Background: Hepatitis C (HCV) direct acting antiviral agents (DAAs) are safe, effective, and tolerable. Most contraindications to interferon-based treatment are no long applicable. The aims of this study were to understand the predictors of approval to drug accessibility.Methods: We studied all consecutive patients with HCV prescribed DAAs between October 2014 and July 2015. Data on demographic, socio-economic status, comorbidities, baseline laboratory values, and assessment of liver disease severity, insurance, and specialty pharmacy type were collected. Multivariate analyses were performed to identify predictors of prescription approval.Results: In total, 410 patients were prescribed DAAs between October 2014 and July 2015. Of those, 332 (81%) patients were insurance approved for therapy. Of the 332 patients accepted, 251 were accepted after the first prescription attempt, and 38 were accepted after the second and third attempts. The number of attempts for the other 43 approved patients was unknown. Older age (p = 0.001), employment (p = 0.001), lack of comorbidities (p = 0.02), liver transplantation (p = 0.018), and advanced liver disease (p = 0.001) were more likely associated with obtaining approval. Household income was not associated with insurance approval. In the multivariate analysis, Medicare insurance (odds ratio [OR]) 2.67, 95% confidence interval [CI] 0.96–7.20), lack of nonliver comorbidities (OR 2.72, 95% CI 1.35–5.43), and the presence of advanced liver disease (OR 1.82, 95% CI 1.04–3.24) independently predicted drug approval.Conclusion: Despite the availability of DAAs for HCV, barriers from insurance carriers continue to impair widespread use. Patients with advanced liver disease, Medicare, and without comorbidities are most likely to be insurance approved for DAAs.
Background and Aims: Recurrent infection of hepatitis C virus (HCV) in liver transplant (LT) recipients is universal and associated with significant morbidity and mortality.Methods: We retrospectively evaluated the safety and efficacy of ledipasvir/sofosbuvir with and without ribavirin in LT recipients with recurrent genotype 1 hepatitis C.Results: Eighty-five LT recipients were treated for recurrent HCV with ledipasvir/sofosbuvirwith and without ribavirin for 12 or 24 weeks. The mean (± standard deviation [SD]) time from LT to treatment initiation was 68 (±71) months. The mean (± SD) age of the cohort was 63 (±8.6) years old. Most recipients were male (70%). Baseline alanine transaminase, total bilirubin, and HCV ribonucleic acid (RNA) values (± SD) were 76.8 (±126) mg/dL, 0.8 (±1.3) U/L, and 8,010,421.9 (±12,420,985) IU/mL, respectively. Five of 43 recipients who were treated with ribavirin required drug cessation due to side effects, with 4 of those being anemia complications. No recipient discontinued the ledipasvir/sofosbuvir. Eighty-one percent of recipients had undetectable viral levels at 4 weeks after starting therapy, and all recipients had complete viral suppression at the end of therapy. The sustained viral response at 12 weeks after completion of therapy was 94%.Conclusion: Ledipasvir and sofosbuvir with and without ribavirin therapy is an effective and well-tolerated interferon-free treatment for recurrent HCV infection after LT. Anemia is not uncommon in LT recipients receiving ribavirin.
Background: The cure for hepatitis B is defined as the hepatitis B surface antigen (HBsAg) seroclearance and/or seroconversion. Predictors of spontaneous seroconversion are not well described. The objective of this study is to identify predictors of spontaneous HBsAg seroconversion from community practice. Methods: We performed a matched analysis of patients who HBsAg seroconverted (cases) and patients who did not HBsAg seroconvert (control) in a 1:5 ratio according to date of clinic visit between 2014 and 2019 in a large community practice situated in Los Angeles area. Baseline laboratory and clinical data were collected. Univariate analysis and 2-sided t tests were performed, χ2 test for proportions, and logistic regression. Results: We identified 14 cases and 70 controls. The mean (±SD) ages of the cases and controls were 53.6 (±12.2) and 49.5 (±13.1), respectively (P=0.45). Most patients were women, and all patients were of Asian descent. There were statistically significant mean (±SD) baseline differences between cases and controls in HBsAg titers (459.8±311.0 and 782.0±393.3 IU/mL, P=0.01) and alanine aminotransferase (ALT) values (17.6±4.4 and 25.1±16.7 IU/mL, P<0.01), respectively. Baseline hepatitis B virus DNA and other pertinent laboratory values did not differ between cases and controls. Eleven of 14 cases (79%) and 11 of 70 controls (16%) baseline HBsAg titers were <1000 IU/mL (P<0.01). The results of a logistic regression demonstrated that HBsAg titers and ALT values were predictor variables for HBsAg seroconversion (P=0.01 and <0.01, respectively). Conclusions: Spontaneous HBsAg seroclearance and seroconversion is an uncommon event in patients with chronic hepatitis B. The most important predictors of seroconversion are HBsAg titers<1000 IU/mL and low baseline ALT values.
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