scholarly journals Sofosbuvir-based therapies achieved satisfactory virological response in Chinese with genotypes 3 and 6 infection: a real-world experience from a centre

2020 ◽  
Author(s):  
Qiao Tang ◽  
Li Wei ◽  
Xiaoqing Liu ◽  
Peng Hu
Keyword(s):  
Sustained Virological Response ◽  
Real World ◽  
Virological Response ◽  
Genotype 3 ◽  
Svr12 Rate ◽  
Real World Data ◽  
Cirrhotic Patients ◽  
The Impact ◽  
High Sustained Virological Response

Abstract BackgroundAs previously shown by others, sofosbuvir-based regimens yield high sustained virological response rates in patients with HCV infection except for genotype 3b complicating with cirrhosis. The real-world study aims to explore efficacy and safety of sofosbuvir-based regimens in genotypes 3 and 6 infected patients, especially the impact of ribavirin co-administration on sustained virological response in cirrhotic patients with genotype 3b infection. MethodsA retrospective cohort study included 173 patients initiated on sofosbuvir-based regimens. Main endpoint of treatment was sustained virological response at post-treatment week 12 (SVR12).Results92 patients with sufficient follow-up were included. Overall, SVR12 rate was 96.7% (89/92), including 62 patients treated with addition of ribavirin to sofosbuvir-based regimens, given superior SVR12 rate (98.4%) than ribavirin free regimens (93.3%). SVR12 rates were 96.3% and 96.7% in patients infected with genotype3 (54) and genotype 6 (38) Among patients with genotype 3b infection, SVR12 was achieved in 97.1%, and 100% when complicating with cirrhosis. SVR12 rate was achieved in 96.6% among patients with cirrhosis (28/29), 100% with ribavirin co-administration regimens and 87.5% without ribavirin. Totally, three patients failed to achieve SVR12, including 2 non-cirrhotic patients with genotype 3b and 6a infection treated with sofosbuvir+ribavirin and sofosbuvir/velpatasvir regimen, one cirrhotic patient with genotype 3k infection treated with SOF/VEL regimen. No sever adverse events occurred.ConclusionsReal-world data show that sofosbuvir-based regimens are highly effective and safe for patients with HCV genotypes 3 and 6 infection. Addition of ribavirin to sofosbuvir-based regimens may improve efficacy, especially in patients with genotype 3 infection and cirrhosis.Trial registrationNot applicable.

Abstract 015: Importance of Balanced Follow-up Time and Other Study Design Considerations When Evaluating Adherence Using Two Novel Oral Anticoagulants

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Craig Coleman ◽  
Zhong Yuan ◽  
Jeffrey Schein ◽  
Concetta Crivera ◽  
Veronica Ashton ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Real World ◽  
Oral Anticoagulant Therapy ◽  
Oral Anticoagulants ◽  
Real World Data ◽  
Adherence Measure ◽  
Adherence Measurement ◽  
Minimum Number ◽  
The Impact

Background: Medication adherence rates decline over time, especially after the first dispensing. Comparing adherence rates for medications that have been on the market for differing period of time may distort real differences in medication adherence. Other analysis factors such as minimum number of dispensing criteria and Pharmacy Quality Alliance (PQA) adherence measures can also affect adherence measurement. Objectives: To use one real world example (rivaroxaban vs apixaban) in non-valvular atrial fibrillation (NVAF) patients to quantify the impact of adjusting for imbalances in follow-up periods, minimum number of dispensing, and use of the PQA adherence measure. Methods: Using IMS Health Real-World Data Adjudicated Claims and Truven MarketScan claims databases, we included adult patients with ≥1 rivaroxaban or apixaban dispensing (index date), ≥1 year of pre-index eligibility, ≥1 AF diagnosis pre-index, newly initiated on oral anticoagulant therapy, and no valvular involvement. Adherence was evaluated using proportion of days covered (PDC) ≥0.8 for cohorts with (1) unbalanced follow-up (2) balanced follow-up (by matching on month and year of follow-up since fill-date) (3) ≥2 rivaroxaban or apixaban dispensings and a balanced follow-up, and using (4) the PQA adherence measure. Results: Rivaroxaban users had significantly longer mean (SD) follow-up than apixaban (408 [300] versus 254 [196] days, respectively). While apixaban users appeared to be more adherent in unadjusted analyses, this finding was reversed after 1) adjusting for unbalanced follow-up 2) excluding single-time users; and 3) applying the PQA-endorsed adherence measure (Figure). Similar results were found using the Truven databases. Conclusion: Comparisons of the adherence rates among medications need to account for the period of time each have been on the market, number of dispensing and PQA measures. Retrospective analyses of adherence that do not adjust for such differences could produce spurious findings.

scholarly journals Favorable Outcomes of Chinese HCV-Related Cirrhotic Patients with Sustained Virological Response after Pegylated Interferon Plus Ribavirin Treatment

2017 ◽  
Vol 2017 ◽  
pp. 1-8
Author(s):  
Geng-lin Zhang ◽  
You-ming Chen ◽  
Ting Zhang ◽  
Qing-xian Cai ◽  
Xiao-hong Zhang ◽  
...  
Keyword(s):  
Sustained Virological Response ◽  
Virological Response ◽  
Clinical Course ◽  
Laboratory Data ◽  
Pegylated Interferon ◽  
Liver Function Tests ◽  
Hcv Rna ◽  
Pegylated Interferon Plus Ribavirin ◽  
Cirrhotic Patients

Few studies have conducted follow-up investigations of the clinical course in HCV-related cirrhotic patients who achieved a sustained virological response (SVR) with pegylated interferon plus ribavirin treatment (PegIFN + RBV). We investigated the clinical course and laboratory data in a prospective cohort study enrolling HCV-related cirrhotic patients who received PegIFN + RBV between August 2008 and July 2013 in China. Complete blood counts, liver function tests, and HCV-RNA were serially examined. Liver-related complications were recorded. To detect hepatocellular carcinoma (HCC), alpha-fetoprotein assays, and ultrasound scans were repeated at 6-month intervals. Twenty-five patients were enrolled, including 8 patients with decompensation events before treatment. Eighteen patients achieved SVR with a mean follow-up period of 25.78 months. During the follow-up period, only one patient exhibited HCV-RNA positivity and no decompensation events were detected, but 4 patients developed HCC after SVR. APRI decreased more in patients with SVR than in patients with non-SVR (median, −1.33 versus 0.86,P<0.001). The albumin levels and platelet counts significantly increased during the follow-up period after SVR (44.27±4.09versus42.63±4.37,P=0.037and173.89±87.36versus160.11±77.97,P=0.047). These data indicated that HCV-related cirrhotic patients with SVR after PegIFN + RBV may have a favorable clinical course and improvements in laboratory data. Moreover, HCC should be monitored.

scholarly journals DOES INSULIN RESISTANCE IMPAIR THE VIROLOGICAL RESPONSE TO PEGINTERFERON/RIBAVIRIN IN CHRONIC HEPATITIS C GENOTYPE 3 PATIENTS?

2018 ◽  
Vol 55 (2) ◽  
pp. 179-183
Author(s):  
Marcela Pezzoto LAURITO ◽  
Giovanni Faria SILVA ◽  
Hugo CHEINQUER ◽  
Rajani SHARMA ◽  
Elizabeth VERNA ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Sustained Virological Response ◽  
Virological Response ◽  
Genotype 3 ◽  
Hcv Genotype ◽  
Hcv Genotype 3 ◽  
The Impact ◽  
Retrospective Multicenter Study

ABSTRACT BACKGROUND: Insulin resistance and diabetes mellitus are common extrahepatic manifestations of chronic hepatitis C (HCV). Insulin resistance assessed by HOMA-IR is associated with low rates of sustained virological response, especially in HCV genotype 1 positive patients treated with peginterferon/ribavirin. The effect of insulin resistance on sustained virologic response in HCV genotype 3 positive patients who were treated with peginterferon/ribavirin still remains unclear. OBJECTIVE: To evaluate the impact of insulin resistance on sustained virological response in HCV genotype 3 patients treated with peginterferon/ribavirin. METHODS: A retrospective multicenter study was performed to evaluate the impact of insulin resistance on sustained virological response in non-diabetic HCV genotype 3 positive patients treated with peginterferon and ribavirin. A total of 200 HCV genotype 3 positive patients were enrolled in the study. All patients were non-diabetic. Each patient had a HOMA-IR value measured before the initiation of HCV treatment with peginterferon/ribavirin. The treatment duration was at least 24 weeks. The HOMA-IR cut-off was defined in the study as ≥2.5 due to the coefficient of correlation with sustained virological response of 0.202 (P=0.004). RESULTS: Univariate analysis showed that age, aspartate aminotransferase, platelets, stage of fibrosis and HOMA-IR were predictors of sustained virological response. However multivariate analysis showed advanced fibrosis [OR=2.01 (95%CI: 0.986-4.119) P=0.05] and age [OR=1.06 (95%CI: 1.022-1.110) P=0.002] as negative predictors of sustained virological response. CONCLUSION: In this retrospective multicenter study of non-diabetic HCV genotype 3 positive patients, insulin resistance was not associated with the sustained virological response in patients who were treated with peginterferon/ribavirin.

Evaluation of PSA progression after initiation of enzalutamide or abiraterone: Real-world data on metastatic castration-resistant prostate cancer (mCRPC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5024-5024
Author(s):  
Fernando López-Campos ◽  
David Lorente ◽  
Casilda Llacer Perez ◽  
Miguel Ramirez-Backhaus ◽  
Paula Peleteiro ◽  
...  
Keyword(s):  
Real World ◽  
Cox Regression ◽  
Castration Resistant Prostate Cancer ◽  
Real World Data ◽  
Castration Resistant ◽  
Real World Setting ◽  
Psa Progression ◽  
Definition Of ◽  
The Impact

5024 Background: PSA value is widely used for the monitoring of treatment outcome in mCRPC in the clinical real-world setting. Early PSA changes are not considered in the definition of PSAProg due to the potential for spurious “flare” reactions. We aimed to evaluate the significance of an early PSA increase in mCRPC patients (pts) treated with enzalutamide or abiraterone (Enz/Abi). Methods: We retrospectively evaluated Enz/Abi-treated mCRPC pts from 11 hospitals between 2011-2020. Early PSAProg was defined as a 25% increase in PSA from baseline at 4 (PSAProg4) or 8 (PSAProg8) weeks after treatment initiation. PSA progression at 12 weeks (PSAProg12) was confirmed by a second reading. Uni- and multivariable (MV) Cox regression models were conducted to explore the association of PSAProg and overall survival (OS) in chemotherapy naïve patients treated with Abi or Enz. Interaction tests were conducted to explore differences in the impact of PSA progression on OS in Abi or Enz-treated pts. Results: We analyzed 511 chemotherapy-naïve mCRPC pts treated with Abi (N=391; 76.5%) or Enz (N=120; 23.5%). Median follow-up: 30.2 months. OS was longer in Enz-treated pts (38.1 vs 29m; HR 1.4; p=0.027). 59 (15.1%), 70 (17.9%) and 48 (12.3%) of Abi-treated and 9 (7.5%), 11 (9.2%) and 10 (8.3%) of Enz-treated pts experienced PSAProg4, PSAProg8 and PSAProg12, respectively, although differences were not statistically significant. PSAProg was associated with worse OS at all 3 timepoints only in Abi-treated pts. In Enz-treated pts, PSAProg4 had a large impact on OS, not observed in PSAProg8 or PSAProg12. We observed no significant interaction between agent (Enz/Abi) and PSA progression (Table). Conclusions: PSA progression at 4 weeks after Enz/Abi is significantly associated with shorter OS and may help identify pts not benefitting from Abi/Enz before clinical or radiographic progression. PSA pattern progression and its association with OS might differ depending on the drug used (Enz/Abi). Prospective validation studies are needed.[Table: see text]

928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 928-P
Author(s):  
REEMA MODY ◽  
MARIA YU ◽  
BAL K. NEPAL ◽  
MANIGE KONIG ◽  
MICHAEL GRABNER
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
Exenatide Qw
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