Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients

NCT02057003 | Unknown

• 1 other identifier: HEPAVIR-DAA
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients. Hypothesis: The efficacy and tolerability of DAA-based regimens in the clinical practice is different to what is observed in clinical trials in HIV/HCV-coinfected patients.

Conditions

Hepatitis C, Chronic; Human Immunodeficiency Virus

Keywords

HIV; hepatitis C virus; sustained virologic response; telaprevir; boceprevir; simeprevir; sofosbuvir; daclatasvir; paritaprevir; pegylated interferon; ribavirin; direct-acting antivirals; dasabuvir; ombitasvir; ledipasvir; velpatasvir; grazoprevir; elbasvir

Outcome Measures

Primary Outcomes (2)

• Number of patients who achieve SVR to DAA-based therapy as measure of efficacy

  Achievement of SVR to DAA-based therapy in the clinical practice in patients with chronic hepatitis C and HIV coinfection.

  18 months

• Number of patients who develop severe adverse events as measure of safety

  Development of severe adverse events related to DAA-based therapy in the clinical practice in patients with chronic hepatitis C and HIV coinfection.

  18 months

Secondary Outcomes (4)

• Number of patients who achieve SVR to a BOC-based regimen as compared to numbers of patients who achieve SVR to a TVR-based regimen.

  18 months

• Number of patients who reach undetectable HCV-RNA at week 4 of PI-based therapy as a measure of on-treatment response to therapy.

  18 months

• Number of patients who develop adverse events during a BOC-based regimen as compared to numbers of patients who develop adverse events during a TVR-based regimen.

  18 months

• Number of patients who achieve SVR to an interferon-free regimen.

  36 weeks

Study Arms (1)

DAA-based therapy against HCV

HIV/HCV-coinfected patients who start therapy against HCV including one or more DAA

Drug: DAA against HCV

Interventions

DAA against HCV DRUG

Also known as: telaprevir, boceprevir, simeprevir, sofosbuvir, daclatasvir, ombitasvir, paritaprevir, dasabuvir, ledipasvir, grazoprevir, elbasvir, velpatasvir

DAA-based therapy against HCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who consecutively attend the Unit of Infectious Diseases of the Study Group for Viral Hepatitis (HEPAVIR) of the Andalusian Society of Infectious Diseases (Sociedad Andaluza de Enfermedades Infecciosas, SAEI), Spain, will be considered for this study.

You may qualify if:

• Older than 18 years
• HIV infection determined by enzymeimmunoassay and confirmed by Western Blot
• Naïve to treatment including a DAA
• Initiation of triple therapy including a DAA
• Written informed consent to participate in the study and to undergo genetic determinations

You may not qualify if:

• Pregnancy
• Any contraindication for the administration of peg-IFN, RBV or the respective DAA
• Patients who are not able to provide informed consent to participate in the study

Sponsors & Collaborators

• Valme University Hospital: lead
• Hospital Universitario Reina Sofia de Cordoba: collaborator
• Hospital Universitario Virgen de la Victoria: collaborator
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator
• Hospital Regional de Malaga: collaborator
• Hospital Torrecárdenas: collaborator
• Complejo Hospitalario Universitario de Huelva: collaborator
• Hospital Universitario Puerta del Mar: collaborator
• Hospital Universitario Virgen Macarena: collaborator
• Hospital La Línea: collaborator
• Complejo Hospitalario de Jaén: collaborator
• Hospital Universitario Puerto Real: collaborator
• Hospital Universitario de Canarias: collaborator
• Hospital Poniente: collaborator
• Hospital Universitario Central de Asturias: collaborator
• Hospital Álvaro Cunqueiro: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator
• Hospital Universitario de Gran Canaria: collaborator

Study Sites (1)

Valme University Hospital

Seville, 41014, Spain

RECRUITING

Related Publications (8)

• Coverdale SA, Khan MH, Byth K, Lin R, Weltman M, George J, Samarasinghe D, Liddle C, Kench JG, Crewe E, Farrell GC. Effects of interferon treatment response on liver complications of chronic hepatitis C: 9-year follow-up study. Am J Gastroenterol. 2004 Apr;99(4):636-44. doi: 10.1111/j.1572-0241.2004.04085.x.

  PMID: 15089895 BACKGROUND

• Berenguer J, Alvarez-Pellicer J, Martin PM, Lopez-Aldeguer J, Von-Wichmann MA, Quereda C, Mallolas J, Sanz J, Tural C, Bellon JM, Gonzalez-Garcia J; GESIDA3603/5607 Study Group. Sustained virological response to interferon plus ribavirin reduces liver-related complications and mortality in patients coinfected with human immunodeficiency virus and hepatitis C virus. Hepatology. 2009 Aug;50(2):407-13. doi: 10.1002/hep.23020.

  PMID: 19575364 BACKGROUND

• Mira JA, Rivero A, de Los Santos-Gil I, Lopez-Cortes LF, Giron-Gonzalez JA, Marquez M, Merino D, del Mar Viloria M, Tellez F, Rios-Villegas MJ, Omar M, Rivero-Juarez A, Macias J, Pineda JA; Grupo HEPAVIR de la Sociedad Andaluza de Enfermedades Infecciosas (SAEI). Hepatitis C virus genotype 4 responds better to pegylated interferon with ribavirin than genotype 1 in HIV-infected patients. AIDS. 2012 Aug 24;26(13):1721-4. doi: 10.1097/QAD.0b013e3283568884.

  PMID: 22695304 BACKGROUND

• Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.

  PMID: 21696307 BACKGROUND

• Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.

  PMID: 21449783 BACKGROUND

• Hezode C, Fontaine H, Dorival C, Larrey D, Zoulim F, Canva V, de Ledinghen V, Poynard T, Samuel D, Bourliere M, Zarski JP, Raabe JJ, Alric L, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Metivier S, Tran A, Serfaty L, Abergel A, Causse X, Di Martino V, Guyader D, Lucidarme D, Grando-Lemaire V, Hillon P, Feray C, Dao T, Cacoub P, Rosa I, Attali P, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) - NCT01514890. J Hepatol. 2013 Sep;59(3):434-41. doi: 10.1016/j.jhep.2013.04.035. Epub 2013 May 10.

  PMID: 23669289 BACKGROUND

• Gonzalez-Serna A, Corma-Gomez A, Tellez F, Corona-Mata D, Rios-Villegas MJ, Merino D, Galera C, Collado-Romacho AR, De Los Santos I, Cucurull J, Santos M, Garcia-Martin S, Rivero A, Real LM, Macias J. Response to glecaprevir/pibrentasvir in HIV/HCV-coinfected patients in clinical practice. J Antimicrob Chemother. 2023 Oct 3;78(10):2591-2596. doi: 10.1093/jac/dkad278.

  PMID: 37671831 DERIVED

• Macias J, Morano LE, Tellez F, Granados R, Rivero-Juarez A, Palacios R, Rios M, Merino D, Perez-Perez M, Collado A, Figueruela B, Morano A, Freyre-Carrillo C, Martin JM, Rivero A, Garcia F, Pineda JA; HEPAVIR group from the Sociedad Andaluza de Enfermedades Infecciosas (SAEI) and the GEHEP group from the Sociedad Espanola de Enfermedades Infecciosas y Microbiologia (SEIMC). Response to direct-acting antiviral therapy among ongoing drug users and people receiving opioid substitution therapy. J Hepatol. 2019 Jul;71(1):45-51. doi: 10.1016/j.jhep.2019.02.018. Epub 2019 Mar 8.

  PMID: 30853642 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; Hepatitis C

Interventions

telaprevir; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; Simeprevir; Sofosbuvir; daclatasvir; ombitasvir; paritaprevir; dasabuvir; ledipasvir; grazoprevir; elbasvir; velpatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Karin Neukam, PhD

  Valme University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Neukam, PhD

CONTACT

0034955015799; karin.neukam@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: February 6, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

ES (1)