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