Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ahvaz Jundishapur University of Medical Sciences | OTHER |
| Shiraz University of Medical Sciences | OTHER |
| Hamadan University of Medical Science | OTHER |
Not provided
Not provided
Not provided
Not provided
Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sovodak | Experimental | Sofosbuvir 400 mg and daclatasvir 60 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir 400 mg and daclatasvir 60 mg | Drug | Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness < 12 KPa) or 24 weeks if cirrhotic |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Viral Response (SVR12) | Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment | 12 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by adverse drug events | Adverse drug events recorded by direct questioning | From start of treatment to 12 weeks after end of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shahin Merat, MD | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shariati Hospital | Tehran | 14117 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31994788 | Derived | Poustchi H, Majd Jabbari S, Merat S, Sharifi AH, Shayesteh AA, Shayesteh E, Minakari M, Fattahi MR, Moini M, Roozbeh F, Mansour-Ghanaei F, Afshar B, Mokhtare M, Amiriani T, Sofian M, Somi MH, Agah S, Maleki I, Latifnia M, Fattahi Abdizadeh M, Hormati A, Khoshnia M, Sohrabi M, Malekzadeh Z, Merat D, Malekzadeh R. The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. J Gastroenterol Hepatol. 2020 Sep;35(9):1590-1594. doi: 10.1111/jgh.14994. Epub 2020 Feb 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D007676 | Kidney Failure, Chronic |
| D006526 | Hepatitis C |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |