One of the stupid things about being an HIV/ID specialist is the highly arcane code we use to abbreviate HIV treatments.
The Strategic Timing of AntiRetroviral Treatment (START) study began in 2009, enrolling over 4000 asymptomatic people with HIV and CD4 cell counts > 500, and randomizing them to immediate ART or to wait until the count dropped to 350. Now, from the National Institute of Allergy and Infectious Diseases comes this important announcement:
It's not often that a FDA drug approval for cosmetic dermatologists and plastic surgeons will get the attention of HIV/ID specialists, but this past week was an exception. From the FDA report:
The new Department of Health and Human Services (DHHS) HIV treatment guidelines are out, and thanks to skillful direction by Alice Pau, it's as usual a must-read document -- all 288 pages, of course!
The scientific publisher Frontiers recently published a paper disputing the link between HIV and AIDS. Yet, the belief system known as HIV/AIDS denialism has no scientific basis. As demonstrated anew with every person who begins a successful therapeutic program, the causative link between HIV and AIDS is among the strongest and most investigated in modern medical science. The published manuscript was also weak -- a one-sided, poorly researched, inaccurate screed by a non-expert on HIV/AIDS with training in theology and education.
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.
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