Has a stalemate been reached in the fight against HIV? After years of significant progress, a recent development could give the impression that progress might be stalled.
In late April, the largest active study of an HIV vaccine was halted by the National Institutes of Health. Only a month after the full enrollment of more than 2,500 patients was completed, the decision was made to pull the plug on the study. Preliminary findings showed that the vaccine simply wasn't working.
While this setback was certainly discouraging, one piece of bad news doesn't necessarily mean that progress has stopped altogether. The larger picture of where we are in the fight against HIV provides more reasons for cautious optimism.
Where things stand
First, let's look at some good news. The rate of growth in numbers of individuals across the world with HIV is definitely slowing.
In the U.S., the outlook for HIV and AIDS looks quite encouraging. Both diagnoses of HIV and death rates have fallen significantly
A major factor in the improvement in reducing deaths associated with HIV has been the ongoing development of antiretroviral drugs. Gilead Sciences (NASDAQ: GILD ) stands as the leader in this market. Its Atripla, a combination of three Gilead HIV drugs, generated nearly $3.6 billion in sales last year. One of Atripla's component drugs, Viread, made more than $848,000 in 2012.
Merck (NYSE: MRK ) also ranks as a significant developer of HIV drugs. In 2007, Isentress became the first integrase inhibitor to be approved by the Food and Drug Administration for treating HIV. The drug brought in more than $1.5 billion in revenue last year.
While the recent vaccine effort failed, some successes have been achieved in preventing people from acquiring HIV. Gilead received FDA approval last July for Truvada, the first HIV prevention drug. Clinical studies found that Truvada significantly reduced the likelihood of acquiring HIV infections.The drug was already approved as a treatment for HIV and generated nearly $3.2 billion in revenue during 2012.
Progress has also been made on the diagnostic front. The FDA approved OraSure Technologies' (NASDAQ: OSUR ) OraQuick home HIV test in July 2012. OraQuick allows an individual to use a mouth swab and find out the results within 40 minutes. The test hasn't exactly leaped off store shelves as of yet, though. OraSure reported only $1.5 million in gross sales for the OraQuick home test during the most recent quarter.
Antiretroviral drugs continue to improve. Gilead launched its integrase inhibitor, Stribild, in the latter part of 2012. Stribild is similar to Atripla, but it reduces some side effects, and clinical studies found it to be a little more effective than its predecessor.
ViiV Healthcare, a collaboration between GlaxoSmithKline (NYSE: GSK ) , Pfizer (NYSE: PFE ) , and Japanese drugmaker Shionogi, could soon have another powerful HIV drug to market. The FDA granted priority review status for dolutegravir in February. A decision on ultimate approval of the drug is expected in August. Glaxo is the majority owner in Viiv with a 76.5% stake, with Pfizer holding a 13.5% share.
Higher adoption rates of home testing could also help. The CDC estimates that almost one in five people with HIV don't know that they have the virus. Use of home tests should enable more individuals with HIV to begin taking appropriate treatments and take actions to reduce the spread of the virus.
There's still hope that an effective vaccine can be developed. A 2009 late-stage study in Thailand found modest results in preventing HIV. The 31% reduction in HIV infection rates obtained by that vaccine wasn't enough to warrant a public rollout, but it did show promise. Just this week, the Makerere University Walter Reed Project in Uganda announced plans to launch another HIV vaccine effort in July.
More disappointments are likely to come, of course. Progress often comes in fits and starts. However, what looks like a stall at first could really just be the beginning of the next big breakthrough.
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