Biotech Values

[DewDiligence]

Re: JNJ/ACHN’s 6-week HCV regimen

Will the market demand a pan-genotype treatment, or will patients still be genotyped and segregated into categories to be treated accordingly?

Everyone (except labs who conduct the genotyping) wants to dispense with genotyping, as far as I can tell. Lack of genotyping lowers cost and increases patient throughput—which is good for physicians, patients, and third-party payers—and it eliminates occasional mistreatment based on erroneous results from the genotyping assay. (In some less-developed markets, genotyping assays are not readily available.)

On the other side of the coin, there is little or no interest within the healthcare industry for shortening the non-cirrhotic GT1 treatment duration from 8 weeks to 6 weeks. Inasmuch as HCV scripts generally cover 4 weeks of pills, a 6-week duration would still require one refill, lessening the compliance advantage from a shorter regimen.

Moreover, JNJ/ACHN’s reported 100% SVR rate for the 6-week regimen was based on only 20 patients (#msg-130712374); in a larger sample, we would likely see the SVR rate for this regimen drop below the 99-100% rate conferred by 8 weeks of Harvoni or G/P in this patient population.

So will JNJ take this forward?

JNJ previously started a phase-2b trial of the 3-DAA regimen with 6- and 8-week arms for non-cirrhotic non-GT3 patients (https://www.clinicaltrials.gov/ct2/show/NCT02765490 ); results are expected in Aug 2017. The big question, of course, is whether they advance the regimen to phase-3.