An Australian physician is sending generic DAAs made in China and India to patients with hepatitis in the US. It's part of an NIH-approved clinical trial.
Using a “Dallas Buyers’ Club” strategy to let patients in many countries to get cheap generic direct-acting antivirals for hepatitis C virus infection, an Australia researcher is determined to speed up the process of getting the drugs to people who cannot afford them. That includes patients in the US.
By setting up a website called http://fixhepc.com/ James Freeman, MD of Hobart, Australia, invited patients to sign up for his two-part US National Institutes of Health-approved trial called REDEMPTION-3 and REDEMPTION-2. The two-part trial, which has a stated goal of measuring whether generics work, will run through June, 2017. Enrollment is limited to 400 patients, but Freeman hopes results will be positive and add to pressure to make the generics more widely available.
The approach is somewhat similar to that used in the early days of the AIDS epidemic where--as portrayed in the Dallas Buyers' Club film--patients used an intermediary to import antivirals they could not get in the US because they were not approved. The difference now is that the HCV drugs are generic versions of FDA-approved drugs.
Freeman offered a preliminary report on his experiment at the International Liver Congress in Barcelona.
The website features an interactive global map showing where it is legal to import the generics from countries like China, India, and Bangladesh.
“It is not free, and entry into the sofosbuvir/daclatasvir arm will cost US $1,400 and entry into the sofosbuvir/ledipasvir arm will cost US $1,600,” the website says, “This is the best price in the market right now and includes shipping.” The site notes that there are virtually no exclusion categories for being part of the study, all patients need is to be HCV infected and not allergic to DAAs
Freeman is taking advantage of the decision made by several DAA manufacturers which announced last year that they would give some generic drug makers the information needed to make sofosbuvir, ledipasvir, daclatasvir and ribavirin.
The idea was to make the drugs available in undeveloped nations where there was no realistic chance of marketing them at the prices charged in the developed world—such as about $98,000 a year in the US for a 12-week course of treatment.
But Freeman is shipping them, legally he says, to people in developed countries as well, including patients in the US and UK. In the US, according to that map all states are listed as “locations where we either know we can ship from personal experience, or expect to be able to achieve medication delivery.”
According to the US Food and Drug Administration, the importation of generics for HCV is technically not legal since the generics are not approved in the US.
But the agency notes that for serious conditions where effective treatment is not available in the US, the FDA “typically does not object to personal imports of drugs that the FDA has not approved under certain circumstances” including that the drug is not marketed directly to US residents, does not represent an unreasonable health risk, is just for the patient’s own use, and is limited to a three-month supply.
It is not clear from the FDA’s wording whether the high price of DAAs effectively makes them “not available” to the patients who then get them shipped from Australia, but advocates argue that is the case.
At the ILC meeting, he presented results showing that the generics safety and efficacy is equivalent to that of brand names.
Freeman said his strategy has great promise and could end the global spread of HCV.
A 12-week course of treatment using generic DAAs being mass-produced now can be obtained for less than $1,000 as a generic, at a manufacturing cost of $200, Freeman said in presenting his study.
To be certain the generics were of high quality, the research team evaluated them, using high precision liquid chromatography, nuclear magnetic resonance and mass spectroscopy.
The tests showed the drugs were effective, achieving a sustained virologic response across genotypes, he said.
“Generic DAAs can deliver the same success rates as branded equivalents but at a price which is one one-hundredth of the current cost” Freeman said.