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Last Post 25 Jun 2012 12:00 AM by  SuperUser Account
HCV Update
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09 Feb 2012 10:50 AM

    Part of work package 3 (task 3.9) indicates commitment to exploring Hepatitis C. To carry out this work, more HCV data needs to be collected, in particular HCV tretment, HCV genotype and subtype. I'm suggesting we add a HCV table to HICDEP with similar specification as tblART. Please see below for my version of the proposed table.

    I also would like to suggest adding two fields to tblLAB_VIRO, namely HCV geotype and HCV subtype.

    tblHCV - Hepatitis C treatment

    holds type of hepatitis drug, start and stop dates and reason for stopping

    Core fields

    Note: Fields marked bold form the unique identifier for a record of the table.

    Field name

    Format

    Description

    PATIENT

    character (or numeric if possible)

    identifies patient

    HCV_ID

    character. see below for proposed codings.

    represents the HCV treatment

    HCV_SD

    yyyy-mm-dd

    date of initiation of treatment

    HCV_ED

    yyyy-mm-dd

    date of stopping treatment

    HCV_RS

    character. need to create codings.

    reason for stopping treatment

    HCV_ID codes

    • Telaprevir - not in HICDEP, how to code?
    • Boceprevir - not in HICDEP, how to code?
    • J05AB04 - Ribavirin
    • L03AB - Interferon (non-pegylated) IFN (unspecified)
    • IFN alfa-2b (Intron-A) - not in HICDEP, how to code?
    • IFN alfa-2a (Roferon) - not in HICDEP, how to code?
    • L03AB-AL2 - Pegylated interferon PEG-IFN (unspecified)
    • L03AB10 - PEG-IFN alfa-2b (PEG-Intron)
    • L03AB11 - PEG-IFN alfa-2a (Pegasys)
    • HCV treatment unspecified - not in HICDEP, how to code?
    • HCV treatment, other - not in HICDEP, how to code?

    I suggest we add the following two fields to tblLAB_VIRO

    Field name

    Format

    Description

    HCV_GEN

    • 1 = I
    • 2 = II
    • 3 = III
    • 4 = IV
    • 5 = V
    • 6 = VI
    • 50 = Mixed
    • 99 = Unknown

    HCV Geotype

    HCV_SUBTYPE

    Character

    HCV Subtype


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    10 Feb 2012 12:00 AM


    Regarding treatment, the only difference to tblMED is the (to-be-developped) reasons for stopping. And, of course, adding the new anti-HCV molecules to the list of drugs. Wouldn't one option be to add reasons for stopping to tblMED? So, cohorts would not have to change too much to their programs...

    Regarding HCV types, I understand that Ashley suggests adding two more codes for VS_ID (the viral test) (e.g. HCV_GEN and HCV_SUBTYPE) in tblLAB_VIRO. This sounds reasonable to me.

    Other ideas?

    Bruno

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    10 Feb 2012 12:00 AM


    So far the HCV treatment has been kept in the tblMED table, perhaps it is worthwhile moving this to the tblART (AntiRetroviral Treatment) both due to the change in the available drugs and also the need to stop treatment for chronic infections.

    tblLAB_VIRO has so far been used to capture pcr, ELISA etc tests rather than phylogenetic genotype/subtype determinations.

    I would propose the method we applied in COHERE where we already twice have been collecting the HCV genotypes as part of the tblLAB_RES. I would propose we should change the name a bit.

    The table has a subtype field - not sure we gain from splitting HCV into genotype and subtype - but rather keep it together (and mixtures) in the same field. To make tblRES work for the purpose we added another variable called VIRUTYPE field to split HIV and HCV records.

    /Jesper

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    13 Feb 2012 12:00 AM


    It would be great if we could collect more data on HCV treatment. For paediatrics we would also wish to collect dose and frequency, so adding HCV treatment to the tblART would work (as this table already has optional fields for these 2 variables).

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    15 Feb 2012 12:00 AM


    I think adding HCV to tblMED is a good idea. My reasoning for creating a new table was to avoid the HCV data getting 'lost' in other medication data. The benefits to adding HCV to tblMED probably outweight the negatives. Perhaps there should be an HCV flag on the HCV treatments in tblMED?

    Adding the genotypes to tblLAB_RES is also a good suggestion. I like the idea of adding a variable that indicates if it's an HIV or HCV result.

    Ashley

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    25 Jun 2012 12:00 AM

    In addition to the previous changes, HCV b-dna will need to be added to VS_ID in tblLAB_VIRO

    Coding Table

    save Download this table as CSV filesave Download this table as XML file
    Code Viral Test
    BVA Bacterial vaginosis unspecified method
    BVAC Bacterial vaginosis - clinical
    BVAG Bacterial vaginosis - gram stain
    CHLA Chalmydia
    CMVA CMV anitbodies
    GONO Gonorrhoe
    HBV Marker for hepatitis B infection (=HBVAC) - test unknown
    HBVAC HBV antibody (core)
    HBVAE HBV antibody (envelope)
    HBVAS HBV antibody (surface)
    HBVD HBV-dna
    HBVGE HBV antigen (envelope)
    HBVGS HBV antigen (surface)
    HCV Marker for hepatitis C infection - test unknown
    HCVA HCV antibody
    HCVG HCV antigen
    HCVBD HCV b-dna
    HCVR HCV-rna
    HIV-1 HIV-1 test
    HIV-2 HIV-2 test
    HIVAE HIV antibodies ELISA
    HIVAWB HIV antibodies Western blot
    MYCO Mycoplasma
    P24AG P24 Ag
    RUB Rubella
    STR Streptococcus, group B
    TOXA Toxo antibodies
    UREP Ureaplasma


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