Efficacy and safety of Sofosbuvir/Velpatasvir for the treatment of treatment-naive, non-cirrhotic patients with chronic hepatitis C genotype 3 infection: integrated analysis of three phase 3 clinical trials

Results: 158 pregnant women (median age 33 yrs, 73% Asian, 63% HBeAgnegative) were included; 30/122 (25%) delivered infants while receiving antiviral therapy during pregnancy. Median HBV DNA level was substantially higher in untreated HBeAg+ vs HBeAgwomen (8.1 vs 2.5 log10 IU/mL). ALT did not change significantly during gestation, but did increase early postpartum among both HBeAg+ and HBeAgwomen (p < 0.001) (see Figure). In contrast to ALT, HBV DNA levels did not change significantly in untreated women. Among the 92 untreated women who delivered infants, 8% (7/92) developed flares (ALT range 107–513 U/L) during pregnancy (10–39 wks gestation) or after delivery (6–11 wks postpartum). After withdrawal of prophylactic antiHBV therapy, 17% (5/29) developed flares (ALT range 107–208 U/L) within 14 wks of stopping drug. Another 2 women had ALT flares despite continuous antiHBV therapy during pregnancy or postpartum without viral rebound. No flares resulted in clinical decompensation. Conclusions: Flares in ALT can occur throughout pregnancy and after delivery. Although ALT flares were more frequent following withdrawal of antiviral therapy, none of the flares were severe or symptomatic. Further studies of the immune basis of spontaneous ALT flares during and after pregnancy are warranted. Image: