According to the World Health Organization, there are 34 million HIV-positive individuals in the world today, and the virus has claimed the lives of 25 million people since the initial cases of the infection were reported more than three decades ago. In the United States, data from the CDC reveals that approximately 50,000 new cases occur every year.
Despite these bleak statistics, researchers have made remarkable progress in slowing mortality rates over the years through the discovery of new medications.
The dramatic drop in HIV-related deaths that started in the mid-1990s was in large part due to the FDA's approval of saquinavir, an antiretroviral drug that Roche marketed as Invirase. This was the first protease inhibitor discovered to treat HIV, and since then several more have become available to patients: AbbVie's Norvir, GlaxoSmithKline's Lexiva, and Bristol-Myers Squibb's Reyataz all belong to the same drug class.
In parallel with the development of more effective HIV treatments, researchers are also making tremendous progress in the prevention of this disease. So what were the key advancements in the past year that can help lower infection rates in the future?
A new use for an old drug
A research article published this week in The Lancet reported that Gilead's (NASDAQ:GILD) Viread can help prevent HIV transmission in users of injecting drugs. The study enrolled more than 2,400 HIV-negative drug users in Bangkok and compared infection rates between a group taking a daily dose of the medication and a placebo group. The data showed that the group on Viread had almost 50% fewer HIV infections.
Viread, a reverse transcriptase inhibitor that the FDA approved more than 10 years ago as an HIV treatment, is one of Gilead's most important compounds. Not only is it the company's third best-seling drug, but it's also a component in its leading blockbuster combination treatments Atripla and Truvada. This newly published data suggests that Viread can now also be considered a pre-exposure prophylaxis, or PrEP, for the prevention of HIV.
It's unclear what public health programs will be established in light of these results. However, with the CDC estimating that injecting-drug use accounts for 8% of infections in the U.S., and considerably higher numbers reported in some Eastern European and Asian countries, this discovery will hopefully drive infection rates lower in the years to come.
Gilead's first triumph
Viread is poised to be the second PrEP drug in Gilead's portfolio. Almost a year ago, the FDA approved Truvada as a preventative drug for individuals at high risk of infection, including those in serodiscordant relationships (where one partner is HIV-negative and the other HIV-positive). This was the first medication for the prevention of HIV to be approved by the FDA, and it in clinical studies it lowered the chance of transmission by 42%.
Revolutionary diagnostic test
While both medications have the potential to reduce infections in the future, easy access to fast and accurate diagnostic tests is another tool in the fight against HIV. It's estimated that 20% of HIV-positive individuals don't actually know their status, and a product manufactured by OraSure Technologies (NASDAQ:OSUR) aims at lowering the barrier for testing. Its over-the-counter OraQuick In-Home HIV test won FDA approval last summer and is the first needle-free diagnostic kit that can be done in complete privacy. Consumer adoption for the product has been slow, and while that has weighed on OraSure's shares significantly, the test still provides a revolutionary way for any individual to quickly determine his or her status. Whether this test will directly curtail rates of HIV infections can't be determined just yet, but easy access to rapid diagnostic kits is a major step forward.
There was promising news earlier this year after researchers announced that a newborn child was cured of HIV following a specific treatment protocol. While this story does inspire hope, it is the only clinical case of its kind, and a widespread cure has been unattainable to date. The most effective way to lower transmission rates in the near term continues to be pioneering new approaches for prevention.