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Hepatitis B Community
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Avatar universal

HBV research & drug take a backseat?

The drug approvals keep coming for Gilead Sciences (Nasdaq: GILD). The drug
developer recently announced that it had received preliminary European Union
(EU) approval of antiviral drug Viread as a treatment for hepatitis B. (Viread
is already approved as a treatment for HIV and AIDS in the EU.)

After preliminary approval comes the approximate 60- to 90-day wait for final
approval. Then it may take awhile for Gilead to get some EU countries to
reimburse it for Viread's use in hepatitis B patients. This label expansion
probably isn't going to lead to big bucks for Gilead, though. There are
already numerous other hepatitis B compounds on the market in the EU. Also,
hepatitis B is unlike other infectious diseases, such as AIDS or hepatitis C,
in that there is a vaccine for the disease, which reduces the market
opportunity for hepatitis B drugs. Nonetheless, every label expansion helps
prolong a drug's sales life cycle, and Viread sales slowed last year.

Viread is also up for approval in the United States and multiple other
countries around the world as a treatment for hepatitis B. Although getting
these label expansion approvals isn't going to dramatically change the outlook
for Gilead's future, it's nice to see Gilead squeezing every ounce of sales
out of its marketed drugs.
6 Responses
Avatar universal
Wonder how potent this drug is and what is its profile regarding resistance.
Avatar universal
It is ranked as potent as Baraclude with very low resistance - Tenofovir.
181575 tn?1250198786
Viread is Tenofovir.  It's shares a similar chemical stucture to ADV, but it's many folds more powerful, better resistance barrier, and less toxic to kidney.  

Approval was expected in Europe and the US.

Yes, there's a business side to meds, but this is great news for those with chronic HepB.
Avatar universal
My main concerns are those comments coming out from HBF saying that the number of researcher in HBV areas dropped significantly. What is going to happen to all those ~400mil CHB if profitability is their sole focus now?
181575 tn?1250198786
HBV has always been 2nd banana to HCV and HIV in research.  We were always in the backseat.  LAM, ADV, TDF all came from HIV research.  We got lucky that way.  We may get lucky with NTZ which is from HCV research.

The point is we are lucky to have exisitng treatment options.  And if managed well, these treatment options are very effective even in the very long term if your doctors knows how to deal with the resistance issue.
Avatar universal
HBV is going to be a huge problem in Asian countries with Vietnam expecting to take a huge financial hit in the next 10 years.  The motivation is going to come from those countries most effected.

New cases may decrease in the US and other countries with rising immigrant populations but new diagnoses of people infected prior to widespread vaccination will rise over the next few years if HepB awareness programs are successful.  There is a financial interest in these countries to find treatment options.

And, we will continue to benefit from HCV and HIV research.
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