Authentic medication or not?

Hello family, I hope this meets you in good condition?

I have a history of hep b in my family, I’ve lost 3 of my senior brothers to liver related ailments, 2 hep b and 1 hep c. All the 3 were aged between 40-55 years. I got to know my hep b status in sept. 2012, at the time all my 3 brothers were still alive. It so happened quickly that between 2015 to 2021, we sadly lost all of them. Alot happened afterwards but Knowing that my life was also in danger, I took my diagnosis more seriously. I was prescribed TDF after a viral load test of around 87 million iu/ml. After taking TDF for a month or so, I got so sick that I had to stop. The doctor switched me to interferon injections which I took for only 11 weeks. The interferon lowered my viral load to <10 iu/ml but the side effects coupled with high cost of it forced me to stop the treatment. Even though my viral load had lowered significantly, my body was generally unwell.
In May 2022, I travelled to our national capital to seek for further care. Fortunately, I had the opportunity for the first time to see a gastroenterologist who took a complete history of my condition and decided to put me on this TAF( Tenofovir Alafenamide) below. She said it was more expensive than TDF but because I couldn’t tolerate TDF I chose the TAF.

She is a good woman, very professional and knowledgeable and I have no reason to doubt her, but I got a bit concerned after reading the above information on the hepatitis B website.

Please is this medication authentic?
Who else here is on it?

I’m exactly a year on it, though my symptoms haven’t gone completely, they have greatly improved.

Hi @Listowel,

First off, I wanted to offer condolences for losing your three brothers. How devastating that must have been during those years. However, I am certainly glad that you were able to see a good GI. I believe her putting you on TAF (Vemlidy) was a sound decision based on your CHB history and your reaction to TDF. I and many others in this community are on TAF. It is the newest antiviral available for HBV. TAF is still on patent which is why you were reading that there are no other names or generics for this drug. I am not an expert so I am not certain I am saying this correctly, but TAF has less dosage of drug while still having as much of an impact as other antivirals. Maybe that is why you have less reaction to it than TDF.

What’s odd is that TAF is manufactured by Gilead so I don’t know how yours is by Natco. Maybe Gilead passes it on to different distributors in different regions of the world.

The experts can explain all of this and answer your questions much better than I. So I will leave you with this until they can respond to you.

-Paul

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@PuallyHBV

Thanks for your warm words and the swift response, I deeply appreciate it.

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Lots of sites show up if you google for “natco tenofovir alafenamide” (most generic, automated copy/paste news release sites though - not reputable sources), for example:

Also here (manufacturer website):

https://www.natcopharma.co.in/about/news/

if you go to “2017” tab:

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is one of the first companies to launch a generic version of Tenofovir Alafenamide, TAF, 25 mg, a once-daily tablet for the treatment of chronic hepatitis B in adults, under its brand TAFNAT, in India. The drug TAF demonstrates comparable efficacy, with an enhanced renal and bone safety profile as compared to earlier formulation of tenofovir (tenofovir disoproxil fumarate).
TAFNAT is manufactured under license from Medicines Patent Pool (MPP) and Gilead Sciences. Natco priced its generic medicine of TAFNAT at an MRP of INR 1900/- for a monthly pack of 30 tablets for the India market.

So the product seems to exist.
Not sure how to check if it might be counterfeit or not though!

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Hi @mantana,

Thanks for finding this article. It reinforces my assumption. The company Natco has TAF under the brand name Tafnat. TAFNAT is manufactured under license from Medicines Patent Pool (MPP) and Gilead Sciences. So Gilead is allowing other companies in certain parts of the world to rebrand TAF under license.

I don’t know much about the MPP but it sounds like it is enabling regions that would otherwise not have access to TAF to be able to get it.

-Paul

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Perhaps some @PharmacyExperts can also provide input here…

@john.tavis perhaps you could provide some outline of the MPP?

Thomas

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I don’t know a huge amount about the MPP, but here’s what I do know: MPP is a centralized, UN-backed organization that promotes broader access to medicines that are under patent, with a primary focus on resource-limited companies. If my understanding is correct, the MPP helps negotiate and manage process of sub-licensing production and distribution of patented medicines to areas in which the brand name drug would be too expensive. My impression is that it is a great organization, and that expanding it’s activities greatly would be one way to help speed access of new medicines to folks who need them but don’t live in the resource-rich countries.

john.

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@PuallyHBV @ThomasTu @john.tavis

Thank you all for always finding time out of your busy schedules to respond to our many questions. My concerns have been adequately addressed. I found this on the MPP website…

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Great, thanks for your input @john.tavis!

I agree, I have just been at a conference in Paris where the World Hepatitis Alliance (@jessicah and @Suwang88) invited the CEO of MPP Charles Gore to give a presenation at a NOhep Medical Visionaries Forum. It was pretty interesting as a way to try to expand access to treatment in resource limited settings.

They were super supportive of what needs to get done to limit the impact of HBV around the world- Hepatitis Can’t Wait! Message from MPP's ED on World Hepatitis Day

TT

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