In the Journals

Raltegravir safe in end-stage liver disease after transplant

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July 15, 2014

Raltegravir appeared to be well tolerated and safe in patients with HIV and end-stage liver disease, according to data published in Clinical Infectious Diseases.

The researchers from Assistance Publique – Hôpitaux de Paris in France also found no pharmacokinetic interaction between raltegravir (Isentress, Merck) and the immunosuppressive regimen used after liver transplantation.

“Moreover, cyclosporine and mycophenolic acid exposure remained unchanged after the introduction of raltegravir, avoiding the need to manage drug-drug interactions during the immediate post-liver transplantation period,” the researchers wrote. “Raltegravir might be recommended as a suitable antiretroviral therapy in HIV-infected patients undergoing liver transplantation.”

The LIVERAL-ANRS148 study included two substudies. Substudy one included 10 patients with end-stage liver disease who were on antiretroviral therapy and had an undetectable viral load for at least 6 months. These patients were switched to 400 mg twice-daily raltegravir and a once-daily fixed dose of tenofovir/emtricitabine (Truvada, Gilead Sciences) or abacavir/lamivudine (Epzicom, Viiv Healthcare). Substudy two included five liver transplant recipients who initiated immunosuppressive treatment immediately following the transplant and also began a raltegravir-based regimen.

In the patients with end-stage liver disease, the raltegravir concentrations appeared unchanged. In addition, the viral load remained undetectable and the median CD4 cell count was similar at study entry and month 3. Among the transplant patients, there were no pharmacokinetic interactions between the raltegravir and the immunosuppressive regimen. There were also no acute rejection episodes or opportunistic infections. In addition, viral load remained undetectable and CD4 cell counts remained stable.

“This study was conducted in a small number of patients, but our safety and pharmacokinetic data nevertheless support the use of raltegravir in patients with liver disease before and after liver transplantation,” the researchers wrote. “Our strategy is only applicable to patients undergoing very close monitoring to detect early virological failure and prompt a switch to a rescue antiretroviral regimen as needed.”

Disclosure: The researchers report no relevant financial disclosures.

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