Buyers’ Clubs: Generic versions of HCV drugs resulted in very high cure rates.
http://www.aidsmap.com/page/3094978/
HEPATITIS C TREATMENT

Generic hepatitis C drugs purchased online achieve high cure rates
Keith Alcorn
Published: 27 October 2016
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Use of generic versions of direct-acting antivirals resulted in very high cure rates for people who obtained the products through three buyers’ clubs, indicating that the generics products are effective, according to three presentations at the International Congress on Drug Therapy in HIV Infection in Glasgow this week.

People who purchased the drugs were cured of hepatitis C at a cost of around $700-$900 in South East Asia and Eastern Europe, Dr Andrew Hill of St Stephen’s AIDS Trust, London, reported in three poster presentations at the conference.

Direct-acting antivirals typically cure 90-95% of hepatitis C infections, even in cases where people have advanced liver disease or previous experience of ineffective treatment. The price of treatment remains a major barrier to curing hepatitis C for millions of people, and where rationing of treatment, lack of health insurance or lack of a national treatment programme deny access to these drugs, people are turning to internet-based buyer’s clubs to obtain generic versions of direct-acting antivirals.

Generic versions of direct-acting antivirals are manufactured in India under voluntary license from Gilead Sciences, and by other Indian companies who are not licensees, and in other countries such as Bangladesh where patents on the products do not exist. The lack of patent protection allows generic manufacturers to produce their own versions of the drugs. In many countries it is legal to import drugs for personal use by ordering them online. In other countries imports of generic drugs are restricted to those carried through customs by individuals in quantities sufficient for personal use.

A previous study by Dr James Freeman of Hobart, Australia, showed very high cure rates when using generic versions of DAAs, and also provided evidence that the products purchased contained the necessary levels of active drug. The studies presented this week, in which data supplied by patients and their physicians were analysed by St Stephen’s AIDS Trust in London, measured virological responses. Two studies identified the generic products used, and one study was able to measure levels of active ingredients. The preliminary results of the three studies show cure rates comparable to those achieved with branded products.

FIXHepC Buyer’s Club

The FIXHepC Buyer’s Club is an online service which directs people towards generic sources of hepatitis C drugs and arranges testing of the drugs to ensure that they contain the correct levels of active ingredients. All drugs purchased by patients whose data were analysed in this study had been tested for active ingredients. Patient data were gathered by Dr James Freeman and analysed by St Stephen’s AIDS Trust. Patients were monitored remotely in many cases and were distributed across every continent.

The data presented at the International Congress on Drug Therapy in HIV Infection represents extended follow up on 438 of the 448 patients reported previously by Dr Freeman.

Fifty-nine per cent of patients contributing data to this study had less advanced fibrosis (F0-F2), 11% had F3 fibrosis and 27% had cirrhosis.

Baseline characteristics
Patients
SOF/RBV
(n=3)
SOF/DCV
(n=19
SOF/LDV
(n=237)
% Male
67%
58%
53%
% Cirrhosis
67%
34%
21%
% GT1
0%
41%
90%
% GT3
0%
46%
5%
+ RBV
100%
11%
9%
Analysis of SVR12 responses by genotype showed that patients with genotype 3 were substantially less likely to achieve a sustained virologic response compared to other genotypes. 80% of genotype 3 patients, predominantly treated with sofosbuvir/daclatasvir, achieved sustained virologic response (SVR12), compared to 94% of genotype 1 patients and all patients with genotypes 2,4,5 and 6. Overall, 90% of patients who had obtained drugs through the FIXHepC Buyer’s Club and who had completed the 12-week post-treatment follow up have achieved sustained virologic response to date.

HCV <25 IU/ml during study
Patients
SOF/RBV
(n=3)
SOF/DCV
(n=19
SOF/LDV
(n=237)
RVR
2/2 (100%)
95/111 (86%)
82/98 (84%)
EOT
3/3 (100%)
182/184 (99%)
191/193 (99%)
SVR 4
3/3 (100%)
100/117 (85%)
119/130 (92%)
SVR 12
3/3 (100%)
107/132 (81%)
129/148 (87%)