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Lamivudine

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21. 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

2015 Health Technology Assessment (HTA) Database.

22. Effectiveness of tenofovir, entecavir and lamivudine in nucleos(t)ide analogue-naive chronic hepatitis B: a systematic review and network meta-analysis

Effectiveness of tenofovir, entecavir and lamivudine in nucleos(t)ide analogue-naive chronic hepatitis B: a systematic review and network meta-analysis Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content

2019 PROSPERO

23. Long-term efficacy and safety of rilpivirine plus abacavir and lamivudine in HIV-1 infected patients with undetectable viral load. (PubMed)

Long-term efficacy and safety of rilpivirine plus abacavir and lamivudine in HIV-1 infected patients with undetectable viral load. A regimen with rilpivirine (RPV), abacavir (ABC) and lamivudine (3TC) is simple and may allow the sparing of tenofovir and protease inhibitors. However, data on use of this combination as a strategy of switch are limited. Aims of the study were to assess the long-term efficacy and safety of this regimen.Retrospective study on HIV-1 infected patients followed

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2018 PLoS ONE

24. 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

25. 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

26. 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

27. Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA <500 000 copies/mL: week 48 outcomes from ACTG 5353. (PubMed)

Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA <500 000 copies/mL: week 48 outcomes from ACTG 5353. The AIDS Clinical Trials Group study A5353 demonstrated the efficacy and safety of dolutegravir and lamivudine for initial treatment of HIV-1 infection at week 24 in individuals with HIV-1 RNA 1000-500 000 copies/mL. Optimal ART for treatment-naive individuals must be durable.The aim of this study was to estimate the efficacy and safety (...) of dolutegravir plus lamivudine at week 48 and compare the efficacy in participants with baseline HIV-1 RNA ≤100 000 copies/mL versus >100 000 copies/mL.Virological success was defined as HIV-1 RNA <50 copies/mL by FDA Snapshot criteria. Definition of virological failure included confirmed HIV-1 RNA >200 copies/mL at week 24 or later. The proportion of participants with virological success was estimated using two-sided exact Clopper-Pearson 95% CI. Comparison between screening HIV-1 RNA (≤100 000 versus >100

2019 Journal of Antimicrobial Chemotherapy

28. Dolutegravir and lamivudine vs other antiviral regimens in HIV-1 treatment-naïve patients: a systematic review and network meta-analysis. (PubMed)

Dolutegravir and lamivudine vs other antiviral regimens in HIV-1 treatment-naïve patients: a systematic review and network meta-analysis. Compare the efficacy and safety of the 2-drug antiretroviral therapy (ART) regimen dolutegravir + lamivudine (DTG+3TC) with traditional 3-drug regimens in treatment-naïve patients with HIV-1.Data from double-blind, randomized controlled trials (RCTs) of ≥48 weeks' duration in treatment-naïve patients with HIV-1 identified by systematic review were evaluated (...) difference for viral suppression at 48 weeks for Dolutegravir + Lamivudine (DTG+3TC) versus the other 13 regimens included in the network ranged from -2.7% (-11.0%, 5.6%) vs DTG + tenofovir alafenamide (TAF)/FTC to 7.3% (0.6%, 13.8%) vs efavirenz + tenofovir disoproxil fumarate/emtricitabine (EFV+TDF/FTC). DTG+3TC was found to be significantly better than EFV+TDF/FTC and similar to all other regimens analysed in terms of viral suppression at 48 weeks. With regards to other outcomes (CD4, AE, SAE, DRAE

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2019 AIDS

29. Long-term virological suppression on first-line efavirenz + tenofovir + emtricitabine/lamivudine for HIV-1. (PubMed)

Long-term virological suppression on first-line efavirenz + tenofovir + emtricitabine/lamivudine for HIV-1. Evaluate long-term rates of virological failure and treatment interruption for people living with HIV (PLWHIV) with viral suppression on first-line efavirenz + tenofovir disoproxil fumarate + emtricitabine/lamivudine (EFV + TDF + FTC/3TC), and compare these according to patient characteristics.PLWHIV enrolled in the Collaboration of Observational HIV Epidemiological Research Europe cohort

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2019 AIDS

30. Switching Lamivudine with Adefovir Dipivoxil Combination Therapy to Entecavir Monotherapy Provides Better Viral Suppression and Kidney Safety. (PubMed)

Switching Lamivudine with Adefovir Dipivoxil Combination Therapy to Entecavir Monotherapy Provides Better Viral Suppression and Kidney Safety. Introduction: Most chronic hepatitis B (CHB) patients in China are primitively treated with a combination of lamivudine (LAM) and adefovir dipivoxil (ADV). Although antiviral resistance can be avoided with this combination therapy, using it can have harmful side effects related to ADV, specifically kidney and bone injury. This study was designed

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2019 International journal of medical sciences

31. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phas (PubMed)

Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phas Bictegravir, co-formulated with emtricitabine and tenofovir alafenamide, has shown good efficacy and tolerability, and similar bone, renal, and lipid profiles to dolutegravir, abacavir, and lamivudine, in treatment-naive adults with HIV-1 (...) infection, without development of treatment-emergent resistance. Here, we report 48-week results of a phase 3 study investigating switching to bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir, abacavir, and lamivudine in virologically suppressed adults with HIV-1 infection.In this multicentre, randomised, double-blind, active-controlled, non-inferiority, phase 3 trial, HIV-1-infected adults were enrolled at 96 outpatient centres in nine countries. Eligible participants were aged

2019 The lancet. HIV Controlled trial quality: predicted high

32. Case report of Triumeq (abacavir/dolutegravir/lamivudine) associated rhabdomyolysis in a human immunodeficiency virus (HIV) infected patient. (PubMed)

Case report of Triumeq (abacavir/dolutegravir/lamivudine) associated rhabdomyolysis in a human immunodeficiency virus (HIV) infected patient. With the existence of the human immunodeficiency virus (HIV) infection as a chronic disease, more often adverse effects of its treatment with the various antiretroviral therapies (ARTs) available have been recognized. Going further, Triumeq has been associated with a myriad of adverse effects, of which rhabdomyolysis is rarely reported

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2019 Medicine

33. Comparable viral decay with initial dolutegravir plus lamivudine versus dolutegravir-based triple therapy. (PubMed)

Comparable viral decay with initial dolutegravir plus lamivudine versus dolutegravir-based triple therapy. To expand understanding of the virological potency of initial dolutegravir plus lamivudine dual therapy (dolutegravir/lamivudine), we compared the viral decay seen in the pilot ACTG A5353 study with the decay observed with dolutegravir plus two NRTIs in the SPRING-1 and SINGLE studies, while also exploring the impact of baseline viral load (VL).Change in VL from baseline was calculated (...) for timepoints shared by A5353 (n = 120, including 37 participants with pretreatment VL >100 000 copies/mL), SPRING-1 (n = 51) and SINGLE (n = 417). The 95% CIs of change from baseline were determined for each observed week, using the mean log10-transformed VL, and compared between the dolutegravir/lamivudine and triple therapy groups using the Wilcoxon Rank Sum test for non-inferiority (δ = 0.5). To assess the impact of baseline VL on viral decay, we examined a bi-exponential non-linear mixed-effect

2019 Journal of Antimicrobial Chemotherapy

34. Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes. (PubMed)

Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes. Describe the pharmacokinetics (PK) of the antiretroviral drugs abacavir and lamivudine in malnourished paediatric patients and relate to viral load outcomes after 12 and 48 weeks of treatment.Severely malnourished human immunodeficiency virus-infected children were randomized to early (within 14 days) or delayed (after nutritional (...) recovery) initiation of antiretroviral treatment (ART) using World Health Organization weight-band dosages. Abacavir and lamivudine concentrations were measured as a secondary objective on day 1 and day 14 and patients were followed-up to week 48. Population PK of abacavir and lamivudine were described using NONMEM.In total, 623 abacavir and 627 lamivudine concentrations were collected from 75 paediatric patients aged 0.1-10.8 (median 1.4) years. Abacavir PK was described by a 2-compartment model

2019 British journal of clinical pharmacology Controlled trial quality: uncertain

35. No Significant Changes to Residual Viremia After Switch to Dolutegravir and Lamivudine in a Randomized Trial. (PubMed)

No Significant Changes to Residual Viremia After Switch to Dolutegravir and Lamivudine in a Randomized Trial. In the ASPIRE trial, antiretroviral therapy (ART) switch to dolutegravir plus lamivudine (DTG+3TC) was comparable to 3-drug ART in maintaining viral suppression by standard viral load assays. We used an ultrasensitive assay to assess whether this switch led to increased residual viremia. At entry, levels of residual viremia did not differ significantly between arms (DTG+3TC vs 3-drug

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2019 Open forum infectious diseases Controlled trial quality: uncertain

36. Dual therapy with lopinavir/ritonavir plus lamivudine could be a viable alternative for antiretroviral-therapy-naive adults with HIV-1 infection regardless of HIV viral load or subgenotype in resource-limited settings: A randomised, open-label and non-inf (PubMed)

Dual therapy with lopinavir/ritonavir plus lamivudine could be a viable alternative for antiretroviral-therapy-naive adults with HIV-1 infection regardless of HIV viral load or subgenotype in resource-limited settings: A randomised, open-label and non-inf This randomised controlled, open-label, non-inferiority trial was conducted in antiretroviral-naïve HIV-1-infected patients to assess the efficacy and safety of 48-week dual therapy of LPV/r plus 3TC (DT group) compared with Chinese first-line

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2019 Indian Journal of Medical Microbiology Controlled trial quality: uncertain

37. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. (PubMed)

Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Bictegravir co-formulated with emtricitabine and tenofovir alafenamide as a fixed-dose combination is recommended for treatment of HIV-1-infection and might be better tolerated than other integrase inhibitor-based single-tablet regimens, but long-term (...) outcomes data are not available. We assessed the efficacy, safety and tolerability of bictegravir, emtricitabine, and tenofovir alafenamide compared with co-formulated dolutegravir, abacavir, and lamivudine at week 96.This ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial was done at 122 outpatient centres in nine countries. We enrolled adults (aged ≥18 years) living with HIV who were treatment naive and HLA-B*5701 negative, did not have hepatitis B virus

2019 The lancet. HIV Controlled trial quality: predicted high

38. Growth in HIV-1-exposed but uninfected infants treated with lopinavir-ritonavir versus lamivudine: a secondary analysis of the ANRS 12174 trial. (PubMed)

Growth in HIV-1-exposed but uninfected infants treated with lopinavir-ritonavir versus lamivudine: a secondary analysis of the ANRS 12174 trial. The tolerance of antiretroviral drugs in infants must be carefully evaluated. In previous studies of children with HIV type 1 (HIV-1) less weight gain was observed in children given lopinavir-ritonavir-based combinations than those given nevirapine. We aimed to compare the effects of lopinavir-ritonavir and lamivudine on growth in HIV-exposed (...) uninfected infants included in the ANRS 12174 trial.ANRS 12174 was a multicentre, randomised, controlled trial of infant prophylaxis to prevent HIV-1 transmission by breastfeeding done at four antenatal clinics in Burkina Faso, South Africa, Uganda, and Zambia. HIV-exposed uninfected infants born to asymptomatic mothers not eligible for antiretroviral therapy (CD4 count >350 cells per μL) were randomly assigned (1:1) to receive lopinavir-ritonavir or lamivudine 7 days after birth, with stratification

2019 The lancet. HIV Controlled trial quality: predicted high

39. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial. (PubMed)

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 suppressed for ≥6 months on 2 nucleoside reverse transcriptase inhibitors plus a boosted protease (...) inhibitor, boosted elvitegravir, or a non-nucleoside reverse transcriptase inhibitor were randomized (2:1) to switch to once-daily, single-tablet doravirine 100 mg with lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg (DOR/3TC/TDF) or to continue their current therapy (Baseline Regimen) for 24 weeks. The primary endpoint was the proportion of participants with HIV-1 RNA <50 copies/mL (defined by the FDA Snapshot approach), with the primary comparison between DOR/3TC/TDF at week 48 and Baseline

2019 Journal of acquired immune deficiency syndromes (1999) Controlled trial quality: uncertain

40. Dual therapy with renally adjusted lamivudine and dolutegravir: a switch strategy to manage comorbidity and toxicity in older, suppressed patients? (PubMed)

Dual therapy with renally adjusted lamivudine and dolutegravir: a switch strategy to manage comorbidity and toxicity in older, suppressed patients? The aim of the study was to evaluate the efficacy of dual therapy with lamivudine (3TC), with dose adjustment for renal function, and dolutegravir (DTG) in a subgroup of patients fully suppressed on treatment who were switched because of concerns about comorbidity and toxicity on their current triple drug regimen.A retrospective evaluation

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2019 HIV medicine

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