Trouble with Sovaldi, Or Not?
I wish that this were some sort of April Fool's entry, but it isn't. There appears to be an outside chance that Gilead's huge-selling Sovaldi (sofosbuvir) for hepatitis C has some cardiovascular problems. There have been a few reports from the field, and the FDA has asked for a label change when the drug is used in patients who have taken amiodarone. But this commentary at Medscape is arguing that the problem might be bigger.The amiodarone interaction could be explained by inhibition of PGP, changing the pharmacokinetics of Sovaldi in some susceptible patients. (Amiodarone has odd PK and a particularly long half-life, raising the chances that you might see something). And/or there could be something intrinsic to sofosbuvir, and that's the open question (the kind of question you can really only answer once a drug's on the market). There's a large patient population taking the drug, and getting larger all the time, so if there's something out there to be seen, the adverse events should show up. But for now, Gilead is just waiting to see what happens - if anything.
Everyone of us stationed at Camp HCV knows the insidious effects of the
disease on our brains-either directly from the Interferon poison they
fed us to the actual debility that eventually ensues from cirrhosis.
Quite simply, ammonia builds up in our systems and causes brain fog.
Doctors call this cognitive disfunction. Call it what you will but it
sneaks up on you. Randy just had a brain fart and suddenly discovered he
had too many pills and not enough days left. Shit happens
We are in the early stages of being able to slay the dragon and it is
expected that some are going to win and some lose. We just didn’t expect
to have several of our members bite the dust. Sovaldi has had
miraculous reviews both with Ribavirin on the 24 week regimen as well as
the dreaded rerun of doing Interferon/Riba/ Sovaldi on a 12 week basis.
I pity the few who went down that road as I consider Interferon useful
for killing or maiming people and little else. Ribavirin is right down
there in the same category or worse- a useless adjunct thrown in to the
mix as a way to get rid of it before the bottom falls out of the market
for it
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Other than the realization that I had dropped the ball and the impending
wait for the new drug I feel OK. After about 15 minutes of lecturing
from the Dr. I had had enough and told her, “look, MY brain does not
function as a normal persons does.” They knew about the encephalopathy
have done nothing short of popping some pills, Rifaximen, for the brain
fog. Hell, some days I cannot get to sleep until 5-6:00 am due to the
side effects of the Sol and Riba which is insomnia. I may be not
sleeping which would account for the short temper which I never had
before. Alas it is a wait and see until the new mix comes out in Nov.
but I will beat this virus. If you miss dosages then the virus comes
back and you are admonished and sent to the new line and thus I have VA
card in hand and wait as patiently as my number will be called soon and I
start anew. Thanks to all for the encouragement.
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Olysio Side Effects Center
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The primary toxicity of Ribavirin is hemolytic anemia, which was observed in approximately 13% of all Ribavirin/peginterferon alfa-2a- treated subjects in clinical trials. Anemia associated with Ribavirin occurs within 1 to 2 weeks of initiation of therapy. Because the initial drop in hemoglobin may be significant, it is advised that hemoglobin or hematocrit be obtained pretreatment and at week 2 and week 4 of therapy or more frequently if clinically indicated. Patients should then be followed as clinically appropriate. Caution should be exercised in initiating treatment in any patient with baseline risk of severe anemia (e.g., spherocytosis, history of gastrointestinal bleeding)
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Ribavirin
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RISK OF SERIOUS DISORDERS AND Ribavirin-ASSOCIATED EFFECTS
Ribavirin monotherapy is not
effective for the treatment of chronic hepatitis C virus infection and
should not be used alone for this indication
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Common Side Effects: the most common side effects for Olysio/Sovaldi are fatigue, headache and nausea. Sun or light sensitivity and rash have also been reported. OLYSIO® combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO
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