Abstract | OBJECTIVE: HIV-infected patients are at increased risk of nonalcoholic steatohepatitis (NASH). Vitamin E is recommended for treatment of NASH in the general population. However, its safety and efficacy among HIV-infected patients remain unknown. DESIGN: Single-centre, phase IV, open-label, single arm clinical trial. METHODS: HIV mono-infected patients without significant alcohol intake or viral hepatitis coinfection were included. The diagnosis of NASH was based on the co-existence of fatty liver, diagnosed by controlled attenuation parameter (CAP) at least 248 dB/m and significant hepatocyte apoptosis, defined by the serum biomarker cytokeratin 18 (CK-18) greater than 130.5 U/L. Participants were treated with 800 IU daily of oral vitamin E ( alpha-tocopherol) for 24 weeks, and followed for an additional 24 weeks postdiscontinuation. Generalized linear mixed effects models were used to evaluate changes in alanine aminotransferase (ALT), CAP and CK-18 at the completion of treatment and end of follow-up, controlling for pretreatment trends. RESULTS: A total of 27 patients were included. Four (15%) had a pretreatment liver biopsy, which confirmed the diagnosis of NASH in all cases. Compared with baseline, 24 weeks of vitamin E treatment improved ALT [-27 units/l; 95% confidence interval (CI) -37 to -17], CAP scores (-22 dB/m; 95% CI -42 to -1) and CK-18 (-123 units/l; 95% CI -201 to -46). Conversely, there was no change in BMI. No serious adverse event was reported and no patient was lost to follow-up. CONCLUSION: In this first clinical trial, we showed that vitamin E is an effective and well tolerated treatment for NASH in HIV-infected patients.
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Authors | Giada Sebastiani, Sahar Saeed, Bertrand Lebouche, Alexandra de Pokomandy, Jason Szabo, Louis-Patrick Haraoui, Jean-Pierre Routy, Philip Wong, Marc Deschenes, Peter Ghali, Marina Klein, LIVEHIV Study Group |
Journal | AIDS (London, England)
(AIDS)
Vol. 34
Issue 2
Pg. 237-244
(02 01 2020)
ISSN: 1473-5571 [Electronic] England |
PMID | 31651429
(Publication Type: Clinical Trial, Phase IV, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Keratin-18
- Vitamin E
- Alanine Transaminase
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Topics |
- Administration, Oral
- Alanine Transaminase
(metabolism)
- Canada
- Coinfection
(drug therapy)
- Female
- HIV Infections
(complications)
- Humans
- Keratin-18
(metabolism)
- Male
- Middle Aged
- Non-alcoholic Fatty Liver Disease
(complications, diagnosis, drug therapy)
- Treatment Outcome
- Vitamin E
(administration & dosage, therapeutic use)
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