Vitamin E is an effective treatment for nonalcoholic steatohepatitis in HIV mono-infected patients

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.

New Drugs for NASH and HIV Infection: Great Expectations for a Great Need

“…At present, vitamin E treatment may be considered as a bridge therapy only, while waiting for availability of new drug combinations simultaneously addressing steatosis and fibrosis (Table 3). ( 38 )…”

Prevalence and risk factors of metabolic associated fatty liver disease among people living with HIV in China

“…Although tesamorelin was well tolerated with no overall change in fasting glucose or HbA1c, there were still two study discontinuations in the tesamorelin group due to hyperglycemia 19 . Another trial showed that 24 weeks of vitamin E treatment decreased ALT and the degree of hepatic steatosis in HIV mono‐infected patients with non‐alcoholic steatohepatitis and showed no change in triglycerides, total cholesterol, HDL cholesterol, and HOMA‐IR 20 . Nevertheless, a randomized controlled trial of statin versus placebo, 147 HIV‐infected individuals with 96‐week follow‐up had hepatic steatosis increased over time, regardless of statin treatment 21 .…”

Role of Vitamin E in Boosting the Immunity from Neonates to Elderly

“…The previous studies with 27 HIV patients with NASH reported that vitamin E supplementation was a most effective treatment as it has enhanced the ALT level, ck-18 and CAP score. Moreover, it does not cause any adverse effects in participated individuals [59].…”