Early Results Show Generic Antivirals Effective in Hep C

“In a breakthrough that rivals the invention of penicillin, drugs that cure hepatitis C have reached the market, yet every 45 seconds, another patient dies from hepatitis C. These are not data points. These are the hopes, dreams, and lives of real people. We could treat 68 million people with hepatitis C and spend the same amount as we spend to treat one person with HIV for 1 year.”
-James Freeman, MD, investigator from the University of Tasmania in Hobart, Australia1

Many treatment options on the market for HCV are effective, but come with a hefty price tag. This has led to a surge in research surrounding the possibility of generic direct-acting antivirals. One such group of researchers is currently working on the REDEMPTION studies, and presented early results at the 2017 International Liver Congress (ILC). Their results point towards the effectiveness of antivirals from countries like Egypt, Bangladesh, China, and India, that are generic for medications such as sofosbuvir, ledipasvir, daclatasvir, and velpatasvir.2

Research Results

A current cohort of 1,087 individuals with HCV are involved in the study, and although information has not currently been released on the status of all 1,087, investigator Dr. James Freeman was able to provide a few updates. Notably, a sustained virologic response at week 4 was achieved by 94% of 523 individuals, and that sustained response remained present at week 12 for 89% of 450 individuals. The mean baseline viral RNA load for these individuals was 6.9 log IU/mL at the outset of the study, with a viral load less than 25 IU/mL being achieved at the end of treatment for 98% of 642 individuals. No unexpected adverse effects were present, however, three individuals developed decompensated and recompensated cirrhosis, one experienced a reactivation of hepatitis B, and four developed hepatocellular carcinoma after or during the treatment regimen.

The studied population was 60% male, and had a mean age of 44 years. Also, 56% of the sample population had genotype 1 HCV, and had a median length of treatment of 12 weeks. Individuals participating were from 42 different countries and were assessed at one of four treatment-access programs in Russia, Australia, and Southeast Asia. Similar results were presented by the REDEMPTION team at last year’s ILC conference, however, last year’s presentation only included information from 448 individuals.

Implication of Generic DAAs in the US

Several studies, including this one from Dr. Freeman and his team, have pointed toward the bioequivalence, safety, and efficacy of generic direct-acting antivirals for HCV. However, access to these generics is the main cause for concern. Legal importation of these drugs is only allowed in certain areas of the world. Currently, America isn’t expected to legally have access to these medications until 2032.

Medical tourism is a hotly debated topic in the United States. Advocacy efforts in the America are focused on furthering equitable access to life-saving hepatitis C cures to more of the millions infected. While many may be tempted to seek treatment outside of their home country, it is important to be cautious and safe.

View References

Comments

Poll