Introduction Measurement of rapid viral response (RVR; non-detectable viral load (ND-VL) at 4/52) and early viral response (EVR; ND-VL at 12/52) allow treatment to be individually tailored. Our hepatitis C (HCV) treatment protocol (“standard”=SP) was changed in 2007, from 24/52 for genotype (GT) 2+3, 48/52 for GT1+4 (if EVR) to an “individualised” new protocol (IP): 16/52 for GT2+3 and 24/52 for GT1+4 if RVR; standard length (24 or 48/52) if full EVR; and pro-longed (48 or 72/52) if partial EVR (>2log-VL-reduction at 12/52).
Methods Retrospective case note analysis of HCV patients treated between 01.01.2006–31.12.2008; n=74. 24 patients were managed according to SP, 50 according to IP. Health professionals, medication (Peg-INF-2α+Ribavirin) and dosages did not change. Primary outcome was sustained virological response (SVR) (ND-VL 6/12 after treatment end). Secondary outcome was “mean length of treatment” and “overall treatment costs”.
Results The two cohorts (SP/IP) were similar with regards to age (mean;42 years/44 years), sex (M;60%/50%), weight (mean;81 kg/75 kg), GT (2+3;75%/72%) and baseline VL (mean; 1×106/3×106). 80% (59/74) were pre-cirrhotic and treatment-naïve. Dropout-rates were 20% (5/24) for SP, 20% (10/50) for IP. On intention-to-treat (ITT), 50% (12/24) of SP-managed patients achieved SVR, compared with 58% (29/50) with IP (p=0.62). Per-protocol analysis (PPA) revealed 63% (12/19) SVR for SP and 70% (28/40) SVR for IP (p=0.76). The following table shows the average length of treatment and overall costs (drug estimates) according to GT and protocol (Abstract 053).
Conclusion The individualised treatment protocol was non-inferior to standard in achieving SVR. On average, we saved £10 200 for GT1+4 patients and £3000 for GT2+3. This equates to approximately £162 000 per year (for 30 patients treated). Those savings shall be reinvested (eg, specialist hepatitis nurse provision), which is likely to translate into reduced dropout rates and higher SVR.