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LBO3
HIGH SUSTAINED VIROLOGICAL RESPONSE RATES USING GENERIC DIRECT ACTING
ANTIVIRAL TREATMENT FOR HEPATITIS C, IMPORTED INTO AUSTRALIA
J. Freeman1, R. Sallie2, A. Kennedy3, P.T.N. Hieu1, J. Freeman4,
G. Jeffreys5, A.M. Hill6.
1GP2U Telehealth, Hobart; 2Hepatology, Nedlands; 3Kingswood Pharmacy; 4Nephrology, Sandy Bay; 5University of Tasmania, Hobart, Australia; 6St Stephens AIDS Trust, Chelsea and Westminster Hospital, London, United Kingdom
1GP2U Telehealth, Hobart; 2Hepatology, Nedlands; 3Kingswood Pharmacy; 4Nephrology, Sandy Bay; 5University of Tasmania, Hobart, Australia; 6St Stephens AIDS Trust, Chelsea and Westminster Hospital, London, United Kingdom
E-mail: microhaart@aol.com
Introduction: High prices of Direct Acting Antivirals (DAAs) prevent access to
treatment in many countries. Generic sofosbuvir, ledipasvir and daclatasvir are
being mass produced for prices under 1% of the current US retail price. Under Australian
law, individuals have the right to import 3 months of medication, for their personal
use. The objective of this analysis was to assess the efficacy and safety of generic DAAs imported
by patients from countries where produced.
Material and Methods: Sofosbuvir, ledipasvir, daclatasvir and ribavirin were imported and evaluated using High Precision Liquid Chromatograhy (HPLC) and Nuclear Magnetic Resonance (NMR). Rapid Virological Response (RVR) testing was conducted to confirm clinical efficacy. Patients were assessed pre-treatment, at weeks 4, 8, 12/End Of Treatment (EOT) and then for SVR 4 and SVR 12. Adverse events were recorded. This analysis includes results from 417 patients monitored in two clinics.
Material and Methods: Sofosbuvir, ledipasvir, daclatasvir and ribavirin were imported and evaluated using High Precision Liquid Chromatograhy (HPLC) and Nuclear Magnetic Resonance (NMR). Rapid Virological Response (RVR) testing was conducted to confirm clinical efficacy. Patients were assessed pre-treatment, at weeks 4, 8, 12/End Of Treatment (EOT) and then for SVR 4 and SVR 12. Adverse events were recorded. This analysis includes results from 417 patients monitored in two clinics.
Results: Of the 419 patients treated, 3 received SOF/RBV, 187 SOF/LDV, 20
SOF/LDV/RBV, 183 SOF/DCV and 26 SOF/DCV/RBV. Summary baseline and interim outcome
data is shown in Table 1. Overall the patients were 56% male and 89% Caucasian with
a mean age of 54 years; 30% had cirrhosis; 64% were Genotype 1, 5% Genotype 2, 28%
Genotype 3, and 3% Genotype 4, 5 or 6. The median baseline HCV RNA was 6.06 log10
IU/mL (1,160,000 IU/mL). Using currently available data, overall percentage HCV
RNA undetectable was 98.0% (149/152) at EOT, 97.4% (75/77) at SVR4 and 96.2% (50/52)
at SVR12.
Treatment
|
SOF/LDV
|
SOF/DCV
|
% Treatment naïve
|
41% (85/207)
|
55% (115/209)
|
% Cirrhosis
|
22% (43/207)
|
36% (75/209)
|
Ribavirin
use
|
10% (20/207)
|
13% (27/209)
|
% Genotype
1
|
89% (185/207)
|
39% (82/209)
|
% Genotype
3
|
6% (13/207)
|
50% (105/209)
|
Week 12/EOT
|
96.4% (81/84)
|
100% (65/65)
|
SVR 4
|
97.9% (47/48)
|
96.2% (25/26)
|
SVR12
|
97.2% (35/36)
|
92.3% (12/13)
|
Conclusion: In this analysis, treatment with legally imported generic DAAs
led to SVR4 rates of 98% on SOF/LDV and 96% on SOF/DCV. These SVR rates are similar
to those seen in Phase 3 trials of the branded treatments. Mass treatment with generic
DAAs is a feasible alternative where high prices prevent access to branded treatment.
