GS-7977 + Daclatasvir + Ribavirin

Case Histories

These are real case histories that document the effectiveness of the treatment along with the increased side-effects experienced by HCV patients treated when Ribavirin was added to the GS-7977 + Daclatasvir protocol.  The names have been withheld to protect the patient’s privacy.

Profile
Name:  Jimeeboy     Sex:  M
Genotype:  Unknown     Grade:  2     Stage:  2

 Date of Contraction:  Infected with Hepatitis C for 35 years.

Treatment History: September 2011 – Viral Load was 11,200,000 prior to initial treatment with Incivek + Pegylated Interferon + Ribavirin.  Within 4 weeks the VL had dropped to 470, by late November the VL had increase to 22,000 and treatment was stopped.

March 15, 2012 – VL was 3,167,028 prior to starting clinical trials of GS-7977 + Daclatasvir + Ribavirin within 7 days the VL was below detectable levels.  Virus is still undetectable at 56 days.  The patient completed treatment on August 30, 2012, and, is still listed as virus undetectable with no side-effects and lots of energy.

Treatment Issues / Side effects:  At Day 42 of clinical trials, still no side effects except a little tightness and shortness of breath that comes and goes. Not really noticeable most of the time.  At day 56 still shortness of breath and some fatigue in the afternoon.

General Comments:  Grade 2 Stage 2 Same as 10 years ago. I’m amazed.  I do work out a lot and no drinking or drugs for over 25 years.  So guess that paid off for me. All my numbers are still normal and everyone else on the trial that I know are all listed as virus undetectable.  I am very grateful to have a chance to be on these meds today.

 Profile
Name:  Tom N.  / Sex:  M
Genotype:  1a

 Method / Date of Contraction:  Diagnosed in 1982

Treatment History:  The patient was treated initially with Interferon + Ribavirin that resulted in treatment failure and severe psychological side-effects.

Subsequently, the patient was treated with Pegylated Interferon + Ribavirin which ended in treatment failure, as well, because of failure to reduce the viral load.

The third treatment consisted of a clinical trial of Pegylated Interferon + Ribavirin + Telaprevir (Incivek). The virus was listed as undetectable within 8 weeks.  After 12 weeks the patient had to be removed from the protocol due to severe mental side-effects.  The virus recovered to pre-treatment levels within 4 weeks.

The fourth treatment was a 24 week course of GS-7977 + Daclatasvir + Ribavirin.  The virus was listed undetectable within 8 weeks.

Treatment Issues / Side effects:  The only side effect I experienced from the most recent treatment was extreme fatigue.

General Comments:  I was diagnosed with Hepatitis C, 30 years ago.  When Interferon alfa-2b + Ribavirin came out I tried that.  After 26 weeks I had to be taken off of it because I thought I was going to kill myself.  Unknowingly, the drug had been creeping up on me for at least 3 months, retrospectively.  I felt like I was slowly losing my mind and was evidently a bit hallucinogenic, as things didn’t look right, especially when I looked in the mirror.  Also, my viral count never got below 70,000 from about 1,200,000.

Then, I was treated with Peg-Interferon alfa-2b + Ribavirin when it became available.  I only lasted 12 weeks, because it failed to reduce my viral load, at all.  And, at this time my virus count was back up to about 2,000,000.

My viral count was at around 2,000,000, when I was enrolled in a clinical trial of Peg-Interferon alfa-2b + Telaprevir + Ribavirin.  This combination reduced my viral load to undetectable status within 8 weeks. Unfortunately, after about 12 weeks the treatment had to be terminated, because I again went completely insane.   In a month the viral load was completely restored.

I have just finished 24 weeks of GS-7977 + Daclatasvir + Ribavirin.  The virus was undetectable within 8 weeks and the only side-effects I experienced was being extremely tired.  I am currently 9 days post-treatment and I am still very tired.   I am told that I will be that way for at least a month, possibly 3 months.  I am not sure, but I think tiredness is from anemia caused by the ribavirin.  It may turn out that the ribavirin will not be necessary for a successful treatment.  I now have follow up for 48 weeks. Hopefully it will stick this time.