This is a very basic sampling of phases II and III clinical trial results for treatments currently within the hep C drug pipeline. These treatments are trying to move towards being allowed to be sold in Canada and then being covered by BC PharmaCare.
For more information about drugs not yet approved, Hep C Drug Pipeline Treatments lists information such as dosage, SVR, common side effects, treatment lengths, and how far the drugs are along in the approval process.
The treatments currently covered by BC PharmaCare have their own pages dedicated to them. Look for them in a drop-down menu under BC’s PharmaCare Covered Treatments.
Treatments in the Canadian Drug Approval Process or Recently Approved by BC’s PharmaCare
| Pharmaceutical Companies | Treatments (brand names first, generic names in brackets) | Targeted Genotypes |
| AbbVie | Holkira Pak (ombitasvir, paritaprevir, ritonavir, and dasabuvir) | 1 |
| Technivie (ombitasvir, paritaprevir, ritonavir) | 4 | |
| Bristol-Myers Squibb | Sunvepra (asunaprevir), Daklinza (daclatasvir), Beclabuvir | 1 – 6 |
| Gilead | Sovaldi (sofosbuvir) | 1 – 4 |
| Harvoni (sofosbuvir and ledipasvir) | 1 | |
| Sofosbuvir / Velpatasvir | 1, 2, 4 – 6 | |
| GS-9857 | 1 | |
| Janssen | Galexos (simeprevir) | 1 |
| Galexos (simeprevir) + Sovaldi (sofosbuvir) | 1 | |
| Merck | Zepatier (elbasvir / grazoprevir) | 1, 3, 4 |
Sampling of Clinical Trial Results Presented at the International Liver Congress 2016 in April |
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Maker: AbbVie
Sampling of Phase III Clinical Trials for Holkira Pak:
| Clinical Trial | Patients | Treatment Regimen | SVR12* | |
| PEARL-II (12 week treatment duration) | Genotype (GT) 1b treatment experienced** with some level of fibrosis, without cirrhosis | Holkira Pak + Ribavirin (RBV) | 97% | |
| Holkira Pak | 100% | |||
| PEARL-III (12 weeks) | GT 1b treatment naive, without cirrhosis | Holkira Pak + RBV | 99% | |
| Holkira Pak | 99% | |||
| PEARL-IV (12 weeks) | GT 1a treatment naive, without cirrhosis | Holkira Pak + RBV | 97% | |
| Holkira Pak | 90% | |||
| TURQUOISE-II (12 & 24 weeks) | GT 1a/b treatment naive & treatment experienced with cirrhosis | Holkira Pak + RBV, 12 weeks | 92% (GT 1a 88%, GT 1b 98%) |
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| Holkira Pak + RBV, 24 weeks | 96% (GT 1a 94% GT 1b 100% ) | |||
| TURQUOISE-III (12 weeks) | GT 1b treatment naive & treatment experienced with cirrhosis | Holkira Pak | 100% | |
| SAPPHIRE-I (12 weeks) | GT 1a/b treatment naive without cirrhosis | Holkira Pak + RBV | GT 1a 95% GT 1b 98% | |
| SAPPHIRE-II (12 weeks) | GT 1a/b treatment experienced without cirrhosis | Holkira Pak + RBV | GT 1a/b 96% | |
| *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. |
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Maker: AbbVie
Sampling of Phase III Clinical Trials for Holkira Pak:
| Clinical Trial | Patients | Treatment Regimen | SVR12* | |
| PEARL-II (12 week treatment duration) | Genotype (GT) 1b treatment experienced** with some level of fibrosis, without cirrhosis | Holkira Pak + Ribavirin (RBV) | 97% | |
| Holkira Pak | 100% | |||
| PEARL-III (12 weeks) | GT 1b treatment naive, without cirrhosis | Holkira Pak + RBV | 99% | |
| Holkira Pak | 99% | |||
| PEARL-IV (12 weeks) | GT 1a treatment naive, without cirrhosis | Holkira Pak + RBV | 97% | |
| Holkira Pak | 90% | |||
| TURQUOISE-II (12 & 24 weeks) | GT 1a/b treatment naive & treatment experienced with cirrhosis | Holkira Pak + RBV, 12 weeks | 92% (GT 1a 88%, GT 1b 98%) |
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| Holkira Pak + RBV, 24 weeks | 96% (GT 1a 94% GT 1b 100% ) | |||
| TURQUOISE-III (12 weeks) | GT 1b treatment naive & treatment experienced with cirrhosis | Holkira Pak | 100% | |
| SAPPHIRE-I (12 weeks) | GT 1a/b treatment naive without cirrhosis | Holkira Pak + RBV | GT 1a 95% GT 1b 98% | |
| SAPPHIRE-II (12 weeks) | GT 1a/b treatment experienced without cirrhosis | Holkira Pak + RBV | GT 1a/b 96% | |
| *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. |
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Sampling of Phase III Clinical Trials for Technivie:
| Clinical Trial | Patients | Treatment Regimen | SVR12 | |
| PEARL-I* (12 weeks) | Genotype (GT) 4 treatment naive, without cirrhosis | Technivie | 91% | |
| Technivie + Ribavirin (RBV) | 100% | |||
| GT4 treatment experienced without cirrhosis | Technivie + RBV | 100% | ||
| AGATE-I (12, 16, or 24 weeks) | A Randomized study to evaluate the safety and efficacy of Technivie with ribavirin (RBV) in adults with GT4 and cirrhosis who are treatment-naive or treatment-experienced | Ongoing | ||
| AGATE-II | A study to evaluate the efficacy and safety of Technivie with ribavirin in those with hep C genotype 4 | Ongoing | ||
| *Pearl-I looked at GT1 and 4, treatment-naive and -experienced patients. See the Holkira Pak table for more genotype 1 (GT1) information. Pearl-I was a small trial. **In the Agate-I treatment experienced patients have already been treated with Sovaldi + pegylated Interferon with ribavirin or Sovaldi with ribavirin. |
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Maker: Bristol-Myers Squibb
Sampling of Phase III Clinical Trial Results for Sunvepra, Daklinza, and/or Beclabuvir:
Length of Treatment:
| Clinical Trial | Patients | Treatment Regimen | SVR12/24* | |
| ALLY-2 (8 or 12 weeks treatment duration) | Any GT, HCV/HIV co-infection, treatment naive, treatment experienced | Daklinza + Sovaldi** (1 daily, no change of HIV meds needed) | SVR12 96% (12 weeks), SVR12 76% (8 week) | |
| ALLY-3 (12 weeks) | Genotype 3 treatment naive without cirrhosis | Daklinza + Sovaldi | 98% | |
| GT 3 treatment naive with cirrhosis | 58% | |||
| GT 3 treatment experienced*** without cirrhosis (except those who had already tried NS5A inhibitors) | 92% | |||
| GT 3 treatment experienced with cirrhosis (except those who had already tried NS5A inhibitors) | 69% | |||
| UNITY-1 (12 weeks) | GT 1 treatment naive without cirrhosis | GT 1a | Sunvepra / Daklinza / Beclabuvir (S / D / B****) | 90% |
| GT 1b | 98% | |||
| GT 1 treatment experienced without cirrhosis | GT 1a | S / D / B | 85% | |
| GT 1b | 100% | |||
| UNITY-2 (12 weeks) | GT 1 treatment naive with cirrhosis | S / D / B + Ribavirin | 98% | |
| S / D / B | 93% | |||
| GT 1 treatment experienced with cirrhosis | S / D / B + Ribavirin | 93% | ||
| S / D / B | 87% | |||
| Collapsing these groups, 90% of all patients who received Sunvepra / Daklinza / beclabuvir alone and 96% who used Sunvepra / Daklinza / beclabuvir plus ribavirin were cured. | ||||
| HALLMARK-Dual (24 weeks) | GT 1b treatment naive | Sunvepra + Daklinza | 90% | |
| GT 1b pegylated interferon with ribavirin (PR) non responder | 82% | |||
| GT 1b PR ineligible/intolerant | 82% | |||
| GT 1b with cirrhosis | 84% | |||
| GT 1b without cirrhosis | 85% | |||
| *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. **Sovaldi is being developed by Gilead Science. ***Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon (pegIFN) ****S / D / B is Sunvepra / Daklinza / beclabuvir |
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Maker: Gilead
Sampling of Phase III Clinical Trials for Sovaldi:
| Clinical Trial | Patients | Treatment Regimen | Duration in Weeks |
SVR12/24 |
| BOSON | Genotype (GT) 2 treatment experienced, with or without cirrhosisGT 3 treatment naive or treatment experienced with or without cirrhosis | Sovaldi + Pegylated Interferon with Ribavirin (PR) | 12 | SVR12 93% (total) GT 2 94% GT 3 93% |
| Sovaldi + Ribavirin (RBV) | 16 | SVR12 72% (total) GT 2 87% GT 3 71% | ||
| 24 | SVR12 85% (total) GT 2 100% GT 3 84% | |||
| NEUTRINO | GT 1, 4, 5 or 6 treatment naive | Sovaldi + PR | 12 | 90% (295/327), GT 4-6 97% |
| FISSION | GT 2 or 3 treatment naive | Sovaldi + RBV | 12 | GT 2 95% GT 3 56% total (cirrhosis GT 2 83%, without GT 2 97%, cirrhosis GT 3 34%, without GT 3 61%), GT 2 relapse rate 5% GT 3 r. rate 40% |
| PR | 24 | GT 2 78%, GT 3 63% total (cirrhosis GT 2 62%, without GT 2 81%, cirrhosis GT 3 30%, without GT 3 71%) | ||
| POSITRON | GT 2 interferon intolerant, ineligible or unwilling | Sovaldi + RBV | 12 | 93% (88%, 100%, 95%) |
| Placebo | 12 | 0% | ||
| GT 3 interferon intolerant, ineligible or unwilling | Sovaldi + RBV | 12 | 61% (70%, 50%, 53%) | |
| Placebo | 12 | 0% | ||
| FUSION | GT 2 relapsers, non responders | Sovaldi + RBV | 12 | 82% |
| 16 | 89% | |||
| GT 3 relapsers, non responders | 12 | 30% | ||
| 16 | 62% |
Sampling of Phase III Clinical Trials for Harvoni:
| Clinical Trial | Patients | Treatment Regimen | Duration in Weeks |
SVR12/24 |
| ION-1 | Genotype 1 (GT 1) treatment naive with or without cirrhosis | Harvoni | 12 | 97.7% |
| Harvoni + RBV | 12 | 97.2% | ||
| Harvoni | 24 | NA | ||
| Harvoni + RBV | 24 | NA | ||
| ION-2 | GT 1 treatment experienced (including 20% percent with cirrhosis) | Harvoni | 12 | 93.6%, 86.4% with cirrhosis |
| Harvoni + RBV | 12 | 96.4% | ||
| Harvoni | 24 | 99.1% | ||
| Harvoni + RBV | 24 | 99.1% ** | ||
| ION-3 | GT 1 treatment naive | Harvoni | 8 | 94%, 8% relapsed |
| Harvoni + RBV | 8 | 93.1% | ||
| Harvoni | 12 | 95.4% | ||
| ERADICATE | Coinfected HCV and HIV | Harvoni | 12 | 98% |
| *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. **In the non-cirrhotic groups, the 12 and 24-week treatment groups, in the presence and absence of RBV, all produced high SVR12 rates (95 to 100%). The SVR rates in cirrhotic and non-cirrhotic patients who previously failed treatment with pegylated interferon or PR were similar to the overall SVR12 of Harvoni 12-and 24-week treatment duration in the presence and absence of RBV. |
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Sampling of Phase III Clinical Trials for Sofosbuvir / Velpatasvir:
| Clinical Trial | Patients | Treatment Regimen | SVR12* |
| ASTRAL-1 (12 week treatment duration) | Genotype (GT) 1, 2, 3, 4, 5, 6 with & without cirrhosis | Sofosbuvir / Velpatasvir | Overall 99% |
| GT1 98% | |||
| GT2 100% | |||
| GT4 100% | |||
| GT5 97% | |||
| GT6 100% | |||
| ASTRAL-2 (12 weeks) | Genotype 2 with & without cirrhosis | Sofosbuvir / Velpatasvir | 99% |
| Sovaldi (sofosbuvir) + Ribavirin | 94% | ||
| ASTRAL-3 (12 weeks) | Genotype 3 with & without cirrhosis | Sofosbuvir / Velpatasvir | 95% |
| Sovaldi (sofosbuvir) + Ribavirin | 80% | ||
| ASTRAL-4 (12 & 24 weeks) | Genotypes 1-6 all with Child-Pugh class B (decompensated) cirrhosis | Sofosbuvir / Velpatasvir | 83% |
| Sofosbuvir / Velpatasvir + Ribavirin | 94% | ||
| Sofosbuvir / Velpatasvir | SVR24 86% |
Maker: Janssen
Sampling of Phase III Clinical Trials for Galexos:
| Clinical Trial | Patients | Treatment Regimen | SVR* | |
| QUEST-1 | Genotype (GT) 1 treatment naive, randomized double-blind placebo-controlled | Galexos + Pegylated Interferon with Ribavirin (PR) for 12 weeks followed by PR for 12 or 36 weeks | Galexos SVR12 81%, Placebo SVR12 49.9% | |
| Placebo + PR for 12 weeks followed by PR for 36 weeks | ||||
| QUEST-2 | GT 1 treatment-naive, randomized double-blind placebo-controlled | Galexos + PR for 12 weeks followed by PR for 12 or 36 weeks | ||
| Placebo + PR for 12 weeks followed by PR for 36 weeks | ||||
| ASPIRE | GT 1 treatment experienced, randomized double-blind placebo-controlled | Galexos + PR | SVR24 65% of prior partial-responders, 53% of prior-null responder patients | |
| Placebo + PR | 9% & 19% of prior partial- & null- responder | |||
| PROMISE | Randomized double-blind placebo-controlled treatment experienced (prior relapse after interferon-based treatment) |
Galexos with PR for 12 weeks followed by PR for 12 or 36 weeks | SVR24 79% | |
| Placebo + PR for 12 weeks followed by PR for 36 weeks | SVR24 37% | |||
| *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. |
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Sampling of Phase III Clinical Trials for Galexos + Sovaldi:
| Clinical Trial | Patients | Treatment Regimen | Duration in Weeks | SVR12 | |
| OPTIMIST-1 (12 week treatment duration) | Genotype (GT) 1, treatment naive or treatment experienced * with cirrhosis | Galexos + Sovaldi | 12 | 97% | |
| Historical control group (HCG)** | 87% | ||||
| Galexos + Sovaldi | 8 | 83% | |||
| HCG | 83% | ||||
| OPTIMIST-2 (12 weeks) | GT 1 treatment naive or treatment experienced with cirrhosis | Galexos + Sovaldi | 12 | 84%*** | |
| HCG | 12 | 70% | |||
| *Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon. **For this trial, historical control group (HCG) means approved regimens of a DAA plus pegylated interferon with ribavirin. DAAs used weren’t listed. ***Higher SVR12 rates were seen in patients with baseline NS5A polymorphisms with or without NS3 Q80K polymorphisms (100%), patients with albumin (94%) and treatment-naive patients (88%). |
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Maker: Merck
Sampling of Phase II/III Clinical Trials for Zepatier:
| Clinical Trial | Patients | Treatment Regimen | Duration in Weeks |
SVR12* |
| C-SWIFT (looked at shorter treatment) | GT 1 treatment naive without cirrhosis | Zepatier + Sovaldi | 4 | 33% |
| 6 | 87% | |||
| GT 1 treatment naive with cirrhosis | 6 | 80% | ||
| 8 | 94%** | |||
| GT 3 treatment naive without cirrhosis | Zepatier + Sovaldi | 8 | 93% | |
| 8 | 100% | |||
| GT 3 treatment naive with cirrhosis | 12 | 91% | ||
| C-EDGE (looked at treatment-naive, treatment experienced and HIV co-infected patients) | GT 1, 4, 6 treatment naive with (C) or without cirrhosis (NC) | Zepatier (once daily) | 12 | 95% (total) NC 94%, C 97%, GT1a 92%, GT1b 99%, GT4 100%, GT6 80% |
| GT 1, 4, 6 HIV/HCV co-infected with (C) or without cirrhosis (NC) | Zepatier (once daily) | 12 | 95% (total) NC 94%, C 100%, GT1a 94%, GT1b 96%, GT4 96%, GT6 100% | |
| GT 1, 4, 6 treatment- experienced with or without cirrhosis | Zepatier +/- Ribavirin (RBV) | 16 | 92% (- RBV total), GT1a 94%, GT1b 96%, GT4 60%, GT6 75% | |
| 97% (+ RBV total), GT1a 95%, GT1b 100%, GT4 100%, GT6 100% | ||||
| C-SALVAGE (looked at retreat duration) |
GT 1, previously failed with PR + a DAA***, with or without cirrhosis | Zepatier + RBV | 12 | 96% (total) |
| 94% (cirrhosis) | ||||
| C-SURFER (still ongoing) | GT 1, treatment-naïve and patients who failed pegylated interferon, with or without cirrhosis, chronic kidney disease stages 4 or 5 | Zepatier | 12 | 99% |
| *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. **Didn’t include early drop outs due to reasons other than virologic failure. ***The direct antiviral agents listed were Incivek (telaprevir), Victrelis (boceprevir), and Galexos (simeprevir). |
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Sampling of Clinical Trials Presented at the EASL’s 2015 International Liver Congress
| Clinical Trial | Patients | Treatment Regimen | Duration in Weeks |
SVR12 |
| BOSON (looked at + PR vs + RBV) | Genotype (GT) 2 treatment experienced, with or without cirrhosis GT 3 treatment naive or treatment experienced with or without cirrhosis | Sovaldi + Pegylated Interferon with Ribavirin (PR) | 12 | GT 2 94%, GT 3 93% |
| Sovaldi + Ribavirin (RBV) | 16 | GT 2 87%, GT 3 71% | ||
| 24 | GT 2 100%, GT 3 84% | |||
| ALLY-2 | Any GT, HCV/HIV co-infection, treatment naive or treatment experienced | Daklinza + Sovaldi | 12 | 96% |
| 8 | 76% | |||
| GIFT-1 | GT 1b with cirrhosis | Ombitasvir/ Paritaprevir/ Ritonavir | 12 | 90% |
| GT 1b, treatment naive without cirrhosis | 94% | |||
| GT 1b, treatment experienced without cirrhosis | 96% | |||
| C-EDGE (looked at treatment-naive, treatment experienced and HIV co-infected patients) | GT 1, 4, 6 treatment naive, without cirrhosis (NC), with cirrhosis (C) | Grazoprevir / Elbasvir | 12 | 95% (total) NC 94%, C 97%, GT1a 92%, GT1b 99%, GT4 100%, GT6 80% |
| GT 1, 4, 6 HIV/HCV co-infected, without cirrhosis (NC), with cirrhosis (C) | Grazoprevir / Elbasvir | 12 | 95% (total) NC 94%, C 100%, GT1a 94%, GT1b 96%, GT4 96%, GT6 100% | |
| GT 1, 4, 6 treatment- experienced, with or without cirrhosis | Grazoprevir / Elbasvir +/- Ribavirin (RBV) | 16 | 92% (- RBV total), GT1a 94%, GT1b 96%, GT4 60%, GT6 75% | |
| Grazoprevir / Elbasvir + RBV | 97% (+ RBV total), GT1a 95%, GT1b 100%, GT4 100%, GT6 100% | |||
| C-SALVAGE (looked at retreating duration) |
GT 1, previously failed with PR + a DAA, with or without cirrhosis | Grazoprevir / Elbasvir + RBV | 12 | 96% (total) |
| 94% (with cirrhosis) | ||||
| More information and links to additional European Association for the Study of the Liver resources. | ||||
The information on this website is meant as a resource only and is not intended to replace qualified medical attention. Please seek advise and guidance from your health practitioners when considering your hep C treatment options.