Imagine a phenomenon that elicits distress and shame by simply mentioning its name. With heightened social anxiety, preexisting stigmas and correlations between risk factors, miseducation and distrust, HIV/AIDS is a phenomenon that has spawned rumors and conspiracy theories. From conflicting statements on transmission, to claims of the existence of a secret cure, skeptical narratives about HIV/AIDS still exist. The practice of HIV prevention can be at the mercy of these rumors and conspiracy theories, and those disproportionately affected by this epidemic are often the most difficult to convince that these misinformed notions can be life threatening.
From all the recent attention to parents' rejection (and some politicians' naiveté) of vaccines and a possible resurgence of measles in the United States, one welcome theme has emerged: Such a controversy could never occur if vaccines weren't so powerfully effective in the first place.
We've made tremendous strides in the treatment of HIV. Antiretroviral therapy can prevent immune decline and death. Additionally, antiretroviral therapy can prevent new infections among babies born to HIV-infected mothers and at-risk HIV-uninfected people. Around many parts of the world, death rates have declined. In some southern African nations, these declines have exceeded 50% in the past five years. Life expectancy for people living with HIV who have access to treatment is approaching normal in several high-income countries and is estimated by UNDP (United Nations Development Programme) to have increased in sub-Saharan Africa by six years from 2002 to 2012.
Gilead has announced both the highest recorded prices ever for its direct acting hepatitis C antiviral, ledipasvir/sofosbuvir (Harvoni), and one of the most stringent anti-diversion programs ever devised. The price, highest in the U.S., comes in at a whopping US$94,000 for a 12-week course of treatment, with slightly lower prices in Europe. Before this combo was approved, Gilead charged US$84,000 -- US$1,000 a pill -- for stand-alone sofosbuvir, earning US$8billion to US$10 billion in the first year of sales. This is for a course of treatment that experts have estimated can be manufactured for approximately US$100. In turn, the emerging anti-diversion program requires patients in low- and middle-income countries to physically come to designated Gilead distribution sites to exchange an empty 30-day pill bottle for the next month's supply. This program undermines the physician-patient and pharmacist-patient relationships, patient autonomy, adherence, and confidentiality. The question arises: Are the excessive pricing and the draconian anti-diversion policies related? The answer is, like gold and diamonds all the way to the bank.
As expected, the FDA approved the next treatment option for HCV on Friday -- "Viekira Pak", a (sometimes complete) regimen consisting of ritonavir-booted parataprevir and ombitasvir given as a two pills once a day, plus one pill of of dasabuvir given twice daily. It is indicated for treatment of HCV genotype 1.
Amidst outbreak hysterias, anti-vaccine imbecility, electronic medical record whining, and slug-related eosinophilia, I bring you this year's version of the good news -- the 2014 edition of Five ID/HIV Things to be Grateful for this Holiday Season, just in time for your holiday turkeys.
For those who read French, here's the official announcement. (Scroll down for the English.) And for those who can't believe the name, it stands for "Intervention Prophylactique pour Et avec les Gays". Of course.
As expected, the FDA just approved the first single-pill treatment for hepatitis C genotype 1, a tablet containing 400 mg of sofosbuvir (SOF) and 90 mg of ledipasvir (LDV). For those not following this story closely, sofosbuvir is the pan-genotypic NRTI polymerase inhibitor approved last December to much rejoicing -- and controversy about the price. Ledipasvir is the first HCV NS5A inhibitor, and is only available as part of this combination.
If you're an ID doc based in the U.S., you probably received notice last week that two new HIV drugs were approved -- cobicistat and elvitegravir.
And if you're wondering what the big deal is, welcome to the club.
One of my HIV pts, doing wonderfully well, is planning to enroll in a nursing program. She does not want to disclose her HIV status (fine with me), but the hospital requests a list of current meds which, of course, would blow her cover. My inclination is simply to leave the HIV meds off the list, but I asked our legal office who advises me not to do so -- they say just decline to fill out the form. However, I don't like that advice, since it essentially means my patient cannot enroll in the program. Of course I question whether the employer has the legal right to know all the meds, but I can't change that in the short term.
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