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1. Dolutegravir/lamivudine (Dovato) - Human Immunodeficiency Virus type 1 (HIV-1)

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

2020 All Wales Medicines Strategy Group

2. Doravirine/lamivudine/tenofovir disoproxil (HIV infection) - Benefit assessment according to §35a Social Code Book V

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

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

3. 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

4. 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

5. 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

6. Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients. Full Text available with Trip Pro

Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients. The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable switching) in patients with LAM-resistant chronic hepatitis B (CHB) and undetectable hepatitis B virus (HBV) DNA is not clear.In this non-inferiority trial, patients with LAM

2018 PLoS ONE Controlled trial quality: uncertain

8. Efficacy and tolerability of lamivudine plus dolutegravir compared with lamivudine plus boosted PIs in HIV-1 positive individuals with virologic suppression: a retrospective study from the clinical practice. Full Text available with Trip Pro

Efficacy and tolerability of lamivudine plus dolutegravir compared with lamivudine plus boosted PIs in HIV-1 positive individuals with virologic suppression: a retrospective study from the clinical practice. Direct comparisons between lamivudine plus bPIs and lamivudine plus dolutegravir as maintenance strategies in virologically-suppressed HIV positive patients are lacking.Time to treatment discontinuation (TD) and virological failure (VF) were compared in a cohort of HIV+ patients (...) on a virologically-effective ART starting lamivudine with either darunavir/r, atazanavir/r or dolutegravir. Changes in laboratory parameters were also evaluated.Four-hundred-ninety-four patients were analyzed (170 switching to darunavir/r, 141 to atazanavir/r, 183 to dolutegravir): median age was 49 years, with 8 years since ART start. Groups differed for age, HIV-risk factor, time since HIV-diagnosis and on ART, previous therapy and reasons for switching. Estimated proportions free from TD at week 48 and 96

2019 BMC Infectious Diseases

9. Lamivudine plus tenofovir versus lamivudine plus adefovir for the treatment of hepatitis B virus in HIV-coinfected patients, starting antiretroviral therapy. Full Text available with Trip Pro

Lamivudine plus tenofovir versus lamivudine plus adefovir for the treatment of hepatitis B virus in HIV-coinfected patients, starting antiretroviral therapy. Combination of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and efavirenz (EFV) is preferred in the treatment of HIV/hepatitis B virus (HBV) coinfection. We postulated that a HBV active nucleoside reverse transcriptase (RT) inhibitor/nucleotide RT inhibitor backbone of adefovir dipivoxil (ADV) +3TC would be as effective as TDF (...) +3TC for the Indian population.ADV + 3TC could be an alternative option for these HIV/HBV coinfected individuals, preserving the dually active TDF + 3TC as second-line nucleoside backbone following failure of the first-line ART.This randomised control trial (CTRI/2012/03/002471) was carried out at the ART Centre of Calcutta School of Tropical Medicine, India. Seventy-eight (39 on each arm) treatment-naïve HIV/HBV coinfected patients were randomised to receive either the combination of lamivudine

2018 Indian Journal of Medical Microbiology Controlled trial quality: uncertain

10. Clinical, Immunological and Virological Responses of Zidovudine-Lamivudine-Nevirapine versus Zidovudine-Lamivudine-Efavirenz Antiretroviral Treatment (ART) Among HIV-1 Infected Children: Asella Teaching and Referral Hospital, South-East Ethiopia Full Text available with Trip Pro

Clinical, Immunological and Virological Responses of Zidovudine-Lamivudine-Nevirapine versus Zidovudine-Lamivudine-Efavirenz Antiretroviral Treatment (ART) Among HIV-1 Infected Children: Asella Teaching and Referral Hospital, South-East Ethiopia Antiretroviral Therapy(ART) remarkably reduced HIV-1 infection-related mortality in children. The efficacy and safety of different ART regimen in pediatric age groups remained issues of debates and available evidence were scarce especially among (...) children taking the of one the two prototypes (NVP or EFV) Non-Nucleoside Reverse Transcriptase Inhibitor(NNRTI) as backbone of ART regimen.Therefore, the objective of this study was to compare clinical, immunological and virological responses of zidovudine-lamivudine-nevirapine (AZT+3TC+ NVP) versus zidovudine-lamivudine-efavirenz (AZT+3TC+EFV) ART regimen among HIV-1 infected children.A retrospective cross-sectional study was done by reviewing medical records of the patients to evaluate clinical

2018 The open medical informatics journal

11. 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

12. 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)

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. Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM

Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study (...) of the RALAM - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID

2017 Clinical Trials

15. Dual therapy with darunavir and ritonavir plus lamivudine versus triple therapy with darunavir and ritonavir plus tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine for maintenance of HIV-1 viral suppression: randomised, open label Full Text available with Trip Pro

Dual therapy with darunavir and ritonavir plus lamivudine versus triple therapy with darunavir and ritonavir plus tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine for maintenance of HIV-1 viral suppression: randomised, open label Our objective was to assess the therapeutic noninferiority of dual therapy with darunavir/ritonavir and lamivudine compared to triple therapy with darunavir/ritonavir plus 2 nucleos(t)ides for maintenance of human immunodeficiency virus type 1 (...) (HIV-1) suppression.This was a multicenter, open-label, noninferiority trial (margin 12%). Patients with HIV-1 RNA <50 copies/mL for 6 months or longer on triple therapy with darunavir/ritonavir and 2 nucleos(t)ides (tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine) and with no resistance were randomized to continue therapy (n = 128) or switch to darunavir/ritonavir and lamivudine (n = 129). The primary endpoint was the proportion of participants with HIV-RNA <50 copies/mL

2017 Clinical Infectious Diseases Controlled trial quality: predicted high

16. Dolutegravir-lamivudine as initial therapy in HIV-1 infected, ARV-naive patients, 48-week results of the PADDLE (Pilot Antiretroviral Design with Dolutegravir LamivudinE) study. Full Text available with Trip Pro

Dolutegravir-lamivudine as initial therapy in HIV-1 infected, ARV-naive patients, 48-week results of the PADDLE (Pilot Antiretroviral Design with Dolutegravir LamivudinE) study. A proof-of-concept study was designed to evaluate the antiviral efficacy, safety and tolerability of a two-drug regimen with dolutegravir 50 mg once daily (QD) plus lamivudine 300 mg once daily as initial highly active antiretroviral therapy (HAART) among antiretroviral (ARV)-naive patients.PADDLE is a pilot study (...) changed the two-drug regimen. Observed failure rate was 5%. This is the first report of integrase strand transfer inhibitor/lamivudine dual regimen in ARV-naive patients.This novel dual regimen of dolutegravir and lamivudine warrants further clinical research and consideration as a potential therapeutic option for ARV-therapy-naive patients.NCT02211482.

2017 Journal of the International AIDS Society

17. 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 (Abstract)

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

18. Assessment of lamivudine, zidovudine, lopinavir, and ritonavir plasma levels in HIV-positive pregnant women: Drug monitoring application to improve patient safety. Full Text available with Trip Pro

Assessment of lamivudine, zidovudine, lopinavir, and ritonavir plasma levels in HIV-positive pregnant women: Drug monitoring application to improve patient safety. Simultaneous therapeutic drug monitoring (TDM) of combination antiretroviral therapy (cART) is critical during pregnancy in order to improve clinical follow-up, monitor viral load, and patient adherence to treatment.A modified simple and fast ultra-high performance liquid chromatography coupled with tandem mass spectrometry (...) and electrospray ionization (UPLC-ESI-MS/MS) method was developed and validated according to national and international guidelines for the simultaneous determination of lamivudine (LMV), zidovudine (ZDV), lopinavir (LPV), and ritonavir (RTV) concentrations in 100-μL plasma sample of Human Immunodeficiency Virus (HIV)-positive pregnant women. Protein precipitation using 0.1% formic acid in cold acetonitrile was used for sample preparation. The chromatographic separation was achieved with a run-time of 3.0

2020 Medicine

19. [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.

20. Lamivudine monotherapy as a holding regimen for HIV-positive children. Full Text available with Trip Pro

Lamivudine monotherapy as a holding regimen for HIV-positive children. In resource-limited settings holding regimens, such as lamivudine monotherapy (LM), are used to manage HIV-positive children failing combination antiretroviral therapy (cART) to mitigate the risk of drug resistance developing, whilst adherence barriers are addressed or when access to second- or third-line regimens is restricted. We aimed to investigate characteristics of children placed on LM and their outcomes.We describe

2018 PLoS ONE

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