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The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie adults with chronic hepatitis C virus ("HCV"), who have not responded to prior treatment with protease inhibitors.
The "Triple therapy" of AbbVie attacks various sites of the viral genome, thus increasing the potential efficacy of the treatment, especially for patients who have failed PI treatment.
Patients with genotype 1 HCV, who underwent past triple therapy (Telaprevir, Boceprevir or Simeprevir with Pegylated interferon / Ribavirin) and are non-responders, partial responders or in relapse - will be screened in all research centers up to 30 days before the first treatment.
At the end of the initial assessment - the recruited participants will be allocated to different treatment groups in accordance with the hepatitis virus subtype 1a, 1b and presence of cirrhosis, as follows:
(* Only this group will not get Ribavirin)
During the treatment period, participants will be asked to describe the treatment's tolerability (in terms of side effects) using self-administered questionnaires: SF-36, and WPAI Hep C v2.0.
The follow up will also include physical assessments, side effects documentation, blood tests, abdominal Ultrasound and Fibroscan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotype 1b without cirrhosis | Experimental | 12 weeks without Ribavirin |
|
| Genotype 1b with cirrhosis | Experimental | 12 weeks with Ribavirin |
|
| Genotype 1a without cirrhosis | Experimental | 12 weeks with Ribavirin |
|
| Genotype 1a with cirrhosis | Experimental | 24 weeks with Ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 weeks without Ribavirin | Drug | 12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| "SVR" (sustained virologic response) rates | Sustained virologic response | 12 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| "SF" (short-form)-36 health survey | psychometrically-based physical and mental health and a preference-based health utility index. | Day 1, weeks 4, 12, 24, 36. |
| WPAI Hep C v2.0 questionnaire | a scoring manual for work productivity and activity impairment assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oren Shibolet, MD | Contact | 97236973984 | orensh@tlvmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Oren Shibolet, MD | Tel-Aviv Sourasky Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32245397 | Derived | Deutsch L, Houri I, Ben-Ari Z, Shlomai A, Veitsman E, Cohen-Ezra O, Issachar A, Mor O, Gozlan Y, Bruck R, Menachem Y, Zelber-Sagi S, Katchman H, Shibolet O. Ombitasvir/paritaprevir/ritonavir & dasabuvir +/- ribavirin following protease inhibitors failure - a prospective multi-centre trial. BMC Infect Dis. 2020 Apr 3;20(1):264. doi: 10.1186/s12879-020-4921-3. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| 12 weeks with Ribavirin | Drug | 12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg. |
|
|
| 24 weeks with Ribavirin | Drug | 24 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg. |
|
|
| Day 1, weeks 4, 12, 24, 36. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |