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Changes over time in creatinine clearance and comparison of emergent adverse events for HIV-positive adults receiving standard doses (300 mg/day) of lamivudine-containing antiretroviral therapy with baseline creatinine clearance of 30-49 vs ≥50 mL/min
- Source :
- PLoS ONE, PLoS ONE, 14(11):e0225199. Public Library of Science, PLoS ONE, Vol 14, Iss 11, p e0225199 (2019)
- Publication Year :
- 2019
-
Abstract
- A retrospective analysis of the randomized controlled DART (Development of AntiRetroviral Therapy in Africa; ISRCTN13968779) trial in HIV-1-positive adults initiating antiretroviral therapy with co-formulated zidovudine/lamivudine plus either tenofovir, abacavir, or nevirapine was conducted to evaluate the safety of initiating standard lamivudine dosing in patients with impaired creatinine clearance (CLcr). Safety data collected through 96 weeks were analyzed after stratification by baseline CLcr (estimated using Cockcroft-Gault) of 30–49 mL/min (n = 168) versus ≥50 mL/min (n = 3,132) and treatment regimen. The Grade 3–4 adverse events (AEs) and serious AEs (for hematological, hepatic and gastrointestinal events), maximal toxicities for liver enzymes, serum creatinine and bilirubin and maximum treatment-emergent hematology toxicities were comparable for groups with baseline CLcr 30–49 versus CLcr≥50 mL/min. No new risks or trends were identified from this dataset. Substantial and similar increases in the mean creatinine clearance (>25 mL/min) were observed from baseline though Week 96 among participants who entered the trial with CLcr 30–49 mL/min, while no increase or smaller median changes in creatinine clearance ( 150 cells/ mm3) in mean CD4+ cells counts from baseline to Week 96 were also observed for participants who entered the trial with CLcr 30–49 mL/min and those with baseline CLcr ≥50 mL/min. Though these results are descriptive, they suggest that HIV-positive patients with CLcr of 30–49 mL/min would have similar AE risks in comparison to patients with CLcr ≥50 mL/min when initiating antiretroviral therapy delivering doses of 300 mg of lamivudine daily through 96 weeks of treatment. Overall improvements in CLcr were observed for patients with baseline CLcr 30–49 mL/min.
- Subjects :
- 0301 basic medicine
Male
RNA viruses
HIV Infections
Toxicology
Pathology and Laboratory Medicine
urologic and male genital diseases
Severity of Illness Index
Biochemistry
Geographical Locations
chemistry.chemical_compound
0302 clinical medicine
Immunodeficiency Viruses
Abacavir
Antiretroviral Therapy, Highly Active
Medicine and Health Sciences
Public and Occupational Health
030212 general & internal medicine
Multidisciplinary
Lamivudine
Hematology
Middle Aged
Vaccination and Immunization
female genital diseases and pregnancy complications
3. Good health
Research Design
Medical Microbiology
Creatinine
Viral Pathogens
Viruses
Medicine
Female
Anatomy
Pathogens
medicine.drug
Research Article
Adult
Zimbabwe
medicine.medical_specialty
Nevirapine
Anti-HIV Agents
Clinical Research Design
Science
Immunology
Urology
Renal function
Antiretroviral Therapy
Research and Analysis Methods
Microbiology
03 medical and health sciences
Zidovudine
Antiviral Therapy
Retroviruses
medicine
Humans
Dosing
Adverse effect
Microbial Pathogens
Toxicity
business.industry
Lentivirus
Organisms
Biology and Life Sciences
HIV
Renal System
030112 virology
CD4 Lymphocyte Count
chemistry
People and Places
Africa
Preventive Medicine
Adverse Events
business
Biomarkers
Subjects
Details
- ISSN :
- 19326203
- Database :
- OpenAIRE
- Journal :
- PLoS ONE
- Accession number :
- edsair.doi.dedup.....06106c51d9a9f7b910d52dc4eb21292d