Real World Study About Anti-viral Regimen Adjustment on Achieving Complete Response in CHB Patients (REACH)
keskiviikko 4. elokuuta 2021 päivittänyt: caidachuan, The Second Affiliated Hospital of Chongqing Medical University
Real World Study on the Effect of HBV-DNA High-precision Detection Based Anti-viral Regimen Adjustment on Achieving Complete Virologic Response in Patients With Chronic Hepatitis B.(REACH)
In the treatment of chronic hepatitis B (CHB), viral suppression is closely related to disease progression, and the lower the viral load, the lower the risk of progression to cirrhosis and hepatocellular carcinoma (HCC).
In addition, a considerable number of patients in China are still using non-first-line antiviral therapy, such as adefovir dipivoxil, lamivudine, and telbivudine (ADV/LAM/LdT).
About 25% of patients who received entecavir(ETV) treatment for more than half a year and confirmed that their DNA had turned negative by non-high-precision detection methods still had low viremia (LLV,DNA>20 IU/ml,IU=international unit), and LLV patients were twice as likely to develop HCC as patients with complete viral response.Patients who have received ETV or second-line NA(LAM/ADV/LdT) treatment for more than half a year to 1 year and confirmed HBV-DNA>10IU/ml by high-precision detection method are recommended to adjust the treatment plan in order to reduce the DNA load below 10IU/ml as soon as possible.
It is up to the doctor, in consultation with the patient, to decide whether or not to make the adjustment.
Tutkimuksen yleiskatsaus
Tila
Tuntematon
Yksityiskohtainen kuvaus
In our hospital, about 150 patients are screened for HBV-DNA every day. Therefore, 54 million patients will be tested for HBV-DNA within one year, of which 30% are estimated to be HBV-DNA ≥10 IU. These patients will be informed to the Department of Infectious Diseases of the Second Affiliated Hospital of Chongqing Medical University for follow-up, and will be randomly divided into three groups according to 1:1. Patients in all three groups will be educated about hepatitis B virus infection and antiviral treatment, and the treatment regimen will be adjusted according to whether their HBV DNA is ≥10 IU/ml or not. Patients in group 1: patients with persistant low level HBV DNA (<10 IU/ml). Patients in group 2: HBV-DNA≥10 IU/ml, receiving HBV-related education and being advised by the doctor to change or to add another NA. Patients in group 2: patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen. Patients in group 3: patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen. Educational methods include videos, including an introduction to hepatitis B virus (disease profile, infection, outcome, HBV infection, vertical transmission and other risk factors) for 5 minutes, brochures with relevant information and consultations with physicians and nurses.
All patients with chronic hepatitis B(CHB) receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen so that the actual prevalence of HBV-DNA load < 10 IU/ml in Chongqing HBV cohort could be obtained . The investigators estimated that 30% of the patients had HBV-DNA≥ 10 IU/ml, so there were about 16,200 patients had HBV-DNA≥ 10 IU/ml among 54,000 patients a year. These patients will be diagnosed with LLV and will undergo a treatment regimen adjustment, with a recommendation to switch to or use a different type of nucleos(t)ide analogue (NA) for anti-viral treatment.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Odotettu)
10000
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Chongqing
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Chongqing, Chongqing, Kiina, 400010
- Rekrytointi
- The Second Affiliated Hospital of Chongqing Medical University
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Ottaa yhteyttä:
- DACHUAN CAI, PhD
- Puhelinnumero: 862362887039
- Sähköposti: 597521685@qq.com
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Ottaa yhteyttä:
- PENG HU, PhD
- Puhelinnumero: 8613608338064
- Sähköposti: hp_cq@163.com
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Päätutkija:
- DACHUAN CAI, Professor
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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
14 vuotta - 70 vuotta (Lapsi, Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
The research subjects were patients with CHB (chronic hepatitis B) receiving ETV or second-line NA(LAM/ADV/LdT) who were admitted to The Second Affiliated Hospital of Chongqing Medical University and other centers.
Kuvaus
Inclusion Criteria:
- any patients treated with ETV\LAM\ADF\LDT\TDF\TAF.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
Exclusion Criteria:
- with a expected life span <48 weeks
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 |
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patients with persistant low level HBV DNA (<10 IU/ml)
No further intervention(s) to be administered except for monitoring of HBV DNA viraemia
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monitoring the viraemia only
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patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen
All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen.
If those patients refuse to change the regimen which they are using , No further intervention(s) to be administered except for monitoring of HBV DNA viraemia until those patients change their idea
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if those patients agree, the regimen will be changed.
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patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen
All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen.They will change their regimen according one which they are using.
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Based on ongoing one, regimen will be changed .
The principle for adjusting anti-viral regimen is as follows: 1.
The patients were treated with second-line drugs: changing ADV to ETV/TAF/TDF , changing LAM to TAF/TDF and changing LdT to TAF/TDF; 2. The patients were treated with ETV: adding or switching to TAF/TDF;3.
TAF or ETV is recommended for patients with one or more TDF risk factors, such as > 40 years old, patients with abnormal bone/kidney related indicators or patients with high risk of bone/kidney injuries.【ADV=adefovir
dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.
Aikaikkuna: 24 weeks
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The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment.
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24 weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.
Aikaikkuna: 12 weeks, 48 weeks ,96 weeks
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The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.
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12 weeks, 48 weeks ,96 weeks
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he proportion of patients with normal Alanine transaminase（ALT） at baseline and at each follow-up time point
Aikaikkuna: baseline,12 weeks,48 weeks,96 weeks
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he proportion of patients with normal Alanine transaminase（ALT ）at baseline and at each follow-up time point
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baseline,12 weeks,48 weeks,96 weeks
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Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.
Aikaikkuna: baseline,12 weeks,48 weeks,96 weeks
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Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.
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baseline,12 weeks,48 weeks,96 weeks
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Changes of serum creatinine(SCr）compared with baseline at each follow-up time point.
Aikaikkuna: baseline,12 weeks,48 weeks,96 weeks
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Changes of serum creatinine(SCr) compared with baseline at each follow-up time point.
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baseline,12 weeks,48 weeks,96 weeks
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Changes of bone mass density（BMD) compared with baseline at each follow-up time point.
Aikaikkuna: baseline,12 weeks,48 weeks,96 weeks
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Changes of bone mass density (BMD) compared with baseline at each follow-up time point.
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baseline,12 weeks,48 weeks,96 weeks
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: DACHUAN CAI, PhD, The Second Affiliated Hospital of Chongqing Medical University
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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