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FDA approves elbasvir/grazoprevir (Zepatier) 8 years 3 months ago #9898
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. $94,000). Click the link below to see more. Attribution: Physician's First Watch, Kelly Young. YMMV | |
FDA approves elbasvir/grazoprevir (Zepatier) 8 years 3 months ago #9902
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This is of interest as a friend of mine had elevated liver elevations on the Abbvie treatment Alt 900 and was hospitalised. GT1a Dec14 F2/8.7 VL 900000-2.5M Jan16 Hepcivir-L MonkMed/Redemption Baseline: VL 913575 Alt 76 Platelets low Wk2 VL1157 Alt 23 DET Wk 8 VL 32 Alt19 'In the slow lane' June16 Fibro 5.7 F0/1 LIF 1.5 Wk 11 VL<12 Alt 13 Det/Unq Extending tx 12 wks Mylan Sofo/Dac MonkMed Wk 14 VL <12 Det/Unq Wk 16 VL UNDETECTED Wk 22 + 4 Wks Sunprevir FixHepC Wk 24 UNDETECTED Alt 13 Wk 12 post tx SVR12 Wk 26 SVR24 Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC |
FDA approves elbasvir/grazoprevir (Zepatier) 7 years 11 months ago #16790
Looks like Europe is close to approving Zepatier as well. finance.yahoo.com/news/merck-gets-favora...-chmp-123856867.html The following user(s) said Thank You: Meg | |
FDA approves elbasvir/grazoprevir (Zepatier) 7 years 11 months ago #16865
Yes Brazil closed a deal with Gelead for US$ 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) The following user(s) said Thank You: fitz | |
FDA approves elbasvir/grazoprevir (Zepatier) 7 years 11 months ago #16875
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 $3.5 billion. G3a since '78 - Dx '12 - F4 (2xHCC) 24wk Tx - PEG/Riba/Dac 2013 relapsed 24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed 16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof SVR7 - 22/06/17 UND SRV12 - 27/07/17 UND SVR24 - 26/10/17 UND | |
FDA approves elbasvir/grazoprevir (Zepatier) 7 years 11 months ago #16878
Perfect case for generic DAAs. Screw Gilead and the corrupt FDA. 12 billion vs 2 billion puts this cost variance into perspective. Fixhepc Brazil I reckon. Em Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016. | |
We are moving the awareness needle 7 years 11 months ago #17045
Hi guys I am not sure this is the thread to post the "news" about the situation in Brazil but I just found out that Gelead's deal of US$ 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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