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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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Substance users are a vulnerable group that should be prioritized in HCV (Hepatitis C Virus) elimination efforts in Mexico and in which it is feasible to carry out micro-elimination programs. It is an important group to treat both because of its high prevalence and because of the dynamic spread of infection among the general population. HCV seropositivity has not been documented in this group of people in Mexico City, the metropolitan area and the northern states of the country, nor has the sustained viral response been evaluated in this group of patients in the Mexican population.
The investigators would use a work team, the program and the value proposal would be presented to the local authorities, the coordinator of the national commission against dependencies and doctors. The investigators would use an algorithm designed for the first-step diagnosis of HCV in SUs (Substances Users) , and defined the key centers for screening and linking to care.
The project is planned as follows:
The importance of this project is characterized by minimal monitoring, patients and doctors education by telementoring, multidisciplinary teams and integral treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substances Users | Substances users confirmed with Viral Load for HCV. after that will be evaluated through laboratory studies (CBC and blood chemistry), HIV/HBV (Hepatitis B Virus) serology, fibrosis status will be evaluated through APRI (AST to Platelet Ratio Index) and FIB-4. The antiviral treatment (sofosbuvir/Velpatasvir) will be chosen according to the characteristics of each patient and follow-up will be maintained according to the national plan with a visit at the end of treatment and 12 weeks after its end to assess SVR. The importance of this project is characterized by minimal monitoring, patients and doctors education by telementoring, multidisciplinary teams and integral treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir 400 MG / Velpatasvir 100 MG [Epclusa] | Drug | 1 tab every 24 hrs for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained viral response (SVR) in people who use substances in the Mexico City metropolitan area and the northern states of the country. | Number por participants who achive SVR whit the treatment | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprevalence and prevalence of HCV in people who use substances in the Mexico City metropolitan area and the northern states of the country. | Number of participants with chronic HCV infection | through study completion, an average of 1 year |
| No Sustained viral response (SVR) in people who use Substances in the Mexico City |
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Inclusion Criteria:
Exclusion Criteria:
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Substances Users who are registered in the rehabilitation centers that comply with the applicable regulations in Mexico City, the metropolitan area and the northern states of the country.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Graciela Castro-Narro, MD | Contact | +52 55 5405 3670 | gracastron@yahoo.com | |
| Valeria Cortés-Mollinedo, MD | Contact | +52 27 1100 7484 | vale.crts.mllnd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Graciela Castro-Narro, MD | INCMNSZ | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24988388 | Background | Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. eCollection 2014. | |
| 31288259 | Background | Mendizabal M, Alonso C, Silva MO. Overcoming barriers to hepatitis C elimination. Frontline Gastroenterol. 2019 Jul;10(3):207-209. doi: 10.1136/flgastro-2018-101114. Epub 2019 Feb 1. No abstract available. |
| Label | URL |
|---|---|
| Global Health Sector Strategy for Viral Hepatitis 2016-2021: Ending Viral Hepatitis. | View source |
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all IPD that underlie results in a publication would be shared
By 2024, once the enrollment of patients and the analyzes have been completed, this publication will be published and can be consulted
An Open Access journal will be searched so that the information can be consulted
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C000604171 | velpatasvir |
| C000611331 | sofosbuvir-velpatasvir drug combination |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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A blood sample will be taken for HCV detection by PCR (polymerase chain reaction)
Number of participants who does not achive RVS |
| through study completion, an average of 1 year |
| 29986353 | Background | Lazarus JV, Safreed-Harmon K, Thursz MR, Dillon JF, El-Sayed MH, Elsharkawy AM, Hatzakis A, Jadoul M, Prestileo T, Razavi H, Rockstroh JK, Wiktor SZ, Colombo M. The Micro-Elimination Approach to Eliminating Hepatitis C: Strategic and Operational Considerations. Semin Liver Dis. 2018 Aug;38(3):181-192. doi: 10.1055/s-0038-1666841. Epub 2018 Jul 9. |
| 28480293 | Background | Wansom T, Falade-Nwulia O, Sutcliffe CG, Mehta SH, Moore RD, Thomas DL, Sulkowski MS. Barriers to Hepatitis C Virus (HCV) Treatment Initiation in Patients With Human Immunodeficiency Virus/HCV Coinfection: Lessons From the Interferon Era. Open Forum Infect Dis. 2017 Feb 11;4(1):ofx024. doi: 10.1093/ofid/ofx024. eCollection 2017 Winter. |
| 25046751 | Background | Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Int J Surg. 2014 Dec;12(12):1500-24. doi: 10.1016/j.ijsu.2014.07.014. Epub 2014 Jul 18. |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |