This is very good news for you! Please keep us posted on this...:)
AASLD: PSI-7977 plus Ribavirin Can Cure Hepatitis C in 12 Weeks without Interferon
An all-oral dual regimen containing Pharmasset's hepatitis C virus (HCV) polymerase inhibitor PSI-7977 plus ribavirin produced 100% sustained response at 12 weeks in previously untreated people with HCV genotypes 2 or 3, according to findings from the ELECTRON study reported at the American Association for the Study of Liver Diseases Liver Meeting (AASLD 2011) this week in San Francisco.
With the approval this spring of the HCV protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek), direct-acting antiviral agents (DAAs) have begun to revolutionize hepatitis C treatment. Until recently, however, most clinical trials have combined investigational DAAs with pegylated interferon/ribavirin standard therapy, which has suboptimal effectiveness and causes side effects that lead many potential patients to delay or refuse therapy.
But several companies are now studying interferon-free oral regimens that combine DAAs that target different steps of the viral lifecycle; some also include ribavirin.
PSI-7977, a uridine nucleotide analog HCV polymerase inhibitor, has previously demonstrated promising safety and antiviral activity alone and in combination with standard therapy in people with HCV genotypes 1, 2, and 3.
Edward Gane from the New Zealand Liver Transplant Unit in Aukland and colleagues sought to determine whether and for how long pegylated interferon should be taken with PSI-7977 and ribavirin to produce the best outcomes.
A total of 40 participants with chronic hepatitis C received 400 mg PSI-7977 once-daily plus ribavirin for 12 weeks. In addition, they were randomly assigned to take pegylated interferon alfa-2a (Pegasys) for 4, 8, or 12 weeks, or not at all.
Because the researchers were uncertain whether the 2 oral drugs alone would work, they chose a population of relatively easy-to-treat patients who could be most easily "rescued" if the experimental regimen failed: treatment-naive people with HCV genotypes 2 (about one-third) or 3 (about two-thirds), and no cirrhosis; about 40% also had the favorable IL28B CC genotype. A majority were men, most were white, and the average age was about 48 years; concurrent use of methadone maintenance was allowed.
Results
By week 4, all participants receiving PSI-7977 achieved HCV suppression below the limit of detection (15 IU/mL), regardless of pegylated interferon duration.
All patients maintained undetectable HCV viral load at the end of PSI-7977 administration at week 12.
All participants went on to achieve sustained virological response -- or continued undetectable HCV after the end of therapy -- at both 12 and 24 weeks post-treatment (SVR12 and SVR24, respectively).
HCV viral kinetics did not differ between people receiving and not receiving pegylated interferon.
No viral breakthrough was observed in any group, confirming that PSI-7977 has a high barrier to resistance.
All participants receiving the PSI-7977 interferon-free regimen experienced ALT normalization.
PSI-7977 plus ribavirin was general well-tolerated.
Serious adverse events were most frequent in the 12-week pegylated interferon arm and least frequent in the interferon-free arm (72% vs 40%, respectively.
No serious (grade 3 or 4) laboratory abnormalities, including blood cell deficiencies, were reported in the interferon-free arm.
Use of ribavirin was still associated with anemia, but less so in the interferon-free arm.
"Potency, high barrier to resistance, and safety/tolerability allows interferon-free cures," the researchers concluded. "PSI-7977 has the potential to dramatically change the treatment paradigm for HCV in all genotypes and populations."
http://hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/3336-aasld-psi-7977-plus
You have two threads going now....hrsepwrguy's link sent us over to your other post....so I don't know which one to follow, lol.
My team (on what must be the same trial) was very positive about possibly moving me to 7977.
I think they stop at week 12 (for not und) so if by some slim chance the 7977 doesn't work you can go back to inf for another 12.
I'm sorry to hear your team was so negative....unless you have some other issues....my team is very excited about the 7977 results.
I am at week 12, my viral load at week 8 was 232. So they said SVR would be unlikely and they are "rolling" me over to the 7977. I haven't received the new meds and have no info on it yet as they said they had to get approval from the trial hq first, but they are working on it ASAP I assume I will be taking it with RIBA?? I have no info on it . The dr came in today (who I never see) and said she had bad news and then told me. So I was hoping to find out what I can expect from it
Ty Jen
I'm in a 7977 study for genotype 2 and 3, on the SOC arm. If I hadn't gone und by wk 12 they would have rolled me over to 7977....I think my tx nurses were almost hoping I'd go that route; that 7977 has been incredibly successful! I would not have been concerned at all.
What are the circumstances, did you not go und or are your platelets too low? Or?
Hi, are you in a study?
I don't know how else you would have access to 7977 othewise. What other med are you taking with it?
7977 is showing great promise, I am very happy for you.
Is this the "rollover" they do when the study drugs aren't successful? I would love more info. on how you got it and what you are taking with it.
I am on 7977 and ribvirin. This is very good new for you. Let us know more details.