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Successful Prevention of Transmission of Integrase Resistance in the Swiss HIV Cohort Study
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Antiretroviral therapy for the prevention of HIV-1 transmission
HIV Transmission Risk Persists During the First 6 Months of Antiretroviral Therapy
Review of the Efficacy, Safety, and Pharmacokinetics of Raltegravir in Pregnancy
Use of Abacavir and Risk of Cardiovascular Disease Among HIV-Infected Individuals
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CD8 T-Cell Expansion and Inflammation Linked to CMV Coinfection in ART-treated HIV Infection
Ongoing HIV Replication Replenishes Viral Reservoirs During Therapy
Incidence and progression of coronary artery calcium in HIV-infected and HIV-uninfected men
Levels of intracellular HIV-DNA in patients with suppressive antiretroviral therapy
Course and Clinical Significance of CD8+ T-Cell Counts in a Large Cohort of HIV-Infected Individuals
Impact of low-level viremia on clinical and virological outcomes in treated HIV-1-infected patients
Predicting the outcomes of treatment to eradicate the latent reservoir for HIV-1
Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial
Published by François RAFFI
Updated: 6 January, 2020
Background : Non-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD.
Methods : This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA. People with HIV infection and a hepatic fat fraction (HFF) of 5% or more by proton magnetic resonance spectroscopy were eligible. Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily. The randomisation list was prepared by the study statistician using a permuted block algorithm within each stratum with randomly varying block sizes. The primary endpoint was change in HFF between baseline and 12 months. The primary safety endpoint was glucose. Analysis was by intention to treat using all available data. This trial is registered with ClinicalTrials.gov, number NCT02196831.
Findings : 61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received placebo. Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of –4·1% (95% CI –7·6 to –0·7, p=0·018), corresponding to a –37% (95% CI –67 to –7, p=0·016) relative reduction from baseline. After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069). Changes in fasting glucose and glycated haemoglobin were not different betweengroups at 12 months. Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
Interpretation : Tesamorelin might be beneficial in people with HIV and NAFLD. Further studies are needed to determine the long-term effects of tesamorelin on liver histology.
