Can Generics Open HCV Therapy Bottleneck?

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• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

BARCELONA -- Many people with hepatitis C (HCV) might be able to make an end run around the high prices for the new direct-acting medications by turning to low-cost generics, a physician said here.

An interim analysis from a cohort of patients using generics shows efficacy and safety similar to brand-name products, according to James Freeman, MBBS, of GP2U Telehealth in Hobart, Australia.

"Generic cure for HCV is available now for less than $1,000 and works as expected," Freeman told reporters at the International Liver Congress.

That's markedly lower than it costs to cure chronic HCV in countries like the U.S., where the sticker price is famously about $84,000 for a 3-month course of a key medication.

The catch is that patients have to import the generics from countries that don't recognize the pharmaceutical patents -- such as India, which has a well-established generic drug industry -- and they might not know exactly what they're getting.

The goal of the study was to see if the generics were chemically the same and if they worked as well as the brand-name products, Freeman said.

Freeman's late-breaker presentation here came as Spanish activists demonstrated outside the convention center, urging their government to control the price of HCV medications.

The study is "timely," commented Laurent Castera, MD, PhD, of Hôpital Beaujon in the Paris suburb of Clichy and secretary-general of the European Association of the Study of the Liver (EASL), which organizes the meeting.

Cost remains an important barrier to access to what can be life-saving drugs, he told MedPage Today, and prices will eventually have to come down. Generic drugs might be part of the solution, but it hasn't been clear how good they are, compared with the brand-name products.

"Generics have been around in several countries," he said, "but we don't have very much data so far."

Freeman said the study "started by accident" when a patient asked him about generics, specifically generic versions of sofosbuvir, ledipasvir, and daclatasvir are being produced for about 1% of their current U.S. retail price.

He said he also learned that many countries, including Australia, allow individual patients to import medications for personal use.

He told MedPage Today that before he was comfortable with prescribing generics, he had to satisfy himself that chemically they were the same as the brand-name products. Testing with high performance liquid chromatography, nuclear MR, and mass spectrometry showed that they were.

But even after that, it remained unclear if they were as safe and effective, he added.

His group enrolled patients on an intent-to-treat basis through an Australian website, fixhepc.com, which helps people import medications, and followed them through the course of their therapy.

Some 448 patients have been enrolled from around the world in the so-called REDEMPTION-1 study, and Freeman presented interim data on outcomes for patients treated with two of the available combinations -- sofosbuvir/ledipasvir and sofosbuvir/daclatasvir and with two of the six HCV genotypes.

Four weeks after the end of treatment, 95% of those with genotype 1 HCV and 90% of those with genotype 3 had undetectable virus. An HCV cure is conventionally defined as no detectable virus 12 weeks after the end of treatment (SVR₁₂) so Freeman's data represent an earlier time point, and the rates can be expected to drop slightly.

He said at the end of his platform presentation that, indeed, most of the patients have now reached an SVR₁₂.

But for comparison, Freeman presented data showing that published SVR₁₂ rates for the branded versions of the two combinations in those genotypes are similar to those he has seen so far -- 96% and 90%, respectively.

There were "no new or unknown side effects," Freeman said. Three patients with compensated cirrhosis decompensated, but were able to continue treatment, and four patients died of hepatocellular carcinoma, including one who died before starting therapy and two who withdrew early.

Exactly how many patients can use such an approach is unclear, since it depends on the legality of importing medications for personal use. In some countries, Freeman said, it's explicitly permitted, in others it's banned, and in many the law is vague.

Freeman disclosed no relevant relationships with industry.

Castera disclosed no relevant relationships with industry.

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Can Generics Open HCV Therapy Bottleneck?