Sunday, August 2, 2015

Harvoni - FDA Side Effects Reported

I started this post a couple of weeks ago but was struggling to upload the FDA report - at any rate, I was able to find a link to the "FDA Adverse Event Reporting System" posted at the bottom.

Awhile back, I read somewhere about a newly released FDA publication that listed Harvoni side effects reported by consumers taking it.    This has recently become available, thanks to being sued by a couple of Patient Advocacy groups.  I have included the link to the FDA file below  - very large - contains over 700 reports of Harvoni Side effects from October 2014 - March 2015.

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD +2.45%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.
As far as the health groups are concerned, the accelerated process “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” according to the lawsuit. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.”
Specifically, the groups hope to learn about different responses that different patients experienced during clinical trials. Tracy Swan of Treatment Action Group points to relapses in a Harvoni clinical trial that occurred only among African-Americans. The groups also want to perform an independent analysis of poor prognostic factors among people who were not cured in order to identify a patient profile.

The rest of the article is here:

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

Back in January of this year, when my doctor first approached me about Harvoni, I was definitely in no rush to be on it.  I told the doctor that and he was almost stunned - "You'd turn down over $60,000 in drugs?"    Yes, I would, at this point.  The stuff hasn't been out long enough to know all of the side effects and long term side effects, etc.  I told him.   However, before I knew it, the pharmacy was contacting me, and would be sending me the Harvoni on this date.   So I went ahead and drank the Kool Aid.

I completed the my last Harvoni of an 8 week treatment on June 2nd.  Both 4 and 10 week labs were Undetectable - No Virus found.    I did have some sides, which I've detailed in earlier posts.

Currently, I do feel better than I did for the first 3 weeks after completing Harvoni.  I do worry about relapse as there does seem to be more in the real world than there was reported in the trials.

 I have included the link to the FDA file below -- very large - contains over 700 reports of Harvoni Side effects from October 2014 - March 2015.  Lord knows how many there have been since then:

FDA Adverse Event Reports 10-2014 thru 3-2015