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 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)

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)

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)

Study: Preventative HIV Dosing Could Be Cost-Effective

Apr17 by D Gregory Smith

Science Daily reports that giving preventative doses of the HIV drug Truvada to high-risk groups could prove to be cost-effective:

A once-a-day pill to help prevent HIV infection could significantly reduce the spread of AIDS, but only makes economic sense if used in select, high-risk groups, Stanford University researchers conclude in a new study.

The researchers looked at the cost-effectiveness of the combination drug tenofovir-emtricitabine, which was found in a landmark 2010 trial to reduce an individual’s risk of HIV infection by 44 percent when taken daily. Patients who were particularly faithful about taking the drug reduced their risk to an even greater extent — by 73 percent.

The results generated so much interest that the Stanford researchers decided to see if it would be cost-effective to prescribe the pill daily in large populations, a prevention technique known as pre-exposure prophylaxis, or PrEP. They created an economic model focused on men who have sex with other men, or MSM, as they account for more than half of the estimated 56,000 new infections annually in the United States, according to the Centers for Disease Control and Prevention.

“Promoting PrEP to all men who have sex with men could be prohibitively expensive,” said Jessie Juusola, a PhD candidate in management science and engineering in the School of Engineering and first author of the study. “Adopting it for men who have sex with men at high risk of acquiring HIV, however, is an investment with good value that does not break the bank.”

Although getting Congress to pass this- the same Congress who killed needle-exchange- is far from realistic. Even though (maybe even especially because) it makes sense.

Full Story Here.

Giving preventive drug to men at high risk for HIV would be cost-effective, Stanford study shows (eurekalert.org)
Stem Cells: Killing HIV (dgsmith.org)
Analysis: Why some people do not receive continuous HIV medical care (dgsmith.org)
AIDS: “The Unnecessary Epidemic” (dgsma.wordpress.com)

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?