Latest & greatest articles for Lamivudine

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Top results for Lamivudine

1. Dovato - dolutegravir / lamivudine - HIV-1 infection

Dovato - dolutegravir / lamivudine - HIV-1 infection dolutegravir / lamivudine | CADTH.ca Find the information you need dolutegravir / lamivudine dolutegravir / lamivudine Last Updated: October 3, 2019 Result type: Reports Project Number: SR0601-000 Product Line: Generic Name: dolutegravir / lamivudine Brand Name: Dovato Manufacturer: ViiV Healthcare Indications: HIV-1 infection Manufacturer Requested Reimbursement Criteria 1 : Indicated as a complete regimen for the treatment of Human

2019 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

2. Dolutegravir lamivudine (Dovato) - human immunodeficiency virus type 1 (HIV-1)

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

2019 Scottish Medicines Consortium

3. Doravirine/lamivudine/tenofovir disoproxil (Delstrigo) - Treatment of adults infected with human immunodeficiency virus 1

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

2019 Scottish Medicines Consortium

4. 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 (PubMed)

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

2018 Lancet Controlled trial quality: predicted high

6. 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. (PubMed)

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

2017 Lancet Controlled trial quality: predicted high

7. HBsAg seroclearance or seroconversion induced by peg-interferon alpha and lamivudine or adefovir combination therapy in chronic hepatitis B treatment: a meta-analysis and systematic review. (PubMed)

HBsAg seroclearance or seroconversion induced by peg-interferon alpha and lamivudine or adefovir combination therapy in chronic hepatitis B treatment: a meta-analysis and systematic review. Seroclearance or seroconversion of hepatitis B surface antigen (HBsAg) is generally considered as the clinical endpoint. The purpose of the present meta-analysis was to evaluate pegylated interferon alpha (PEG-IFNα) with or without lamivudine (LAM) or adefovir (ADV) combination treatment in HBsAg

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2016 Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva

8. Triumeq (dolutegravir/abacavir/lamivudine), fixed-dose combination of antiretrovirals - in the treatment of Human Immunodeficiency Virus (HIV)

Triumeq (dolutegravir/abacavir/lamivudine), fixed-dose combination of antiretrovirals - in the treatment of Human Immunodeficiency Virus (HIV) TRIUMEQ SUMMARY CT13894

2015 Haute Autorite de sante

9. Dolutegravir/abacavir/lamivudine (Triumeq®)

Dolutegravir/abacavir/lamivudine (Triumeq®) Dolutegravir/abacavir/lamivudine (Triumeq®) Dolutegravir/abacavir/lamivudine (Triumeq®) All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Dolutegravir/abacavir/lamivudine (Triumeq®) Penarth: All Wales Therapeutics and Toxicology Centre (...) (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 2365. 2015 Authors' conclusions Dolutegravir/abacavir/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. Final

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2015 Health Technology Assessment (HTA) Database.

10. Dolutegravir/abacavir/lamivudine (Triumeq) - Human Immunodeficiency Virus (HIV)

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

2015 All Wales Medicines Strategy Group

11. Dolutegravir/abacavir/lamivudine - Benefit assessment according to §35a Social Code Book V (dossier assessment)

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

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

12. [Dolutegravir/abacavir/lamivudine - benefit assessment according to section 35a Social Code Book V (dossier assessment)]

[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

2015 Health Technology Assessment (HTA) Database.

13. Dutrebis - lamivudine / raltegravir potassium

Dutrebis - lamivudine / raltegravir potassium 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged 22 January 2015 EMA/154027/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report DUTREBIS International non (...) -proprietary name: lamivudine / raltegravir potassium Procedure No. EMEA/H/C/003823/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Medicinal product no longer authorised EMA/154027/2015 Page 2/72 Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Manufacturers 7 1.3. Steps taken for the assessment of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.2. Quality aspects 9

2015 European Medicines Agency - EPARs

14. 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. (PubMed)

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

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2014 JAMA Controlled trial quality: predicted high

15. Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B (PubMed)

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

2014 EvidenceUpdates Controlled trial quality: uncertain

16. Peginterferon Monotherapy versus Peginterferon and Lamivudine Combination Therapy for Chronic Hepatitis B

Peginterferon Monotherapy versus Peginterferon and Lamivudine Combination Therapy for Chronic Hepatitis B "Peginterferon Monotherapy versus Peginterferon and Lamivudine Combinat" by Thao M. Van < > > > > > Title Author Date of Graduation Summer 8-9-2014 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies First Advisor James Ferguson, PA-C, MS. Second Advisor Annjanette Sommers, PA-C, MS. Rights . Abstract Background: Chronic hepatitis B is a major health (...) problem and may lead to cirrhosis, liver failure, liver cancer, and death if untreated. Interferon is currently better than nucleot(s)ide analogues in sustained seroconversion or loss of HBeAg and HBsAg. Peginterferon prolongs interferon’s effects. This review compared benefits and risks of peginterferon monotherapy versus peginterferon with lamivudine therapy in chronic hepatitis B. Methods: Exhaustive search of medical literature was performed using key words peginterferon, peginterferon alfa-2a

2014 Pacific University EBM Capstone Project

17. Triumeq - abacavir/dolutegravir/lamivudine (ABC/DTG/3TC)

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

2014 FDA - Drug Approval Package

18. Triumeq - abacavir sulfate / dolutegravir sodium / lamivudine

Triumeq - abacavir sulfate / dolutegravir sodium / lamivudine 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 26 June 2014 EMA/580654/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Triumeq (...) International non-proprietary name: dolutegravir / abacavir / lamivudine Procedure No. EMEA/H/C/002754/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/580654/2014 Page 2/114 Table of contents 1. Background information on the procedure 4 1.1. Submission of the dossier 4 1.2. Manufacturers 5 1.3. Steps taken for the assessment of the product 5 2. Scientific discussion 6 2.1. Introduction 6 2.2. Quality aspects 6 2.2.1

2014 European Medicines Agency - EPARs

19. Efficacy of lamivudine combined with adefovir dipivoxil versus entecavir monotherapy in patients with hepatitis B-associated decompensated cirrhosis: A meta-analysis (PubMed)

Efficacy of lamivudine combined with adefovir dipivoxil versus entecavir monotherapy in patients with hepatitis B-associated decompensated cirrhosis: A meta-analysis Whether the combination of lamivudine (LAM) plus adefovir (ADV) de novo is more effective than entecavir (ETV) monotherapy in patients with HBV-associated decompensated cirrhosis is still controversial. We searched seven randomized controlled trials that included 411 patients in this meta-analysis. There are 205 and 206 patients

2013 EvidenceUpdates

20. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. (PubMed)

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

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2013 NEJM Controlled trial quality: predicted high