FDA Approves Two New, Promising HIV Drugs
August 14th, 2013 // 1:42 pm @ jmpickett
Latest FDA and cGMP Compliance News
We were pleased to see this week that FDA has issued two new drug approvals for HIV drugs that could offer new hope to people who are suffering from this deadly illness.
CDC reports that 50,000 new cases of HIV occur every year, and about 16,000 people a year die from the disease. Also, about 1.2 million people currently are living with HIV in the US, and a shocking 18% of them had no idea they have the disease!
The great news is that the two new FDA approvals could help to alter the preventative aspects of how one contracts the disease, and also could improve the quality of life for patients who do have HIV.
The first drug is Alere Determine, which is an HIV 1 and HIV 2 diagnostic test. Not all types of infections of HIV are the same, and this new test is going to help to figure out which type of HIV antibody that patient may have. This could result in a quicker treatment plan that is more effective. Also, this point of care test could detect HIV 1 p24 antigens which appear in patients before the HIV 1 and HIV 2 antibodies appear. The bottom line here is that this point of care diagnostic by Alere is one of the most highly accurate early detection products for HIV 1 and 2.
Also, FDA just approved Tivicay, which is an orgal drug that is used with other types of antiretroviral drugs to treat HIV 1. This drug was developed by the firm ViiV Healthcare, which is owned partially by GSK. It also is partially owned by Pfizer and Shionogi Pharma.
Tivicay has shown very impressive results in late state clinical studies, and one of these trials showed a totally suppressed viral load, or an undetectable disease level, in 64% of patients after 6 months.
What we like about Tivicay is that it could possibly treat a bigger audience than the four in one drug Stribild, which Gilead Sciences has come up with to treat HIV 1 in some patients. Tivicay is approved to treat HIV 1 in those who have been treated with other HIV drugs, and also those who have never been treated before. Also, where Stribild was approved only for adults, Tivicay is proving safe in treating kids as well. It was given approval for treatment in children as young as 12.
