Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 1 hepatitis C virus infection with and without cirrhosis.

BACKGROUND: The once-daily, all oral, RBV-free, pangenotypic direct-acting anti-viral regimen consisting of co-formulated NS3/4A protease inhibitor glecaprevir and NS5A inhibitor pibrentasvir (G/P), demonstrated high rates of sustained virologic response (SVR) in phase 2 and 3 studies outside Japan. METHODS: CERTAIN-1 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in Japanese patients with chronic HCV GT1 infection. Patients without cirrhosis received 8 weeks of G/P or 12 weeks of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r, 25/150/100 mg); patients with cirrhosis received G/P for 12 weeks. The primary efficacy endpoint was non-inferiority of G/P compared to OBV/PTV/r by assessing SVR at post-treatment week 12 (SVR12) among non-cirrhotic patients without the NS5A Y93H polymorphism. RESULTS: SVR12 was achieved by 128/129 (99.2%; one patient lost to follow-up) non-cirrhotic patients in the 8-week G/P Arm (including 23/23 patients with the NS5A Y93H polymorphism) and 52/52 (100%) patients in the 12-week OBV/PTV/r Arm. No patients from the G/P Arm prematurely discontinued the study drug or experienced a treatment-emergent serious adverse event (TESAE). Three patients from the OBV/PTV/r Arm experienced five TESAEs and one of these patients discontinued the study drug due to TESAEs. All 38 (100%) patients with compensated cirrhosis achieved SVR12; in this group, no TESAEs were reported and one patient discontinued treatment due to an AE. CONCLUSIONS: CERTAIN-1 study results demonstrate high efficacy and favorable tolerability of G/P in GT1-infected Japanese patients including those with the NS5A Y93H polymorphism, with no virologic failures observed.

Compliance in Rhode Island emergency departments with American Academy of Pediatrics recommendations for adolescent sexual assaults.

OBJECTIVES: We assessed the offering of American Academy of Pediatrics-recommended tests and prophylaxes after sexual assault to adolescents who presented to Rhode Island emergency departments for 3 categories of sexual exposures: sexual assault, consensual sex, and suspected sexual abuse. PATIENTS AND METHODS: This study entailed a retrospective review of visits for adolescent sexual exposures across 11 Rhode Island emergency departments between January 1995 and June 2001. Cases were identified through billing codes. Offering of each test and prophylaxis was compared by gender, category of sexual exposure, and type of sexual assault. Multivariable linear regression models were used to identify factors associated with the offering of a greater number of tests and prophylaxes after sexual assault. RESULTS: The vast majority of emergency department visits for adolescent sexual exposures were by sexually assaulted girls (82.5%). Across the 3 sexual exposure categories, girls were offered tests and prophylaxes more often than boys (eg, chlamydia or gonorrhea testing and prophylaxis). Among sexually assaulted adolescents, 32.8% of girls and no boys were offered all recommended tests and prophylaxes. The multivariable linear regression found that vaginally and/or anally assaulted girls were offered, on average, 2.5 more tests and prophylaxes than patients with other types of sexual assaults. Girls presenting for care at the state's women's health care specialty hospital emergency departments were offered 1.7 more tests and prophylaxes than those evaluated in general hospital emergency departments. CONCLUSIONS: Many adolescents did not receive American Academy of Pediatrics-recommended tests and prophylaxes after sexual assault. Boys received fewer tests than girls. Testing and prophylaxis varied by type of emergency department. Efforts are needed to improve and standardize emergency department medical management of adolescent sexual exposures.