Efficacy and safety of entecavir and/or tenofovir for prophylaxis and treatment of hepatitis B recurrence post-liver transplant.

AIMS: To establish the efficacy and safety of entecavir (ETV) and/or tenofovir (TDF) in the treatment and prevention of hepatitis B virus (HBV) recurrence after liver transplantation. PATIENTS AND METHODS: Eight patients (four men) received treatment with ETV and/or TDF after liver transplantation as prophylaxis for HBV recurrence or as posttransplant treatment of HBV. Four liver transplants were in patients with HBV-associated cirrhosis who had received prior nucleos(t)ide analogue treatment until HBV DNA became undetectable. After transplantation, two of these four were treated with ETV + TDF and the other two with just TDF. All received intramuscular hepatitis B immunoglobulins. The reasons for the other four liver transplants were primary biliary cirrhosis in two cases, alcoholic cirrhosis, and hepatitis C virus. Two of the patients were donor anti-HBcAb-positive/recipient anti-HBcAb-negative. They received no anti-HBV prophylaxis so they had a recurrence of HBV. These four patients required treatment with ETV+TDF for the HBV DNA to become negative. RESULTS: The mean age was 60 (39-67) years. The mean follow-up was 9.5 (3-20) months. The mean follow-up of the patients who received prophylaxis was 8.2 (3-19) months. These had no HBV recurrence. The mean follow-up of the patients who received treatment for HBV recurrence was 12 (3-19) months. ETV combined with TDF was necessary for the HBV DNA to become undetectable because this was not possible using different nucleos(t)ide analogues. There were no significant adverse effects from these drugs and no alteration of renal function during the follow-up period. CONCLUSIONS: Therapy with ETV and/or TDF seems to be efficient and safe when used in the prophylaxis and treatment of HBV recurrence after liver transplantation. They are well tolerated and seem to have no interactions with immunosuppressive medication.

Hepatitis C virus recurrence after liver transplantation: analysis of factors related to sustained viral response.

OBJECTIVES: To determine the efficacy and safety of pegylated interferon (peg-IFN) plus ribavirin to treat hepatitis C virus (HCV) recurrence, analyzing possible factors associated with sustained viral responses (SVR). PATIENTS AND METHODS: Forty-one patients (25 men and 16 women) of overall mean age of 50 years (range, 33-60) with recurrent HCV were treated with peg-IFN plus ribavirin including 33 (80%) subjects displayed genotype 1. The following variables were analyzed: gender, donor and recipient ages, immunosuppressant, genotype, treatment duration, early viral response (EVR), pretreatment viral load, degree of fibrosis, levels of alanine aminotransferase and gamma-glutamyltransferase (IU/L), time since liver transplantation (OLT), use of stimulating factors (epoetin and granulocyte colony stimulating factor [G-CSF]) and side effects, and their association with SVR. The time from OLT to the start of treatment was 29 months (range, 6-90). Seventy-one percent of patients received cyclosporine and 29% tacrolimus. RESULTS: The mean treatment duration was 31 (range, 4-72) months with an EVR achieved in 12/38 (31.5%) of patients and a SVR in 16/41 (39%). Treatment was discontinued in 23 patients due to side effects. Epoetin was necessary in 29% and G-CSF in 10%. There were 3 cases of rejection (1 mild and 2 severe culminating in death). On univariate analysis genotype non-1B (P < .02), pretherapy RNA (P < .02), complete treatment, and EVR (P < .005) were the only variables associated with SVR. The mean donor age of 43 years showed no statistical significance. CONCLUSION: Therapy with peg-IFN plus ribavirin achieves an acceptable SVR, although not entirely free from severe side effects. Ensuring completion of the full treatment course is fundamental to achieve SVR.

Efficacy and safety of monotherapy with mycophenolate mofetil in liver transplantation.

AIM: To analyze the efficacy and safety of mycophenolate mofetil (MMF) as monotherapy in liver transplant patients who have adverse effects associated with calcineurin inhibitors (CNIs). PATIENTS AND METHODS: Seventeen patients, 13 men and four women, mean age 62 years, who received a liver transplant between 1998 and 2003 and initial immunosuppressive therapy with CNIs (10 tacrolimus and seven cyclosporine), were converted to monotherapy with MMF due to adverse events associated with CNIs: chronic renal failure in 16 patients (four with diabetes mellitus and seven with hypertension) and neurotoxicity in one patient. The mean time between transplant and starting monotherapy was 32 months (range: 18 to 70) and the mean follow-up time on monotherapy was 20 months (range: 8 to 39). MMF was introduced gradually at the same time as the CNIs were reduced. RESULTS: There was a progressive decrease in creatinine during the initial months. Compared with baseline levels, the differences at 3 and 6 months of monotherapy were significant (P < .001), remaining so throughout the follow-up period. Renal function improved in 15 of 17 patients (88%) and normalized in 10 of 17 (60%). The patient with neurotoxicity due to CNI improved. One patient (6%) had moderate rejection that was corrected after reintroducing tacrolimus. In two patients it was necessary to suspend MMF, one due to gastrointestinal intolerance and the other due to severe myelotoxicity and Pneumocystis jiroveci infection. Other, minor adverse events were corrected by adjusting the dose: one herpes zoster, two diarrhea, and two anemia. CONCLUSIONS: Monotherapy with MMF efficiently and safely corrected renal dysfunction associated with CNIs, with few side effects and a low incidence of rejection.