Sofosbuvir based regimens in the treatment of chronic hepatitis C genotype 1 infection in African–American patients: a community-based retrospective cohort study

Abstract

BackgroundDirect-acting antiviral (DAA) drugs have been highly effective in the treatment of chronic hepatitis C (HCV) infection. Limited data exist comparing the safety, tolerability, and efficacy of DAAs in African–American (AA) patients with chronic hepatitis C genotype 1 (HCV GT-1) in the community practice setting. We aim to evaluate treatment response of DAAs in these patients.Patients and methodsAll the HCV GT-1 patients treated with DAAs between January 2014 and January 2018 in a community clinic setting were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy with a sustained virologic response at 12 weeks post-treatment (SVR12), and adverse reactions were assessed.ResultsTwo-hundred seventy-eight patients of AA descent were included in the study. One-hundred sixty-two patients were treated with ledipasvir/sofosbuvir (SOF)±ribavirin, 38 were treated with simeprevir/SOF±ribavirin, and 38 patients were treated with SOF/velpatasvir. Overall, SVR at 12 weeks was achieved in 94.6% in patients who received one of the three DAA regimens (93.8% in ledipasvir/SOF group, 92.1% in simeprevir/SOF group, and 97.4% in SOF/velpatasvir group). Previous treatment experience, HCV RNA levels and HIV status had no statistical significance on overall SVR achievement (P=0.905, 0.680, and 0.425, respectively). Compensated cirrhosis in each of the treatment groups did not influence overall SVR of 12. The most common adverse effect was fatigue (27%). None of the patients discontinued the treatment because of adverse events.ConclusionIn the real-world setting, DAAs are safe, effective, and well tolerated in African–American patients with chronic HCV GT-1 infection with a high overall SVR rate of 94.6%. Treatment rates did not differ on the basis of previous treatment and compensated cirrhosis status.

Outcomes of Direct-Acting Antiviral Treatment of Psychiatric Patients with Comorbid Hepatitis C Virus Infection

“…It is important to highlight the point that our results add to the growing literature that consistently shows the tolerability and efficacy of DAAs in this demographic section that consists of those who have been excluded from the traditional IFN therapy. Another major significance of our study is that unlike previous studies, the majority of our study population are African-Americans, a vastly understudied group in clinical trials, making up 68.7% of our entire cohort, and 73.8% with primary psychiatric diagnosis, 73.2% have at a positive urine toxicology, and 19.2% on methadone maintenance therapy for opioid use disorder [16,23,24].…”

“…The treatment of HCV has shifted toward more tolerable, safer oral regimens with the use of direct-acting antiviral agents (DAAs). These regimens have truly revolutionized the efficiency of HCV treatment by achieving a sustained virologic response (SVR), shortening the duration of treatment, and improving patient outcomes without the burden of neuropsychiatric adverse effects [11,[16][17][18][19][20][21][22].…”

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

“…These findings have been confirmed in real-world cohort studies for both glecaprevir/ pibrentasvir (153,(165)(166)(167)(181)(182)(183) and sofosbuvir/ velpatasvir. (169,170,(184)(185)(186)(187)(188)(189) Based on these data, recommended regimens for adults eligible for the simplified treatment algorithm are 8 weeks of glecaprevir/pibrentasvir for patients with genotype 1-6 or 12 weeks of sofosbuvir/velpatasvir for those with genotype 1, 2, 4, 5, or 6. Pretreatment RAS testing is recommended for persons with genotype 3 because only those without a baseline NS5A Y93H RAS are eligible for a 12-week course of sofosbuvir/ velpatasvir.…”

Global real‐world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts

“…Several real-world cohorts have evaluated SOF/VEL effectiveness and safety in varying settings, with the results being similar to those of clinical trials. 10,[15][16][17][18][19][20][21][22][23][24] In this integrated real-world analysis, data from 12 clinical practice cohorts across different real-world settings in Canada, Europe and the USA were pooled to allow the evaluation of the real-world effectiveness of SOF/VEL for 12 weeks without ribavirin (based on the label or physician discretion) in the largest available heterogeneous HCV patient population and to investigate any patient characteristics affecting the risk of not achieving SVR. (Table 1)…”