The decadeslong search for more effective HIV treatments has led otherwise competitive pharmaceutical companies to enter into collaborations toward a common goal of improving the lives of almost 38 million people around the world with the infection.
Johnson & Johnson Global Head of Development for Infectious Diseases Brian Woodfall Source: J&J |
These partnerships are formed not only out of business interests but in many cases by the nature of HIV itself — decreasing a patient's viral load often requires a "cocktail" of drugs that are often developed by different companies. Executives say partnering was a necessity at the beginning of the epidemic due to a lack of treatment options and remains so to this day.
One potential newcomer is a long-acting, two-drug injection of rilpivirine from Johnson & Johnson's Janssen Pharmaceuticals Inc. arm and cabotegravir from ViiV Healthcare Ltd. with an approval expected from the U.S. Food and Drug Administration in December.
In clinical studies, the injection suppressed the virus for up to four weeks at a time, similar to daily antiretroviral cocktails. A more recent late-stage study demonstrates that the effect lasted for eight weeks at a time. The single injections would take the place of daily pills that last a lifetime.
"Recognizing that HIV treatment is long-term treatment, people are going to need to stay on therapy essentially for the rest of their lives," Brian Woodfall, Global Head of Development for Infectious Diseases at J&J, told S&P Global Market Intelligence. "And so long-term compliance and adherence to therapy, making sure that people don't get pill fatigue and stop taking their medication, are very important for long-term success."
Woodfall said the development of rilpivirine began in 2005, using technology for long-acting schizophrenia medications. The technical achievement of getting rilpivirine to be successful between doses, however, was not enough without an additional therapy to go along with it.
"We were pleased when ViiV came forward with the integrase inhibitor [cabotegravir] ... that looked like it could be combined with our rilpivarine," Woodfall said. "Usually we think of pharmaceutical companies as competitors, but certainly in HIV we collaborate on many things because combination therapy really is important — the combination of these phase 3 programs has really been a combination of about 15 years of work."
Gilead Sciences Inc. and Merck & Co. Inc. are also major players in the HIV market; J&J has worked with Gilead on several single-tablet regimens.
ViiV's Senior Vice President and Head of Research & Development Kimberly Smith said in an interview that a collaborative approach to HIV has been a major reason innovation has advanced exponentially in recent years. ViiV is largely backed by shareholders GlaxoSmithKline PLC, Pfizer Inc. and Shionogi & Co. Ltd.
ViiV Healthcare Senior Vice President and Head of Research & Development Kimberly Smith Source: ViiV Healthcare |
"In the very beginning, one company didn't have three medicines to combine," Smith said. "Each company might have one, and it would mean that companies needed to come together to bring those tablets into a combination."
She added that HIV/AIDS clinics were combining medications themselves to provide the best care for their patients, without caring which companies made each drug. Woodfall said companies combining their interests was therefore a natural progression to provide for patients.
Aiming for prevention, potential cure
Although drug combinations that help patients manage HIV and AIDS dominate the market, vaccines and potential cures are on the minds of many researchers.
Gilead's Truvada, a combination of emtricitabine and tenofovir, and Descovy are the only therapies approved by the FDA as pre-exposure prophylaxis, or PrEP, to decrease the risk of infection.
But more prevention options are in the works. For example, J&J is enrolling a large late-stage study in sub-Sarahan Africa to test a potential new type of vaccine it calls a "mosaic," which Woodfall said builds upon Truvada's success.
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"From the very first days of HIV, we've thought if we can have a vaccine, that'll have the biggest impact," Woodfall said. "But most vaccine efforts have failed, and failed pretty miserably. We have a unique approach that should theoretically offer protection globally irrespective of which strain of the virus is circulating in any given country, and we're reaching an inflection point in the development of this vaccine with the big studies being enrolled."
The ultimate goal is "to make HIV history," Smith said. ViiV and GlaxoSmithKline researchers are collaborating with University of North Carolina scientists in a joint venture called Qura Therapeutics to find a possible cure.
"Folks have been trying from the beginning of the epidemic to find a cure, and I think there's progress and that we understand a lot more about the virus and how it functions than we did in the beginning," Smith said. "But we're still a good ways away from a broadly available, scalable cure for HIV."
Challenges remain, decades later
Although scientific problems in HIV are a significant hurdle, the social and political stigma around the infection has remained another major hindrance to development, according to Smith.
"HIV is still a disease that is associated with a tremendous amount of stigma," Smith said. "And that's part of why the long-acting regimen actually has the potential to be so appealing to patients. It takes away so many fears that they have."
These fears include the difficulty a patient has in divulging that he or she is infected, and being able to take medications less often could play a big part in letting them live more normal lives, Smith said. In the U.S., communities of color, particularly African Americans, are statistically hit harder for a number of reasons including poverty, lack of healthcare and overall stigma, she said.
Geographically, HIV poses a challenge in areas with limited resources and high infection rates, including sub-Saharan Africa.
"Despite all our best prevention efforts, there were 1.8 million new infections last year," Woodfall said. "So despite knowing how to prevent the disease and having some methods available, we just haven't been able to really have that impact in certain areas of the world geographically."
Woodfall said the pharmaceutical industry has scaled up its ability to develop and deliver treatments, and patients now have many more options than they did decades ago.
"I was involved through those very bad years where people were diagnosed very late in their disease, they had overwhelming opportunistic infections and their life expectancy was months," Woodfall said. "So how far we've come is a tremendous testament to a lot of different things: not only the cutting edge of science and new approaches to medical treatment and care, but political revolution to fund things and the social activism have all really coalesced to drive the response to HIV over the years."



