The United States Food and Drug Administration recently announced that they have approved a new injectable drug as an HIV prevention measure.
This medication, called cabotegravir, is administered through a needle just once every four weeks and contains the active ingredient of tenofovir disoproxil fumarate (TDF) which has been used for decades to prevent HIV infections in people already infected with it. It’s injected into muscle tissue in the arms or thighs, so the effect will last approximately three months.
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Cabotegravir blocks a viral enzyme that is necessary for HIV to replicate and reproduce. This is the first medication of its kind to be approved by the USFDA. It was tested in three clinical trials and was found to show effectiveness at reducing the risk of contracting HIV.
The FDA’s Dr. William Maisel, who worked with the Committee on Anti-viral Products which approved cabotegravir in a unanimous vote, stated that this kind of prevention is “like taking a daily aspirin except that you only take it once every three months.”
Here are some points discussed about USFDA-
1. Type of Drug:
It is an injectable drug and as such requires strict manufacturing and testing standards in order to prove its safety. The TDF component of the drug has been used in oral contraceptives for years, so the FDA is confident that these standards have been met.
2. The Effectiveness:
In clinical trials it was shown to reduce the risk of acquiring HIV by nearly 35% when compared to a placebo without any added side effects.
This is an important step in the prevention and treatment of HIV, especially since people are becoming resistant to many other treatments for AIDS as a result of continued use through pills.
3. The Side Effects:
Two thirds of those who took the drug reported some minor side effects, like mild headaches and nausea that faded after the first couple of weeks.
These were temporary, not lasting longer than two weeks and were easily resolved as soon as one discontinued taking the medication. There have been no other major side effects associated with this drug yet.
4. The Cost:
The cost for cabotegravir per dose is $1,600. This is substantially more expensive than current HIV treatments, but since it lasts for three months rather than daily there are hopes that in the long run the new medication will prove to be cheaper to use and more effective in preventing HIV from spreading.
Some questions about the drug:
How effective is this treatment? Will it be cost effective in the long haul?
These things are unknown, as the drug is still only being tested and approved by the FDA. However, there will likely be a benefit to using it, especially since many people have found that their current pills are no longer helping them prevent HIV from spreading. If it proves to be cost effective and highly efficacious, it may become a common practice for HIV prevention in the near future.
Is this a good thing?
It appears to be good for HIV prevention since there are many cases where current AIDS drugs seem to act as an ineffective antidote rather than preventing spread of infection altogether. This is another point in which the effectiveness of cabotegravir should be tested.
Should there be further study?
The studies conducted so far show a benefit to the drug, but there are still many unanswered questions about its effectiveness and side effects. Because it is an injection and may not be used by everyone, some feel that more clinical testing will best ensure that it is safe for all people to use as a preventative measure for HIV infection.
What about other substances?
It appears that this drug works only against certain strains of HIV, but there has been no mention of what others would do if used in conjunction with it to make it more effective.
This is important since HIV is known to mutate and change in order to fight off certain treatments.
This drug was approved for use as an HIV preventative, and it will likely be more readily used because of its unique benefits in combating the spread of the virus by weakening its viral activity that normally prevents it from reproducing.
This may be the first step toward further research on this matter, and if it proves to be safe for people who are already infected with HIV as well, it may continue being used as a more effective treatment against AIDS than we have today.