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April 1. This is the day upon which we are reminded of what we are on the other three hundred and sixty-four.
--Mark Twain, Pudd'nhead Wilson

Fool Us Once...

We're being duped by our government agencies. We're being hoodwinked by the Affordable Care Act (ACA). We're being bamboozled by pharmaceutical companies and research networks. In this April Fools' issue of TAGline, we highlight several missteps in research and policy that have required some degree of advocacy to remedy and ensure that the jokes don't remain on us.

Forgotten Negatives: The Limits of Treatment as Prevention
The CDC's High-Impact Prevention strategy takes aim at the stubborn HIV incidence rate in the United States. The only problem: it doesn't include an ambitious plan for those at risk for the virus - By Jeremiah Johnson
There is no shortage of depressing statistics when it comes to HIV prevention in the United States: 50,000 new HIV infections annually; a 12% increase in new infections among gay and bisexual men and transgender women between 2008 and 2010; an estimated infection rate of nearly 50% among black transgender women; and a projected 50% infection prevalence  in gay and bisexual men by the time they're 50.
For the people who have been most affected by the epidemic, we have failed to make any measurable progress; if anything, the spread of the virus has worsened.

The White House's Fuzzy Math
An Office of National AIDS Policy progress report obscures the state of the domestic U.S. HIV/AIDS response
- By Mark Harrington
On World AIDS Day, December 1, 2013, the White House Office of National AIDS Policy (ONAP) issued a peppy and upbeat status report on the National HIV/AIDS Strategy (NHAS), claiming progress on eight of nine outcome indicators. Yet when reviewed in tandem with a companion document, HIV Prevention Progress Report, 2013, released by the U.S. Centers for Disease Control and Prevention (CDC), many of the White House claims are misleading and undermined by flawed methodology.

Marketplace Menaces: Discriminatory Practices by the ACA's Qualified Health Plans
Advocates scramble to stay ahead of coverage rejections, formulary concerns, and exorbitant
out-of-pocket expenses facing people living with HIV
- By Kenyon Farrow
#GetCovered
That's the White House's official hashtag and marketing campaign to spike the number of Americans enrolling into qualified health plans (QHP) through the Affordable Care Act (ACA). The deadline for individual enrollment without penalty was March 31. But many people with HIV who tried to join the ranks of the enrolled found their third-party payments--primarily Ryan White subsidies to offset monthly premiums--rejected by insurance plans. Others discovered that their drug regimens weren't covered, leaving them with huge out-of-pocket coinsurance expenses.

Better Late Than Never: Efavirenz Dose Optimization
After a study suggests that we've been using too high a dose of efavirenz for a decade and a half, the move toward scaling up a lower and more cost-effective one faces some hurdles
- By Tim Horn and Polly Clayden
Fifteen years after efavirenz was approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV and went on to become one of the most widely prescribed components of antiretroviral (ARV) therapy worldwide, a question has arisen: have we been using an unnecessarily high dose to treat adults living with HIV?

Punked by Pharma: Public Funds for Private Products
Tax dollars are making it easier for the drug and diagnostics industry to develop and market essential TB products. Is the public getting a fair return on its investment?
- By Lindsay McKenna
Motivating the pharmaceutical industry to step up and respond to the burgeoning tuberculosis (TB) epidemic is one thing. Publicly funding its research and development (R&D) only to have it yield prohibitively expensive drugs is something else entirely.



Fool's Errand: The Sloppy Science of the MDR-TB STREAM Trial
Confirming the efficacy and safety of bedaquiline-inclusive regimens is a priority. Comparing them to unvalidated MDR-TB drug combinations in the planned STREAM study is not the way to go about it
- By Mike Frick
They should have left well enough alone. The original design of a landmark clinical trial evaluating a shortened course of treatment for multidrug-resistant tuberculosis (MDR-TB) was just what was needed to confirm its potential benefits over the World Health Organization's (WHO's) standard of care. The clinical trial's aim has since been conflated with another research priority--confirming the safety and efficacy of new MDR-TB drug bedaquiline--resulting in a study design that detracts from the importance of validating a tweaked Bangladesh regimen and may potentially undercut a scientifically sound assessment of bedaquiline in today's MDR-TB armamentarium.

An unavoidable aspect of moving forward with efforts to end the HIV, TB, and viral hepatitis epidemics is having to address potential miscues that have been made along the way, sometimes years after the fact. Determining culpability is invariably part of the process. What matters most, however, are the strategies put into place to secure breaches, right wrongful courses, and ultimately turn mistakes into opportunities for advancement.

Gasping for Change

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On Tuesday, December 3rd, a 29-year-old HIV-positive man died on a New York City bus while on his way home from a doctor's appointment. As word of Lamont Valentin's death made its way through the community and HIV activism circles, heartbreak and anger quickly set in. The death of a young person is always difficult for anyone to wrap his or her head around. But when the death is likely the result of an injustice, the demand for answers -- and, indeed, solutions -- quickly turns grief into action.

Lamont Valentin
Lamont Valentin
Born with HIV in 1984, more than a decade before potent combinations of antiretrovirals were an option for children living with the virus, Lamont struggled with numerous bouts of AIDS-related pulmonary infections. Though he persevered and was eventually able to access drug regimens to keep his viral load in check and his CD4 out of the red, there was no reversing the damage done to his lungs. Tethered to an oxygen tank and a litany of medications to manage the symptoms of his lung disease and its resulting pulmonary hypertension, Lamont's only option for long-term survival -- to watch his young son grow and flourish -- was a double lung transplant.

Denied.

Lamont was initially told that he could not receive a lung transplant in New York. Advocates with connections to NewYork-Presbyterian -- long a pioneer in the field of transplants among people living with HIV -- reached out to explore options for Lamont, but were told, in no uncertain terms, that HIV is an "absolute contraindication" to lung transplantation at NewYork-Presbyterian and many other centers in the country. In turn, Lamont wasn't evaluated as a possible lung transplant candidate and, as a result, died without even having the luxury of being placed onto the all-too-long waiting list for a possible match.
My colleague, TAG's Michael Palm Basic Science, Vaccines, and Prevention Project Coordinator Richard Jefferys, asks in a recent blog post: "What Does it Take to Achieve a Community-free AIDS Conference?"

A conference being held in San Francisco from November 3-5, named "What Will it Take to Achieve an AIDS-free World?" and sponsored by the scientific journals The Lancet and Cell, is ignominiously answering the question posed in the title of this post: don't provide an option to register until less than a month before the event and charge a $400 registration fee (the public registration option at this "special rate" was only added to the conference website in the last couple of days). TAG's plea to the organizers--made in March of this year--requesting that they at least allow an option for local community members to attend without paying a steep fee has seemingly fallen on deaf ears. It is lamentable that an event attempting to look toward a brighter future should harken back to the dark days when people with HIV and community-based activists were excluded from attending scientific meetings.

TAG encourages HIV activists to reach out to the conference organizers to offer a feasible alternative to paying $400, at least for local community members seeking to participate in the critical dialog that is expected to take place. Please take few minutes to reach out to members of the conference's organizing committee:

Pamela Das (ELS-CAM) <Pamela.Das@lancet.com>
Rosy Hosking (ELS-CMA)" <rhosking@cell.com>
Kenneth Mayer <khmayer@gmail.com>
Robert Siliciano <rsiliciano@jhmi.edu>
John McConnell <IDeditorial@lancet.com>
Richard Turner <richard.turner@lancet.com>

The following is an excerpt from an article published in the October 2013 issue of Treatment Action Group's newsletter, TAGline.


TAG cascade
Click the image to view a larger version.
Viral-load suppression remains the holy grail of HIV care. Its associations with AIDS-free survival and a profound reduction in transmission risk are well established. To maximize the odds of getting viral load undetectable and keeping it there, numerous safe, effective, and miraculously simplified HIV drugs and fixed-dose combinations have been developed and approved. But there's a problem: far too many people living with HIV in the United States--and elsewhere around the world--aren't accessing the care they need to benefit from the personal and public health benefits of antiretroviral therapy.

The good news is that roughly 75 percent of HIV-positive people who are engaged continuously in care have suppressed virus. The bad news is that this accounts for only one in four of all people with HIV residing in this country. According to the U.S. Centers for Disease Control and Prevention (CDC) HIV continuum of care--also known as the treatment cascade--only 62 percent of people living with HIV have been linked to a care provider, and an abysmal 37 percent are engaged in regular care--the initial steps required to get HIV-positive people on treatment.

Every now and then, a new HIV drug moves through the pipeline that generates a great deal of hope and encouragement. Gilead Science's new nucleotide reverse transcriptase inhibitor, tenofovir alafenadine fumarate (TAF), is one such drug.
 
TAF works very much like tenofovir disoproxil fumarate (TDF)--the active ingredient in Viread and a component of Truvada, Atripla, Complera, and Stribild--though with better distribution in lymph tissues (where roughly 98 percent of HIV resides) and, at least in test tube studies, greater antiviral activity. Best of all, it can be used as a once-daily drug at doses that are roughly ten times less than that of TDF, which means that it will potentially have fewer kidney- and bone-related side effects.
 
Activists and the scientific community have known about the potential benefits of TAF, over that of TDF, for twelve years--it is both disappointing and curious that its development was delayed until TDFs patent expiration could be seen on the immediate horizon (2017). Still, the encouraging interim 24-week analysis from Study GS-US-292-0102, presented at the 20th Conference on Retroviruses and Opportunistic Infections, indicate that TAF shows significant potential as an effective alternative to TDF in first-line therapy regimens, with reduced impact on bone and kidney markers.
 
The problem? Gilead seems only to have plans to develop the drug as a component of fixed-dose combinations (FDCs): a tablet containing elvitegravir, cobicistat, emtricitabine, and TAF (a newer version of Stribild); an FDC containing darunavir, cobicistat, emtricitabine, and TAF; and, possibly, an FDC containing emtricitabine and TAF (a newer version of Truvada).
 
But we also need a stand-alone version of TAF--a tablet containing only TAF that can be used in combination with other HIV meds of a person's choosing. Unfortunately, this does not appear to be on Gilead's to-do list.
 
This is an issue because not everyone can, should, or wants to take one of the TAF-inclusive FDCs in development. First, it needs to be available for use as a component of generic-based treatment in the US, particularly once efavirenz (found in Sustiva and Atripla) is approved as such (~2017) and now that generic lamivudine is widely available. Second, for generic versions of TAF to be approved for use in resource-poor countries, it needs to be studied in regimens that do not contain boosting agents like cobicistat (which alters the pharmacokinetics of TAF). Third, according to exciting new test tube data, TAF may actually be active against some HIV strains resistant to TDF and other NRTIs, which means TAF absolutely needs to be studied and made available for individualized second-line and salvage regimens.
 
Though Gilead is interested in utilizing TAF to ensure its place as the leading developer of highly effective one-tablet regimens for years to come, a decision to focus solely on FDCs would be shortsighted. Gilead stands to make a nice chunk of change from the availability of a stand-alone version of TAF. Most importantly, ignoring its development will effectively keep the drug out of the hands of millions of people living with HIV who need a less toxic version of tenofovir, or a drug effective against TDF, for use in a variety of possible combinations.
 
Please consider signing on to a letter co-developed by TAG, Project Inform and UK's HIV i-Base to request that Gilead carefully consider the importance of stand-alone TAF.

The Immune System, Aging, and HIV

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Little more than a decade ago, it was almost inconceivable that the issue of aging with HIV infection would emerge as an important concern. But it has now become clear that antiretroviral therapy can suppress virus replication for many years--likely for life--in most people who can access the drugs, and the opportunistic infections that were once the primary causes of illness have largely evanesced everywhere treatment is available. Morbidity and mortality from HIV infection has plummeted, and the survival of HIV-positive individuals is edging ever closer to that of comparable HIV-negative people. With the specter of AIDS having finally been chased from the near horizon, attention has turned to health problems that may lie further down the road.

HIVAgingcover_1-1.jpgLooming largest are illnesses typically associated with aging. Examples include cardiovascular, kidney, and liver disease; bone loss and increased fracture risk; frailty; cognitive impairment; and cancer. Evidence is accumulating that the risk of these conditions is elevated in HIV-positive individuals and, in some cases, they may be occurring at a younger age, on average, than is typically observed among comparable HIV-negative populations. As the proportion of older individuals living with HIV grows, there is an urgent need to understand how a broad array of factors may be contributing to this phenomenon; these factors include inflammation, immune dysregulation, polypharmacy, long-term drug toxicities, and coinfections and comorbidities that are disproportionally prevalent among people with HIV, such as hepatitis B and C, current or former substance-use disorders, stress, and depression.

It is important to emphasize that the reported elevations in risk for aging-associated diseases among people with HIV (compared to their HIV-negative counterparts) are typically relatively small. There are also inconsistencies between studies and as yet unresolved controversies regarding the extent to which HIV infection is an independent risk factor for specific illnesses. So while there is cause for vigilance and concern, there is no reason to panic, and it is likely that many HIV-positive people will not face a significant additional hazard of aging-associated conditions. As a general recommendation, HIV-positive individuals should consider the lifestyle factors that are now known or expected to maximize health once a person reaches old age; these include daily exercise, a healthy diet, maintaining low blood pressure and cholesterol, and avoiding substance abuse and excess fat gain.

In a new report published by the Treatment Action Group, Richard Jefferys and I outline current scientific knowledge regarding the immunologic connections between HIV and aging, and provide an introduction to some of the unresolved questions that are being addressed--or need to be addressed--by research.

Have a look, give it a read, and let us know your thoughts!



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