turquoise II) showing that treatment with Holkira Pak, with or without ribavirin (RBV), achieved high rates of SVR12 (cure at 12 weeks) for both those who have and those who haven’t already tried treatment.
  2. Holkira Pak’s results (quality-adjusted life years) and costs are similar to other hep C treatments, such as Harvoni. Provinces will have to consider drug plan and health care system sustainability when deciding whether or not to cover newly available expensive hep C treatments.
  3. CDEC couldn’t evaluate the cost-effectiveness of Holkira Pak according to liver fibrosis stage due to limitations in the manufacture’s pharmacoeconomic evaluation.
Other Reported Discussion Points
  • Holkira Pak may offer a greater range of therapeutic options to some patients, but it requires more pills be taken than Harvoni.
  • There may be a greater chance of drug interactions while taking Holkira Pak than while taking Harvoni.
  • A phase 2 clinical trial (TURQUOISE I) tested hep C patients co-infected with HIV with 12 or 24 weeks of Holkira Pak and ribavirin (RBV). SVR12 rates were 93.5% and 90.6% for the 12 and 24 week groups.
Reported Research Gaps
  • There isn’t a comparison between Holkira Pak and Harvoni.
  • The consequences of reinfection following treatment with hep C direct-acting antiviral require further study.
Holkira Pak

Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-oral, short-course, interferon-free treatment that can be taken with or without ribavirin.

In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).

For more information about Holkira Pak, CADTH,  or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Drug Pipeline

Holkira Pak, CADTH, and the pCPA

Holkira PakHolkira Pak (generic name: ombitasvir / paritaprevir / ritonavir and dasabuvir) has been listed on the pan-Canadian Pharmaceutical Alliance‘s most recent table of active drug product negotiations. Negotiations between the pan-Canadian Pharmaceutical Alliance (pCPA), a negotiations team from different provinces and territories that works to get the best value for brand name and generic drugs for publicly funded drug programs, and Holkira Pak’s manufacturer, AbbVie, are currently underway.

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) assesses the drug’s clinical and cost-effectiveness as it compares to other treatments.

For Holkira Pak, CADTH started this step on November 3rd, 2014, when it called for patient input. Although, Holkira Pak’s submission for a Common Drug Review is listed as only being accepted on December 3rd, 2014, one month later.

According to the pan-Canadian Pharmaceutical Alliance (pCPA)’s website, once a CDR is complete, the pCPA may then step in after deciding that joint pan-Canadian negotiations for the drug will occur. A province/territory then assumes the lead in negotiations, contacts the manufacturer, and negotiations get underway. If an agreement is reached about treatment prices, the lead province, the manufacturer, and the other jurisdictions all sign a Letter of Intent. The Letter of Intent ends the pCPA’s involvement in the drug’s approval process.

Provinces/territories then make their own final decisions about funding the drug or not through their healthcare plans. If they choose to do so, they then sign a product listing agreement with the manufacturer.

This is where it gets a bit more interesting. Currently, Holkira Pak is listed by CADTH as still undergoing a CADTH Common Drug Review (CDR). The last step listed as completed on the CDR’s Submission Status sheet for Holkira Pak is dated May 28th, 2015. On May 28th, the CDR reports and the recommendation by the Canadian Drug Expert Committee (CDEC), the committee of experts who review all of the data and analyses involved, were sent to the provincial/territorial drug plans and the drug’s manufacturer. A target date for the final CDEC recommendations being sent to drug plans and manufacturer is tentatively listed as 15 business days after that, June 18th.

The pan-Canadian Pharmaceutical Alliance’s most recent table of active drug product negotiations, the one that lists Holkira Pak as a new drug product undergoing negotiations, was dated April 30th, 2015.

And so, we wait. We wait for news from all three parties currently involved, AbbVie (Holkira Pak’s manufacturer), CADTH, and the pan-Canadian Pharmaceutical Alliance.

Holkira Pak

Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-oral, short-course, interferon-free treatment that can be taken with or without ribavirin.

In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).

For more information about Holkira Pak, CADTH, the pan-Canadian Pharmaceutical Alliance, or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Drug Pipeline

HOLKIRA PAK Approval

holkira pak trialsThis morning Health Canada approved AbbVie’s HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir and dasabuvir) for the treatment of patients with chronic genotype 1 hep C, including those with cirrhosis.

HOLKIRA PAK is an all-oral, short-course, interferon-free treatment. It can be taken with or without ribavirin (RBV).

In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of genotype 1 hep C patients, and 98 percent of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of discontinuation due to adverse reactions were low (0.2 percent).

The recommended treatment regimens and durations for HOLKIRA PAK are:

Patient

Treatment

Duration
Genotype 1a, without cirrhosis HOLKIRA PAK + ribavirin 12 weeks
Genotype 1b, without cirrhosis HOLKIRA PAK 12 weeks
Genotypes 1a and 1b, with cirrhosis HOLKIRA PAK + ribavirin 12 weeks*
*24 weeks of HOLKIRA PAK + ribavirin is recommended for patients with genotype 1a-infection with cirrhosis who have had a previous null response to pegylated interferon (pegIFN) and ribavirin.
Note: HOLKIRA PAK with ribavirin is recommended in patients with an unknown genotype 1 subtype or with mixed genotype