Clinical Trial Results

clinical trial results sq_drugsThis is a very basic sampling of phases II and III clinical trial results for treatments currently within the hep C drug pipeline or recently approved for use. Many of these treatments are trying to move towards being allowed to be sold in Canada and then being covered by PharmaCare programs.

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 Health Canada

Pharmaceutical Companies Treatments (brand names first, generic names in brackets) Targeted Genotypes being Tested
AbbVie Holkira Pak (ombitasvir / paritaprevir / ritonavir / dasabuvir) 1
Technivie (ombitasvir / paritaprevir / ritonavir) 4
Maviret (glecaprevir / pibrentasvir) 1 – 6
Bristol-Myers Squibb Sunvepra (asunaprevir), Daklinza (daclatasvir) 1 – 6
Gilead Sovaldi (sofosbuvir) 1 – 4
Harvoni (sofosbuvir / ledipasvir) 1
Epclusa (sofosbuvir / velpatasvir) 1 – 6
Vosevi (sofosbuvir / velpatasvir / voxilaprevir) 1 – 6
Janssen Galexos (simeprevir) 1
Galexos (simeprevir) + Sovaldi (sofosbuvir) 1
AL-335 + Odalasvir (ACH-3102) + Simeprevir 1
Merck Zepatier (elbasvir / grazoprevir) 1, 3, 4. 6

MK-3682B (MK-3682 / grazoprevir / ruzasvir) 1 – 6
Sampling of Clinical Trial Results Presented at the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, to be held November 11 – 15, 2016.
Sampling of Clinical Trial Results Presented at the International Liver Congress 2016 in April

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%)
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.

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.

Sampling of Phase III Clinical Trials for Maviret:

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.

Maker: Bristol-Myers Squibb

Sampling of Phase III Clinical Trial Results for Sunvepra and Daklinza:

Clinical Trial Patients Treatment Regimen SVR12/24*
ALLY-1
Post-transplant Daklinza + Sovaldi + ribavirin 94%
With advanced cirrhosis 92- 94%
ALLY-2 Any GT, HCV/HIV co-infection, treatment naive Daklinza + Sovaldi** (1 daily, no change of HIV meds needed) 97%
Any GT, HCV/HIV co-infection, treatment experienced 98%
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%
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%
HALLMARK QUAD GT 1 prior non-responders (partial and null responders) S / D + Pegylated Interferon with Ribavirin 93.2%
GT 4 prior non-responders (partial and null responders) 100%
*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 was 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)

Maker: Gilead

(Drug Pipeline Diagram)

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.

Sampling of Phase III Clinical Trials for Epclusa:

Clinical Trial Patients Treatment Regimen SVR12*
ASTRAL-1 (12 week treatment duration) Genotype (GT) 1, 2, 3, 4, 5, 6 with & without cirrhosis Epclusa Overall 98%
GT1 98%
GT2 100%
GT4 100%
GT5 97%
GT6 100%
ASTRAL-2 (12 weeks) Genotype 2 with & without cirrhosis Epclusa 99%
Epclusa + Ribavirin 94%
ASTRAL-3 (12 weeks) Genotype 3 with & without cirrhosis Epclusa 95%
Sovaldi (sofosbuvir) + Ribavirin 80%
ASTRAL-4 (12 & 24 weeks) Genotypes 1-6 all with decompensated cirrhosis (Child-Pugh class B), treatment naive or treatment experienced Epclusa (12 weeks) 88-100%
Epclusa + Ribavirin (12 weeks) 94-100%
Epclusa (24 weeks) 92-100%

Sampling of Phase III Clinical Trials for Vosevi

Clinical Trial Patients Genotype Duration Treatment SVR12
POLARIS-1 GT1-6, 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 91 – 100%
Placebo 0%
POLARIS-4 DAA-experienced (No NS5A inhibitor), 46 percent (153/333) had cirrhosis 1-4 12 weeks SOF/VEL/ VOX 94- 100%
SOF/VEL 85-97%
POLARIS-2 DAA-naive, 18 percent (174/941) had cirrhosis 1-6 8 weeks SOF/VEL/ VOX 92 – 100%
12 weeks SOF/VEL 97- 100%
POLARIS-3 DAA-naive, All had cirrhosis 3 8 weeks SOF/VEL/ VOX 96%
12 weeks SOF/VEL 96%

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.

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%).

Sampling of Phase III Clinical Trials for AL-335 + Odalasvir (ACH-3102) + Simeprevir:

Clinical Trial Patients Treatment Regimen Duration in Weeks
SVR12*
2016 Trial (looked at safety and efficacy) GT1 treatment naive without cirrhosis ODV + AL-335 8 90%
ODV + AL-335 + SMV 6 100%
8

Maker: Merck

(Drug Pipeline Diagram)

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).

Sampling of Phase II Clinical Trials for MK3 (3682/GZR/Ruzasvir):

Clinical Trial Patients Treatment Regimen Duration in Weeks
SVR12*
C-CREST 1&2 PART B (looked at safety and efficacy) GT 1a MK-3682B +/- RBV 8 93%
12 98%
16 98% SVR4
GT 1b 8 98%
12 100%
16
GT 2 8 86%
12 97%
16 100%
GT 3 8 95%
12 97%
16 96%

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.