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Dossier assessment

Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-43
Last updated

Report documents

  1. Extract of dossier assessment

    Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 138 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 138 kB, EN, not accessible)

  2. Dossier assessment

    Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Adults infected with HIV-1

Result of dossier assessment:

Treatment-naive adults and pretreated adults with indication for a treatment switch: added benefit not proven. Without indication for a treatment switch: added benefit not proven for men; indication of lesser benefit versus the appropriate comparator therapy for women.

Additional information

Federal Joint Committee (G-BA)

2018-12-20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-43
Commission
Commission awarded on 28.06.2018 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Immune system and infections
Note

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

Connected Projects

  1. Addendum

    Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) - Addendum to Commission A18-43

    Project no.
    A18-77
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Bictegravir/ emtricitabine/ tenofovir alafenamide (HIV infections in children and adolescents) – Benefit assessment according to § 35a SGB

    Project no.
    A22-134
    Last updated

    Status: Commission completed

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