Tag Archives: sofosbuvir

Drug Pipeline

Patient Group Input sent for Sofosbuvir / Velpatasvir

Patient group input was just sent in for the hep C treatment sofosbuvir / velpatasvir. Thank you to all of you who completed PHCN’s sofosbuvir / velpatasvir survey and shared it 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 sofosbuvir / velpatasvir report was sent in last night. We now wait to hear the outcome of the treatment’s submission. The Hepatitis C Treatment Information Project will keep you apprised of any news.

Sofosbuvir / Velpatasvir

Sofosbuvir / velpatasvir is an all-pill, short-course (possibly only 8 weeks), interferon-free treatment that can be taken with or without ribavirin. In Phase 3 clinical trials, sofosbuvir/velpatasvir (with or without ribavirin) cured an overall 99% of those with genotype 1, 2, 4, 5, or 6 hep C and was found to be well tolerated by patients.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

Hepatitis C Treatment Information Project

PHCN’s Hepatitis C Treatment Information Project is a source of information that doesn’t post a ‘site last modified date’ because it is truly forever changing. Pay it a visit for more information about currently approved hep C treatments, new and emerging drugs, or resources to help in getting ready for treatment. You can also email us your questions about hep C treatments.

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

Drug Pipeline

Sofosbuvir/Velpatasvir CTAC Webinar

Sofosbuvir/Velpatasvir CTAC Patient Group Input WebinarThis Monday, May 2nd, from 11 AM to 12 PM (PDT/in BC) / 2 PM to 3 PM (EDT/in Ontario), the Canadian Treatment Action Council (CTAC) will be hosting a webinar about the exciting new hep C treatment sofosbuvir/velpatasvir.

Following the webinar, there will be a survey to collect information that will help them write a patient input report for sofosbuvir/velpatasvir’s Common Drug Review. CTAC’s sofosbuvir/velpatasvir survey is different from PHCN’s patient input survey or PHCN’s loved ones/caregivers survey. Please consider filling out the still available PHCN survey that was created for you as well as CTAC’s survey.

Registration for the CTAC webinar is required to attend. Click here to register and for more information about the webinar.

The Canadian Treatment Action Council (CTAC)

CTAC is a Canadian non-governmental organization led by and for people living with HIV and HIV/HCV co-infection. Since 1996, they have been working to secure and ensure equitable, affordable, and timely access to treatment and care and support for people in Canada living with HIV and HIV/HCV co-infection.

Patient Group Input Reports Requested by CADTH’s Common Drug Reviews

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

During Common Drug Reviews, CADTH requests patient input reports. These patient input reports help ensure that health outcomes and issues important to patients are incorporated into the Common Drug Review process in a formal and meaningful way.

 Sofosbuvir/Velpatasvir

Sofosbuvir/velpatasvir is an all-pill, short-course (sometimes only 8 weeks), interferon-free treatment that can be taken with or without ribavirin. In Phase 3 clinical trials, sofosbuvir/velpatasvir (with or without ribavirin) cured an overall 99% of those with genotype 1, 2, 4, 5, or 6 hep C and was found to be well tolerated by patients.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

Drug Pipeline

Daklinza and Sovaldi’s BC PharmaCare Decision (for HCV GT3)

Daklinza and Sovaldi's PharmaCare DecisionBC PharmaCare has posted notice that it will not cover Daklinza (generic name daclatasvir) when it is combined with Sovaldi (generic name sofosbuvir) for the treatment of chronic hepatitis C genotype 3 infection, in their list of covered treatments.

BC PharmaCare listed the following three reasons for their decision:

  • “The available clinical evidence included only a small number of genotype 3 patients treated, and did not provide sufficient evidence to demonstrate efficacy compared to current sofosbuvir plus ribavirin (RBV) regimen. There are no comparative head-to head trials with sofosbuvir plus RBV or other combinations. Therefore, there is no evidence that daclatasvir plus sofosbuvir is more effective or safer than sofosbuvir plus RBV.” (BC PharmaCare)
  • “At the submitted confidential price, daclatasvir plus sofosbuvir 12-week regimen is less costly than the transparent price of a 24-week course of sofosbuvir plus RBV.” (BC PharmaCare)
  • “The Ministry of Health engaged in discussions with the manufacturer for daclatasvir through the pan-Canadian Pharmaceutical Alliance (pCPA), but the pCPA participating jurisdictions agreed that the parameters required for negotiations by both the manufacturer and the participating jurisdictions cannot be achieved through negotiations at this time.” (BC PharmaCare)

More information about this decision can be found in the treatment’s Drug Coverage Decision for B.C. PharmaCare.

Daklinza and Sovaldi

Daklinza and Sovaldi is a Health Canada approved treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free treatment.

A sustained viral response (SVR12), or ”cure”, has been achieved by  ~90% of patients infected by hep C genotype 3 who have been treated with Daklinza and Sovaldi. The treatment has had higher success rates when treating hep C genotypes 1 or 2. (Health Canada)

More information about the treatment combination and its Health Canada approval can be found on Health Canada’s Summary Basis of Decision for Daklinza page.

Bristol-Myers Squibb Canada’s CLAIRE Program

Canadians and British Columbians prescribed the Health Canada approved treatment Daklinza and Sovaldi, with, in some cases, ribavirin, can still request to be enrolled in the CLAIRE patient support program. The CLAIRE patient support program was designed to help patients seek coverage and provide access to a customized list of services. It was designed so that one person will take care of each patient through the program’s duration. For more information, contact your doctor, nurse, or contact the program at: 1-844-HCV-2559 (phone number), 1-844-FAX-2559 (fax number), [email protected] (email address).

Drug Pipeline

In the Final Steps of the Canadian Drug Approval Pipeline

In the Final Steps of the Canadian Drug Approval PipelineCurrently, there are a couple of hepatitis C treatments making their way through the final steps of the Canadian drug approval pipeline. The following table was created to highlight these treatments and highlight the ways that you may be able to include your voice in their approval process.

Hepatitis C Treatments in the Final Steps of the Canadian Drug Approval Pipeline

Technivie (ombitasvir, paritaprevir, ritonavir) +/- Ribavirin (RBV) Sovaldi (sofosbuvir) + Daklinza (daclatasvir) +/- RBV Sofosbuvir / Velpatasvir +/- RBV Zepatier (elbasvir / grazoprevir) +/- RBV Zepatier (elbasvir / grazoprevir) + Sovaldi (sofosbuvir)
Treatment Drug Classes NS5A Inhibitor, NS3/4A Protease Inhibitor, and Ritonavir, a booster for paritaprevir Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, Nucleotide NS5B Polymerase Inhibitor
Steps in Canadian Drug Approval Pipeline Step 5 – Provincial Review Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review
Currently Seeking Patient Input No No Yes Yes Yes
Genotype (GT) Health Canada has Approved it for 4 1, 2, 3 This treatment has just begun the Canadian review process. Clinical trials have examined it on hep C genotypes 1-6. 1, 3, 4 3
Under BC PharmaCare Review for Genotype 4 Genotype 1, 2 or 3 without RBV, Genotype 2 or 3 with RBV Genotype 1, 3, 4 with or without RBV 3
Approximate SVR (Approx Rate of Cure) 90% without RBV, 100% with RBV 90 – 100% 94 – 100% 93 – 100% 91 – 100%
May Require PR* No
May Not Require RBV
 Yes
Daily Pills 1 +/- twice daily RBV 2 +/- twice daily RBV 1 +/- twice daily RBV 1 +/- twice daily RBV 2 once daily
Possible Weeks of Treatment 12 12 or 24 8, 12, or 24 8, 12, or 16 12
Limited Most Common Side Effects**  (Ribavirin can affect side effects)
  • Headache
  • Insomnia
  • Nausea
  • Tiredness
  • Weakness (asthenia)
  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Anemia
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
Drug Warnings (Healthcare providers, patient assistance programs, and/or online product monographs, links below, have more information)

Technivie is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Technivie should not be taken while taking: ethinyl estradiol-containing medicines, drugs that are sensitive cytochrome P450 (CYP) 3A substrates and for which elevated plasma concentrations are associated with serious adverse reactions, strong CYP2C8 inhibitors and inducers, moderate or strong inducers of CYP3A.

 Sovaldi is not for patients taking amiodarone. Tell your doctor if you are taking CYP3A inhibitors or P-gp, OATP 1B1, 1B3, BCRP, phenytoin, carbamazepine, rifampin, or St. John’s wort (Hypericum perforatum) as they limit Daklinza’s effectiveness. Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.
General Hep C Treatment Usage Warning Do not take treatments while taking recreational drugs or over-the-counter drugs, such as St. John’s wort, without first talking with your healthcare provider as they may interact with each other. Tell your doctor if you may be or may become pregnant. The safety and efficacy of most of these treatments in children less than 18 years of age has not been established.
Patient Assistance Program Contact Information AbbVie Care 1-844-471-2273 Bristol-Myers Squibb Canada’s CLAIRE Program 1-844-HCV-2559 Gilead’s Momentum Patient Assistance Program 1-855-447- 7977 Merck Care Program 1-866-872-5773
Information by Health Canada Technivie Daklinza Zepatier
Information about HCV / HIV Co-infection Technivie (by CATIE) Daklinza (by CATIE)

Sovaldi / Velpatasvir (by hepmag)

 Zepatier (by CATIE)
*PR stands for pegylated interferon with ribavirin. It may be combined with other drugs for the treatment of hep C. RBV stands for ribavirin. **If patients experience treatment side effects, they are usually not severe enough to stop treatment. 

—

Information was gathered from Health Canada’s Drug and Health Products sheets, BC PharmaCare Drug Information sheets,  CATIE, hepmag, product monographs, and the Hepatitis C Treatment Information Project within the past week.

Drug Pipeline

Take this survey. Sofosbuvir / Velpatasvir Input Requested.

The above survey links will only remain open until April 27th, 2016, so please complete a survey and share the survey links with others ASAP.

The Drug Approval Process is Seeking Patient and Caregiver Input

The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you! They are currently reviewing the hep C treatment sofosbuvir / velpatasvir. As part of their review, they are seeking patient and caregiver input about hep C and hep C treatments from Canadian patient groups. Therefore, we, the Pacific Hep C Network (PHCN), are seeking your thoughts, opinions, and experiences for our patient group input report.

More information about CADTH and patient group reports is below.

PHCN’s Sofosbuvir / Velpatasvir Patient Input Surveys

There are two PHCN Input Surveys

The first survey was written for those with hep C or those who have had hep C. It includes 14 questions, some multiple choice, and is divided into 4 sections. The most important of these sections are ‘Section 2 of 4: Your Expectations of Sofosbuvir / Velpatasvir’ and Take this survey. Sofosbuvir / Velpatasvir Input Requested.‘Section 3 of 4: Your Experience with Sofosbuvir / Velpatasvir’, if you have been treated with sofosbuvir / velpatasvir. If you haven’t taken sofosbuvir / velpatasvir, the survey lets you skip this section.

The second survey was written for loved ones or caregivers of those living with hep C/have had hep C. It includes 7 questions divided into 2 sections.

If the surveys don’t focus on something you would like to add, please use a textbox and include it as one of your answers. Some of the questions require answers but others were written to, hopefully, help you share your experiences and voice your opinion.

Survey responses are anonymous (we don’t know your name or other information about you). The information gathered will be used as part of the sofosbuvir / velpatasvir patient group input report for CADTH.

By completing the survey you accept that PHCN can use the information gathered by it in our patient group input report for CADTH.

The survey links will only remain open until April 27th, so please complete a survey and share the survey links with others ASAP.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

During Common Drug Reviews, CADTH requests patient input reports. These patient input reports help ensure that health outcomes and issues important to patients are incorporated into the Common Drug Review process in a formal and meaningful way.

They help ensure that patients and their loved ones are a part of the drug review process!

Email the Hepatitis C Treatment Information Project for more information about the surveys or for more information about sofosbuvir / velpatasvir.

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

Drug Pipeline

Sofosbuvir / Velpatasvir Fact Sheet

Sofosbuvir / Velpatasvir Facts SheetThe below treatment fact sheet was designed to give you more information about sofosbuvir / velpatasvir and to encourage you to help us, PHCN, with our sofosbuvir / velpatasvir patient group input report for CADTH. The fact sheet was put together in hopes that you will help us advocate on behalf of those with hep C and their loved ones.

Sofosbuvir / velpatasvir, an exciting new hepatitis C treatment, is currently being reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Therefore,  CADTH is seeking patient input about hep C, hep C treatments, and  sofosbuvir / velpatasvir.

PHCN’s Sofosbuvir / Velpatasvir Surveys

  • Take this survey if you are living with hep C/if you have had hep C.

  • Take this survey if you are a caregiver or loved one of someone who is living with hep C/had hep C.

Sofosbuvir / Velpatasvir Facts

Genotypes Tested Against: 1 – 6

Treatment Description: Sofosbuvir / velpatasvir is made up of two direct-acting antivirals, sofosbuvir and velpatasvir. Sofosbuvir (brand name Sovaldi) is a nucleotide NS5B polymerase inhibitor that “…targets the hep C virus to stop it from making copies of itself in the liver. Sofosbuvir attaches itself to the genetic information (RNA) to block the virus from multiplying.” (Gilead)

Velpatasvir is a pan-genotypic NS5A inhibitor that blocks a virus protein, NS5A, that the hep C virus needs for reproducing and various stages of infection.

Approximate Sustained Viral Response (SVR)/”Cure Rate”:  94 – 100%

Daily Dose:  1 pill +/- ribavirin

Possible Length of Treatment:  8, 12, or 24 weeks

Common Side Effects Reported in Clinical Trials: 

  • Headache
  • Nausea
  • Tiredness (fatigue)

Usage Warning: Do not take sofosbuvir in any combination while taking Amiodarone or with bradycardia.

Step in Drug Approval Pipeline:  Step 4 – Common Drug Review by CADTH

 Availability:  Not approved for use in Canada

Sampling of Phase II/III Clinical Trials for Sofosbuvir / Velpatasvir:

Patients
Treatment Regimen
Duration in Weeks
SVR12
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 from AASLD’s Liver Meeting 2015)
Genotype (GT) 1, 2, 4, 5, 6 Hepatitis C with and without cirrhosis; 740 patients Sofosbuvir / Velpatasvir (SOF/VEL)
 12 Overall: 99% (618/624)

GT1: 98% (323/328)

GT2: 100% (104/104)

GT4: 100% (116/116)

GT5: 97% (34/35)

GT6: 100% (41/41)
Placebo 116 patients received placebo, experienced similar adverse effects, SVR12 0%
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 14% with cirrhosis SOF/VEL 12 99% (133/134)
Sofosbuvir + ribavirin (RBV) 94% (124/132)
GT3 30% with cirrhosis SOF/VEL 12 95% (264/277)
Sofosbuvir + RBV 24 80% (221/275)
ASTRAL-4: Sofosbuvir/Velpatasvir Fixed Dose Combination for the Treatment Of HCV in Patients with Decompensated Liver Disease
Genotypes 1-6 All with Child-Pugh class B (decompensated) cirrhosis SOF/VEL 12 83% (75/90) Overall (GT1 88% GT2 100% GT3 50% GT4 100%)
SOF/VEL + RBV 94% (82/87) Overall (GT1 95% GT2 100% GT3 84% GT4 100%)
SOF/VEL 24 86% (77/90) Overall (GT1 91% GT2 75% GT3 50% GT4 100% GT6 100%)

Additional Facts about Sofosbuvir / Velpatasvir can be Found in the Following Resources:

Please email or visit the Hepatitis C Treatment Information Project for more information about Sofosbuvir / Velpatasvir or any other hep C treatment.

Drug Pipeline

U.S. FDA Approved Harvoni for More Patients

U.S. FDA Approved Harvoni for More PatientsIn the U.S,. the FDA approved Harvoni for more hep C patients today. Harvoni (ledipasvir/sofosbuvir), a FDA approved hepatitis C treatment, was also FDA approved to treat patients with advanced liver disease. The treatment was approved to be prescribed with ribavirin for 12 weeks for patients with:

  • Hep C genotypes 1 or 4 who are liver transplant recipients and who have compensated cirrhosis (Child-Pugh A) or don’t have cirrhosis;
  • Hep C genotype 1 with decompensated cirrhosis (Child-Pugh B or C), including those who have had liver transplants.

See today’s press release for more information about Harvoni in the U.S., the FDA approval, clinical trial results, and safety information for Harvoni (ledipasvir/sofosbuvir).

Harvoni in Canada

Harvoni is an all-oral (one pill daily), short-course (8 – 24 weeks), interferon-free, ribavirin-free, treatment for patients with chronic hep C genotype 1, who have or don’t have liver cirrhosis. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 93% of the patients who have been treated with Harvoni. Harvoni is listed by Canadian pharmacare programs. More information about the hep C treatment can be found here.

Drug Pipeline

U.S. FDA Approves Expanded Use of Daklinza

U.S. FDA Approves Expanded Use of DaklinzaIn the U.S., Daklinza (daclatasvir) plus Sovaldi (sofosbuvir), a FDA approved hepatitis C treatment for those with hep C genotype 3, is now also FDA approved to treat hep C genotype 1 or 3 patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of hep C. The treatment is approved to be prescribed on its own or combined with ribavirin.

See yesterday’s press release for more information about the FDA approval, suggested treatment lengths, and clinical trial results for Daklinza and Sovaldi.

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb, in the company’s press release.

Daklinza in Canada

In Canada, Daklinza was approved for use with Sovaldi last August. Daklinza with Sovaldi, when prescribed in Canada, is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free, treatment for patients with chronic hep C genotype 1, 2, or 3, who have or don’t have liver cirrhosis. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.

Drug Pipeline

Final Recommendation for Daklinza (daclatasvir)

Daklinza (daclatasvir)Daklinza (generic name daclatasvir), developed by Bristol-Myers Sqibb, just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation.

The Canadian Drug Expert Committee (CDEC) Final Recommendation is important within the Canadian drug approval process as it is sent to the provinces and territories to help them decide on PharmaCare coverage.

The CDEC’s Final Recommendation advocates for Daklinzain combination with Sovaldi (sofosbuvir) to be listed as a treatment for adults with chronic hepatitis C genotype 1, 2, or 3 if the following criteria is met:
Clinical Criteria
  • Treatment experienced patients without cirrhosis who have not responded to pegylated interferon with ribavirin (PR).
    The report highlighted that this does not mean that patients who haven’t been treated, are treatment-naive, should be treated with pegylated interferon with ribavirin (PR) first.
Conditions

  • Treatment should be started by hepatologists or physicians experienced with treating chronic hep C.

  • Drug plans should not pay more for Daklinza than they do for Sovaldi (sofosbuvir) plus ribavirin.

Reasons for the Daklinza Recommendations

  1. The clinical trial ALLY-3 results showed high rates of sustained virologic response (SVR12), cure, for treatment experienced patients with chronic hep C genotype 3.

  2. The manufacturer’s pharmacoeconomic evaluation showed that Daklinza plus Sovaldi was a cost-effective option, when it was compared with 24 weeks of Sovaldi plus ribavirin for patients with hep C genotype 3 who are treatment experienced and don’t have liver cirrhosis. However, Daklinza plus Sovaldi was not a cost-effective option for patients with hep C genotype 3 who are treatment naive and/or have cirrhosis.

Reported Research Gaps
  • There aren’t any comparisons between Daklinza and sofosbuvir and the other hep C direct-acting antivirals that are currently used in Canada.
  • There is limited data on patients who have cirrhosis, are co-infected with other diseases, such as AIDS, or who have been treated with other hep C direct-acting antivirals but who weren’t cured.
Other Highlighted Information
  • Four groups responded to CADTH’s call for input from patient groups. This input successfully explained what it’s like to have hep C, what stigma surrounds hep C, what side effects are like, and the importance of having access to inferferon free/low toxicity treatments with shorter treatment durations and no drug interactions.
Daklinza (daclatasvir)

Daklinza is approved for use with Sovaldi (sofosbuvir). It may be combined with other drugs for different results in the future.

Daklinza with Sovaldi is a treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free treatment. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.

Drug Pipeline

Health Canada Approves Daklinza (daclatasvir)

Daklinza with SovaldiThose with hepatitis C genotypes 1, 2, or 3 now have a new treatment option!

Health Canada has granted the treatment Daklinza (daclatasvir) a Notice of Compliance (NOC) for treating adult patients with hep C genotypes 1 and 2 with compensated liver disease, including cirrhosis, and a Notice of Compliance with conditions (NOC/c) for the treatment of genotype 3 patients with compensated liver disease.

Notice of Compliance and Notice of Compliance with Condition

Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance a doctor may prescribe the drug – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

A Notice of Compliance with conditions (NOC/c) is issued when Health Canada allows a drug to be marketed in Canada, with the condition that the manufacturer of the treatment undertakes additional studies to verify the treatment’s efficacy (how well it works). In this case, it was issued pending the submission of final clinical study results from the clinical trial ALLY-3.

Daklinza (daclatasvir) with Sovaldi (sofosbuvir)

Daklinza is now approved for use with Sovaldi (sofosbuvir). It may be combined with other drugs for different results in the future.

Daklinza with Sovaldi is a treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free treatment. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.

Patients prescribed Daklinza will be supported by Bristol-Myers Squibb Canada’s Claire Patient Support Program. More information about the program will follow shortly.

This is a link to Bristol-Myers Squibb Canada’s press release about today’s Daklinza approval.

“This is another important milestone for hepatitis C patients across genotypes. But the significance of this approval is the impact it will have on the one in five patients who have genotype 3 and are being treated but not achieving cure rates like we’re seeing with those living with other genotypes. This gives them a chance to hear the very same words that many of us are being told – you are cured.” –Joan King, Vice President of a hepatitis C patient group in Canada

For more information about Daklinza (daclatasvir), or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.