This month’s edition of HCV Drugs will be short due to the upcoming European Association for the Study of the Liver (EASL) conference. Join us for extensive coverage on www.hcvadvocate.org for the latest news and the next edition of the HCV Advocate newsletter. There is, however, important news included in this issue: Merck is granted Breakthrough Therapy designation; phase 2 study results of AbbVie’s combo to treat genotype 4; and, lastly not really drug-related, a new study that is being sponsored by the National Institutes of Health (NIH) that may finally help expand care and treatment to other medical providers.
Merck
Just when we thought that the Food and Drug Administration (FDA) had rescinded Breakthrough Therapy designation for all HCV therapies – we were wrong—they have given it to Merck’s combination of grazoprevir plus elbasvir for the treatment of people with HCV genotype 1 who have end-stage renal (kidney) disease on hemodialysis and for people with HCV genotype 4. The designation will allow for expedited review and approval.
Just when we thought that the Food and Drug Administration (FDA) had rescinded Breakthrough Therapy designation for all HCV therapies – we were wrong—they have given it to Merck’s combination of grazoprevir plus elbasvir for the treatment of people with HCV genotype 1 who have end-stage renal (kidney) disease on hemodialysis and for people with HCV genotype 4. The designation will allow for expedited review and approval.
Comment: These two groups are definitely in need of expedited review! This is very good news for people living with hepatitis C. Merck has this combination of medications in multiple studies.
Source: Company press release
AbbVie
Results from a small phase 2 trial was recently published in The Lancet. The trial included 86 HCV genotype 4 patients who had never been treated (treatment naïve) as well as those who had been treated previously (treatment-experienced). The patients were treated with ombitasvir (once-daily), paritaprevir/ritonavir—with and without ribavirin (twice daily) for 12 weeks.
Results from a small phase 2 trial was recently published in The Lancet. The trial included 86 HCV genotype 4 patients who had never been treated (treatment naïve) as well as those who had been treated previously (treatment-experienced). The patients were treated with ombitasvir (once-daily), paritaprevir/ritonavir—with and without ribavirin (twice daily) for 12 weeks.
Forty-nine patients who had previously received treatment (treatment-experienced) received the AbbVie combination treatment plus ribavirin for 12 weeks.
In the treatment-naïve group the cure rate was 100% in the group that received ribavirin and 91% in the group that did not receive ribavirin. In the treatment-experienced group the cure rate was 100%.
Comment: More good news for patients—although genotype 4 is uncommon in the United States it is estimated that about 13% of the global population (mostly in Egypt) is infected with genotype 4. However, when I conduct training workshops it always surprises me that there is usually one or more persons with genotype 4!
Source: Hézode C et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): A randomised, open-label trial. Lancet 2015 Mar 30; [e-pub].
NIH
The NIH and the city of Washington, D. C., with support from the NIH Office of AIDS Research has launched a study that will include 600 patients with HCV or HIV/HCV coinfection. Of the patients enrolled, 350 will continue with their current specialist, and 250 will be assigned to a primary care doctor, physician, physician assistant or nurse practitioner for treatment. The treatment will be Harvoni for two to six months.
Comments: There has always been a lack of medical providers to manage and treat people with hepatitis C. This is increasingly becoming a problem due to the increased awareness, testing and treatments that are easier to tolerate and more effective. Hopefully, this will show that more medical providers can safely and effectively manage and treat people with hepatitis C.
Source: NIH News press release
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