Last year Time magazine anointed the Ebola fighters as its "Person of the Year," signifying just how much this horrible disease has played into the mind-sets of Americans. In the U.S., there were only four confirmed cases and one death related to Ebola in the U.S., but globally, there were just over 20,000 cases, of which around 40% of those infected wound up passing away.
An even bigger threat
Ebola is a terrible disease, and it certainly needs research into a cure. But on a relative scale, Ebola is far from being a truly global killer. That dubious title goes to HIV/AIDS, which, based on World Health Organization statistics, was the sixth-leading global killer in 2012, claiming 1.5 million lives. For context, this is down from 1.7 million deaths associated with HIV/AIDS in 2000.
But, just because HIV/AIDS awareness and education has increased, it doesn't mean that the spread of the disease has reversed course. In fact, the number of people living with HIV each year hit 10 million in 1991, 20 million in 1996, 30 million in 2002, and based on data published by WHO sat at 35 million in 2012, including 3.2 million children who are less than 15 years old. WHO estimated another 2.1 million people worldwide became infected with the disease in 2013.
In short, if there's a disease that's truly worthy of billions of dollars in research that we as a society need to nip in the bud, it's HIV/AIDS.
The good news is that a collaboration from researchers at more than a dozen institutions may have done just that.
Did these researchers find a cure?
According to a recently released study from The Scripps Research Institute's Florida campus, its research has led to the creation of a drug vaccine candidate capable of halting the spread of HIV/AIDS. Not only did it stop the spread of the most common variant of the disease, HIV-1, but it also worked against HIV-2 and simian immunodeficiency virus, or SIV. It also offered protection over an extremely long period of time and against high dose levels of the disease, suggesting it could be a long-term solution.
Under normal circumstances, HIV invades a cell and injects its RNA sequencing into that cell, turning it into an HIV-replicating machine. These virus strains then target the CD4 lymphocyte, or T-helper cells, which play an important role in supporting the destruction of foreign cells. Researchers' vaccine binds in two areas with the HIV virus, catching it before it has a chance to bind with CD4 lymphocytes. As noted by TSRI research associate Matthew Gardner, "We've developed a direct mimic of the receptors without providing many avenues that the virus can use to escape, so we can catch every virus thus far."
The other genius aspect of TSRI's work is how it's delivering the HIV/AIDS drug candidate. The team engineered an adeno-associated virus, or an "innocuous virus that causes no disease," which they can inject directly into an infected patients' muscle tissue. The harmless virus then invades cells and turns those cells into protein factories -- the proteins responsible for binding with the HIV virus prior to its binding with CD4 lymphocytes. In theory, researchers believe an injection could create self-sustaining protein production and protection that could last for years or even decades.
What's the catch? For the time being this vaccine has been tested only in monkey models. The viruses injected into the muscles of monkeys produced proteins capable of binding with HIV for the full 40 weeks of the study, but there's no evidence (even with this impressive study on monkeys) that an adeno-associated virus will prove a better protector against HIV than natural HIV antibodies. The truth is that no one knows for sure if the engineered protein-producing virus will work in humans, but researchers are eager to begin moving its study into human clinical trials.
The current standards of treatment are unlikely to change
Although HIV/AIDS patients may have a new treatment to look forward to in a few more years depending on the success of TSRI's human clinical trials, it's unlikely that the two current standards of treatment for HIV/AIDS are going to be displaced anytime soon.
The first is Gilead Sciences' (NASDAQ:GILD) Stribild. Gilead Sciences is no stranger to infectious disease therapies, and has actually developed multiple generations of HIV-1 medications, with Stribild being its next-generation med.
Stribild is a four-in-one pill taken once daily. Its purpose is to interfere with an enzyme that HIV needs to multiply, thus slowing or halting the spread of the disease. When Stribild was compared against Gilead's prior-generation HIV therapies Truvada and Atripla, it proved superior. Stribild eliminated 88% to 90% of all detectable levels of HIV in clinical patients compared to 87% for Truvada and 84% for Atripla after 48 weeks.
Best of all, it's a win-win for Gilead's investors and HIV patients. Gilead Sciences owns the rights to all four components of Stribild, meaning it gets to keep all of the profits created from the sale of the drug. Atripla, the prior-generation HIV drug before Stribild, was a three-in-one drug where Gilead split the revenue and profits three ways with two additional companies that were involved in its development. And, more importantly, a majority of HIV patients get a potentially long-term solution to controlling their disease.
The other fairly new drug expected to make a significant impact on curbing HIV's progression is ViiV Healthcare's Tivicay. ViiV is majority-owned by GlaxoSmithKline (NYSE:GSK), but Pfizer (NYSE:PFE) and privately held Shinogi also own a stake.
Tivicay comes from a relatively new class of drugs known as integrase inhibitors which work by keeping HIV from entering host cells. Tivicay is a twice-daily pill that, in clinical trials, reduced all detectable levels of HIV in 88% of patients after 48 weeks. This compared to Atripla which reduced detectable levels of the disease in 81% of patients after 48 weeks.
The only real downside to both drugs is their cost. Tivicay will run users $14,105 per year, while Stribild's wholesale costs top $28,000! It's a price point that could make pharmacy-benefit managers and insurers cringe in horror, and it could prevent HIV-positive patients from getting the medicine that they need.
Critical steps forward
Over the past three years we've witnessed HIV/AIDS therapies take some major leaps forward with the introduction of Stribild and Tivicay. Now, it looks as if something even more exciting could be three to five years on the horizon, assuming everything goes well with human clinical trials.
Obviously, increased attempts at educating the public about the dangers of HIV/AIDS will help control the proliferation of the disease, but pharmaceutical agents are clearly also needed to halt this global killer in its tracks. I feel confident that we're making small but critical steps forward toward this goal and look forward to a day when we have a real-world cure for HIV/AIDS.