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FDA Announces Approval For 2 New HIV Drugs

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Two new medications for patients with HIV-1, the most common strain of the virus, have received the approval from the U.S. Food and Drug Administration. 

Merck & Co Inc announced on Thursday, Aug. 30, that the treatments have received the greenlight two months earlier than scheduled. 

Two New HIV Drugs

"As part of Merck's 30-year commitment to the care of people with HIV, we are pleased to now bring forward these two new antiretroviral treatment options, Delstrigo and Pifeltro," stated George Hanna, vice president of Global Clinical Development at Merck Research Laboratories.

The new drugs to be taken orally will target adult patients with HIV-1 infection who have not received antiretroviral treatment in the past. Neither Delstrigo nor Pifeltro cure HIV or AIDS. 

Delstrigo and Pifeltro were approved because of the successful results of their Phase 3 trials involving more than 700 participants. During its DRIVE-AHEAD trial, Delstrigo showed a sustained viral suppression in patients to up to 48 weeks. Pifeltro takers also exhibited viral suppression of HIV-1 RNA throughout its DRIVE AHEAD. 

A unique side effect of both drugs is lowered cholesterol levels that would be beneficial to patients at risk of cardiovascular issues. 

"As a result of the remarkable strides made in the fight against HIV, clinicians and their patients have the opportunity to work together to identify treatment regimens that may be best for each individual, taking into account other aspects of that person's health, including other medicines they may be taking," explained David Wohl of University of North Carolina. "Today's approvals of Delstrigo and Pifeltro provide two new options for the treatment of HIV-1 in appropriate treatment-naïve adult patients."

Merck hopes to start distributing the drugs through wholesalers in one month. 

HIV/AIDS Problem In United States

According to the Centers for Disease Control and Prevention, there were 38,500 new HIV infections reported in the United States in 2015. Around 26,000 patients or 68 percent of the new cases were gay and bisexual men while nearly 9,000 or 23 percent were among heterosexuals. The rest were drug users infected through injections. 

Since the epidemic began in the 80s, a total of 1.2 million people have been diagnosed with AIDS. 

The HIV virus can be transmitted via contact with blood, mucus, semen, pre-seminal fluid, rectal and vaginal fluid, and breast milk. It can also be transmitted from mother to child during pregnancy. 

There is currently no vaccine to prevent the infection of HIV/AIDS. There are treatments available to help patients manage the disease. 

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