Faculty Bibliography

Background Treatment with sofosbuvir (SOF)-based regimens for HCV infection has resulted in sustained virologic response (SVR) rates of approximately 90% in pivotal trials, in which Asian patients were underrepresented. This study aims to assess the efficacy and safety of SOF-based therapy in the Asian-American patients. Methods Asian patients with HCV genotype 1-6 mono-infection, who received SOF-based therapy for 12 or 24 weeks, were retrospectively enrolled from multiple centers throughout the United States. The primary endpoint was SVR 12. Secondary endpoints were the safety and tolerability of SOF-based treatment regimens. Results Among the 80 patients enrolled, 45 were treated with SOF+ribavirin (RBV), 15 with SOF+simprevir (SIM), 10 with SOF+RBV+peginterferon, 8 with ledipasvir+SOF and 2 with SIM+SOF+RBV. Patient baseline values are shown in Table 1. By week 4, a rapid decrease in HCV RNA levels to <20 IU/mL was observed in 85% (68/80) of patients. SVR12 was achieved in 98.3% (60/61) patients who have reached the SVR12 assessment point. One genotype 4 patient, who was non-cirrhotic and treatment naive, experienced relapse after completing a 12 week SOF+RBV therapy. ALT normalization occurred in 91% (39/43) patients who had abnormal ALT at the baseline. At the time of abstract submission, 11 patients remain on therapy and 8 are <12-week post treatment follow-up; all were included in the safety analysis. No viral breakthrough occurred during therapy. Regimens were generally well tolerated with <15% patients reporting insomnia, nausea, rash, dyspnea and epigastric discomfort, however, fatigue was reported by 31.3% of patients. Of 57 patients on a RBV containing regimen, 6 required dose reduction and 2 discontinued RBV due to severe fatigue. Conclusions SOF-based therapies for Asian Americans with HCV were well tolerated. Their SVR12 rates were similar to the SVR12 rates of non-Asians in pivotal trials. No safety concerns were identified in this real life cohort. (Table Presented)

Purpose: TIPS creation fails to control ascites in 40% or more of patients, but the variables predicting outcome are unclear, with prior studies highlighting pre-TIPS portosystemic gradient (PSG) (Nair et al 2004; JVIR 15:1431). We studied which variables predict outcome of TIPS for refractory ascites. Materials and Methods: We retrospectively identified patients who underwent TIPS for refractory ascites between 1/12 and 5/14, yielding 40 patients. We excluded 17 patients due to insufficient peri-procedural documentation or technical failures, leaving 23 patients (16 men, 7 women, mean age 60 +/-2 yrs) for assessment of variables influencing osmotic (albumin and sodium levels) and hydrostatic (pre- and post- TIPS PSG and large varices) pressure. Responders were defined as those requiring fewer or no paracenteses; nonresponders had persistent ascites, with similar pre-TIPS frequency of therapeutic paracentesis. Complications within 1 month requiring hospitalization were noted. Multiple logistic regression, Mann-Whitney U tests, and one-tailed chi² tests assessed group differences. Results: Ten patients (43%: responders) had documented improvement in ascites. Multiple logistic regression including pre- and post-TIPS PSG significantly impacted outcome (p=0.04). Post- but not pre-TIPS PSG predicted outcome (p=0.04 vs. p=0.84). Responders had significantly lower post- TIPS gradient (5.8) compared with non-responders (7.6) (p=0.02). In contrast, responders and non-responders did not differ in albumin (2.7 vs. 2.7) or sodium (136 vs. 134) levels, or pre-TIPS gradient (13.9 vs. 14.7 mmHg) (p>0.05). Similar numbers of responders (50%) had large varices compared to non-responders (61%) (p=0.3). Responders (50%) had significantly more complications compared to non-responders (15%) (p=0.04), mostly encephalopathy (85%) requiring hospitalization. Conclusion: Only post-TIPS PSG predicted which patients had significantly reduced ascites, in contrast to prior studies suggesting importance of pre-TIPS gradient. Findings suggest aggressively lowering the gradient below 6 mmHg may be the most reliable technique to improve outcomes, although with expected higher risk of complications

Hepatitis B remains a leading cause of cirrhosis, hepatocellular carcinoma and liver transplantation worldwide. Management of chronic hepatitis B during pregnancy is challenging. Transmission of hepatitis B to infants still occurs perinatally although immunoprophylaxis is widely available for infants born to mothers with chronic hepatitis B infection. The emerging data suggest that initiation of antiviral therapy in the beginning of the third trimester in highly viremic mothers can prevent immunoprophylaxis failure in their infants. The available drug safety data show that lamivudine, telbivudine and tenofovir are generally safe to be used during the pregnancy. In order to minimize the fetal exposure to the antiviral medication, antiviral therapy during the pregnancy should be limited to a selected group of patients with cirrhosis, high hepatitis B viral load, or prior history immunoprophylaxis failure. An elective Caesarean section may reduce the risk of perinatal transmission. For those females planning for pregnancy or in early stage of pregnancy, communication and follow-up among obstetrician, gastroenterologist, and primary care physician are important. In this article, we will review the features of hepatitis B infection before, during and after the pregnancy; the risk factors that increase mother-to-child transmission; safety data on antiviral drug use during pregnancy; and the potential role of Caesarean section in selected cases.