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Yes. Also, i hope we will get some “self-reported” SVR data from russian-spoken forums in near future. Several patients on these forums already finished therapy with new indian NS5A generics, and it requires several weeks to get SVR data. Self-reported SVR data for indian licensed sofosbuvir generics (mostly, it seems, hepcinat and myhep) for 1b genotype looks good. I know about 2 reported relapses per approximately 100 svr’s reported for genotype 1 (mostly 1b) for sof+dac (dac mostly based on chinese api) containing therapy. One of these two relapses, probably, occurs due to previous failure of dac+asun therapy and subsequent resistance. Both relapsers used generic sof from Egypt, not from India.
Probably infected in 1977
2005 – diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320
2005-2006 – PegIFN/rib 48 weeks treatment, relapse
2016 – compensated F4, MELD 8-9, ALT 100-160
2018 – compensated F4, MELD 8, ALT 91I hope yes. Dr.Gane said that
Gilead has licenced 11 generic companies in India to produce sofosbuvir (and very soon the ledipasvir/sofosbuvir combination tablet) for the local markets. Strict quality control from Gilead ensures that these drugs are identical to those produced for European and American markets.
Probably infected in 1977
2005 – diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320
2005-2006 – PegIFN/rib 48 weeks treatment, relapse
2016 – compensated F4, MELD 8-9, ALT 100-160
2018 – compensated F4, MELD 8, ALT 91There is a patent about spray-drying technique (mentioned by Gane) for ledipasvir – http://www.google.com/patents/US20140212487 If i correctly understand, food has negative effect on absorption of ledipasvir, and spray-drying is applied to mitigate this effect. This does not mean that ledipasvir will not absorb “at all” without spray-drying. If ledipasvir is used in fasted condition – their absorption, possibly, may be good even without spray-drying…
Probably infected in 1977
2005 – diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320
2005-2006 – PegIFN/rib 48 weeks treatment, relapse
2016 – compensated F4, MELD 8-9, ALT 100-160
2018 – compensated F4, MELD 8, ALT 91Thanks. I will wait “real world” SVR statistics for NS5A indian generics before starting on 24 weeks.
Probably infected in 1977
2005 – diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320
2005-2006 – PegIFN/rib 48 weeks treatment, relapse
2016 – compensated F4, MELD 8-9, ALT 100-160
2018 – compensated F4, MELD 8, ALT 91Hi James! Thank you very much.
Yes, 8 weeks of therapy is not optimal in my case. Well, ribavirin will not add much for SVR probability… But this based on clinical trials with expensive original drugs (and, possible, with selected patients having good predictors). We cannot be completely sure in high quality of new dac/led indian generics yet (because we have no SVR statistics at this time)… Even without NS5A inhibitor, sof+rib may give some chances for SVR (48 week with sof+rib in cirrhotics may give more than 50% SVR – http://www.natap.org/2015/EASL/EASL_23.htm) And, AASLD recommends 12 week sof/led with riba (or 24 without riba) for F4 – this means that riba may have some positive effect in terms of SVR probability, at least for 12 week treatment…
It is interesting idea – to combine 12 week of sof+dac and 12 week of sof+led… I will think about it.
Thank you.
P.S. Great decision support tool!
Probably infected in 1977
2005 – diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320
2005-2006 – PegIFN/rib 48 weeks treatment, relapse
2016 – compensated F4, MELD 8-9, ALT 100-160
2018 – compensated F4, MELD 8, ALT 91James, Alsdad – thank you very much!
Today I received answer from Gilead about Harvoni storage conditions. They wrote that for -20 celsius acceptable duration of storage is 28 days. It seems good enough. Text of their answer:
Harvoni tablets do not require any special storage conditions.
Data extrapolated from results of in-house stability studies demonstrate that LDV/SOF tablets are stable when stored in the recommended container system and exposed to a variety of temperatures and relative humidity (RH) conditions beyond those described in the Prescribing Information. A summary of results from these studies is shown in Table 1. The “acceptable duration” solely relates to the stability of the tablets relative to the specified storage conditions, but does not endorse dispensing tablets in alternative packaging or use beyond the expiration date stated on the original packaging.
Table 1: Summary of Storage Conditions and Acceptable Duration for LDV/SOF Tablets
Storage Condition Pack Type Acceptable Duration
25°C (77°F)/60% RH Original bottle 24 months
30°C (86°F)/75% RH Original bottle 24 months
40°C (104°F)/75% RH Original bottle 6 months
5°C (41°F) Original bottle 45 days
25°C (77°F)/80% RH Original bottle 45 days
50°C (122°F) Original bottle 45 days
Open dish 25°C (77°F)/60% RHa No Container 45 days
Open dish 30°C (86°F)/75% RHa No Container 45 days
-20°C (-4°F) Original bottle/No Container 28 days
Light exposure No Container 2-3 days to 3 monthsbAbbreviations: RH: relative humidity
a Tablets are stored outside of the commercial packaging configuration in an open petri dish.
b Acceptable duration depends on the type of light exposure and ranges from 2-3 days for exposure to full sunlight such as through a window to 3 months for exposure to fluorescent light such as in an office environment.
Probably infected in 1977
2005 – diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320
2005-2006 – PegIFN/rib 48 weeks treatment, relapse
2016 – compensated F4, MELD 8-9, ALT 100-160
2018 – compensated F4, MELD 8, ALT 91 -
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