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Impact of Hepatitis C Therapy and Bone Health (HCV)

15. august 2019 oppdatert av: Dallas VA Medical Center

Impact of HCV Therapy on Cardiovascular Risk and Bone Health

An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Both HCV and HIV are associated with an increased risk of osteoporosis and osteoporotic fractures among HIV-infected patients and the general population. While HIV significantly increases cardiovascular risk, the contribution of HCV to cardiovascular disease (CVD) is less certain. Increased inflammation could potentially underlie the effect of HCV on CVD, bone health, and other extra-hepatic complications. HCV appears to remain an independent predictor of osteoporotic fractures even after controlling for severity of liver disease. The impact of HCV therapy on inflammation, CVD and bone health is unclear. Our previous studies suggest a beneficial impact of interferon therapy on bone turnover and some CVD markers, while others studies have found on-treatment increases in bone mineral density with interferon-based therapy. Whether these are related to the interferon itself or the virologic response, and whether changes in biomarkers lead to improved fracture risk or CVD morbidity is uncertain. Investigator propose to conduct a prospective analysis of markers of inflammation, immune activation, and bone turnover as well as bone mineral density (BMD) among both HIV/HCV co-infected and HCV mono-infected patients undergoing treatment with the novel direct-acting antiviral elbasvir/grazoprevir (EBR/GZR). Should EBR/GZR therapy significantly improve CV risk and bone health, it would be an additional benefit and indication for its use in HCV therapy.

Studietype

Intervensjonell

Registrering (Faktiske)

6

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Dallas, Texas, Forente stater, 75216
        • Dallas VA Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  1. HCV antibody and HCV RNA positive
  2. HCV Genotype 1a, 1b, or 4

  3. Liver staging assessment:

    a. Cirrhosis will be defined by any of the following: i. A liver biopsy prior to day 1 of this study showing cirrhosis (F4) ii. Fibroscan within 12 calendar months of day 1 of this study showing cirrhosis with result > 12.5 kPa iii. FibroSURE performed during screening with a score > 0.75 and APRI > 2 b. Absence of cirrhosis will be defined by any of the following: i. Liver biopsy performed within 24 months of day 1 of this study showing absence of cirrhosis ii. Fibroscan performed within 12 months of day 1 of this study with a result of ≤ 12.5 kPa iii. FibroSURE score ≤ 0.48 and APRI ≤ 1 during screening

  4. If HIV co-infected, HAART regimen will consist of two NRTIs (abacavir, tenofovir disoproxil fumarate or tenofovir alafenamide, each in combination with lamivudine or emtricitabine) with one of the following 3rd agents:

    1. raltegravir
    2. dolutegravir
    3. rilpivirine HIV co-infected patients must be on their stable HAART regimen for at least 6 months, with HIV viral load < 50 c/mL at screening

Exclusion Criteria:

  1. Hepatitis B surface antigen positivity
  2. Decompensated cirrhosis (Child Pugh B or C)
  3. Any prior hepatitis C treatment
  4. Pregnant or nursing
  5. Treatment with any medication specifically contraindicated with EBR/GZR or not recommended for concomitant use as per the prescribing label (Table 2)
  6. Age less than 18
  7. Prisoners or subjects otherwise involuntarily incarcerated
  8. Absence of signed informed consent by patient or appropriate surrogate
  9. Known hypersensitivity to elbasvir or grazoprevir
  10. For patients with genotype 1a, one more of the following mutations on baseline NS5A genotype: M28, Q30, L31, or Y93

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: EBR/GZR (Zepatier) - HCV/HIV co-infected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
Legemiddel: EBR/GZR
Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
Andre navn:
  • Zepatier
Eksperimentell: EBR/GZR (Zepatier) - HCV monoinfected
Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.
Legemiddel: EBR/GZR
Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
Andre navn:
  • Zepatier

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluate the impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients and HIV/HCV co-infected patients
Tidsramme: 48 weeks
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, positron emission tomography (PET) scanning for arterial inflammation, coronary calcification and myocardial viability.
48 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tidsramme: Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) scan and trabecular bone score (TBS).
Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tidsramme: Bone mineral density measured at week 0 of therapy
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Bone mineral density measured at week 0 of therapy
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tidsramme: Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tidsramme: Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.
Tidsramme: Bone mineral density measured at week 48 of therapy.
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Bone mineral density measured at week 48 of therapy.
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tidsramme: Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Biomarkers of inflammation and bone turnover measured at week 0 of therapy.
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tidsramme: Bone mineral density measured at week 0 of therapy
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Bone mineral density measured at week 0 of therapy
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tidsramme: Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Biomarkers of inflammation and bone turnover measured at week 12 of therapy.
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tidsramme: Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Biomarkers of inflammation and bone turnover measured at week 24 of therapy.
Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HIV/HCV co-infected patients.
Tidsramme: Biomarkers of inflammation and bone turnover measured at week 48 of therapy.
Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, PET scanning for arterial inflammation, coronary calcification and myocardial viability. Bone health will be assessed by serological markers of bone turnover and bone mineral density (BMD) by DXA scan and trabecular bone score (TBS).
Biomarkers of inflammation and bone turnover measured at week 48 of therapy.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dallas VA Medical Center

Samarbeidspartnere

Merck Sharp & Dohme LLC

Etterforskere

  • Hovedetterforsker: Roger Bedimo, MD, Dallas VAMC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. august 2017

Primær fullføring (Faktiske)

26. november 2018

Studiet fullført (Faktiske)

30. november 2018

Datoer for studieregistrering

Først innsendt

27. juni 2017

Først innsendt som oppfylte QC-kriteriene

13. juli 2017

Først lagt ut (Faktiske)

18. juli 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MISP 54850

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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