Purpose: We tested the efficacy, feasibility, and safety of early switching (≤30 days) from intravenous (i.v.) to subcutaneous (s.c.) anti-hepatitis B immunoglobulins (HBIg) after liver transplantation (LT). Methods: This is a pilot, single-arm, single-center, open-label study in 12 de novo LT recipients. Inclusion criteria called for: adult (≥18 years), hepatitis B virus surface antigen (HBsAg)-positive patients on nucleos(t)ide therapy before LT; undetectable HBV DNA; no hepatitis C virus (HCV) co-infection, and informed consent. Patients received 30,000 IU i.v. HBIg over 5 days immediately after surgery. If patients had 3 consecutive anti-HBs titers ≥150 IU/L they were converted to s.c. HBIg on the first outpatient visit within 30 days after LT. s.c. HBIg were administered as per label throughout the study period (i.e. 500/1000 IU per week if body weight <75 kg/≥75 kg, respectively). Nucleos(t)ides were left unchanged. Primary endpoint at month (M) 6 post-LT was efficacy, as per anti-HBs titers ≥150 UI/L, negative HBV DNA and HBsAg. Key secondary endpoints were feasibility of self-administration and safety. Results: Twelve patients (M:F = 8:4; median age 56 years; median body weight 65 kilos) were enrolled between December 2010 and March 2011. All patients were converted to s.c. HBIg at a median of 25 days after LT and completed the 6-month schedule. Median (mean ±SD) anti-HBs titers (IU/L) at conversion, M2, M3, M4, M5, and M6 post-LT were respectively: 608 (648±256.6); 371 (428.9±146.8); 345 (392.5±170.1); 300.3 (341.8±122.4); 346.7 (385.7±92.2), and 270 (325.6±130.1). Protective titers were reached throughout the study period with no viral breakthrough. Conclusion: Early (≤30 days) switching from i.v. to s.c. HBIg is feasible and allows for protective anti-HBs titers through M6 post-LT. Longer follow-up periods and larger series are advocated to confirm these preliminary results.
Early switching to subcutaneous anti-hepatitis B virus immunoglobulins (HBIg) after liver transplantation: 6-month results of a single-center study.
DE SIMONE, PAOLO
2012-01-01
Abstract
Purpose: We tested the efficacy, feasibility, and safety of early switching (≤30 days) from intravenous (i.v.) to subcutaneous (s.c.) anti-hepatitis B immunoglobulins (HBIg) after liver transplantation (LT). Methods: This is a pilot, single-arm, single-center, open-label study in 12 de novo LT recipients. Inclusion criteria called for: adult (≥18 years), hepatitis B virus surface antigen (HBsAg)-positive patients on nucleos(t)ide therapy before LT; undetectable HBV DNA; no hepatitis C virus (HCV) co-infection, and informed consent. Patients received 30,000 IU i.v. HBIg over 5 days immediately after surgery. If patients had 3 consecutive anti-HBs titers ≥150 IU/L they were converted to s.c. HBIg on the first outpatient visit within 30 days after LT. s.c. HBIg were administered as per label throughout the study period (i.e. 500/1000 IU per week if body weight <75 kg/≥75 kg, respectively). Nucleos(t)ides were left unchanged. Primary endpoint at month (M) 6 post-LT was efficacy, as per anti-HBs titers ≥150 UI/L, negative HBV DNA and HBsAg. Key secondary endpoints were feasibility of self-administration and safety. Results: Twelve patients (M:F = 8:4; median age 56 years; median body weight 65 kilos) were enrolled between December 2010 and March 2011. All patients were converted to s.c. HBIg at a median of 25 days after LT and completed the 6-month schedule. Median (mean ±SD) anti-HBs titers (IU/L) at conversion, M2, M3, M4, M5, and M6 post-LT were respectively: 608 (648±256.6); 371 (428.9±146.8); 345 (392.5±170.1); 300.3 (341.8±122.4); 346.7 (385.7±92.2), and 270 (325.6±130.1). Protective titers were reached throughout the study period with no viral breakthrough. Conclusion: Early (≤30 days) switching from i.v. to s.c. HBIg is feasible and allows for protective anti-HBs titers through M6 post-LT. Longer follow-up periods and larger series are advocated to confirm these preliminary results.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
