Up to 25,000 Americans with HIV are currently multidrug resistant, of which 12,000 are in urgent need of a new treatment option because their current treatment regimen is failing them.
On February 7, 2018, Gilead pharmaceuticals introduced Biktarvy, a new 3-drug combination tablet. It is approved as a complete regimen for initial treatment in patients with no treatment history. The cost is approximately $36,000 per year. On the same day, Mylan introduced Symfi Lo, which is a new product; but it contains 3 older drugs; efavirenz (Sustiva), tenofovir disoproxil (Viread), and lamivudine (Epivir). The annual cost is about $24,000. Symfi, which contains a higher dosage of efavirenz, will be hitting the market within the coming weeks.
One month later, on March 8, 2018, TaiMed Biologics introduced Trogarzo (ibalizumab-uiyk), an intravenous treatment approved to be used in combination with other antiretrovirals. In contrast to Biktarvy, this is to be used only in patients who have failed multiple other HIV drugs. It is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications. It carries a hefty price tag of approximately $118,000 per year.
Though several new generics for HIV/AIDS are now available, they likely would not create significant disruptions to the market due to the current preference and ease of use of combination therapies. Two generic products have been introduced: Mylan launched a generic version of Bristol-Myers Squibb’s Sustiva (efavirenz), and Teva Pharmaceutical Industries Ltd. launched a generic version of Gilead Sciences’ Viread (tenofovir disoproxil fumarate). These two products are mainly used in combination therapies with other drugs that still have patent protection. “Switching a patient to take two or three individual HIV/AIDS drugs instead of a two-or-three-drug combination has never been successful,” stated Mesfin Tegenu, the President of PerformRx.
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