Лечение хронического гепатита D в Краснодарском крае – опыт реальной практики

Abstract

Objective. To analyze the results of treatment of patients with chronic hepatitis D (CHD) in Krasnodar Krai in the conditions of real practice using bulevirtide, an HBV/HDV entry inhibitor. Patients and methods. Interim treatment outcomes were studied in 11 patients with CHD, predominantly at the cirrhotic stage (82%), with the presence of portal hypertension (55%), liver failure (n = 3), and hepatocellular carcinoma (n = 2, detected during treatment). Patients received bulevirtide as monotherapy (n = 7) or in combination with peginterferon (n = 4); evaluation periods ranged from 24–96 weeks of treatment. Results. All patients with known baseline HDV RNA level (n = 5) achieved virologic response, HDV RNA level reduction was -1.8 and -5.5 log10 after 24 and 96 weeks of monotherapy, -2.0–4.9 log10 after 24–72 weeks of combined therapy, with aviremia in 1 patient. In patients with unknown baseline HDV RNA level (n = 6) its dynamics during treatment corresponded to virologic response in 4 patients (decrease from -1.5 to -4.0 log10 in the period from 12/24/48 to 72 weeks of monotherapy, with aviremia in 1 patient). Efficacy improved as treatment continued to 72–96 weeks in 5 of 7 patients (4 received monotherapy, 1 received combination therapy). The overall virologic response rate was 82%, aviremia 18%, and biochemical response (ALT level reduction/normalization) 55%/45%, respectively. All patients with liver dysfunction (n = 3) showed virological and biochemical response, including aviremia and ALT normalization (1 and 2 patients, respectively). Treatment was characterized by good tolerability, absence of severe and serious adverse reactions, cases of treatment withdrawal, stability of liver function indices, including cirrhosis with dysfunction. In 1 patient after hepatectomy for HCC there was a temporary deterioration of liver function with the transition of class A to class B according to Child-Pugh, unrelated to treatment. Conclusion. Interim results of HDV treatment in real practice have demonstrated efficacy, safety and good tolerability of bulevirtide in monotherapy or combination therapy, including in patients with liver dysfunction. Further development of an optimal treatment algorithm is necessary, taking into account the results of ongoing studies, in order to improve patient prognosis and achieve cure of HDV infection. Key words: bulevirtide, hepatocellular carcinoma, decompensated cirrhosis, monotherapy, combination therapy, chronic hepatitis D, liver cirrhosis