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| Name | Class |
|---|---|
| Baqiyatallah Research Center for Gastroenterology and Liver Diseases | OTHER |
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Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir/Ledipasvir for 12W | Experimental | Patients without cirrhosis and previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks. |
|
| Sofosbuvir/Ledipasvir+Ribavirin for 12W | Experimental | Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks. |
|
| Sofosbuvir/Ledipasvir for 24W | Experimental | Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks. |
|
| Sofosbuvir/Ledipasvir+Ribavirin for 24W | Experimental | Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir/Ledipasvir 12W | Drug | Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response | Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection | 12 weeks after completion of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyed Moayed Alavian, MD | Contact | +989121073195 | alavian@thc.ir | |
| Heidar Sharafi, PhD | Contact | +989125176030 | h.sharafi@meldcenter.com |
| Name | Affiliation | Role |
|---|---|---|
| Seyed Moayed Alavian, MD | Iran Hepatitis Network | Study Chair |
| Heidar Sharafi, PhD | Iran Hepatitis Network | Study Director |
| Bita Behnava, MD |
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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 |
|---|---|
| D000069474 | Sofosbuvir |
| C586541 | ledipasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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| Sofosbuvir/Ledipasvir plus Ribavirin 12W | Drug | Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks. |
|
| Sofosbuvir/Ledipasvir 24W | Drug | Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks. |
|
| Sofosbuvir/Ledipasvir plus Ribavirin 24W | Drug | Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks. |
|
| Iran Hepatitis Network |
| Principal Investigator |
| Mohammad Saeid Rezaee-Zavareh, MD | Iran Hepatitis Network | Principal Investigator |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |