16.04.2016

O leczeniu generykami na konferencji EASL w Barcelonie

Dr James Freeman zebrał informacje o leczeniu 419 australijskich chorych za pomocą leków generycznych. Dane zbierał m.in. przy pomocy znanego bloggera Grega Jefferysa. Wyniki przedstawił dziś na konferencji w Barcelonie. Otrzymane rezultaty nie odbiegają od rezultatów uzyskiwanych za pomocą leków oryginalnych.
Poniżej cytuję abstrakt.
Natomiast pokaz slajdów jest dostępny na witrynie FixHepC »»»
(Więcej o generykach i możliwościach zakupu w zakładce „Leki z Indii”).

Dr James Freeman i Greg Jefferys w Barcelonie


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
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.
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.




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