“Lost To Follow Up” Patients Have Equivalent Sustained Viral Response Rates To Patients Attending Their Scheduled SVR12 Visit.

Author: Boyle A, Marra F, Peters E, Barclay S

Theme: Clinical Research Year: 2018

Background: In routine practice patients may be less likely to attend for SVR12 blood tests than in clinical trials. Failure to attend as scheduled may call in to question compliance during treatment, and give concern that SVR rates may be lower for such patients. We sought to examine whether patients who complete treatment but fail to attend as scheduled for SVR12 bloods differ in baseline characteristics and treatment outcomes compared to those attending. Methods: Non trial patients completing treatment with Sofosbuvir/Ledipavir, Viekerax/Exveira or Sofosbuvir/Daclatasvir, ± Ribavirin prior to 01/05/2016 in Glasgow were identified from the Scottish HCV database. Patient’s prematurely discontinuing treatment, and those who never attended for SVR bloods were excluded from further analysis. Baseline characteristics and SVR rates were compared for those attending for SVR12 bloods at 12-17 weeks post treatment (SVR12-17) and those attending beyond 18 weeks (SVR18+). Results: 435 patients completed treatment, of whom 10 prematurely discontinued treatment and 9 remained without SVR12 bloods at minimum of 2 years of follow up. Of 416 patients eligible for analysis 389 (93.5%) attended for SVR12-17, and 27 (6.5%) attend for SVR18+. Patients attending for delayed SVR were younger (mean age 44.0 (±8.9), vs 48.9 (±9.0), p=0.006), however no significant differences were seen in gender (71.2% male vs 74.1%, p=0.82), cirrhosis (49.6% vs 44.4%, p=0.69), OST (44.4% vs 49.6% p=0.69), previous maximum alcohol >50u/week (40.7% vs 22.6% , p=0.05) or genotype 3 infection (7.4% vs 11.0%, p=.075). SVR rates were equivalent: 27/27 (100%) in the SVR18+ group and 376/389 (96.6%) in the SVR12-17 group. (p=1.00) Conclusion: Patients who complete treatment but do not attend for SVR12 bloods as scheduled are equally likely to achieve SVR. Clinicians should have confidence that per protocol SVR rates are generalisable to those with missing data at the time of analysis. Disclosure of Interest Statement: See example below: Dr Barclay has received Grants, Speakers fees and Advisory board fees from Abbvie and Gilead, and Speakers fees and advisory board fees from MSD Ms Marra has received speaking fees and educational grants from Gilead, Abbvie, Merck, Janssen Dr Peters has received support to attend conferences from Gilead and Abbvie. Speakers fees Gilead and Abbvie Ms Boyle has received Grants and support to attend conference from Gilead and Abbvie.

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