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An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C

maanantai 5. elokuuta 2019 päivittänyt: Elizabeth A. McGlynn, Kaiser Permanente

Safety of Direct-Acting Antiviral Medications for Hepatitis C

The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients with HCV who are untreated. The investigators hypothesize that patients receiving DAAs do not experience higher rates of adverse events compared to patients who have not received DAAs. The study population is adults between the ages of 18 and 88 with any indication of a diagnosis of HCV. An intervention group (those receiving a DAA) and comparison group (those who are not treated) will be created using medication dispensing data. Eligibility for the study will be determined from January 1, 2011 through December 31, 2017. Covariates will be collected from January 1, 2011 through December 31, 2017. Individual study sites may have access to historical data prior to 2011 that can be used as covariates or to identify individuals with HCV. The primary outcomes of interest include acute myocardial infarction, neurological outcomes (e.g. acute stroke, intracranial bleed), acute kidney failure, acute on chronic liver failure, hepatic decompensation, multiple organ dysfunction syndrome, cancer, bradyarrhythmia, and death. The secondary outcomes include decompensated cirrhosis, hospitalization, emergency department visit, and arrhythmia. Outcomes will be assessed from January 1, 2011 through December 31, 2017. The investigators will use two different analytic approaches to answer the question of interest: a Poisson regression model and marginal structural modeling (MSM). The simpler Poisson model is an extension of tabular rate of event analysis. The more complicated MSM model incorporates modeling of the treatment decision to more flexibly control for confounding by indication. For each outcome, the investigators will only record the first date an outcome occurs. Each outcome will be modeled separately.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

33808

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 88 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei käytössä

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Todennäköisyysnäyte

Tutkimusväestö

The groups/cohorts will consist of all HCV patients from Kaiser Permanente Southern California region, Kaiser Permanente Northern California region, and the OneFlorida Clinical Research Consortium.

Kuvaus

Inclusion Criteria:

  • HCV viral load
  • HCV genotype
  • HCV qualitative
  • HCV antibody
  • HCV drug
  • Continuously enrolled 12 months

Exclusion Criteria:

  • Each outcome will be analyzed separately as time to first event, thus people who experience an outcome prior to their study start date are ineligible for analyses related to that particular outcome.

The results will be examined for sensitivity to the following possible exclusion criteria:

  • Achieved SVR-12 prior to index date
  • HCV treatment experienced prior to index date
  • No visit in GI, Infectious Disease, or Liver Transplant / Hepatology
  • No positive HCV test (genotype, viral load, or qualitative)
  • No recent positive HCV test (genotype, viral load or qualitative)

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
Direct Acting Antivirals
Patients who receive a direct acting antiviral enter the DAA cohort at the time of initiation of the drug.
Lääke: Direct Acting Antivirals
The time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication.
Comparison
The exposure time of patients who have not received a direct acting antiviral (patients can change from the comparison to the DAA group once they receive the medication)

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Incidence of Acute Myocardial Infarction (AMI)
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounter with an ICD-9 diagnosis code of 410.xx or ICD-10 diagnosis code of I21.xx.
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Acute on Chronic Liver Failure
Aikaikkuna: Labs and diagnoses collected from clinical encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
An acute change in MELD (model for end stage liver disease) score of 5 or more and the change is deemed to have persisted (defined as meeting one of the following criteria: MELD continues to be elevated 3 months later, liver transplant, death). The minimum value for the MELD is 6.43, but there is no maximum value. Higher scores mean a worse outcome.
Labs and diagnoses collected from clinical encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Acute Kidney Failure (AKF)
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Encounters with an ICD-9 diagnosis code of 584.xx or ICD-10 diagnosis code of N17.xx.
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Multiple Organ Dysfunction Syndrome (MODS)
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounters with ICD-9 diagnosis code of 995.92, 995.94, 785.52 or ICD-10 code of R65.11 or R65.2x.
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Death
Aikaikkuna: Death dates will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Date of death in one or more records. Death data comes from medical records, Social Security, or state databases.
Death dates will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Ischemic Stroke
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounters with ICD-9 diagnosis code of 433.xx, 434.xx or ICD-10 code of I63.xx, I65.xx.
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Hemorrhagic Stroke
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounters with ICD-9 diagnosis code of 430.xx-432.xx or ICD-10 code of I60.xx-I62.xx
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Decompensated Cirrhosis
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
A patient will be characterized as having decompensated cirrhosis from an encounter indicating jaundice (ICD-9 diagnosis code of 782.4 or ICD-10 code of R17), ascites (ICD-9 diagnosis code of 789.5, 789.51, 789.59 or ICD-10 diagnosis code of R18.0, R18.8, K71.51, K70.11, or K70.31), or varices (ICD-9 diagnosis code of 456.0, 456.20 or ICD-10 diagnosis code of I85.01 or I85.11, or a medication dispense of lactulose or rifaximin along with a diagnosis of cirrhosis.
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Rate of Hospitalizations
Aikaikkuna: Hospitalizations will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
An encounter in which the place of service is an inpatient hospitalization.
Hospitalizations will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Rate of Emergency Department Visits
Aikaikkuna: ED visits will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
An encounter in which the place of service is an emergency department or urgent care center.
ED visits will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Arrhythmia
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Inpatient encounters with an ICD-9 diagnosis code of 427.1, 427.42, 427.5, 427.9 or an ICD-10 diagnosis code of I47.2, I49.01, I49.02, I46.9, I49.9.
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Liver Cancer
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Encounters with ICD-9 diagnosis code of 155.xx or ICD-10 code of C22.xx.
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of Cancers Other Than Liver Cancer
Aikaikkuna: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Encounters with ICD-9 codes 140.xx through 208.xx, except 155.xx or ICD-10 coes C00-C97 except C22.xx.
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
Incidence of HBV Reactivation
Aikaikkuna: Labs will be for up to 180 days following the initiation of a DAA.
We identified HBV reactivations in three different ways [Di Bisceglie et al., 2015; Yanny et al., 2018]: (1) patients who had a history of Hepatitis B core antibody (HBcAb) positive and were Hepatitis B surface antigen (HBsAg) negative at the time of initiating DAA therapy who became HBsAg positive within 180 days after receiving a DAA; (2) patients with undetectable levels of HBV DNA at the time of initiating DAA therapy who had a numerical result within 180 days after receiving a DAA; (3) patients with a numerical HBV DNA result at the time of initiating DAA therapy whose viral load increased by a factor of 10 within 180 days after receiving a DAA. For all methods of detecting a reactivation, we required that the reactivations be clinically significant: bilirubin at least 3, aspartate aminotransferase (AST) at least 400, or alanine aminotransferase (ALT) at least 500.
Labs will be for up to 180 days following the initiation of a DAA.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Kaiser Permanente

Yhteistyökumppanit

Patient-Centered Outcomes Research Institute
OneFlorida Clinical Research Consortium

Tutkijat

  • Päätutkija: Elizabeth A McGlynn, PhD, Kaiser Permanente

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Lauantai 1. tammikuuta 2011

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 31. joulukuuta 2017

Opintojen valmistuminen (Todellinen)

Sunnuntai 31. joulukuuta 2017

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 31. tammikuuta 2018

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 31. tammikuuta 2018

Ensimmäinen Lähetetty (Todellinen)

Tiistai 6. helmikuuta 2018

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 7. elokuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 5. elokuuta 2019

Viimeksi vahvistettu

Torstai 1. elokuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • RI-RCR-1000

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

PÄÄTTÄMÄTÖN

IPD-suunnitelman kuvaus

Current plan is to make a de-identified data set available to investigators under specified conditions.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

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Kliiniset tutkimukset Hepatiitti C, krooninen

Kliiniset tutkimukset Direct Acting Antivirals

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