4 HCV SPRINT-1 FINAL RESULTS: SVR 24 FROM A PHASE 2 STUDY OF BOCEPREVIR PLUS PEGINTRON™ (PEGINTERFERON ALFA-2B)/RIBAVIRIN IN TREATMENT- NAIVE SUBJECTS WITH GENOTYPE-1 CHRONIC HEPATITIS C

Background: High maternal serum HBV DNA is a risk factor for vertical transmission of HBV.Lamivudine (LAM; US pregnancy category C) and tenofovir disoproxil fumarate (TDF; US pregnancy category B) are licensed for the treatment of both HIV-1 and chronic HBV infection.The use of LAM and TDF to prevent HBV vertical transmission is of interest, but efficacy and safety data are limited.Methods: The Antiretroviral Pregnancy Registry (APR) is a prospective international registry of voluntary reports to detect major teratogenic effects involving antiretrovirals (ARVs) and HBV drugs administered in pregnancy.Founded in 1989, the APR enrolls ~1300 pregnant women/year in the US (~20% of live births to HIV-1 infected women).Results: Cumulative APR data on HBV drug exposure in pregnancy for LAM, TDF, adefovir, entecavir and telbivudine (7,720, 942, 30, 2, and 1 live births, respectively) were reviewed from 11,950 prospective cases (9,948 live births) reported to the APR through July 31, 2008.Most cases were in HIV-1-infected women, typically exposed to combination ARVs; 107 cases were HIV-1/HBV co-infected and 99 had HBV mono-infection.Congenital anomaly rates with LAM and TDF are comparable to those in the CDC population-based birth defects surveillance system in the US (2.72/100 live births) and to rates of other ARVs in the APR.