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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. Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients. (PubMed)

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

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2018 PLoS ONE Controlled trial quality: uncertain

6. 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. (PubMed)

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

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2019 BMC Infectious Diseases

7. Lamivudine plus adefovir combination therapy versus entecavir monotherapy for lamivudine-resistant chronic hepatitis B: a systematic review and meta-analysis

Lamivudine plus adefovir combination therapy versus entecavir monotherapy for lamivudine-resistant chronic hepatitis B: a systematic review and meta-analysis Lamivudine plus adefovir combination therapy versus entecavir monotherapy for lamivudine-resistant chronic hepatitis B: a systematic review and meta-analysis Lamivudine plus adefovir combination therapy versus entecavir monotherapy for lamivudine-resistant chronic hepatitis B: a systematic review and meta-analysis Sheng YJ, Liu JY, Tong SW (...) , Hu HD, Zhang DZ, Hu P, Ren H CRD summary The review concluded that lamivudine plus adefovir was more effective and longer lasting than entecavir monotherapy in the treatment of lamivudine-resistant patients with chronic hepatitis B. The limited number patients and poor quality studies, along with no significant benefit shown in the analyses for virological response (the primary outcome), mean that the authors' conclusions may not be reliable. Authors' objectives To determine the efficacy

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2011 DARE.

8. Lamivudine plus tenofovir versus lamivudine plus adefovir for the treatment of hepatitis B virus in HIV-coinfected patients, starting antiretroviral therapy. (PubMed)

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

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2018 Indian Journal of Medical Microbiology Controlled trial quality: uncertain

9. 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 (PubMed)

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

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2018 The open medical informatics journal

10. Lamivudine plus tenofovir combination therapy versus lamivudine monotherapy for HBV/HIV coinfection: a meta-analysis (PubMed)

Lamivudine plus tenofovir combination therapy versus lamivudine monotherapy for HBV/HIV coinfection: a meta-analysis Currently, there is no consensus on the efficacy and safety of lamivudine (LAM) plus tenofovir disoproxil fumarate (TDF) combination therapy versus lamivudine monotherapy in HBV/HIV coinfected patients.A comprehensive literature search was performed in English and Chinese databases. Both relevant dichotomous and continuous variables were extracted, and the combined outcomes were

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2018 Virology 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. 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. (PubMed)

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.

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2017 Journal of the International AIDS Society

16. 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 (PubMed)

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

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2017 Clinical Infectious Diseases Controlled trial quality: predicted high

17. Zidovudine/Lamivudine vs. Abacavir/Lamivudine vs. Tenofovir/Emtricitabine in fixed-dose combinations as initial treatment for HIV patients: a systematic review and network meta-analysis. (PubMed)

Zidovudine/Lamivudine vs. Abacavir/Lamivudine vs. Tenofovir/Emtricitabine in fixed-dose combinations as initial treatment for HIV patients: a systematic review and network meta-analysis. Initial treatment of the HIV is based on the use of three drugs, two of which are nucleoside analog reverse-transcriptase inhibitors. There are three combinations of these drugs which have been approved by different guidelines, each with divergent results in terms of efficacy and safety.To compare the efficacy (...) and safety of these three combinations.Systematic review and network meta-analysis of randomized clinical trials comparing fixed doses of Tenofovir Disoproxil Fumarate / Emtricitabine (TDF/FTC), Abacavir / Lamivudine (ABC/3TC) and Zidovudine / Lamivudine (ZDV/3TC).Seven clinical trials met the eligibility criteria. The results suggested higher efficacy with TDF/FTC vs. ABC/3TC at 96 weeks and vs. ZDV/3TC at 48 weeks. However, there is clinical and statistical heterogeneity. Subgroup analysis were

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2017 Colombia medica (Cali, Colombia)

18. Efavirenz reduces renal excretion of lamivudine in rats by inhibiting organic cation transporters (OCT, Oct) and multidrug and toxin extrusion proteins (MATE, Mate). (PubMed)

Efavirenz reduces renal excretion of lamivudine in rats by inhibiting organic cation transporters (OCT, Oct) and multidrug and toxin extrusion proteins (MATE, Mate). Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor used in first-line combination antiretroviral therapy (cART). It is usually administered with nucleoside reverse transcriptase inhibitors (NRTI), many of which are substrates of OCT uptake solute carriers (SLC22A) and MATE (SLC47A), P-gp (MDR1, ABCB1), BCRP (ABCG2 (...) ), or MRP2 (ABCC2) efflux transporters. The aim of this study was to evaluate the inhibitory potential of efavirenz towards these transporters and investigate its effects on the pharmacokinetics and tissue distribution of a known Oct/Mate substrate, lamivudine, in rats. Accumulation and transport assays showed that efavirenz inhibits the uptake of metformin by OCT1-, OCT2- and MATE1-expressing MDCK cells and reduces transcellular transport of lamivudine across OCT1/OCT2- and MATE1-expressing MDCK

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2018 PLoS ONE

19. 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

20. [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.

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