FDA Approves new HIV Treatment

Aug27 by D Gregory Smith

The FDA approved “the Quad”- a four-medication-in-one-pill treatment for controlling HIV. Two of the medications comprising Stribild, tenofovir and emtricitabine, have been previously combined and sold under the brand name Truvada (itself approved a few weeks ago as a preventative or prophylactic for HIV, see related articles below).

Two of the medications are new, and – as a condition of approval- will require greater testing in women and children, as well as studying possibilities and occasions of resistance.

This is good news.

Simplifying regimens is a helpful strategy in helping keep HIV-infected persons faithful to their medication schedules, a key in effectively treating HIV. Cost is yet to be determined- and most HIV regimens cost in excess of $18,000.00 a year (mine cost $24k).

Still no picnic- but good news for those who need a simpler med schedule.

FDA Approves Gilead’s HIV Quad Pill Stribild – Wall Street Journal (drugstoresource.wordpress.com)
FDA’s Approval of Stribild Will Simplify Treatment for HIV Patients (guardianlv.com)
Truvada Approved For HIV Prevention (dgsmith.org)

HIV Home Test A “Double Edged Sword”

Aug2 by D Gregory Smith

Kudos to Great Falls Tribune Reporter Michael Beall for writing about the newly approved Rapid HIV Home Test- and asking Montanans in the field what they think about it.

Greg Smith, the executive director of AIDS Outreach in Bozeman, said he and others have mixed feelings about the U.S. Food and Drug Administration’s decision to approve the first over-the-counter HIV test kits.

English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)

“I think it’s great that people will have access to testing,” said Smith, who was diagnosed with HIV in 2007. “But my concern is that they wouldn’t have the support that we offer in community-based testing situations.”

The OraQuick test is similar to the OraSure tests health clinics use and detects the presence of HIV in saliva. It returns results within 20 to 40 minutes.

The test is as simple as swabbing the upper and lower gums and inserting the test stick into a solution.

But Smith said the home test is a double-edged sword.

“On one hand, information is great, but on the other we need to provide that information so that it’s received well,” he said. “We want that support there.”

Trisha Gardner, City County Health Department community health education specialist, said reviews of the test are overwhelmingly positive, but she’s concerned because those who take the tests at home and test positive won’t have someone there to help them know what to do next. At the same time, she knows how important testing is to stopping the spread of the disease.

“You can’t do anything to control the spread of it if you don’t know you have it,” Gardner said. “People will be more likely to (get tested) because they don’t have to go in anywhere. They don’t have to be seen.”

Full story here.

Wrap It Up: FDA Approves First Ever At-Home HIV Test (bossip.com)
HIV self-test raises questions (toledoblade.com)
San Francisco Thwarts HIV With Wide Testing, Universal Treatment (npr.org)

HIV Treatment Breakthrough: Weekly Injection Could Replace Daily Pill Regimen

Jul21 by D Gregory Smith

HIV-1 Gag (Photo credit: AJC1)

For a number of people with HIV, treatment can be troublesome because medicine should be taken at the same time every day- sometimes more than once a day. Some medications must be taken with food, some without. Some can only be taken near bedtime because they cause drowsiness.

Science Daily reports a treatment breakthrough:

(A) University of Nebraska Medical Center research team’s progress toward developing weekly or twice-monthly injectable antiretroviral therapy (ART) nanomedicines for patients with human immunodeficiency virus (HIV) infection will be highlighted as the cover story in the Journal of Infectious Diseases.

A long-acting, nanoformulated ART (nanoART) would be a substantive improvement over daily and sometimes more complex regimen of pills, said Howard Gendelman, M.D., the lead investigator on the development of nanoART for HIV/AIDS and professor and chairman of the department of pharmacology and experimental neuroscience (PEN) at UNMC.

The journal article hails the successful testing of UNMC’s ART injectables as treatment of HIV-infected mice and in preventing new infections.

“We actually followed the process exactly as we would with a person — and it worked,” Dr. Gendelman said. “This is all very exciting. Although there are clear pitfalls ahead and the medicines are not yet ready for human use, the progress is undeniable.”

This could prove to be helpful- most especially in the developing world- where people have trouble managing a regimen of pills or have low access to long-term medication treatments. But it may have significant impact everywhere, changing the way HIV is treated….

Full article here.

First HIV-prevention pill approved by FDA (cbsnews.com)
Truvada Approved For HIV Prevention (dgsmith.org)
Could New Anti-HIV Pill Reshape AIDS Strategy in Africa? – Bloomberg (bloomberg.com)

Guest Post: People Living with HIV Can Increase Physical Health and Quality of Life through Exercise

Jul19 by D Gregory Smith

By Jim Rollince, GymSource

Adhering to a rigid exercise program can seem intimidating to a person who has been diagnosed with HIV. Because this particular disease is so varied in how it affects each person who has it, people with HIV are often at various stages of physical health and emotional health. Sometimes, the disease can seemingly lie dormant for years. Other times, the disease can attack and leave a person feeling extremely ill, mentally depleted, and exhausted of nearly all energy. Exercise is one way that a person who has HIV can fight back and take positive steps to regaining strength and increasing his or her overall health.

Increased Cardio Health Benefits Stem from Consistent Exercise Routines

It is well known that physical exercise can greatly improve cardio health. In many situations, healthy hearts equal healthy bodies. Many people are able to fight diseases through consistent exercise programs. While beginning with a rigorous exercise program may not be feasible for an HIV patient who is fighting severe symptoms of the disease, beginning with a mild program and then steadily increasing it can result in wonderful improvements on the way the person feels each day.

Setting up home gym equipment is an ideal way to be prepared to exercise any time there is free time to do so. If an HIV patient is working full time or part time, going to regular doctor visits, and taking care of other responsibilities, a home gym may be the best solution to find time to exercise. Using a treadmill, an exercise bike, and an elliptical machine can result in tremendous health benefits and improved heart conditions. Improving the heart and blood circulation throughout the body will make the person feel physically stronger and this can have a great and lasting impact on how well the person is physically able to cope with the disease.

Remain Committed to Regular Fitness Activities for Increased Health

The US National Library of Medicine provides an online medical journal that details numerous benefits that people who have been diagnosed with HIV or AIDS can gain from committing to regular exercise sessions. Psychological benefits, increased circulation, easier breathing, and stronger muscles are all potential benefits a person can gain by committing to exercise on a regular basis.

Getting outside during nice weather and taking advantage of warm and pleasant weather to hike, swim, or go biking with friends is an ideal way to enjoy exercise and socialization at the same time. When time is short, the individual can take advantage of fitness equipment at home to get in a few minutes of treadmill jogging or working out on an elliptical. Every time a person engages in physical activity, the body will respond by increasing metabolism and potentially increasing levels of energy.

HIV/AIDS: The Importance of Exercise (aidsinfonet.org)
The benefits of exercise for those with HIV (hivblogger.me.uk)
HIV Diminishes Lung Function
HIV and Exercise
Exercise and HIV/AIDS (TheBody.com)

Truvada Approved For HIV Prevention

Jul17 by D Gregory Smith

From Mother Nature News:

The first-ever daily pill to help prevent against HIV was approved Monday by U.S. regulators for use in uninfected adults who are at risk for getting the virus that causes AIDS.

Truvada, made by Gilead Sciences in California, has been on the market since 2004 and was approved by the Food and Drug Administration for a new use as a tool to help ward off HIV in otherwise healthy people, in combination with safe sex and regular testing.

The pill as pre-exposure prophylaxis has been hailed by some AIDS experts as a potent new tool against human immunodeficiency virus, but some health care providers are concerned it could encourage risky sex behavior.

In addition, the regimen is estimated to cost around $14,000 per year, making it out of reach of many.

The National Association Of People With AIDS (NAPWA) had this to say:

The National Association of People With AIDS (NAPWA) strongly supports today’s move by the United States Food and Drug Administration to approve use of Truvada (emtricitabine/ tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

“It’s time for people at high risk of HIV infection to be empowered to protect themselves and others,” said Frank J. Oldham, Jr., NAPWA’s President and CEO. “Today’s approval of Truvada for HIV prevention gives them an important new tool to do that.

“PrEP is not a final solution to the spread of HIV,” Oldham continued, “but it can be one tool, and a very useful one, in a well stocked toolkit of prevention measures. We urge all Americans to assess their HIV risk realistically and use condoms if they are at risk, but we thank the FDA for approving Truvada for PrEP for those who cannot or will not.”

Truvada is one of the pills I take every day- if it can prevent anyone from getting HIV- it should. The “how” is still being determined.

FDA approves Truvada, the first pill to help prevent HIV – USA TODAY (usatoday.com)
FDA Approves First Medication to Reduce HIV Risk (fda.gov)

Reminder: AIDS Is Alive And Well In Montana

Jul16 by D Gregory Smith

Kim McGeehan wrote an article for the Bozeman Magpie about HIV in Montana- and shared some of my story along the way. Excerpt:

English: HIV-1 particles assembling at the surface of an infected macrophage. Français : Des particules de HIV-1 s’assemblant à la surface d’un macrophage infecté. (Photo credit: Wikipedia)

“I wasn’t diagnosed because I was scared. Now, I have memory issues and damage to my joints. HIV attacks soft tissues in the body—gums, brain, liver—even if you don’t have outward symptoms, the virus can still be doing damage,” Smith says. “At first, there were no treatments. Now there is a lot we can do. We can stop it or slow it down. You can live a healthy life. If you are on your meds and have a low viral load, your risk of transmitting the disease can be as low as 4%.”

That isn’t permission to take behavioral risks, but information that should encourage people to take advantage of the services offered by AIDS Outreach. Those services include fast, free, anonymous HIV tests, an HIV-positive support group, educational literature, and condoms condoms condoms.

Americans will soon be able to purchase an over-the-counter, rapid-response HIV test, but Smith worries that dealing with a positive result alone will be challenging for folks: “Denial is such a strong force in the human psyche. I remember it in myself. I’m worried that someone might test positive and not tell anyone, not get counseling or medical care.”

Read the rest:

http://www.bozeman-magpie.com/perspective-full-article.php?article_id=502

Gay Men and the HIV Stigma (everydayhealth.com)
FDA Approves New In-Home HIV Test (philadelphia.cbslocal.com)
A “Positive” One Night Stand (notsoperfectme.com)
Not all H.I.V Survivors Thrilled With H.I.V Home-Test Kit (dfw.cbslocal.com)
HIV Is In Montana- It’s No Bull (dgsmith.org)
HIV In Montana: It’s Not Classified (dgsmith.org)

FDA Panel Recommends Approval Of Preventative HIV Med

May11 by D Gregory Smith

From CBS News:

In a landmark decision, an advisory panel to the Food and Drug Administration voted to recommend approval of Truvada to prevent HIV infection. The FDA is not required to the follow the panel of experts’ advice, though it typically does.

In a series of votes, a Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

A final decision on Truvada is expected by June 15, but the FDA doesn’t confirm such action dates and says the review of the application is ongoing, a spokesperson told CBS News.

“I think this is a huge milestone,” Dr. Robert Grant, associate director of the Center for AIDS Research at the University of California, San Francisco, who led the panel’s research, told CBS News medical correspondent Dr. Jon LaPook. “I think we are in an era for the first time when we can see the end of the AIDS epidemic.”

Gilead Sciences Inc., based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe it as part of a drug cocktail to repress the virus.

Since Truvada is already on the market to manage HIV, some doctors have prescribed it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use.

While panelists ultimately backed Truvada for prevention, Thursday’s 12-hour meeting highlighted concerns created by the first drug to prevent HIV. In particular, the panel debated whether Truvada might lead to reduced use of condoms, the most reliable defense against HIV. The experts also questioned the drug’s effectiveness in women, who have shown much lower rates of protection in studies.

The panel struggled to outline steps that would ensure patients take the pill every day. In clinical trials, patients who didn’t take their medication diligently were not protected, and patients in the real world are even more likely to forget than those in studies.

“The trouble is adherence, but I don’t think it’s our charge to judge whether people will take the medicine,” said Dr. Tom Giordano of Baylor College of Medicine, who voted in favor of the drug. “I think our charge is to judge whether it works when it’s taken and whether the risks outweigh the benefits.”

My view: This also allows sero-discordant couples- one HIV+, one not- an extra layer of protection. It may also help adherence if two persons are taking the same meds (or at least having to share a daily regimen) in the same household. That in itself is worth it….

Full story here

FDA panel backs first pill to block HIV infection (sfgate.com)
Truvada HIV drug could ‘turn tide’ on spread of Aids (theweek.co.uk)

HIV 2fer: Early Treatment Works and Truvada Prevents

Dec20 by D Gregory Smith

Today’s HIV News shelf is crowded. Two stories on the HIV front involve good news about early HIV treatment and Pre-Exposure Prophylaxis(PrEP) to reduce infection rates among high-risk persons.

A study (popularly known as the Setpoint Study) finds that people newly-infected with HIV-1 who immediately start anti-retroviral therapy are more likely to have beneficial medical outcomes than those who wait until CD4 counts fall below medically acceptable levels (currently 350-500 depending who you talk to).

“This is very welcome news,” said Frank J. Oldham, NAPWA President and CEO. “The study supplies scientific confirmation of something we at NAPWA have always believed: the closer we can come to bringing all people living with HIV into treatment, and the earlier they start treatment, the better. We already knew this is true for populations as a whole: more and earlier treatment means fewer new infections. Now we know that – on the whole – it’s also better for individuals already infected.”

The news on the HIV front just keeps getting better. The setpoint study follows on the heels of a groundbreaking study which provides proof of HIV treatment as prevention: HIV-infected persons on medication with undetectable viral levels are 96% less likely to pass on the virus.

It also accompanies Gilead’s application to offer Truvada as the first drug marketed to prevent HIV:

Gilead Sciences Inc. announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA)for the approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP. The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP, sponsored by the U.S. National Institutes of Health (NIH) and the University of Washington. Several other clinical studies support the use of Truvada for HIV risk reduction.

“The data from these large-scale clinical trials suggest that Truvada may have a role to play in meeting the urgent public health need to reduce new HIV infections,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. “Gilead is proud to have played a part in helping to define the use of Truvada as a potential new prevention tool and we commend the many institutions, investigators and study volunteers for their commitment to advancing this important area of research.”

Truvada is not currently labeled to reduce the risk of infection, it is labeled only for HIV treatment.

This could be an important step in slowing HIV. Around 50,000 people are still being infected with HIV every year in the U.S. according to the CDC. More than half of new infections (61%) occur among men who have sex with men, and nearly a quarter (23%) occur among women.

If Truvada can be given to high-risk persons (which includes negative partners in a sero-discordant relationship) and insurance companies will pay for it, it may, along with the groundswell of early treatment science, start a trend of slowing the progression of HIV in this country.

But only if we can get more high-risk people in for testing and treatment….

When was your last HIV test?