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EASL results GS 7977


Gilead Announces Sustained Virologic Response Data for 12-Week Regimen of GS-7977 Plus Pegylated Interferon and Ribavirin in Genotype 1 Hepatitis C Patients

– ATOMIC Data Demonstrate High Cure Rates in Genotype 1 Patients With 12 Weeks of Treatment –


Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced interim data from a Phase 2 trial (ATOMIC) examining a 12-week course of treatment with the once-daily nucleotide GS-7977 plus pegylated interferon (Peg-IFN) and ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. The study found that 90 percent of patients (n=47/52, missing data equals failure analysis) achieved a 12-week sustained virologic response (SVR12), defined as maintaining undetectable viral load (HCV RNA <25 IU/mL) 12 weeks after the completion of therapy. These findings will be presented today during an oral session at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain.

“These data suggest that this GS-7977-based regimen could offer most patients with genotype 1 a simple, short, three-month course of treatment with very high cure rates,” said Kris Kowdley, MD, Director of the Liver Center of Excellence at the Virginia Mason Medical Center in Seattle and the study’s principal investigator. “An all-oral regimen for HCV remains the ultimate treatment goal. In the interim, these results suggest that we may soon be able to end the complex process of response-guided HCV therapy and shorten the duration of treatment, which would be a significant advance for patients and for physicians who manage their care.”

In this study, 52 patients were randomized to the 12-week treatment arm. One patient was lost to follow up during the course of treatment. At the end of treatment, 51/51 patients (100 percent) were HCV RNA undetectable. At the 12-week, post-treatment time period, data were available for 50/51 patients, as one patient was lost to follow up during the post-treatment time period. Of the 50 patients, 47 (94 percent) remained HCV RNA undetectable. Three patients experienced viral relapse after the end of treatment.

Overall, GS-7977 was well tolerated. The frequency and severity of adverse events were consistent with the historical safety profile of Peg-IFN and RBV and included fatigue, headache, nausea, chills and insomnia.
(to read the rest of the article please use the above provided link. - willy)
9 Responses
1815939 tn?1377991799
Thaks for posting that news. It sounds very promising and will give people who fail triple med treatment some hope of cure

As with many of us, I am still on treatment and I do have a concern about relapsing after finishing treatment. Therefore, any news about successful new treatments is very good news for me and for all of us.
1707536 tn?1334974077
I put this together and posted to another forum where people are a lot less knowledgeable about trials but thought I'd post here as well.

This is what I understand from the info released this morning.

7977 + Ribavirin, 12 weeks, gt 1, SVR4 88%
7977 + BMS 790052 (daclatasvir) 24 weeks, gt 1, SVR4 100%
7977 + BMS 790052 (daclatasvir) 24 weeks, gt 2/ 3, SVR4 91%
7977 + Peg IFN + Riba 12 weeks, gt 1, SVR12 90%

7977 + Ribavirin,   gt 1SVR4, 59% - (Quantum study) only 16% had the ILB28 CC on this.
So,interestingly, the IL28B seems to be strong indicator of SVR. My understanding was that it was thought to have been a response to interferon. It doesn't seem like that anymore.




Avatar universal
Just read the news myself! As Pooh said, as a current treater the thought of failing triple therapy is there ...this gives me much relief!! My family has yet to be tested (I know their chances of having it are low) but if I do get hit with some unexpected news the results above make me feel much better. I would never want my husband or son on peg/riba/Inc for 24-48 weeks if there is something like this coming out within the next 5 years.
Avatar universal
These are all great results and the future certainly looks bright ,however keep in mind these are all results on "naives " from what I can tell.

Avatar universal
I am just praying this is the only time I will have to do this. Being one of the hardest things I have ever endured in my life, I think of finishing treatment as one of my greatest accomplishments in my life. (To achieve SVR would be one GIANT. cherry on top.) I have hope my triple will work..;) the news above makes me SO happy for all the treaters to come.
Avatar universal
Did anyone see the Street mention that Gilead and Bristol can't seem to work together and that may keep this combo from going any further? How disappointing!!
Avatar universal
I had not heard that ,however something tells me that ,like all "pharma's", their insatiable appetite for profit will keep things moving in the right direction.  
Best to you..
163305 tn?1333668571
Having friends with hep C and so far, minimal liver damage, I am excited about the new orals. I believe they will be the treatment of the future.

Of course, those of us who've done tx, do not want to go down this road again. For those who do relapse, there is now hope for an easier treatment option.
170011 tn?1335076097
Story about the two pharma's not wanting to work together  :-(    That will put a damper on future clinical trials.   Dang pharmas!

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