December 15, 2014
This year's top stories will begin and end with viruses other than HIV. Topping the list is the continued spectacular advance in the treatment of hepatitis C virus (HCV) infection. Approximately one-third of HIV-infected people in the U.S. are coinfected with HCV, and liver disease is becoming a leading cause of death in people living with both viruses. Therefore, what's good for people with HCV is good for people with HIV.
The approval of sofosbuvir and simepravir meant that tolerable, interferon-sparing regimens had finally arrived. That new HCV therapies work just as well in the coinfected as in the mono-infected was evidenced in the PHOTON-1 trial. Sustained virologic response rates in this study of sofosbuvir and ribavirin in HIV/HCV-coinfected patients were high, laying to rest any concerns for differential responses by HIV status.
But it was the approval in October of the combination of sofosbuvir and ledipasvir in a once-daily single tablet regimen for genotype 1 virus that finally delivered us to the promised land. Based on the results of the ION-1 and ION-2 studies of this duo in naive and experienced mono-infected genotype 1 patients, respectively, the drug is approved for broad use without exclusion of those coinfected with HIV. Comparative trials of sofosbuvir/ledipasvir in HIV-infected cohorts are ongoing, but in the small (n=50), single-arm ERADICATE study of coinfected patients, all but one volunteer achieved sustained virologic response.
Of course, the fly in this ointment is the incredible price of these incredible medications. With the cost a single tablet of sofosbuvir reaching $1,000, and for the fixed-dose sofosbuvir/ledipasvir a cool $1,250, eyebrows and ire have been raised. Debates regarding price and profits boiled within the media and at congressional hearings. On one side are the cries of opportunistic price gouging, and on the other are cost analyses of the long-term value of these medications.
All expect prices to decline as competition heats up with the imminent entry of other nifty HCV agents. Meanwhile, payers are hammering out criteria designed to save the bank from breaking -- generally restricting access to those with more advanced disease (which makes some sense) and those who are completely substance abuse free (which does not).
Undoubtedly, 2015 will see more battles over access. But all the while, not just a few people will have their HCV cured. That is big news.
What are some other top clinical developments of 2014? Read more of Dr. Wohl's picks.
David Alain Wohl, M.D., is an associate professor of medicine in the Division of Infectious Diseases at the University of North Carolina and site leader of the University of North Carolina AIDS Clinical Trials Unit at Chapel Hill.
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