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HIV Treatment: Dual Therapies and Dueling Companies
Posted on September 12th, 2016 by Betsy Davis in Pharma R&D
After years of the AIDS epidemic taking a horrible toll on human life, some relief arrived in the 1990s as treatment for HIV, the virus that causes AIDS, came in the form of “cocktail” therapies that were developed by combining three or more antiretroviral drugs.
Although the drugs have improved over time, the triple therapy combinations have continued to be the standard for treating HIV.
However, The Wall Street Journal reports that GlaxoSmithKline has been working all year on trials for a new dual therapy that could shake up HIV treatment as we know it. “The drug in question, dolutegravir, is one of a class of HIV drugs known as integrase inhibitors that rapidly reduce the level of virus in the blood. It is already approved for use as part of traditional triple therapy and so far, there are no reported cases of the virus developing resistance to dolutegravir in patients who are new to treatment,” writes Denise Roland. GSK is running multiple large clinical trials that each pair dolutegravir with one other HIV medicine, such as rilpivirine or 3TC, to show that the dual combinations work as well as triple therapies.
Fewer Side Effects for HIV Patients
If the trials prove successful, the new dual therapy could be a huge win for GSK. Though many of the current HIV therapies are very effective, the major advantage of only needing to take two drugs is that it will likely produce fewer side effects. AIDS.gov says that the short-term side effects from HIV drugs can include anemia, diarrhea, headaches, fatigue, and nausea, and that long-term effects like insulin resistance, lipid abnormalities, lactic acidosis, and a decrease in bone density are also possible.
In a piece on HIV InSite’s Knowledge Base, Dr. Edward L. Machtinger and Dr. David R. Bangsberg of the University of California San Francisco examined Adherence to HIV Antiretroviral Therapy and estimated the rate of adherence to be approximately 70%. They discussed reasons why patients might not stick to their therapy, which include the nature of the treatment regimen itself. “Factors related to the treatment regimen include the number of pills prescribed, the complexity of the regimen (dosing frequency and food instructions), the specific type of antiretroviral drugs, and the short- and long-term medication side effects. The complexity of the regimen and side effects caused by it are clearly associated with nonadherence,” explained the doctors.
A reduction in some side effects would clearly make treatment more comfortable and therefore improve adherence to the treatment regimen for HIV patients overall, but it would be especially advantageous for those who are older and have to increasingly take more age-related medications. Dual therapy would allow them to have one less drug in the mix.
GlaxoSmithKline’s biggest rival in the area of HIV drugs is Gilead Sciences, which has dominated the market with a strategy that has included smart acquisitions, partnerships and focusing on unmet need. Fast Company, which rated Gilead #16 on its Most Innovative Company of 2015 list, notes that the company has ushered through four effective new treatments for HIV in just the past few years, and has three more HIV medications in the works.
GSK hopes that dolutegravir will allow it to give Gilead a run for its money, though. As Ben Hirschler of Reuters reported in September 2015, dolutegravir (which is also known as Tivicay) has a superior resistance profile to many other HIV meds and is already a key component of the approved three-in-one combination Triumeq. Reuters quoted Dominique Limet, CEO of GSK’s majority-owned ViiV Healthcare unit, saying “We have a growth rate that is very substantial and we have beaten the competition in many markets with the launch of Tivicay and Triumeq.” ViiV is also working on another integrase inhibitor called cabotegravir, which they expect to be used in HIV drug cocktails.
At the very end of last year, the company further demonstrated its intent when it forked over $1.4 billion to take over Bristol-Myers Squibb’s HIV drug development assets. According to BBC News, those assets include fostemsavir, an HIV infection treatment that is in the final phase III stage of development, as well as pre-clinical and early stage research assets.
With so many promising HIV drugs in various stages of development, GlaxoSmithKline could be poised to regain dominance in the HIV market. And if the dolutegravier dual therapy trials are ultimately successful, GSK could even fundamentally change the way that HIV is treated.
All opinions shared in this post are the author’s own.
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