Recently has discovered HIV treatment in the developed world today.This is a regimen consisting of a combination of drugs taken daily to suppress viral reproduction and prevent the emergence of resistant strains. The advent of HAART has transformed HIV/AIDS from a deadly disease to a manageable, chronic one for most patients.
The first FDA approved drug for HIV was Azido-thymidine (AZT), from GlaxoSmithKline (LON:GSK, NYSE:GSK) in 1987, only six years after the disease was first documented and three years after the virus was isolated. AZT was originally developed as a cancer drug but found to have activity as a nucleoside reverse-transcriptase inhibitor (NRTI), preventing the HIV virus from copying its RNA genome into a double stranded DNA. This breakthrough drug had a tough dosage schedule: one pill, every four hours non-stop.
In the decades that followed, multiple new classes of anti-HIV drugs have reached approval. Including multi-drug combinations and reformulations, the FDA lists 35 drugs in six classes available for patients. The time to approval of AIDS drugs has historically been quite brisk. The FDA only took 3.5 months to review GSK’s drug AZT, while Merck’s (NYSE:MRK) Crixivan was approved in a mere 1.4 months in 1996. Timelines have lengthened in recent years as the market has matured and the need for new medicines became less acute.
Work progressed quickly on new NRTIs over the next few years. Due to the inherently high mutation rate of the HIV virus, resistance developed shortly after AZT usage began. It became obvious the virus needed to be hit simultaneously with multiple drugs.
Inovio Pharmaceuticals (AMEX:INO) is another biotech working in the field of DNA vaccines. It recently reported interim Phase I data from an ongoing study of healthy volunteers for its PENNVAX-G HIV vaccine. The procedure followed a protocol similar to that of the HVTN 505 study: participants were inoculated with immunogen at months 0 and 1, followed by boosting with MVA-CMDR at 3 and 6 months. Inovio noted CD4+ and CD8+ T-cell response rates of 73% (8 of 11) and 45% (5 of 11) respectively after the second MVA boost.
Despite the maturity of the HIV drug market, scientific progress continues. Just as HAART revolutionized HIV treatment in the late 1990s, DNA vaccines look to do the same in the coming years. Leading the charge are non-profits, governments, and small biotechs; Big Pharma is sitting on the sidelines. Proof of concept has been achieved. It is only a matter of time before an effective vaccine is developed. Almost 50,000 individuals are newly diagnosed with HIV in the US each year and over 2 million worldwide. The market for an HIV vaccine is huge.
Now we will be able to save our life.
The first FDA approved drug for HIV was Azido-thymidine (AZT), from GlaxoSmithKline (LON:GSK, NYSE:GSK) in 1987, only six years after the disease was first documented and three years after the virus was isolated. AZT was originally developed as a cancer drug but found to have activity as a nucleoside reverse-transcriptase inhibitor (NRTI), preventing the HIV virus from copying its RNA genome into a double stranded DNA. This breakthrough drug had a tough dosage schedule: one pill, every four hours non-stop.
In the decades that followed, multiple new classes of anti-HIV drugs have reached approval. Including multi-drug combinations and reformulations, the FDA lists 35 drugs in six classes available for patients. The time to approval of AIDS drugs has historically been quite brisk. The FDA only took 3.5 months to review GSK’s drug AZT, while Merck’s (NYSE:MRK) Crixivan was approved in a mere 1.4 months in 1996. Timelines have lengthened in recent years as the market has matured and the need for new medicines became less acute.
Work progressed quickly on new NRTIs over the next few years. Due to the inherently high mutation rate of the HIV virus, resistance developed shortly after AZT usage began. It became obvious the virus needed to be hit simultaneously with multiple drugs.
Inovio Pharmaceuticals (AMEX:INO) is another biotech working in the field of DNA vaccines. It recently reported interim Phase I data from an ongoing study of healthy volunteers for its PENNVAX-G HIV vaccine. The procedure followed a protocol similar to that of the HVTN 505 study: participants were inoculated with immunogen at months 0 and 1, followed by boosting with MVA-CMDR at 3 and 6 months. Inovio noted CD4+ and CD8+ T-cell response rates of 73% (8 of 11) and 45% (5 of 11) respectively after the second MVA boost.
Despite the maturity of the HIV drug market, scientific progress continues. Just as HAART revolutionized HIV treatment in the late 1990s, DNA vaccines look to do the same in the coming years. Leading the charge are non-profits, governments, and small biotechs; Big Pharma is sitting on the sidelines. Proof of concept has been achieved. It is only a matter of time before an effective vaccine is developed. Almost 50,000 individuals are newly diagnosed with HIV in the US each year and over 2 million worldwide. The market for an HIV vaccine is huge.
Now we will be able to save our life.
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