B.A.R.C.O.S. (Brazilian Argentine Hepatitis C Collaborative Observational Study): Effectiveness and clinical outcomes of HCV treatment with daclatasvir and sofosbuvir with or without ribavirin

Abstract

Real-world data evaluating the effectiveness of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) treatment have been reported from different regions. Our aim was to evaluate the effectiveness and clinical outcomes of daclatasvir (DCV) and sofosbuvir (SOF) ± ribavirin (RBV) in a prospective multicentre cohort study including patients from Argentina and Brazil who received DCV/SOF ± RBV for 12 or 24 weeks from 2015 to 2018. Multivariable logistic regression models were carried out to identify factors associated with failure to achieve sustained virologic response (SVR) as a primary end point, and to death, decompensation, hepatocellular carcinoma (HCC) or liver transplantation (LT) as a composite secondary end point. From a total of 1517 patients treated with DCV/SOF, 906 completed 12 weeks post-treatment evaluation and were included in the analysis. Overall SVR12 rate was 96.1% (95% CI: 94.6%-97.2%), and 95% (95% CI: 92.8%-96.6%) in patients with cirrhosis. LT recipients and presence of cirrhosis were independently associated with failure to achieve SVR. During post-SVR12 follow-up, cumulative incidence of the secondary end point was 2.4% (95% CI: 1.5%-3.6%); two patients died from nonliver-related causes and two from HCC, five underwent LT, 12 developed HCC and 17 patients developed hepatic decompensation. Independent variables associated with these composite | 1201 RIDRUEJO Et al.

A Two-Year Outcome Evaluation of Government-Led Initiative to Upscale Hospital-based Hepatitis C Treatment Using a Standard Two-Drug Regimen in Malaysia

“…It is noteworthy that some of these studies generated their findings from either a clinical trial or a structured treatment accessibility program (12)(13)(14)(15). A few of them were undertaken in settings in which the sofosbuvir-daclatasvir combination only served as an option among many others (16)(17)(18)(19)(20)(21)(22)(23), while the rest presented the data limited to specific populations, HCV genotypes and liver cirrhotic status (24)(25)(26)(27)(28)(29)(30)(31)(32).…”

Direct‐Acting Antivirals and Hepatocellular Carcinoma: No Evidence of Higher Wait‐List Progression or Posttransplant Recurrence

“…The introduction of DAAs in Latin America was later than in Europe, Asia, and North America, but it achieved similar successful results in terms of viral eradication in real‐life studies. ( 2‐4 )…”

Effectiveness of direct‐acting agents for chronic hepatitis C treatment in South America: A systematic review and meta‐analysis

“…Finally, screening and full‐text assessment resulted in 20 included studies (14 manuscripts and 6 conference abstracts) that reported on SVR12 by DAAs in 7,393 individuals from South American countries (Figure 1). 27‐46 A total of 16 studies were published in English, two in Spanish 40,44 and two in Portuguese 29,33 . In addition, included studies were performed in Brazil (n = 11), Argentina (n = 4), Chile (n = 1), Colombia (n = 1), Peru (n = 1), and international collaborations in South America (n = 2) [Argentina, Chile, Colombia and Uruguay (n = 1); Argentina and Brazil (n = 1)].…”

“…Finally, screening and full-text assessment resulted in 20 included studies (14 manuscripts and 6 conference abstracts) that reported on SVR12 by DAAs in 7,393 individuals from South American countries ( Figure 1). [27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] A total of 16 studies were published in English, two in Spanish 40,44 and two in Portuguese. 29,33 In addition, included studies were performed in Sofosbuvir/Simeprevir ± Ribavirin (SOF/SIM ± RBV), Sofosbuvir/ Ledipasvir (SOF/LDV) or Ombitasvir/Paritaprevir/Ritonavir + Dasa buvir ± Ribavirin (OBV/PTV/r/DSV ± RBV).…”