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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.

Contents

Version: Final (with redactions)

Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.

While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.

CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials.

This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites.

Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third party supplier of information.

This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk.

This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.

Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK544820PMID: 31393687

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