Meta AnalysisID 4015
病毒学抑制稳定患者换用增效蛋白酶抑制剂联合拉米夫定双药方案对比三联抗病毒治疗的疗效与安全性：一项对随机对照试验的个体患者数据Meta分析
CRD42017058511
How efficacious is the switching to boosted protease inhibitor (PI) plus lamivudine dual therapy, as compared to two nucleos(t)ides (NUCs) plus PI triple therapy in maintaining virological response in suppressed stable H
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 4015
- Evidence Id
- 12573
- Core Evidence Id
- 12573
- Source Meta Analysis Id
- 3974
- Herb2 Meta Analysis Id
- HBMA003974
- Crd Id
- CRD42017058511
- Title
- Efficacy and safety of switching to dual therapy with boosted protease inhibitor plus lamivudine dual regimens compared to triple antiretroviral treatment in virologically suppressed stable patients. an individual patient data meta-analysis of randomized controlled trials
- Review Question
- How efficacious is the switching to boosted protease inhibitor (PI) plus lamivudine dual therapy, as compared to two nucleos(t)ides (NUCs) plus PI triple therapy in maintaining virological response in suppressed stable HIV-1 infected patients? How safe is this switching strategy? Is the efficacy significantly different according to particular patients' characteristics such as sex, active Hepatitis C Virus (HCV) virus infection, time on cART, duration of viral load suppression, CD4 cell count (current and nadir) and type of PI?
- Study Type Included
- Randomised controlled trials.
- Condition Being Studied
- Treatment of chronic HIV-1 infection
- Participant
- * Inclusion criteria: Patients aged >=18 years with chronic HIV-1 infection, Stable cART based on two Nucleos(t)ides (NUCs) plus a third drug such as a PI, a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor (InI), Viral suppression (HIV-1-RNA <50 copies/mL for >=6 months), HBsAg-negative status. * Exclusion criteria: Previous virological failure on study drugs, Pregnancy or breastfeeding.
- Animal
- Human Disease Modelled
- Intervention
- Switch to boosted protease inhibitor plus lamivudine dual therapy (PI+3TC).
- Comparator Control
- Antiretroviral triple therapy based on boosted protease inhibitor plus two nucleos(t)ides (PI+2NUCs).
- Main Outcome
- The primary endpoint is to demonstrate the non-inferiority of PI+3TC vs PI+2NUCs with regard to the proportion of patients with virological failure. Measures of effect Virological failure is defined as the proportion of patients with an HIV-1 viral load equal to or above 50 copies/mL at 48 weeks. The margin for non-inferiority will be fixed at 4% (for a 95% confidence interval). This stringent endpoint is in line with the new recommendations made by the FDA for switching trials. Virological failure: failure is defined as two consecutive viral loads (14 days or longer and not more than 30 days apart) equal or greater than 50 copies/mL at any scheduled visit. Missing patients, lack of virological data at 48 weeks and changes in any study drug, will not be considered virological failures in this analysis. Virological failure will be evaluated in the per-protocol and intention to treat population using the snapshot algorithm.
- Outcome Measure
- Additional Outcome
- To demonstrate the non-inferiority of the virological response between treatment groups (PI+3TC vs. PI+2NUCs). Safety: proportion of adverse reactions (grade 3-4) and proportion of treatment discontinuation through 48 weeks. Changes in CD4 cell count through 48 weeks. Proportion and type of resistance mutations after virological failure. Average change from baseline in renal function, blood lipid levels, bone mass density and neurocognitive performance. Measures of effect Virological response is defined as the proportion of patients with an HIV-1 viral load of less than 50 copies per mL at week 48. The margin for non-inferiority will be fixed at 12% (for a 95% confidence interval) using the snapshot algorithm. Patients without virological response can belong to the following categories: Virological failure: failure is defined as two consecutive viral loads (14 days or longer and not more than 30 days apart) greater than 50 copies/mL at any scheduled visit. Missing patients. Changes in any study drug. Virological response will be evaluated using the SNAPSHOT algorithm in the per-protocol and intention to treat populations.
- Study Method
- Systematic review
- Keyword
- Anti-HIV Agents; Humans; Lamivudine; Protease Inhibitors; Randomized Controlled Trials as Topic; Reverse Transcriptase Inhibitors
- Contact
- José A. Pérez-Molina [email protected]
- Organisational Affiliation
- Funding Source
- The review is sponsored by a scientific Society through its charity, Fundación SEIMC-GeSIDA (http://fundacionseimcgesida.org/en). The review is funded by an unrestricted grant from Janssen to Fundación SEIMC-GeSIDA.
- Other Selection Criteria
- Final Publication
- Individual patient data meta-analysis of randomized controlled trials of dual therapy with a boosted PI plus lamivudine for maintenance of virological suppression: GeSIDA study 9717 J A Perez-Molina, F Pulido, S Di Giambenedetto, E Ribera, S Moreno, J Zamora, C Coscia, B Alejos, J Pitch, J M Gatell, A De Luca, J R Arribas. Journal of Antimicrobial Chemotherapy, Volume 73, Issue 11, November 2018, Pages 2927–2935. https://doi.org/10.1093/jac/dky299 Published: 03 August 2018. https://academic.oup.com/jac/article/73/11/2927/5066381
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Spain
- Review Stage
- Review Completed published
- First Submission Date
- 2018-02-16
- Registration Date
- 2017-06-07
- Anticipated Start Date
- 2017-03-06
- Anticipated Completion Date
- 2017-11-06
- Title Cn
- 病毒学抑制稳定患者换用增效蛋白酶抑制剂联合拉米夫定双药方案对比三联抗病毒治疗的疗效与安全性：一项对随机对照试验的个体患者数据Meta分析
- Title En
- Efficacy and safety of switching to dual therapy with boosted protease inhibitor plus lamivudine dual regimens compared to triple antiretroviral treatment in virologically suppressed stable patients. an individual patient data meta-analysis of randomized controlled trials
- Bilingual Status
- complete