Plus   Neg

The First Two-Drug Regimen For New HIV Patients

fdaapproval march25 lt

An estimated 37 million people in the world live with human immunodeficiency virus (HIV) infection, of which 1.8 million are children below 15 years. HIV, which attacks the immune cells in the body, had killed 940,000 people in 2017.

According to a report by "Our World in Data", the number of people dying of AIDS, which is the most severe phase of HIV infection, reached a peak in 2004, 2005 when in both years 2 million people died. However, since then, the death toll has been on the decline, thanks to new HIV drugs available that slow down the progression of the disease.

HIV-related diseases are usually fatal. The only effective solution is managing the disease by proper care and taking all precautions to not transmit the disease.

The treatment for HIV is known as ART or antiretroviral treatment that keeps the level of HIV in the body low, thereby letting the immune system recover and stay strong. ART uses a combination of HIV medicines called antiretroviral (ARV) drugs to suppress the HIV virus and stop the advancement of the HIV disease.

2018 saw the highest number of drugs approved by the FDA for HIV. Gilead Sciences' Biktarvy, Mylan's Symfi Lo, Merck's Delstrigo and Pifeltro are some of the drugs approved by the agency last year.

The standard HIV treatment involves a three-drug regimen.

On April 8, the FDA approved Dovato, a two-drug regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral treatment history.

Developed by ViiV Healthcare, Dovato gives the option of a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug for naive HIV patients.

ViiV has set the wholesale Aquisition Cost (WAC) for Dovato at $27,540.

Dovato has a black box warning for people with hepatitis B virus (HBV).

The drug is under review in Europe, Canada, Australia and South Africa.

Now, let's take a look at the new drugs that won FDA approval in March.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT