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Liver enzyme spikes--then normalizes--when elderly start dolutegravir
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Download the PDF here
22nd International AIDS Conference, Amsterdam, Netherlands, July 23-27, 2018
Mark Mascolini
Starting the integrase inhibitor dolutegravir led to an early spike in alanine aminotransferase (ALT) among people 60 or older, a change not seen with raltegravir or elvitegravir in this Frankfurt-Berlin study [1]. ALT returned to normal after 52 weeks in the dolutegravir group, and no one had to stop treatment because of liver toxicity.
University Hospital Frankfurt investigators noted that integrase inhibitors have generally good toxicity profiles. But elderly people with HIV may still run a risk of high liver enzymes because of comedications or comorbidities. To track liver enzyme changes after integrase inhibitors start, they retrospectively analyzed pooled data from Frankfurt and Berlin HIV cohorts of people beginning dolutegravir, elvitegravir, or raltegravir before November 2017. They charted liver enzyme levels when integrase inhibitor therapy began (baseline) and 4, 12, 36, and 52 weeks later.
The analysis included 486 people, 78 of them (16%) women, 390 younger than 60, and 96 (20%) older. While 333 people started dolutegravir, 105 began raltegravir and 48 elvitegravir. Numbers of participants 60 or older starting these integrase inhibitors were 54 on dolutegravir, 38 on raltegravir, and 4 on elvitegravir. CD4 count averaged 513 in people 60 or older and 621 in younger people.
Median baseline ALT measured 28 IU/mL (range 8 to 325) in the dolutegravir group, 28 IU/mL (range 8 to 210) in the raltegravir group, and 26 IU/mL (range 12 to 134) in the elvitegravir group. ALT rose significantly by a median of 10.0 IU/mL (range 5 to 225) (P < 0.003) through the first 4 weeks of dolutegravir therapy in the elderly group. From week 4 to 52, ALT fell significantly in this group so that the week-52 level (median 30 IU/mL, range 8 to 120) did not differ significantly from the baseline value (P > 0.1). Neither liver comorbidity nor use of a concomitant medication could explain the week-4 ALT jump. No one had to stop dolutegravir because of liver toxicity.
Elderly people starting raltegravir or elvitegravir did not have a similar 4-week spike in ALT, and ALT did not change significantly with any integrase inhibitor in people younger than 60. Through 52 weeks of follow-up, ALT did not differ significantly between HIV/HCV-coinfected people and HIV-monoinfected people with any of the 3 integrase inhibitors.
The clinical investigators warned colleagues to be aware of possible transient ALT peaks in elderly people starting dolutegravir.
Reference
1. de Leuw P, Wiedmann K, Filmann N, et al. Elderly patients on antiretroviral therapy with dolutegravir are at increased risk for ALT elevation. AIDS 2018: 22nd International AIDS Conference, Amsterdam, Netherlands, July 23-27, 2018. Abstract TUPEB131.
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Poster pdf attached to better view tables
P. de Leuw1*, K. Wiedmann1, N. Filmann2, I. Krznaric3, P. Ingiliz3, A. Haberl1, G. Kann1, G. Schüttfort1, J. Severain1, T. Wolf1, C. Stephan1
1HIV-Center, University Hospital, Department of Infectious Diseases, Frankfurt am Main, Germany; 2Institute of Biostatistics and Mathematical Modeling, Department of Medicine, Goethe University, Frankfurt am Main, Germany; 3Center for Infectious Diseases Berlin, Berlin, Germany; * Correspondence: philipp.deleuw@kgu.de
P. de Leuw1*, K. Wiedmann1, N. Filmann2, I. Krznaric3, P. Ingiliz3, A. Haberl1, G. Kann1, G. Schüttfort1, J. Severain1, T. Wolf1, C. Stephan1
1HIV-Center, University Hospital, Department of Infectious Diseases, Frankfurt am Main, Germany; 2Institute of Biostatistics and Mathematical Modeling, Department of Medicine, Goethe University, Frankfurt am Main, Germany; 3Center for Infectious Diseases Berlin, Berlin, Germany; * Correspondence: philipp.deleuw@kgu.de
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