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Lamivudine

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21. No difference in effectiveness of treatment simplification to boosted or unboosted atazanavir plus lamivudine in virologically suppressed in HIV-1-infected patients. Full Text available with Trip Pro

No difference in effectiveness of treatment simplification to boosted or unboosted atazanavir plus lamivudine in virologically suppressed in HIV-1-infected patients. Simplification strategies of antiretroviral treatment represent effective tools for the reduction of drug-induced toxicity, resistance mutations in case of virological failure and costs.To assess the effectiveness of simplification to atazanavir/ritonavir (ATVrtv) or unboosted atazanavir (ATV400) plus lamivudine, and if low plasma (...) or intracellular ATV Ctrough influence virological outcomes.Ambispective observational study in patients with undetectable HIV-RNA who were switched to ATVrtv or ATV400 plus lamivudine once daily. Previous virological failures (VF) were allowed if the resistance tests showed major resistance mutation neither to ATV nor to lamivudine. VF was defined as two consecutive plasma HIV-RNA >200 copies/mL. Effectiveness was assessed by intention-to-treat and on-treatment analyses. Plasma and intracellular ATV Ctrough

2018 PLoS ONE

22. Long-term efficacy and safety of rilpivirine plus abacavir and lamivudine in HIV-1 infected patients with undetectable viral load. Full Text available with Trip Pro

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

2018 PLoS ONE

23. Efavirenz reduces renal excretion of lamivudine in rats by inhibiting organic cation transporters (OCT, Oct) and multidrug and toxin extrusion proteins (MATE, Mate). Full Text available with Trip Pro

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

2018 PLoS ONE

24. Raltegravir plus abacavir/lamivudine in virologically suppressed HIV-1-infected patients: 48-week results of the KIRAL study. Full Text available with Trip Pro

Raltegravir plus abacavir/lamivudine in virologically suppressed HIV-1-infected patients: 48-week results of the KIRAL study. Long-term combination antiretroviral therapy often results in toxicity/tolerability problems, which are one of the main reasons for switching treatment. Despite the favorable profile of raltegravir (RAL), data on its combination with abacavir/lamivudine (ABC/3TC) are scarce. Based on clinical data, we evaluated this regimen as a switching strategy.Multicenter, non

2018 PLoS ONE

25. 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

26. 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

27. 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

28. Lamivudine plus adefovir combination therapy versus entecavir monotherapy for lamivudine-resistant chronic hepatitis B: a systematic review and meta-analysis Full Text available with Trip Pro

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

2011 DARE.

29. A 24-week pilot study of dual maintenance therapy with raltegravir and lamivudine. (Abstract)

A 24-week pilot study of dual maintenance therapy with raltegravir and lamivudine. There is an increasing interest in two-drug regimens. We hypothesized that maintenance therapy with raltegravir and lamivudine would keep HIV-1 suppressed and be well tolerated.Virally suppressed HIV-1-infected adults without previous viral failures or known resistance mutations to integrase inhibitors or 3TC/FTC or chronic hepatitis B were randomized 2 : 1 to switch to fixed-dose combination 150 mg lamivudine (...) : raltegravir and lamivudine 2 (4%) vs. control 5 (20%). The difference in proportions of therapeutic failures raltegravir and lamivudine minus control was -0.159 (95% confidence interval: -0.353 to -0.012). There was a trend to more weight gain with raltegravir and lamivudine, but no significant changes in other secondary outcomes. Sixty-four percent of patients in each arm had at least one adverse effect. Two (6%) patients in control arm and 4 (7%) patients in raltegravir and lamivudine arm had severe

2019 AIDS Controlled trial quality: uncertain

30. 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 Full Text available with Trip Pro

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

2019 Indian Journal of Medical Microbiology Controlled trial quality: uncertain

31. No Significant Changes to Residual Viremia After Switch to Dolutegravir and Lamivudine in a Randomized Trial. Full Text available with Trip Pro

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

2019 Open forum infectious diseases Controlled trial quality: uncertain

32. Case report of Triumeq (abacavir/dolutegravir/lamivudine) associated rhabdomyolysis in a human immunodeficiency virus (HIV) infected patient. Full Text available with Trip Pro

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

2019 Medicine

33. Lamivudine-based maintenance antiretroviral therapies in patients living with HIV-1 with suppressed HIV RNA: derivation of a predictive score for virological failure. (Abstract)

Lamivudine-based maintenance antiretroviral therapies in patients living with HIV-1 with suppressed HIV RNA: derivation of a predictive score for virological failure. Two-drug antiretroviral regimens based on lamivudine (3TC) plus either a protease inhibitor (PI) or dolutegravir (DTG) are becoming increasingly popular in switch strategies. Our goal was to derive a predictive score for virological failure (VF).We retrospectively analysed data for a cohort of 587 virologically suppressed (HIV RNA (...) < 37 HIV-1 RNA copies/mL), adult (≥ 18 years old) patients starting lamivudine plus either a boosted PI or dolutegravir. Predictors of VF (defined as a single HIV RNA measurement ≥ 1000 copies/mL or two consecutive HIV RNA measurements ≥ 50 copies/mL) were identified using a multivariate Cox regression model. A 'weighted' score was assigned to each variable associated with VF; the discriminative power of the score obtained was expressed as the area under the receiver-operator characteristic curve

2019 HIV medicine

34. Depot medroxyprogesterone acetate and the vaginal microbiome as modifiers of tenofovir diphosphate and lamivudine triphosphate concentrations in the female genital tract of Ugandan women: Implications for TDF/3TC in pre-exposure prophylaxis. (Abstract)

Depot medroxyprogesterone acetate and the vaginal microbiome as modifiers of tenofovir diphosphate and lamivudine triphosphate concentrations in the female genital tract of Ugandan women: Implications for TDF/3TC in pre-exposure prophylaxis. Effective concentrations of antiretrovirals in the female genital tract (FGT) are critical for suppression of viral shedding or effective pre-exposure prophylaxis. The disposition of tenofovir diphosphate (TFVdp) and emtricitabine triphosphate (FTCtp (...) ) in the FGT have been previously described. Despite widespread use, however, lamivudine triphosphate (3TCtp) exposure in FGT is unknown. Depot medroxyprogesterone acetate (DMPA) and vaginal dysbiosis have been implicated in increased risk of HIV acquisition but whether they alter TFVdp or 3TCtp exposure, and therefore compromise prevention efficacy, is unknown.Fifty pre-menopausal women living with HIV in Kampala, Uganda and receiving daily tenofovir disoproxil fumarate/lamivudine, were recruited

2019 Clinical Infectious Diseases

35. Long-term virological suppression on first-line efavirenz + tenofovir + emtricitabine/lamivudine for HIV-1. Full Text available with Trip Pro

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

2019 AIDS

36. Dual therapy with renally adjusted lamivudine and dolutegravir: a switch strategy to manage comorbidity and toxicity in older, suppressed patients? Full Text available with Trip Pro

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

2019 HIV medicine

37. DOLAMA study: Effectiveness, safety and pharmacoeconomic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients. Full Text available with Trip Pro

DOLAMA study: Effectiveness, safety and pharmacoeconomic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients. Dolutegravir (DTG) has shown effectiveness in combination with rilpivirine in with experience of antiretroviral therapy (ART) and with 3TC in naïve patients (GEMINI trial). The main objectives of this real-life study were to analyze the effectiveness and safety of 3TC plus DTG in virologically suppressed HIV-1 patients and to conduct

2019 Medicine

38. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial. Full Text available with Trip Pro

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

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

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

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

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

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