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| Name | Class |
|---|---|
| RojanPharma Pharmaceutical Company | UNKNOWN |
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In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
To achieve the goal of elimination of hepatitis C in 2030 as set forward by the world health organization (WHO) a main group requiring treatment are subjects co-infected with HIV. These subjects offer a particular challenge as they are receiving ART which frequently interferes with hepatitis treatment. The number of pills they are already taking also limits the compliance of these patients.
In order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular ART medicine being used by the patient - a multi-center study of 200 co-infected patients has been designed.
The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
The study is one of the pilots being run for hepatitis C elimination in Iran.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sofosbuvir/daclatasvir | Experimental | Once daily fixed-dose combination pill of sofosbuvir and daclatasvir for 12 weeks if the patient is non cirrhotic and for 24 weeks if cirrhotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sofosbuvir and daclatasvir | Drug | Depending on the ART received by each patient one of the fixed-dose combination pills below will be used:
|
| Measure | Description | Time Frame |
|---|---|---|
| The sustained viral response rate | Qualitative hepatitis C virus RNA polymerase chain reaction | 12 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug events | Questionnaire | weeks 2, 4, 8, 12 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Malekzadeh | Tehran University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shariati Hospital | Tehran | 14117 | Iran | |||
| Emam Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33930223 | Derived | Dehghan Manshadi SA, Merat S, Mohraz M, Rasoolinejad M, Sali S, Mardani M, Tabarsi P, Somi MH, Sedghi R, Tayeri K, Nikbin M, Karimi J, Sharifi AH, Kalantari S, Norouzi A, Merat D, Malekzadeh Z, Mirminachi B, Poustchi H, Malekzadeh R. Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus. Int J Clin Pract. 2021 Aug;75(8):e14304. doi: 10.1111/ijcp.14304. Epub 2021 May 17. |
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|
| Tehran |
| Iran |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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