Meta AnalysisID 4012
增效蛋白酶抑制剂联合拉米夫定双药方案作为病毒学抑制HIV-1感染成人维持治疗的疗效与安全性：一项Meta分析
CRD42015024565
Assess the efficacy and safety of dual therapy in patients with long-term virological suppression in comparison to standard triple therapy.
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 4012
- Evidence Id
- 12570
- Core Evidence Id
- 12570
- Source Meta Analysis Id
- 3971
- Herb2 Meta Analysis Id
- HBMA003971
- Crd Id
- CRD42015024565
- Title
- Efficacy and safety of dual therapy with boosted protease inhibitor plus lamivudine as a maintenance regimen in virologically suppressed HIV-1 infected adults: a meta-analysis
- Review Question
- Assess the efficacy and safety of dual therapy in patients with long-term virological suppression in comparison to standard triple therapy.
- Study Type Included
- Randomized controlled trials and cohorts.
- Condition Being Studied
- The current standard of treatment in Human Immunodeficiency Virus (HIV) infection often involves a combination of at least three antiretroviral agents to fully suppress HIV-1 viremia. However, there are enormous challenges associated with the management of chronically HIV-infected patients: presence of co-morbidities, drug-drug interactions, long-term drug toxicities and lack of treatment compliance. Therefore, simplified HIV treatment has emerged as option to maintain viral control in selected individuals. In this context, dual therapy consisting of ritonavir boosted protease inhibitor (PI/r) plus lamivudine (3TC), is a treatment simplification strategy for patients whom intolerance and toxicity related to nucleos(t)ides (NtRTI) is a major concern. Furthermore, this combination has the potential advantages of once-daily administration, fewer interactions and lower cost, especially now that the generic formulation of 3TC is widely available.
- Participant
- Inclusion criteria: Studies are considered eligible if they are randomized controlled trials or observational studies evaluating the efficacy and safety of dual therapy including boosted protease inhibitor plus lamivudine in virologically suppressive HIV-infected adults patients. Patients must be HIV-1 treatment-experienced with a maintained plasma virological suppression for at least 6 months before switching to dual therapy. Exclusion criteria: A study is excluded if it described the efficacy of dual therapy in HIV treatment-naïve subjects or if dual therapies other than 3TC plus PI/r are evaluated.
- Animal
- Human Disease Modelled
- Intervention
- Dual therapy consisting of lamivudine and boosted protease inhibitors.
- Comparator Control
- Triple therapy (standard therapy consisting of 2 nucleosi(t)ides plus a boosted protease inhibitor).
- Main Outcome
- The primary outcome is the proportion of patients maintaining HIV-1 RNA levels < 50 copies/ml through 48-week duration calculated in an intention-to-treat (loss-of follow-up or missing data or discontinuation of assigned drugs equals failure) basis for RCTs. For observational studies, we will extract the proportion of subjects that develop treatment failure through 48-week. Measures of effect Effect measure that will be used is risk ratio of virologic failure. Virological failure is defined as confirmed HIV-RNA > 50 copies per mL in two consecutive determinations. Treatment failure is defined as a discontinuation or switching of the regimen or virological failure.
- Outcome Measure
- Additional Outcome
- Secondary outcomes that will be included are the immunologic recovery rate, renal function and lipid parameters from the baseline to end of 48-week, for each antiretroviral strategy. Measures of effect The effect measure that will be used is standardized differences in means. Changes in CD4+ cell count, total cholesterol, and estimated glomerular filtration rate (eGFR) from the baseline to the end of the maintenance phase.
- Study Method
- Keyword
- Adult; Anti-HIV Agents; HIV Infections; HIV-1; Humans; Lamivudine; Protease Inhibitors
- Contact
- Dr Moreira [email protected]
- Organisational Affiliation
- Instituto Nacional de Infectologia Evandro Chagas (INI), FIOCRUZ www.ini.fiocruz.br
- Funding Source
- Brazilian National Council for Scientific and Technological Development (CNPq)
- Other Selection Criteria
- Final Publication
- Same Topic Review
- There is no prior review on this topic.
- Published Protocol
- Review Type
- Language
- English
- Country
- Brazil
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2015-07-16
- Anticipated Start Date
- 2015-06-01
- Anticipated Completion Date
- 2015-09-01
- Title Cn
- 增效蛋白酶抑制剂联合拉米夫定双药方案作为病毒学抑制HIV-1感染成人维持治疗的疗效与安全性：一项Meta分析
- Title En
- Efficacy and safety of dual therapy with boosted protease inhibitor plus lamivudine as a maintenance regimen in virologically suppressed HIV-1 infected adults: a meta-analysis
- Bilingual Status
- complete