FDA approves `Technivie` for treatment of patients with Gen. 4
mallani said
Jul 29, 2015
Hi Jill,
I guess AbbVie are happy to have another Drug Combo approved. Technivie is just Viekira Pak without the fairly useless NS5B non-nucleoside inhibitor, Dasabuvir.
Tig, the NS5B complex in Genotype 4 is very different from the same complex in Geno 1's. The active site is the same, so Sovaldi works fine. IMHO, non-nuc's are a waste of time.
I see Technivie results aren't very good for cirrhotics.
Genotype 4 is rare in the USA, so Trials are sparse. However, the NIAID Synergy Trial (Phase 2a) showed a 100% SVR rate for 12 weeks of Harvoni (no Riba). Admittedly there were only 20 patients, but some were cirrhotic.
If I was a Geno 4, I'd want Harvoni.
Anyway, one more string to the bow. Given that Geno 4 is Egypt and North Africa, I can see generic Harvoni undercutting any price gain from Technivie. Cheers.
Tig said
Jul 28, 2015
Thanks Jill, that's great news for all the GT 4's out there. It's interesting that Technivie contains the same drugs as Viekira Pak, with the exception of Dasabuvir, which is the NS5B PI component. Makes me wonder why GT 4 doesn't require/benefit from a 5B inhibitor. Malcolm, any specifics you're aware of? Ultimately I guess that's why we have to wade through all of the trials. Lots of trial and error involved. Eliminating Interferon is a huge advance as well.
Cinnamon Girl said
Jul 28, 2015
The U.S. Food and Drug Administration today (24th July, 2015) approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).
Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection.
Hi Jill,
I guess AbbVie are happy to have another Drug Combo approved. Technivie is just Viekira Pak without the fairly useless NS5B non-nucleoside inhibitor, Dasabuvir.
Tig, the NS5B complex in Genotype 4 is very different from the same complex in Geno 1's. The active site is the same, so Sovaldi works fine. IMHO, non-nuc's are a waste of time.
I see Technivie results aren't very good for cirrhotics.
Genotype 4 is rare in the USA, so Trials are sparse. However, the NIAID Synergy Trial (Phase 2a) showed a 100% SVR rate for 12 weeks of Harvoni (no Riba). Admittedly there were only 20 patients, but some were cirrhotic.
If I was a Geno 4, I'd want Harvoni.
Anyway, one more string to the bow. Given that Geno 4 is Egypt and North Africa, I can see generic Harvoni undercutting any price gain from Technivie. Cheers.
Thanks Jill, that's great news for all the GT 4's out there. It's interesting that Technivie contains the same drugs as Viekira Pak, with the exception of Dasabuvir, which is the NS5B PI component. Makes me wonder why GT 4 doesn't require/benefit from a 5B inhibitor. Malcolm, any specifics you're aware of? Ultimately I guess that's why we have to wade through all of the trials. Lots of trial and error involved. Eliminating Interferon is a huge advance as well.
The U.S. Food and Drug Administration today (24th July, 2015) approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).
Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection.
Link to full details and press release...
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455857.htm