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Harvoni well-tolerated in patients with kidney transplant, HCV

Kidney transplant recipients with hepatitis C virus genotype 1 or 4 were safely and effectively treated with Harvoni for up to 24 weeks, according to research published in Annals of Internal Medicine.

“Nearly 10% of kidney transplant recipients in Western countries have chronic hepatitis C virus (HCV) infection,” Massimo Colombo, MD, from Fondazione IRCCS Ca’ Ganda Ospedale Maggiore Policlinico in Milan, and colleagues wrote.

“Use of interferon and ribavirin to treat [HCV] infection in kidney transplant recipients is limited because of the risk for allograft rejection and poor tolerability,” they added.

Colombo and colleagues performed a phase 2, open-label study in five locations in Europe to evaluate the safety and efficacy of Harvoni (ledipasvir-sofosbuvir, Gilead Sciences), an interferon- and ribavirin-free regimen, for kidney transplant recipients with chronic HCV genotype 1 or 4. The study included 114 patients (median age, 53 years; 53% male), 69% of whom were treatment-naïve, who received a kidney transplant at least 6 months prior to study initiation. Most patients (91%) had HCV genotype 1, and 15% had compensated cirrhosis. All patients had an estimated glomerular filtration rate (eGFR) of 40 mL/min or higher (median eGFR, 56 mL/min). The patients were randomly assigned to receive fixed-dose combination ledipasvir-sofosbuvir for 12 weeks (n =57) or 24 weeks (n = 57).

Results indicated that all patients treated with Harvoni for 12 or 24 weeks achieved the primary endpoint, sustained virologic response at 12 weeks (SVR12). Thirteen participants (11%) reported serious adverse events, of which three were treatment-related (syncope, pulmonary embolism and serum creatinine increase). The patient with syncope terminated treatment. Overall, headache (19%), asthenia (14%) and fatigue (10%) were the most common adverse events.

“Despite patients being treated with immunosuppressive regimens for an average of 10 years, median pretreatment HCV RNA levels, which ranged from 4.45 to 7.62 log IU/mL, were not significantly higher than those reported in immunocompetent patients,” the researchers wrote. “These HCV RNA levels, as well as the generally mild stage of hepatitis in the participants, may have resulted in the high absolute SVR rates achieved in this study,” Colombo and colleagues concluded. “The exclusion of ribavirin also may have contributed to increased safety and adherence without compromising treatment efficacy, even in patients in whom previous interferon-based treatment failed.” – by Alaina Tedesco

Disclosure: The authors report primary funding from Gilead Sciences. Please see full study for complete list of relevant financial disclosures.