Efficacy and safety of sofosbuvir and ledipasvir in Japanese patients aged 75 years or over with hepatitis C genotype 1

Abstract

AIMTo evaluate the efficacy and safety of a regimen containing sofosbuvir (SOF) and ledipasvir (LDV) in Japanese patients aged ≥ 75 years with hepatitis C genotype 1.METHODSThis multicenter, retrospective study consisted of 246 Japanese patients with HCV genotype 1 at nine centers in Miyazaki prefecture in Japan. Demographic, clinical, virological, and adverse effects (AE)-related data obtained during and after SOF/LDV therapy were collected from medical records. These patients were divided into two groups, younger (aged < 75 years) and elderly (aged ≥ 75 years). Virological data and AEs were analyzed by age group.RESULTSThe sustained virological response (SVR) rates at 12 wk after treatment were 99.2%, 99.4%, and 98.7% in the overall population and in patients aged < 75 and ≥ 75 years, respectively. Common AEs during therapy were headache, pruritus, constipation, and insomnia. These occurred in fewer than 10% of patients, and their incidence was not significantly different between the younger and elderly groups. Two patients discontinued treatment, one due to a skin eruption and the other due to cerebral bleeding.CONCLUSIONCompared with younger patients, elderly patients had a similar virological response and tolerance to SOF/LDV therapy.

Real‐world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan

“…5,20,28 Additionally, other real-world Japanese studies have shown LDV/SOF to have low frequencies of reported AEs and high SVR12 rates among older patients and those with or without cirrhosis at baseline. 3,16,17 Two notable differences in this study were the ability to assess and constipation, were very low, which is consistent with other real-world LDV/SOF studies conducted in Japan. 16,17 SVR12 results observed were similar and among the highest in comparison with other LDV/SOF studies in the post-marketing setting, ranging from 94% to 99% overall 9,12,13,[15][16][17][18][19]29 and among elderly patients.…”

“…3,16,17 Two notable differences in this study were the ability to assess and constipation, were very low, which is consistent with other real-world LDV/SOF studies conducted in Japan. 16,17 SVR12 results observed were similar and among the highest in comparison with other LDV/SOF studies in the post-marketing setting, ranging from 94% to 99% overall 9,12,13,[15][16][17][18][19]29 and among elderly patients. [15][16][17][18]30 If the 97 patients that were missing HCV RNA information after treatment completion were considered as virologic failures, the SVR12 would remain high at 95.59% (95% CI: 94.84%-96.27%), which is also within the range observed in other post-marketing studies of LDV/SOF treatment for HCV GT1 infection.…”

“…3 LDV/ SOF was an enhancement compared to previous therapies, with high SVR, minimal drug-drug interactions [5][6][7][8] and improved patient-reported health-related quality of life compared to ribavirin (RBV)-containing therapies. 9 Clinical trials [5][6][7][8]10,11 and observational studies 3,[12][13][14][15][16][17][18][19] of LDV/ SOF for the treatment of HCV GT1 infection have demonstrated a favourable safety profile and high efficacy overall, among elderly, 3,[16][17][18] and both treatment-experienced and treatment-naïve patients 11 worldwide and in Japan. The most common AEs reported with 12 weeks of LDV/SOF treatment in clinical trials were fatigue, headache, nausea and insomnia.…”

Anticholinergic Burden and Safety Outcomes in Older Patients with Chronic Hepatitis C: A Retrospective Cohort Study

“…Recently, the efficacy and safety of direct acting antivirals (DAA) in elderly patients has been a topic of interest [14][15][16][17][18][19][20][21][22][23][24][25][26][27]. These are highly effective also in older patients with hepatitis C-related liver disease, comorbidities and concomitant medications causing drug-drug interactions (DDIs) [14,15,[20][21][22].…”

Frailty Status Predicts New Long-term Care Insurance Certification in Hepatitis C Patients Receiving Antiviral Therapy

“…In fact, most Japanese patients with hepatitis C are elderly, and those aged ≥70 years account for more than 50% of HCV carriers (7). While new DAA therapies for patients with HCV infection deliver higher cure rates and lower frequencies of adverse events than existing therapies (8), the cost of these drugs is approximately 5-7 million yen ($45,000-64,000) in Japan (9). All patients with HCV infection are considered candidates for DAAs, except for those with shorter life expectancies.…”