Monday, July 27, 2015

REPRIEVE for Heart Disease in HIV

June 27,2015
by Steven Grinspoon and Aaron Laxton
Why is heart disease increased among people living with HIV?
Aaron Laxton
Aaron Laxton
Steven Grinspoon
Steven Grinspoon, MD
In the United States, people living with HIV are living longer, due to the dramatic success of antiretroviral (ARV) therapy. However, a silent epidemic of heart disease has been shown to affect HIV-positive people, who may be without symptoms and thus unaware of the increased risk for stroke or heart attack. Data suggest that the risk for heart disease is increased 50 percent to 100 percent among people with the virus. 

This increased risk of heart disease is seen even among younger HIV-positive people, including those in their 40s to 50s. In addition, women, who typically are at lower risk for heart disease in the general population, have a relatively higher risk of heart disease in the HIV population. Indeed, heart disease is a leading cause of death among HIV-positive people. 

Why is heart disease increased among people living with HIV, and can anything be done to prevent it? A number of factors are likely to contribute to increased heart disease in HIV, including traditional risk factors — for example smoking, high cholesterol, and other factors, such as family history. In addition, recent data suggest that non-traditional risk factors may also contribute, including increased immune activation and inflammation. 

These factors may contribute to plaque buildup in the arteries of the heart, which may be uniquely prone to rupture among HIV-positive people. Low level but persistent activation of the immune system is increasingly recognized as a major issue among HIV-positive people, which may lead to a number of non-AIDS-morbidities, including heart disease. 

People living with HIV should be encouraged to maintain a healthy lifestyle, including smoking cessation, good dietary habits and regular exercise. In addition, use of medications may be warranted. Among HIV-negative people, a class of medications, called statins, has proven effective to treat heart disease and in some selected populations, to even prevent heart disease. Similarly among HIV-positive people, these drugs may prove useful to prevent heart disease because they not only lower cholesterol, but also reduce immune activation. Preliminary data show that the drugs are generally well tolerated and effectively lower cholesterol and reduce plaque in the arteries of the heart in HIV-positive people. 

Should all people living with HIV be taking a statin? The answer is that although the data are promising, we need proof from a large trial to show that these medicines are effective and well tolerated over the long run in the HIV population. To answer this critical question for the HIV population, the National Institutes of Health (NIH) has recently funded the largest cardiac prevention trial in HIV, called REPRIEVE, a Randomized Trial to Prevent Vascular Events in HIV. 

REPRIEVE is designed to be very simple and easy for patients and aims to recruit 6,500 people in mostly U.S. and some international sites, and will utilize the AIDS Clinical Trial Group (ACTG) sites, as well as many other sites across the United States, Canada and Thailand. There are approximately 90 to 100 sites scheduled to participate in REPRIEVE. The medication chosen for REPRIEVE is thought to be particularly promising for HIV-positive people as it has no known significant interaction with ARV therapy. A subset of participants will also have a virtual coronary angiogram done to see if they have plaque lesions in their coronaries and how these respond to statin medication. 

Why is it critical to participate in REPRIEVE? Largely through participation in clinical trials, the HIV population has helped to develop effective ARV therapy and accelerated the development of potent, well tolerated, life-saving therapies. Without data from such trials, this progress would not have been made. Similarly, we are at a critical juncture for heart disease. 

We know the rates of heart disease are increased and we need to develop effective medications for this emerging HIV co-morbidity. Pitavastatin is a promising drug and data from this large clinical trial will tell us if this drug is effective. People  interested in learning more regarding REPRIEVE can go to the website at reprievetrial.org and find a site enrolling near them. Ask your doctor about REPRIEVE, it could save your life. 

Steven Grinspoon, MD, is principal Investigator for REPRIEVE. Aaron Laxton is community advisory board representative for REPRIEVE.

Wednesday, July 22, 2015

How to Get Money to Pay for Your HIV Medication

Treatment can be expensive but there are programs that will lower the cost, sometimes even making meds free
By Trudy Ring


HIV meds are often expensive, but even if you don’t have private insurance or a low enough income to qualify for Medicaid, there are other programs that can help you pay. Also, if you are insured but have a high co-pay, help is available for that as well.

The Affordable Care Act, a.k.a. Obamacare, requires insurers to provide prescription drug coverage, whether it’s a policy you buy through the ACA marketplace or (in most cases)another plan, such as insurance provided by your employer. They also must cover at least one drug in every class and count your out-of-pocket drug costs — usually meaning co-pays — toward your lifetime cap on out-of-pocket expenses. The ACA marketplace has made coverage available to millions of previously uninsured Americans, as has Medicaid expansion, enacted through the ACA and a related bill. Find more information at Healthcare.gov.

Also, the federally created, state-managed AIDS Drug Assistance Program (ADAP) can help uninsured or underinsured people pay for their HIV medications. The requirements vary by state, but typically you have to be a resident, have HIV, and earn less than a certain amount per year, calculated as a percentage of the federal poverty level.

Following is a guide to ADAP income requirements and contact information. Each state’s Maximum Qualifying Income (MQI) to be in ADAP is shown as a percentage of the federal poverty level as well as the dollar amount for a one-person household (for 2015, in the 48 contiguous states the federal poverty level for one person is $11,770; add $4,160 per family member).

ALABAMA
Website: adph.org/aids
Phone: (334) 206-5364
MQI: 250% or $29,425


ALASKA
(907) 452-4222
MQI: 300% or $44,160


ARIZONA
Website: bit.ly/ARIZadap
Phone: (800) 334-1540
MQI: 300% or $35,310


ARKANSAS
Website: bit.ly/ARadap
Phone: (501) 661-2408
MQI: 200% or $23,540


CALIFORNIA
Website: bit.ly/CAadap
Phone: (916) 449-5900
MQI: less than $50,000


COLORADO
Website: bit.ly/COadap
Phone: (303) 692-2716
MQI: 400% or $47,080


CONNECTICUT
Website: bit.ly/CTadap
Phone: (800) 233-2503
MQI: 400% or $47,080


DELAWARE
Website: bit.ly/DEadap
Phone: (302) 744-1050
MQI: 500% or $58,350


DISTRICT OF COLUMBIA
Website: bit.ly/DCadap
Phone: (202) 671-4900
MQI: 500% or $58,850


FLORIDA
Website: floridaADAP.org
Phone: (800) 352-2437
MQI: 400% or $47,080


GEORGIA
Phone: (404) 657-3100
MQI: 300% or $35,310


HAWAII
Phone: (808) 586-4400
MQI:  400% or $54,200


IDAHO
Phone: (208) 334-6527
MQI: 200% or $23,540


ILLINOIS
Website: bit.ly/ILLadap
Phone: (217) 782-4977
MQI: 300% or $35,310


INDIANA
Phone: (866) 588-4948
MQI: 300% or $35,210


IOWA
Website: bit.ly/iowaADAP
Phone: (515) 281-0926
MQI: 200% or $23,540


KANSAS
Website: bit.ly/KANadap
Phone: (785) 368-8218
MQI: 300% or $35,310


KENTUCKY
Phone: (866) 510-0005
MQI: 300% or $35,310


LOUISIANA
Phone: (504) 568-7474
MQI: 300% or $35,310

MAINE
Website: bit.ly/MEadap
Phone: (207) 287-3747
MQI: $55,850, add $3,960 per dependent


MARYLAND
Website: bit.ly/MDadap
Phone: (800) 205-6308
MQI: 500% or $58,850


MASSACHUSETTS
Website: crine.org/hdap/
Phone: (800) 228-2714
MQI: 500% or $58,850


MICHIGAN
Website: michigan.gov/dap
Phone: (888) 826-6565
MQI: 450% or $52,965


MINNESOTA
Phone: (800) 657-3761
MQI: 300% or $35,310


MISSISSIPPI
Phone: (601) 362-4850
MQI: 400% or $47,080


MISSOURI
Phone: (866) 628-9891
MQI: 300% or $35,310


MONTANA
Phone: (406) 444-4744
MQI: 330% or $38,841


NEBRASKA
Website: bit.ly/NEadap
Phone: (402) 559-4673
MQI:  200% or $23,540


NEVADA
Phone: (775) 684-4247
MQI: 400% or $47,080


NEW HAMPSHIRE
Website: bit.ly/NHadap
Phone: (603) 271-4502
MQI: 300% or $35,310


NEW JERSEY
Phone: (877) 613-4533
MQI: 500% or $58,850


NEW MEXICO
Website: nmhivguide.org
Phone: (505) 827-2435  
MQI: 400% or $47,080


NEW YORK
Phone: (800) 542-2437
MQI: 435% or $51,199


NORTH CAROLINA
Website: bit.ly/adapNCar
Phone: (877) 466-2232
MQI: 300% or $35,310


NORTH DAKOTA
Website: ndhealth.gov/HIV
Phone: (800) 472-2180
MQI: 300% or $35,310


OHIO
Website: bit.ly/OHadap
Phone: (800) 777-4775
MQI: 300% or $35,310


OKLAHOMA
Website: bit.ly/OKADAP
Phone: (405) 271-4636
MQI: 200% or $23,540


OREGON
Phone: (800) 805-2313
MQI: 400% or $47,080


PENNSYLVANIA
Website: bit.ly/PennADAP
Phone: (800) 922-9384
MQI: 500% or $58,850


RHODE ISLAND
Phone: (401) 462-3294
MQI: 400% or $47,080


SOUTH CAROLINA
Website: bit.ly/SCadap
Phone: (800) 569-9954
MQI: 300% or $35,310


SOUTH DAKOTA
Website: bit.ly/SDakADAP
Phone: (605) 773-3737
MQI: 300% or $35,310


TENNESSEE
Website: bit.ly/TNadap
Phone: (615) 532-2392
MQI: 300% or $35,310


TEXAS
Website: bit.ly/texasADAP
Phone: (800) 255-1090
MQI: 200% or $23,540


UTAH
Website: bit.ly/utahADAP
Phone: (801) 538-6197
MQI: 250% or $29,425


VERMONT
Phone: (802) 863-7245
MQI: 500% or $58,850


VIRGINIA
Phone: (855) 362-0658
MQI: 400% or $47,080


WASHINGTON
Website: bit.ly/WAadap
Phone: (360) 236-3426
MQI: 400% or $47,080


WEST VIRGINIA
Phone: (304) 558-2195
MQI: 400% or $47,080


WISCONSIN
Website: bit.ly/WIadap
Phone: (800) 991-5532
MQI: 300% or $35,310


WYOMING
Website: bit.ly/WYadap
Phone: (307) 777-5856
MQI: $40,150-$45,100,
depending on county


ADAP also covers Puerto Rico, Guam, the Virgin Islands, and Pacific Island Territories.
Visit bit.ly/HHSadap for more information.

Monday, July 20, 2015

New Proof That Passing On HIV While Undetectable Is Very Unlikely

July 20, 2015

IAS 2015

A major study examining how antiretrovirals (ARVs) reduce the risk of HIV transmission among heterosexuals has found that no participant with a fully suppressed viral load infected his or her long-term HIV-negative partner. These final results from the HPTN 052 study of 1,763 mixed-HIV-status heterosexual couples were presented at the Eighth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, British Columbia.

“The study now makes crystal clear that when an HIV-infected person takes antiretroviral therapy that keeps the virus suppressed, the treatment is highly effective at preventing sexual transmission of HIV to an uninfected heterosexual partner,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a press release. “For heterosexuals who can achieve and maintain viral suppression, the risk to their partners is exceedingly low.”

In 2011, interim results from HPTN 052 revolutionized the global approach to HIV prevention by showing that starting ARV treatment reduced by 96 percent the risk than an individual with HIV would transmit the virus to an HIV-negative primary partner (at least among heterosexuals). The notion of “treatment as prevention” (TasP) went mainstream. With the U.S. approval of Truvada (tenofovir/emtricitabine) as pre-exposure prophylaxis (PrEP) in 2012, biomedical prevention efforts extended to at-risk HIV-negative individuals as well: giving them the opportunity to take ARVs to reduce their risk of acquiring the virus.

Then, in 2014, an interim analysis of the still-ongoing PARTNER trial, focusing on 767 heterosexual and gay mixed-HIV status couples in which the HIV-positive partner was taking ARVs, found that there were no transmissions of the virus within the couples. (The trial is set to complete in 2017.) When presenting the findings at a major conference, Jens Lundgren, MD, chief physician and director of the Copenhagen HIV Programme, estimated that the chance of transmitting HIV when the virus is fully suppressed by ARVs is close to zero, and might even be zero.

The final results of HPTN 052 add support to Lundgren’s assessment.

HPTN 052 included couples in Malawi, Zimbabwe, South Africa, Botswana, Kenya, Thailand, India, Brazil, and the United States. Enrollment began in April 2005 and the trial concluded in May 2015. The HIV-positive partners had CD4 counts between 350 and 500 upon entering the study and were randomly divided into two groups: Members of one group, called the early arm, received HIV treatment immediately; those in the other group, the delayed arm, received ARVs once their CD4s hit 250 or below, or they developed AIDS-defining illnesses.

After the 2011 analysis showed how well ARVs prevented transmission, all participants were offered treatment.

By the end of the trial, 1,171 (66 percent) of the original couples remained in the study, including 603 of 886 (68 percent) in the early arm and 568 of 877 (65 percent) in the delayed arm. All told, the participants contributed 9,822 person-years of follow-up.

Before the investigators offered HIV treatment to all, there was one HIV transmission within a couple in the immediate arm. The investigators proved that this was what they call a “linked infection” by conducting genetic testing on all HIV-positive partners’ viruses as well as anyone who contracted the virus during the study, and then comparing genetic similarity. There were also 35 linked infections in the delayed arm.

During the entire decade-long study, there were 46 linked infections, 3 in the immeidate arm and 43 in the delayed arm. Eight of these cases were transmissions from an HIV-positive partner taking ARVs. Four of those eight infections were diagnosed not long after the HIV-positive partner started treatment, suggesting that the partner may not have had an undetectable viral load yet, or that the transmission occured just before he or she started treatment. The remaining four transmissions were diagnosed when the HIV-positive partner experienced failure of their ARV regimen (perhaps because they were not taking their medications as prescribed or had a strain of the virus resistant to one or more ARV in their regimen) and developed a detectable viral load.

“These findings demonstrate that HIV transmission is very unlikely when viral replication is suppressed,” the study authors conclude.

The new analysis estimates that starting ARVs earlier rather than waiting reduces the risk of HIV transmission by 93 percent.

The study results highlight that failing an HIV regimen can open the door for transmission of the virus. (A separate analysis found that taking longer to suppress the virus in the first place raises the likelihood of eventual treatment failure, and that those who start treatment with a higher viral load tend to take longer to suppress the virus on treatment.) So, in the context of treatment as prevention, simply being on ARVs is not necessarily a safeguard against passing on the virus; the most central factor is actually succeeding on therapy and having an undetectable viral load.

ARVs, the authors write, “combined with counseling and provision of condoms provides durable, highly effective protection from HIV transmission in serodiscordant couples.”

To read the press release, click here.

To read a Q&A about the trial, click here.



Monday, July 13, 2015

Using Naturally-Occurring Antibodies to Treat HIV




Using Naturally-Occurring Antibodies to Treat HIV
Article written on July 7, 2015: by Emily Newman


A recent report published in Nature describes promising findings of a study testing the safety, tolerability and antiviral efficacy of a broadly neutralizing antibody (nBAb) called 3BNC117. This is the first study to show, in human participants, that a broadly neutralizing antibody significantly reduces viral loads and decreases viral rebound in people living with HIV—giving hope for its eventual use in treatment and cure strategies.

Broadly neutralizing antibodies (bNAbs) are produced by the immune system of some people living with HIV. What’s special about bNAbs is that they are able to prevent HIV from entering host CD4 cells—and they’re able to do this with many different strains of HIV. The bNAb 3BNC117 is able to neutralize 195 (out of 237 total) strains of HIV. It was isolated from an elite controller—a person whose body spontaneously controls HIV infection without antiretroviral therapy.