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Dolutegravir/lamivudine (Dovato) - Human Immunodeficiency Virus type 1 (HIV-1) Final Appraisal Recommendation Advice No: 0220 – February 2020 Dolutegravir/lamivudine (Dovato ® ) 50 mg/300 mg film-coated tablets Limited submission by ViiV Healthcare UK Ltd In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (reference number 3659), which includes the AWMSG Secretariat Assessment Report (ASAR), the Preliminary Appraisal (...) Recommendation (PAR) and the applicant company’s response to the PAR, clinical expert opinion (where available), the views of patients/patient carers (where available) and the lay member perspective. This recommendation has been ratified by Welsh Government and will be considered for review every three years. Recommendation of AWMSG Dolutegravir/lamivudine (Dovato ® ) is recommended as an option for use within NHS Wales for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults
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 V 1 Extract of dossier assessment A19-05 Version 1.0 Doravirine/lamivudine/tenofovir disoproxil fumarate (HIV infection) 11 April 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Doravirine/lamivudin/tenofovir disoproxil
Dolutegravir lamivudine (Dovato) - human immunodeficiency virus type 1 (HIV-1) Published 9 September 2019 1 Product update SMC2205 dolutegravir 50mg / lamivudine 300mg film-coated tablets (Dovato®) ViiV Healthcare Ltd 9 August 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated (...) submission dolutegravir / lamivudine (Dovato®) is accepted for use within NHSScotland. Indication under review: for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. In patients for whom this two-drug combination regimen is appropriate dolutegravir / lamivudine (Dovato®) offers a single tablet at no additional cost compared
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 has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. Advice context: No part of this advice may be used without the whole of the advice being quoted
Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferior Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen (...) for the treatment of HIV-1 infection in ART-naive adults.We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300
2018LancetControlled trial quality: predicted high
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Integrase strand transfer inhibitors (INSTIs) are recommended components of initial antiretroviral therapy with two nucleoside reverse transcriptase inhibitors. Bictegravir is a novel, potent INSTI with a high in-vitro barrier to resistance and low (...) adults (aged ≥18 years) who were previously untreated (HIV-1 RNA ≥500 copies per mL); HLA-B*5701-negative; had no hepatitis B virus infection; screening genotypes showing sensitivity to emtricitabine, tenofovir, lamivudine, and abacavir; and an estimated glomerular filtration rate of 50 mL/min or more. Participants were randomly assigned (1:1), via a computer-generated allocation sequence (block size of four), to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide
2017LancetControlled trial quality: predicted high
Dolutegravir/abacavir/lamivudine (Triumeq) - Human Immunodeficiency Virus (HIV) Final Appraisal Recommendation Advice No: 0415 – March 2015 Dolutegravir/abacavir/lamivudine (Triumeq ®? ) 50 mg/600 mg/300 mg film-coated tablets Limited submission by ViiV Healthcare UK Ltd In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (reference number 2365), which includes the AWMSG Secretariat Assessment Report (ASAR (...) /lamivudine (Triumeq ®? ) is recommended as an option for use within NHS Wales for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme is utilised. Statement of use: No part of this recommendation may be reproduced without the whole recommendation being quoted in full and cited as: All Wales Medicines Strategy Group. Final Appraisal
Dolutegravir/abacavir/lamivudine - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Dolutegravir/Abacavir/Lamivudin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 18 December 2014). 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. A14-34 Dolutegravir/abacavir/ lamivudine – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-34 Version 1.0 Dolutegravir/abacavir/lamivudine – Benefit assessment acc. to §35a SGB V 18 Dec 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir/abacavir/lamivudine – Benefit assessment according to §35a SGB V Commissioning agency
[Dolutegravir/abacavir/lamivudine - benefit assessment according to section 35a Social Code Book V (dossier assessment)] Dolutegravir/abacavir/lamivudin – Nutzenbewertung gemass Section 35a SGB V [Dolutegravir/abacavir/lamivudine - benefit assessment according to section 35a Social Code Book V (dossier assessment)] Dolutegravir/abacavir/lamivudin – Nutzenbewertung gemass Section 35a SGB V [Dolutegravir/abacavir/lamivudine - benefit assessment according to section 35a Social Code Book V (dossier (...) assessment)] IQWiG Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation IQWiG. Dolutegravir/abacavir/lamivudin – Nutzenbewertung gemass Section 35a SGB V. [Dolutegravir/abacavir/lamivudine - benefit assessment according to section 35a Social Code Book V (dossier assessment)] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen
Entecavir vs lamivudine for prevention of hepatitis B virus reactivation among patients with untreated diffuse large B-cell lymphoma receiving R-CHOP chemotherapy: a randomized clinical trial. Hepatitis B virus (HBV) reactivation is a serious complication for patients with lymphoma treated with rituximab-containing chemotherapies, despite lamivudine prophylaxis treatment. An optimal prophylactic antiviral protocol has not been determined.To compare the efficacy of entecavir and lamivudine (...) large B-cell lymphoma. Patients enrolled in the parent study who were seropositive for the hepatitis B surface antigen and had normal liver function, serum HBV DNA levels of less than 103 copies/mL, and no prior antiviral therapy were randomized to entecavir (n = 61) or lamivudine (n = 60).Daily entecavir (0.5 mg) or lamivudine (100 mg) beginning 1 week before the initiation of R-CHOP treatment to 6 months after completion of chemotherapy.The primary efficacy end point was the incidence of HBV
Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited.In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n = 141) or a combination (...) of emtricitabine (FTC, 200 mg; n = 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg)-positive or HBeAg-negative, with levels of HBV DNA ≥3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V ± rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA <69 IU/mL (Roche COBAS Taqman assay; Roche Molecular Systems, Inc, Pleasanton, CA).Patient groups were
Triumeq - abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205551Orig1s000 MEDICAL REVIEW(S) NDA 205551 Yodit Belew, M.D. Charu Mullick, M.D. Clinical Review 1 Clinical Review Date June 2, 2014 From Yodit Belew, M.D. Charu Mullick, M.D. Subject Clinical Review NDA/BLA # Supplement# 205551 000 Applicant GSK Date of Submission October 22, 2013 PDUFA Goal Date August 22, 2014 Proprietary Name / Established (USAN) names Triumeq abacavir (...) /dolutegravir/lamivudine (ABC/DTG/3TC) Dosage forms / Strength Fixed dose combination tablet containing 600mg/50mg/300mg of ABC/DTG/3TC Proposed Indication(s) Treatment of HIV-1 infection Recommended: Approval 1. Introduction Dolutegravir (DTG), an integrase strand transfer inhibitor (INSTI) developed by GSK, was approved for the treatment of HIV-1 infection on August 12, 2013 under NDA 204790. GSK has co-formulated dolutegravir with two nucleoside reverse transcriptase inhibitors (NRTIs) abacavir
Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. Dolutegravir (S/GSK1349572), a once-daily, unboosted integrase inhibitor, was recently approved in the United States for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination with other antiretroviral agents. Dolutegravir, in combination with abacavir-lamivudine, may provide a simplified regimen.We conducted a randomized, double-blind, phase 3 study involving adult participants who had (...) not received previous therapy for HIV-1 infection and who had an HIV-1 RNA level of 1000 copies per milliliter or more. Participants were randomly assigned to dolutegravir at a dose of 50 mg plus abacavir-lamivudine once daily (DTG-ABC-3TC group) or combination therapy with efavirenz-tenofovir disoproxil fumarate (DF)-emtricitabine once daily (EFV-TDF-FTC group). The primary end point was the proportion of participants with an HIV-1 RNA level of less than 50 copies per milliliter at week 48. Secondary end
Lamivudine with or without adefovir dipivoxil for postoperative hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a significant cause of death, especially in Asia and sub-Saharan Africa. Removal of the cancer through surgery or other techniques is considered the first-line therapy in early HCC, but relapse of HCC is the main postoperative problem. The main risk factor for HCC is hepatitis B virus (HBV) infection. Lamivudine and adefovir dipivoxil are effective and tolerable (...) for chronic hepatitis B by suppressing the viral load and to reduce fibrosis in the liver. To assess the benefits and harms of postoperative administration of lamivudine with or without adefovir dipivoxil in participants with surgically treated HCC and chronic HBV infection or HBV carrier state.A systematic search was performed in The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science
Lamivudine/Zidovudine Teva 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail email@example.com Website www.ema.europa.eu An agency of the European Union 18 November 2010 EMA/41752/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment report Lamivudine / Zidovudine Teva International nonproprietary name: lamivudine / zidovudine Procedure No. EMEA/H/C/001236 Assessment Report as adopted (...) of the dossier The applicant Teva Pharma B.V. submitted on 5 October 2009 an application for Marketing Authorisation to the European Medicines Agency (EMA) for Lamivudine / Zidovudine Teva , through the centralised procedure falling within the scope of the Article 3 (3) – ‘Generic of a Centrally authorised product’ of Regulation (EC) No. 726/2004. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 30 June 2008 The legal basis for this application refers to: Article 10(1