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Avatar universal

long time not here

I'm so glad to hear that everyone is doing so good, great news Hector..I started SOVALDI & RIBA 2 weeks ago and feel ok but have symptoms of a cold. Just wondering if anyone else has symptoms like that. Maybe just allergies. Anyway so happy that it seems like we have finally busted thru the long wait.  Hope that we will one day shut this site down as it will no longer be needed.  crankykk
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446474 tn?1446351282
This may help you...

:6 ADVERSE REACTIONS

6.1 Adverse Reactions from Clinical Trials Experience

SOVALDI should be administered with ribavirin or peginterferon alfa/ribavirin. Refer to the prescribing information of peginterferon alfa and ribavirin for a description of adverse reactions associated with their use.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety assessment of SOVALDI is based on pooled Phase 3 clinical trial data (both controlled and uncontrolled) including 650 subjects who received SOVALDI + ribavirin (RBV) combination therapy for 12 weeks, 98 subjects who received SOVALDI + ribavirin combination therapy for 16 weeks, 250 subjects who received SOVALDI + ribavirin combination therapy for 24 weeks, 327 subjects who received SOVALDI + peginterferon (Peg-IFN) alfa + ribavirin combination therapy for 12 weeks, 243 subjects who received peginterferon alfa + ribavirin for 24 weeks and 71 subjects who received placebo (PBO) for 12 weeks.

The proportion of subjects who permanently discontinued treatment due to adverse events was 4% for subjects receiving placebo, 1% for subjects receiving SOVALDI + ribavirin for 12 weeks, <1% for subjects receiving SOVALDI + ribavirin for 24 weeks, 11% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2% for subjects receiving SOVALDI + peginterferon alfa + ribavirin for 12 weeks.

Treatment-emergent adverse events observed in ≥15% of subjects in clinical trials are provided in Table 3. A side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs.

The most common adverse events (≥ 20%) for SOVALDI + ribavirin combination therapy were fatigue and headache. The most common adverse events (≥ 20%) for SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia."

Fatigue
12 weeks 38%
24 weeks 30%

Headache
12 weeks 24%
24 weeks 30%

Nausea
12 weeks 22%
24 weeks 13%

Insomnia
12 weeks 15%
24 weeks 16%

Pruritus
12 weeks 11%
24 weeks 27%

Anemia
12 weeks 10%
24 weeks 6%

Asthenia
12 weeks 6%
24 weeks 21%

Rash
12 weeks 8%
24 weeks 9%

Decreased Appetite
12 weeks 6%
24 weeks 6%

Chills
12 weeks 2%
24 weeks 2%

Influenza Like Illness
12 weeks 3%
24 weeks 6%

Hector
Avatar universal
Isn't that just fantastic?  You nailed it, " ... we will one day shut this site down as it will no longer be needed."  I wish with all my heart.
446474 tn?1446351282
My experience on Sovaldi (called GS-7977 when I started the trial) + Ribavirin over 48 weeks was...
I only had headaches around weeks 4-5. Then increasing fatigue over the 48 weeks of treatment. I was so sick from my cirrhosis I hardly noticed the increase in fatigue. I wasn't sure if was from the treatment or cirrhosis. When I stopped treatment in about a month I felt much less fatigue so knew it was the treatment. Of course that was when I relapsed also. :-(

Onward and upward!
Hector
Avatar universal
Thank You, I still am computer stupid so looking things up is crazy for me I will continue as I have no option but to find the right path to get better. I know in time we all will get there. So far nothing I can't handle.  God Bless and keep getting stronger. Kelly 55
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