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Benefit of Early versus Deferred Antiretroviral Therapy on Progression of Liver Fibrosis among People with HIV in the START Randomized Trial
Benefit of Early versus Deferred Antiretroviral Therapy on Progression of Liver Fibrosis among People with HIV in the START Randomized Trial
- Source :
- Hepatology (Baltimore, Md.)
- Publication Year :
- 2018
-
Abstract
- The role of antiretroviral therapy (ART) in reducing or contributing to liver fibrosis in persons with human immunodeficiency virus (HIV) is unclear. We evaluated participants in the Strategic Timing of AntiRetroviral Treatment (START) trial for liver fibrosis using the AST to Platelet Ratio Index (APRI) and Fibrosis-4 Index (FIB-4), and assessed for a benefit of early versus delayed ART on liver fibrosis progression. ART-naive persons with high CD4 counts (>500 cells/µL) from 222 clinical sites in 35 countries were randomized to receive ART either at study enrollment (immediate treatment arm) or when their CD4 count fell below 350 cells/µL (deferred treatment arm). The following outcomes were evaluated: fibrosis (APRI > 0.5 or FIB-4 > 1.45), significant fibrosis (APRI > 1.5 or FIB-4 > 3.25), hepatic flare, and resolution of elevated APRI and FIB-4 scores. Of the 4,684 enrolled into the START study, 104 did not have APRI or FIB-4 results and were excluded. Among 4,580 participants (2,273 immediate treatment; 2,307 deferred treatment), the median age was 36 years, 26.9% were female, and 30.4% were black. Three percent had an alcoholism or substance abuse history, 6.4% had hepatitis B and/or C, and 1.1% had significant fibrosis at baseline. The median CD4 count was 651, and 5.3% had HIV RNA ≤ 200. Immediate arm participants were at lower risk of developing increased fibrosis scores than deferred arm participants (hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.57-0.78; P < 0.001) and more likely to have resolution of elevated baseline scores (HR 1.6; 95% CI 1.3-1.9; P < 0.001). Conclusions: Significant liver fibrosis was rare among ART-naive HIV-positive persons with high CD4 counts. Our findings suggest a benefit of early ART in preventing the development of liver fibrosis.
- Subjects :
- Adult
Liver Cirrhosis
Male
medicine.medical_specialty
HIV Infections
Lower risk
law.invention
Time-to-Treatment
Cohort Studies
03 medical and health sciences
Liver disease
Steatohepatitis/Metabolic Liver Disease
0302 clinical medicine
Randomized controlled trial
law
Fibrosis
Internal medicine
Early Medical Intervention
medicine
Humans
030212 general & internal medicine
Hepatology
business.industry
Hazard ratio
Original Articles
Hepatitis B
medicine.disease
Confidence interval
3. Good health
Substance abuse
Anti-Retroviral Agents
Disease Progression
030211 gastroenterology & hepatology
Female
Original Article
business
Subjects
Details
- ISSN :
- 15273350
- Volume :
- 69
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- Hepatology (Baltimore, Md.)
- Accession number :
- edsair.doi.dedup.....a0985570039bb1fb8009cfb14f54ea76