hm,  in this one they should have devoted a few more words about how "kinetic modeling"  is not only potentially  "cost-saving", (by allowing a 12 week course to be a shortened), but that another benefit of "kinetic modeling calculations" is justifying and providing the patient a possibly more expensive (than planned), needed, longer course which would actually effect cure as opposed to not achieving SVR. Ultimately the lengthening of courses (by kinetic modelling calculations) would be, as well, "cost" saving in preventing failures, re-treatments, and the continuing tolls on health.

Published in Gastroenterology - Journal Scan / Research · April 13, 2016

Hepatitis C Virus Kinetic Modeling to Tailor Antiviral Treatment Regimens

Journal of Hepatology

TAKE-HOME MESSAGE

·         The authors of this study evaluated the use of viral kinetics to determine the length of treatment necessary in order to achieve sustained virologic response (SVR) with the newer direct-acting antiviral agents in 58 patients with chronic hepatitis C virus infection. This study demonstrates, through the use of viral kinetics, that treatment could often be shorter than the recommended 12 weeks and still result in SVR. Around 43% of patients were predicted to reach cure within 6 weeks of treatment; conversely, patients who relapsed may have benefitted from a prolonged course of therapy.

• This study has significant implications for cost-savings moving forward, with treatment individualized for each patient.  

- Natasha VonRoenn, MD

Abstract

BACKGROUND&AIMS

Recent clinical trials of direct-acting-antiviral agents (DAAs) against hepatitis C virus (HCV) achieved >90% sustained-virological response (SVR) rates, suggesting that cure often took place before the end of treatment (EOT). We sought to evaluate retrospectively whether early response kinetics can provide the basis to individualize therapy to achieve optimal results while reducing duration and cost.

METHODS

58 chronic-HCV patients were treated with 12-week sofosbuvir+simeprevir(n=19), sofosbuvir+daclatasvir(n=19), or sofosbuvir+ledipasvir in three French referral centers. HCV was measured at baseline, day 2, every other week, EOT and 12 weeks post EOT. Mathematical modeling was used to predict the time to cure,i.e,<1 virus copy in the entire extracellular-body fluid.

RESULTS

All but one patient who relapsed achieved SVR. Mean age was 60±11 years, 53% were male, 86% HCV genotype-1, 9% HIV coinfected, 43% advanced fibrosis (F3), and 57% had cirrhosis. At weeks 2, 4 and 6, 48%, 88% and 100% of patients had HCV<15 IU/ml, with 27%, 74% and 91% of observations having target-not-detected, respectively. Modeling results predicted that 23(43%), 16(30%), 7(13%), 5(9%) and 3(5%) subjects were predicted to reach cure within 6, 8, 10, 12 and 13 weeks of therapy, respectively. The modeling suggested that the patient who relapsed would have benefitted from an additional week of sofosbuvir+ledipasvir. Adjusting duration of treatment according to the modeling predicts reduced medication costs of 43%-45% and 17%-30% in subjects who had HCV<15 IU/ml at weeks 2 and 4, respectively.

CONCLUSIONS

The use of early viral-kinetic analysis has the potential to individualize duration of DAA therapy with a projected average cost-saving of 16%-20% per 100-treated persons.

• Article Citation - Journal of Hepatology

HCV Kinetic and Modeling Analyses Indicate Similar Time to Cure Among Sofosbuvir Combination Regimens With Daclatasvir, Simeprevir or Ledipasvir

J. Hepatol. 2016 Feb 21;[EPub Ahead of Print], H Dahari, L Canini, F Graw, SL Uprichard, ES Araújo, G Penaranda, E Coquet, L Chiche, A Riso, C Renou, M Bourliere, SJ Cotler, P Halfon