FDA approves elbasvir/grazoprevir (Zepatier)

This topic has 7 replies, 7 voices, and was last updated 8 years, 5 months ago by Meg.

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2 February 2016 at 1:55 am #10945
Dr James
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@fixhepc
FDA Approves New Single-Pill Regimen for Hepatitis C Genotypes 1 and 4

The FDA has approved elbasvir/grazoprevir (Zepatier) to treat adults with chronic hepatitis C virus (HCV) genotypes 1 and 4 infection. The oral therapy can be used with or without ribavirin and in patients with chronic kidney disease.

The combination of elbasvir (an NS5A inhibitor) and grazoprevir (an NS3/4a protease inhibitor) was approved after clinical trials of roughly 1400 patients. After 12 or 16 weeks’ treatment, sustained virologic response was observed in 94–97% of patients with genotype 1 infection and 97–100% of patients with genotype 4 infection. Clinicians should screen patients with genotype 1a infections for certain NS5A polymorphisms before initiating treatment to establish proper dosage and duration.

Roughly 1% of patients experienced liver enzyme elevations — above five times the upper limit of normal — beginning in the eighth week of treatment. The agency recommends conducting liver-related blood tests before and periodically during treatment. Patients with moderate to severe liver impairment should not be prescribed the pill.

In HIV and ID Observations, physician-blogger Paul Sax explains potential reasons why the list price for 12 weeks of elbasvir/grazoprevir is substantially lower than the other approved single pill option, ledipasvir/sofosbuvir ($54,000 vs. $94,000). Click the link below to see more.

Attribution: Physician’s First Watch, Kelly Young.

YMMV
2 February 2016 at 2:49 am #10949
LondonGirl
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@londongirl
Roughly 1% of patients experienced liver enzyme elevations — above five times the upper limit of normal — beginning in the eighth week of treatment.

This is of interest as a friend of mine had elevated liver elevations on the Abbvie treatment Alt 900 and was hospitalised.

GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC
28 May 2016 at 4:46 pm #17983
klhilde
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@klhilde
Looks like Europe is close to approving Zepatier as well.

http://finance.yahoo.com/news/merck-gets-favorable-opinion-chmp-123856867.html
30 May 2016 at 9:01 pm #18061
Price
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@price
I forgot to tell you, Brazil got sof for $6,400.

P
30 May 2016 at 10:39 pm #18063
Meg
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@meg
Yes Brazil closed a deal with Gelead for US$ 6.400 a 12 weeks tx with Harvoni. But so far to treat F3 and F4 only. Distribution by the government is VERY slow though and people are suffering not knowing what will happen, if they will get tx or not.

Blood transfusion in 1992 – Diagnosed in 2007
Tx naive -G1b – F1
VL 2.270.000
ALT 40
Start tx June 4th/2016 with DAAs – Sof/Led from India
Bloods on two weeks of tx (June 18th)
AST 17 – ALT 10 – GGT 19
Virus UND
Bloods on six weeks of tx (July 16th)
AST 17 – ALT 8 – GGT 12
Virus UND
EOT on August 8th (did 9 weeks and 3 days)

SVR 4 Virus UND (September 7th)
AST 13 – ALT 5

SVR 14 Virus UND (November 12th)
31 May 2016 at 3:07 am #18074
Gaj
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@gaj
To put that price in some perspective, Brazil is estimated to have 2 million people with HCV. Which means that treating all of them would cost $12.8 billion against an annual primary health care budget of $3.5 billion.

G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
31 May 2016 at 4:15 am #18078
emilio
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@emilio
Perfect case for generic DAAs. Screw Gilead and the corrupt FDA. 12 billion vs 2 billion puts this cost variance into perspective. Fixhepc Brazil I reckon. Em
2 June 2016 at 10:28 pm #18270
Meg
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@meg
Hi guys I am not sure this is the thread to post the “news” about the situation in Brazil but I just found out that Gelead’s deal of US$ 6.400 for 12 w tx is for SOFOSBUVIR only.! Harvoni hasn’t been licensed in Brazil. So whoever is prescribed Harvoni – needs to appeal against either the government or their private Health Insurance and the cost is still US$ 84.000 for tx. Since Sofosbuvir doesn’t work alone, Brazilian government is also importing Daclastavir from Bristol Myer Squib. Not sure how much the deal for Dac is yet. So far only F3 and F4 are being treated with Sof/Dac by the National Health Agency called SUS.

Blood transfusion in 1992 – Diagnosed in 2007
Tx naive -G1b – F1
VL 2.270.000
ALT 40
Start tx June 4th/2016 with DAAs – Sof/Led from India
Bloods on two weeks of tx (June 18th)
AST 17 – ALT 10 – GGT 19
Virus UND
Bloods on six weeks of tx (July 16th)
AST 17 – ALT 8 – GGT 12
Virus UND
EOT on August 8th (did 9 weeks and 3 days)

SVR 4 Virus UND (September 7th)
AST 13 – ALT 5

SVR 14 Virus UND (November 12th)
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