Doravirine/lamivudine/tenofovir disoproxil (HIV infection) ' Benefit assessment according to '35a Social Code Book V 1 Translation of Sections I 1 to I 5 of the dossier assessment Doravirin/Lamivudin/Tenofovirdisoproxilfumarat (HIV-Infektion bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 July 2022). Please note : This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A22-49 Doravirine/lamivudine/tenofovir disoproxil fumarate (HIV infection in adolescents) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A22-49 Version 1.0 DOR/3TC
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Doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) - HIV Published 8 March 2021 1 Product update SMC2333 doravirine/lamivudine/tenofovir disoproxil fumarate 100mg/300mg/245mg film-coated tablets (Delstrigo®) Merck Sharp & Dohme (UK) Limited 5 February 2021 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated submission doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo®) is accepted for use within NHSScotland. Indication under review: for the treatment of adults infected with HIV-1 without past or present
Doravirine/lamivudine/tenofovir disoproxil (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Doravirin/Lamivudin/Tenofovirdisoproxilfumarat (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 April 2019). Please note : This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-05 Doravirine/lamivudine/tenofovir disoproxil fumarate (HIV infection) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A19-05 Version 1.0 Doravirine/lamivudine/tenofovir
Doravirine/lamivudine/tenofovir disoproxil (Delstrigo) - Treatment of adults infected with human immunodeficiency virus 1 Published 11 February 2019 Statement of advice SMC2163 doravirine 100mg / lamivudine 300mg / tenofovir disoproxil 245mg film-coated tablets (Delstrigo®) Merck Sharp & Dohme Limited 11 January 2019 ADVICE: in the absence of a submission from the holder of the marketing authorisation doravirine / lamivudine / tenofovir disoproxil (Delstrigo®) is not recommended for use within NHSScotland. Indication under review: Treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class, lamivudine, or tenofovir. The holder of the marketing authorisation
Prophylaxis by doravirine-lamivudine-tenofovir disoproxil fumarate or elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide after sexual exposure to HIV. HIV post- exposure prophylaxis (PEP) is a prevention tool for individuals with a recent potential exposure to HIV. Doravirine has been available since 2019 in combination with tenofovir disoproxil fumarate and lamivudine and has not been
Efficacy, Safety, and Tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Results Through Week 96 from IMPAACT 2014. IMPAACT 2014 study is a phase I/II, multicenter, open-label, nonrandomized study of doravirine (DOR) co-formulated with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) as fixed-dose combination
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/Emtricitabine/TDF in Treatment-naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double-blind, Phase 3 DRIVE-AHEAD Noninferiority Doravirine (DOR) is a nonnucleoside reverse-transcriptase inhibitor. In the phase 3 DRIVE-AHEAD trial in treatment-naive adults with human
Population Pharmacokinetic and Pharmacodynamic Analysis to Evaluate a Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in People Living with HIV-1. Doravirine is a non-nucleoside reverse transcriptase inhibitor for treatment of human immunodeficiency virus type 1 (HIV-1) infection. A population pharmacokinetic (PK) model for treatment-naive participants in doravirine clinical
Doravirine exposure and HIV-1 suppression after switching from an efavirenz-based regimen to doravirine/lamivudine/tenofovir disoproxil fumarate. Doravirine is a non-nucleoside reverse transcriptase inhibitor approved for the treatment of HIV-1. In a phase 1 trial, doravirine exposure was transiently decreased when treatment was started immediately after stopping efavirenz. In a post-hoc subgroup analysis of participants who switched from an efavirenz-based regimen to doravirine/lamivudine/tenofovir disoproxil fumarate in the phase 3 DRIVE-SHIFT trial, doravirine plasma levels at week 4 were similar to non-induced levels, and HIV-1 suppression was maintained at weeks 24 and 48.
Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial. Doravirine is a novel, nonnucleoside reverse transcriptase inhibitor with demonstrated efficacy in treatment-naive adults with HIV-1. In this open-label, active-controlled, noninferiority trial, adults with HIV-1 virologically
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial. Doravirine (DOR), a novel non-nucleoside reverse-transcriptase inhibitor (NNRTI), is active against wild-type Human Immunodeficiency Virus (HIV)-1
Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF? Weight gain with the integrase inhibitors and tenofovir alafenamide has been observed in observational cohorts and randomized controlled clinical trials. Although some risk factors have been identified, the cause is unknown and it remains to be determined if the changes are reversible are substantiated for ART-associated weight gain. Doravirine/lamivudine/tenofovir DF (DOR/3TC/TDF) is an attractive option to explore as it does not include an INSTI or TAF, is a well tolerated once daily single tablet, minimal drug interactions and has not been associated with significant weight gain to date. The investigators hypothesize that switching from an INSTI regimen to DOR/3TC/TDF will slow or reverse
Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis. undefined
. ClinicalTrialsGov. Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents [online]. 2021. URL: https://ClinicalTrials.gov/show/NCT03332095. 4. Merck. CSR IMPAACT 2014 - Data Cut 48 week: Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439 ) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-infected Children and Adolescents. 5. E. U-Clinical Trials Register. Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-infected Children and Adolescen [online]. URL: https://www.clinicaltrialsregister.eu/ctr-search/search