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Cover of Common Drug Review New Combination Product: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination (Delstrigo)

Common Drug Review New Combination Product: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination (Delstrigo)

Merck Canada Inc.

Indication: A complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults without past or present evidence of viral resistance to doravirine, lamivudine, or tenofovir

CADTH Common Drug Review

Human immunodeficiency virus is responsible for causing HIV infection, a condition that gradually weakens the immune system. HIV is transmitted via body fluids such as blood, semen, genital secretions, and breast milk; most commonly from unprotected sexual intercourse or through sharing of contaminated needles and syringes with an infected person. Left untreated, HIV infection can progress to AIDS and ultimately death. Surveillance data from the Public Health Agency of Canada estimates that, at the end of 2016, there were approximately 84,409 people in Canada living with HIV/AIDS, with an incidence rate of 6.4 per 100,000 population, or 2,344 new reported cases yearly. Since the invention of highly active antiretroviral (ARV) therapy in the mid-1990s, antiretroviral therapy (ART) has improved steadily with the availability of newer potent-combination therapies. Treatments are aimed at lowering the level of HIV in the body, thereby allowing the immune system to recover and respond to other infections. Newer ARTs have significantly reduced HIV-associated morbidity and mortality, and HIV is now largely considered a manageable chronic condition.

The following section provides an overview of the evidence pertaining to the studies relevant for this review. This review was conducted in tandem with an evaluation of the DOR single-dose product, Pifeltro, which includes additional study data that are not presented in this report. Readers are therefore suggested to consult the Pifeltro report for additional context.


Version: Final (with redactions)

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Bookshelf ID: NBK544820PMID: 31393687


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