Friday, March 30, 2012

Game changers in HIV/AIDS this past year and the year to come...

What a year it has been with regard to scientific research, new treatment, new guidelines, and the hiring of D.R Colfax to run the Office of AIDS Policy (ONAP), and ever growing AIDS Drug Assistance Program challenges.  These have all been game changing events in the face of HIV/AIDS. 

August 5th, 2011 – nearly 10,000 individuals on ADAP wait-lists
At the height of the economic downturn the ADAP waitlist had grown to nearly 10,000 people across the United States.  At this point states began to scramble to find ways to save ADAPs.  Federal  and State contributions at this point were down significantly from prior years, and cash strapped states dis-enrolled individuals from the program, a re-certification process started, and states began making changes to financial and medical criteria, making it harder for People living with HIV/AIDS to enroll (PLWHA) into ADAPs.  Over the past year the number has now decreased to about 4,000 PLWHA.  The reason for this lowered number is because as states began changing financial and medical criteria, this virtually shut people out from enrolling into ADAPs when they would have been able to previously.

HPTN052 – Treatment as Prevention
One of the biggest highlights of the past year in May 2011 was the revelation of a study known as HPTN052 conducted by Professor Myron Cohen of the University of North Carolina at Chapel Hill. The study revealed that those on Anti-Retroviral therapy are 96% less likely to transmit the virus to their partner. This stresses the importance starting Anti-Retroviral early to suppress viral load, and lessen the likelihood of transmitting the virus. Thus, Treatment as Prevention was coined.

Complera – Once a day

Then, in August 2011 the FDA approves Complera.  A once daily pill which consists of Gilead’s Truvada (emtricitabine/tenofovir) and Tibotec Pharmaceuticals’ Edurant (rilpivirine), which was approved by the FDA in May.  The only other once daily pill on the market is Atripla that has been out since 2007.

CROI 2012 – Many research developments

Jumping ahead to March 2012 at the Conference of Retroviruses and Opportunistic Infections (CROI) promising research was announced. Currently 31 drugs are approved to treat HIV, and a list of these drugs can be found at www.positivelyaware.com/chart , but in the coming year this chart will be expanded.  One drug, dolutegravir (still experimental) is a second-generation integrase inhibitor that is active against HIV strains resistant to first generation inhibitors. This drug combined with other drugs in a once a day pill is currently being explored.

The other promising drug is GILEAD’s ‘QUAD’ tablet containing the experimental integrase inhibitor elvitegravir and boosting agent cobicistat along with tenofovir and emtricitabine and tenofovir. This quad tablet has been submitted for FD A approval – and seems to address the limitations of sustiva’s psychological side effects, such as found in Atripla.

Also from CROI 2011; Latent HIV was discussed. This is HIV that is not actively replicating and it lies dormant in reservoirs (In the gut, the brain…etc.) throughout the body.  This has been the biggest challenge, how to eliminate latent HIV from these reservoirs?  Anti-retrovirals work on blocking replication of HIV, but do not work on latent HIV.

Eradicating latent HIV is a TOP priority for scientists attempting to cure HIV and currently several drugs are currently being tested for their ability to reduce or eliminate this hidden reserve of the virus. One of the most discussed avenues behind curing AIDS is intensifying ARV treatment and combining new potent and less toxic drugs that can reach HIV infected latent cells, activate them and with those same drugs inhibit their ability to replicate – then it may be possible to eradicate HIV from the body.  Also, results of a small study using Zolina, a drug used to treat lymphoma may successfully reduce the size of the latent HIV reservoirs in HIV positive adults taking antiretrovirals. This study indicates latency can be targeted and will continue to be a significant step towards eradication of HIV.

Also at CROI 2012 Researchers in many of their discussions noted that rates of Metabolic problems, notably cardiovascular disease and diabetes, are elevated in people living with HIV.

CROI 2012: Co-Infection; new hope

With regard to co-infection of HIV and Hepatitis C Merck’s new drug boceprevir had a cure rate of 60 percent in people who completed 48 weeks of treatment and who had a sustained virologic response 12 weeks post treatment.  With Vertex’s drug called Telaprevir, 74 percent of co-infected study individuals were cured, after finishing treatment.  These two drugs in the past year have given hope to many, when interferon and ribavirin alone gave people with chronic HCV infection only about a 15-20 percent cure rate.

March 2012, the Institute of Medicine (IOM) Report
“Monitoring HIV Care in the United States” Indicators and Data Systems
The Office of National AIDS Policy (ONAP) asked the IOM to convene an expert committee to identify core indicators related to continuous HIV clinical care and access to supportive services, and to monitor the effect of both the National HIV/AIDS Strategy (NHAS) and ACA on improving HIV care. The committee outlined a number of obstacles that prevent people living with HIV to optimal health. These obstacles included; late diagnosis, delayed access to care, delayed prescriptions and intermittent use of life-saving antiretroviral therapy (ART), untreated substance use disorders, and unmet basic needs.

The expert committee concluded that the vision provided by the National HIV/AIDS strategy and the changes to the US Health Care system embodied in the ACA both have the potential to help curb the HIV epidemic and blunt it’s impact. The changed eligibility requirements for public and private health insurance resulting from ACA are expected to expand access to prescription medications and clinical care for HIV and other conditions that affect people living with HIV/AIDS (PLWHA), including mental health and substance use disorders.

The expert committee also concluded that an increased focus on why people diagnosed with HIV fail to enter or remain in care, as well as removing obstacles to care, such as by providing supportive services, will improve individual health and reduce transmission of HIV to others. As the committee outlined in its report it is critical to continue to monitoring improvements in HIV care resulting from the NHAS and ACA.

March 29th, 2012: The National Institutes of Health updated its guidelines

It’s biggest update is a recommendation that ALL HIV treatment Naive patients should be on Anti-Retroviral therapy.  Though, they triaged their recommendations as follows:

The Panel’s recommendations are listed below.
• ART is recommended for all HIV-infected individuals. The strength of this recommendation
a varies on the basis of pretreatment CD4 cell count:
    o CD4 count <350 cells/mm3 (AI)
    o CD4 count 350 to 500 cells/mm3 (AII)
    o CD4 count >500 cells/mm3 (BIII)
• Regardless of CD4 count, initiation of ART is strongly recommended for individuals with the following conditions:
    o Pregnancy (AI) (see perinatal guidelines for more detailed discussion)
    o History of an AIDS-defining illness (AI)
    o HIV-associated nephropathy (HIVAN) (AII)

    o HIV/hepatitis B virus (HBV) coinfection (AII)
• Effective ART also has been shown to prevent transmission of HIV from an infected individual to a sexual partner. Therefore, ART should be offered to patients who are at risk of transmitting HIV to sexual partners (AI [heterosexuals] or AIII [other transmission risk groups]).
• Patients starting ART should be willing and able to commit to treatment and should understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors.  


Key Considerations When Managing Patients Co-infected with HIV and Hepatitis C Virus:

• All HIV-infected patients should be screened for hepatitis C virus (HCV) infection, preferably before starting antiretroviral therapy (ART).  • ART may slow the progression of liver disease by preserving or restoring immune function and reducing HIV-related immune activation and inflammation. For most HIV/HCV-coinfected patients, including those with cirrhosis, the benefits of ART outweigh concerns regarding drug-induced liver injury (DILI). Therefore, ART should be considered for HIV/HCV-coinfected patients, regardless of CD4 count (BII).  • Initial ART combination regimens for most HIV/HCV-coinfected patients are the same as those for individuals without HCV infection. However, when treatment for both HIV and HCV is indicated, consideration of potential drug-drug interactions and overlapping toxicities should guide ART regimen selection or modification (see discussion in the text).  • Combined treatment of HIV and HCV can be complicated by large pill burden, drug interactions, and overlapping toxicities. Although ART should be initiated for most HIV/HCV-coinfected patients regardless of CD4 cell count, in ART-naive patients with CD4 counts >500 cells/mm3 some clinicians may choose to defer ART until completion of HCV treatment.  • In patients with lower CD4 counts (e.g., <200 cells/mm3), it may be preferable to initiate ART and delay HCV therapy until CD4 counts increase as a result of ART.

Rating of Recommendations:  A = Strong; B = Moderate; C = Optional
 Rating of Evidence:  I = data from randomized controlled trials; II = data from well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = expert opinion


Highlights to come within the next year:

The RAPID 20 minute Orasure HIV Home Test Kit
Up for FDA Approval on May 15th, 2012, this at home test kit has been in the planning stages for years. There is already a Home Access test kit on the market in drug stores and supermarkets across the country to test for HIV and Hepatitis C; this new test from Orasure would be the standard 20 minute test you need to go to clinics for now. This test is already available in Europe could be approved within the next year here in the US. Also, it’s no surprise a rapid 20 minute at home Hepatitis C test is in development too.  

Also in the next year battles will rage over PrEP (Pre-Exposure Prophylaxis), and an introduction of another Quad pill or two could be further game changers in the face of HIV/AIDS, and pharmecuetical companies will also be heavily invested in Hepatitis C therapies that pre-clude interferon based treatment. Discussions surrounding a ‘common portal’ for easier access and linkage to care for people living with HIV/AIDS will also be a hot topic.

DR Colfax

Within the past couple weeks the White House has chosen D.R Colfax to head up the Office of National AIDS Policy (ONAP).  This replacement of Jeff Crowley, who resigned in November 2011, is being hailed as a wise choice by many in the community. Undoubtedly D.R Colfax will alone be a game changer in the face of HIV/AIDS.

Grant Colfax, MD, Director of the HIV Prevention Section in the San Francisco Department of Public Health will coordinate the continuing efforts of the government to reduce the number of HIV infections across the United States. “Dr. Colfax has been instrumental in the decline of new HIV infections in San Francisco in recent years,” said San Francisco AIDS Foundation CEO Neil Giuliano. “His unique blend of experience serving on the front lines of the epidemic, implementing the national strategy at the local level, working as a direct service provider within the Ryan White CARE system, and conducting cutting-edge research makes him the right person at the right time to lead the Obama administration’s efforts to end HIV/AIDS in the United States.”

“Dr. Colfax will play a critical role over the next several years to ensure the implementation of the Affordable Care Act and HIV service integration to address the health care needs of people living with HIV,” said Ernest Hopkins, director of legislative affairs at San Francisco AIDS Foundation. “Having worked closely with him on complex issues and having seen his consensus-building skills among diverse populations, including communities of color, I am confident that the AIDS community will have a strong advocate within the administration. I know Dr. Colfax will work to ensure that the coming changes to our health care system are made thoughtfully, carefully, and with a strong focus on improving the health status of the most vulnerable people.” -–San Francisco AIDS Foundation.

Conclusion

The pace doesn’t seem to be slowing down with regard to advancements in science, research, new developments, and new guidelines for HIV AND Hepatitis C.  It can only be surmised that in the next year, and years to come, better treatments will become available, more people will enter care, and the forever quest for the cure will become closer and closer to a reality. D.R Colfax will undoubtedly be a strong advocate inside the white house for people living with HIV/AIDS (PLWHA), with firsthand knowledge of events happening on the ground, and capabilities and the knowledge to implement ideas and sway opinions inside congress. I look forward to the continuing work of the National AIDS Strategy, and look forward to the work of D.R Colfax and the Office of National AIDS Policy.  Welcome to Washington, D.C, D.R Colfax!

Until theres a cure,

Kevin Maloney
RiseUpToHIV
Facebook: http://www.facebook.com/riseuptohiv
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e-mail: kevin@riseuptohiv.org
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