Displaying items by tag: Generic
Released in 2016, Epclusa has the remarkable ability to cure 96% of Hepatitis C sufferers regardless of genotype. It was an exciting new drug from Gilead Sciences, the innovator of the breakthrough medication Harvoni. Unfortunately, similar to Harvoni, which was released two years prior, the excitement was short lived due to the price tag. While Harvoni was priced at $94,000 USD for the standard 12 weeks treatment course, Epclusa’s price didn’t provide much relief, it cost $75,000 USD for the standard course. This meant that patients had to be either very rich or be eligible for insurance coverage to access it and sadly 90% of patients were neither. Insurance companies, because of Epclusa’s outrageous price tag, refused to cover patients unless they were in a very late disease stage, defined as severe liver fibrosis (i.e. F3 or F4). This left 90% of patients unable to access originator Epclusa and either resign themselves to wait and hope or look overseas for generic versions and navigate the notion of buying drugs on the Internet.
So, how can a patient safely access Epclusa generics on the internet that are of the same quality as the brand name medication? Glad you asked...
If you take the following 5 factors into consideration, you will be able to find a trustworthy and affordable online supplier. FixHepC (that's us) was founded by the Australian doctor James Freeman and is one such supplier. If you read on, you’ll learn why we are a trusted supplier and what to look for from others.
1. Watch out for scammers
We hear a lot about scam websites on the internet, especially foreign sites in developing countries. So how can you make sure you don't get taken? To avoid scam artists, patients need to do a bit of research to separate honest medication suppliers from scammers. Google is your friend here, it's a great tool for discovering information. You should search Google for the website's name, the name of its founder (if available), and find out about their track record. If you find none or multiple bad reviews, definitely avoid that supplier as it will be quite risky. Here's a quick guide.
Additionally, if media outlets (such as TV networks, newspapers, or reputable websites) publish good or bad information about the website you're researching, this will give you excellent insights about it. It's worth noting that here has been a lot of positive scientific and mainstream media coverage on FixHepC and its founder, Dr. James Freeman, such as in WebMD, Healthline, The Lancet Medical Journal, BBC Newsnight, Medscape, The Sydney Morning Herald, and many others. Here is a BBC Newsnight video investigation of one of the early FixHepC patients.
2. Verifying the Quality of the Epclusa Generic
Just like with any other product, there are good and bad quality generics. So how to ensure the quality of the Epclusa generic you buy? There are three factors that decide the quality of all generic medications: Licensing, Bioequivalence (biological equivalence), and CGMP (Current Good Manufacturing Practice).
One of the best ways to guarantee that a generic medication is of the highest quality is licensing. Licensed generics are medications produced under license from brand (originator) pharmaceutical companies. This pretty much guarantees that they are the same as their brand name counterparts. So if licensed generics are available, patients should try to source these medicines. This is the main reason why FixHepC sources its generics from the U.S. pharmaceutical company Mylan as it produces its Hepatitis C medicines under license from the brand name company (Gilead Sciences).
A generic drug is considered bioequivalent to its brand name counterpart if their pharmacological effects are exactly the same. It’s the gold standard for verifying the quality of a generic. This is explained in detail in this post. Bioequivalence studies done by independent labs are required to establish this. However, the easiest way to guarantee bioequivalence is licensing, as it includes technology transfer from the originator to the generic pharmaceutical company. At FixHepC we only use medication from manufacturers that have proven bioequivalence.
Current Good Manufacturing Practice certificates, as the name implies, are issued by the US FDA and EMA (European Medicines Agency) when a drug manufacturer meets all the requirements for highest quality mass production of pharmaceuticals. CGMP is the only thing that guarantees that the latest batch of medication meets the same high-quality standards as the batch that passed bioequivalence testing. Needless to say, you should choose manufacturers that were awarded this certificate. Again, licensing notionally covers this requirement since CGMP is a basic condition for entering into a licensing agreement with the originator.
3. Avoiding Fake Drugs
Unfortunately, fake drugs are a real problem in many developing countries, such as India and Bangladesh, and almost all generic Hepatitis C drugs are sourced from there. So how can you make sure that you’re buying authentic generic Epclusa and not fall victim to dishonest or incompetent online suppliers? The answer is that you have to check the Supply Chain Integrity of the online seller, but that is easier said than done. Here is a primer on how to do that.
4. Getting Guaranteed Delivery
Patients in most countries are not sure if they can legally import generic medications from abroad, and are worried that the medications they will pay for may be stopped by border customs and confiscated. In some countries, importing 3 months worth of personal medications is perfectly legal, as long as a doctor’s prescription is attached with the medications. However in some other countries, this is a gray area, and delivery is not guaranteed. It requires expertise by the shipper and learning how to abide by these countries laws and preparing the required paperwork. To make sure that you will not lose your medicines package due to an overzealous customs officer, only buy from suppliers who offer guaranteed delivery or 100% of your money back. It’s not common to find an overseas medication supplier who would take this risk and provide this guarantee. To give patients peace of mind, FixHepC does just that, and they are able to do it because they have learned over 6 years how to deliver drugs successfully all over the world.
5. Getting a Prescription and Medical Support
For one reason or another, many patients are not able to get a prescription for generic Harvoni from their doctor, so how can they get one? Also, many doctors will not monitor patients if they didn’t write their prescription, so what if you need medical support during treatment? It’s inconceivable, you may say, that online drug suppliers would provide such services, after all they are not doctors. Well, you would be right, except in the case of FixHepC. FixHepC was founded and is managed by a licensed Australian doctor, Dr. James Freeman, who is is arguably a leading expert in the field of Hepatitis C treatment. If patients have any questions during or after treatment, they can pose them for free on the site’s live chat platform and get them answered by one of FixHepC’s excellent doctors, or they can post them to the FixHepC Forum and get them answered directly by people who have been there and done that. If patients need a prescription for Epclusa, they can get one by booking a video appointment at the Australian online doctor service GP2U (Australian prescriptions can be legally used to import personal medicines into the vast majority of countries, including the US). The cost for this service is 70 USD. Follow up can be through further video appointments.
You don’t have to be fabulously rich, wait years, or get very sick before somebody agrees to treat you. You owe to yourself and to your family to take matters into your own hands and to get treated and cured now. Visit FixHepC to learn how to access licensed generic Epclusa for only $1100 USD all inclusive and rediscover what it feels like to be well again.
Just out of embargo for AASLD 2017 is the rather innocuous sounding Abstract 1078 which says, in brief, that these generic DAAs are inarguably proven the same as the originator DAAs.
Bioequivalent pharmacokinetics for generic and originator Hepatitis C Direct Acting Antivirals
Andrew M. Hill1, Loai Tahat2, Mohammed Khalil Mohammed3, Sanjay Nath4, Rabab Fayez Tayyem3, James A. Freeman5, Ismahane Benbitour7, Sherine Helmy6; 1Department of Translational Medicine, University of Liverpool, Liverpool, United Kingdom; 2Pharmaceutical Research Unit, Amman, Jordan; 3ACDIMA BioCentre, Amman, Jordan; 4Faculty of Medicine, Imperial College London, London, United Kingdom; 5GP2U Telehealth, Hobart, TAS, Australia; 6R&D Project Innovations, Pharco, Cairo, Egypt; 7BEKER Laboratories, Algiers, Algeria
Background: Mass production of low-cost generic directacting antivirals (DAAs) will be required to achieve targets of eliminating hepatitis C (HCV) by 2030. Gilead and Bristol-Myers Squibb have granted voluntary licenses to generic companies to mass-produce the DAAs sofosbuvir and daclatasvir at low cost. However generic manufacturers need to demonstrate bioequivalent pharmacokinetics for their generic DAAs compared to the originator versions, to fulfil World Health Organization standards for pre-qualification.
Methods: Randomised, single-dose, two-way, two-period pharmacokinetic studies were performed in 35-54 healthy volunteers, to compare generic forms of sofosbuvir and daclatasvir with the originator versions. Generics evaluated were from Pharco (Egypt), Beker (Algeria) and Hetero (India), versus originator sofosbuvir (Gilead) and daclatasvir (Bristol-Myers Squibb). All studies were conducted under Good Clinical Practice (GCP). Plasma concentrations of each DAA were assessed over 24 hours. Maximum concentration (Cmax) and Area Under the Curve (AUC) were calculated for each subject. Geometric mean ratios and associated 90% confidence intervals were used to compare each generic DAA with the originator version. Pre-specified limits for the 90% confidence intervals were 80% to 125% of the originator pharmacokinetic concentrations for AUC, and 69-145% for Cmax.
Results: Table 1 shows summary Geometric mean ratios for generic versus originator versions of sofosbuvir and daclatasvir. NB Results from Natco and Virchow came in after the deadline for AASLD submission, but are included here.
Table 1: Geometric mean ratio (90% confidence intervals) for generic versus originator HCV DAAs
|Sofosbuvir||Pharco||36||101.0 (88.1-115.7)||103.5 (97.6-109.7)|
|Sofosbuvir||Beker||35||95.4 (84.7-107.5)||98.5 (91.6-106.0)|
|Daclatasvir||Beker||35||35 104.1 (93.1-116.3)||103.0 (94.4-112.4)|
|Sofosbuvir||Hetero||54||95.7 (97.2- 105.2)||100.8 (96.2-
|Sofosbuvir||Natco||N/A||96.1 (81.0-114.0)||100.7 (94.2-107.8)|
|Daclatasvir||Natco||N/A||94.5 (83.1-107.4)||96.5 (87.1-106.8)|
|Sofosbuvir||Virchow||24||94.8 (83.3-107.9)||95.8 (86.9-105.7)|
All three (now expanded to 5) generic forms of sofosbuvir met pre-specified bioequivalence criteria. The Cmax and AUC of daclatasvir were bioequivalent in both cases. There were no serious adverse events observed.
Conclusions: The pharmacokinetics of generic sofosbuvir and daclatasvir were bioequivalent to the originator versions, in three independent single-dose PK studies. WHO pre-qualification of bioequivalent generic DAAs could then permit their export to high-burden countries for mass treatment programmes.
Disclosures: James A. Freeman - Advisory Committees or Review Panels: Pharco Pharmaceuticals, Beker Pharmaceuticals, Beacon Pharmaceuticals; Stock Shareholder: FixHepC, GP2U Telehealth
Ismahane Benbitour - Management Position: BEKER Laboratories
Sherine Helmy - Board Membership: Presidio Pharmaceuticals; Stock Shareholder: Pharco Pharmaceuticals
The following people have nothing to disclose: Andrew M. Hill, Sanjay Nath