Merck Gets FDA Approval On 2 New HIV Meds

Pharmaceutical drug giant Merck has obtained approval from the Food and Drug Administration (FDA) for two new medications to address HIV.

Pifeltro (doravirine) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI). That medication is paired in a three-drug single tablet dose to be marketed as Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).

Both are indicated for treating HIV-1 in adults with no prior anti-retroviral treatment.

The approval for the once-a-day pills come after two double-blind, active-controlled phase 3 trials showed positive results.

In a trial called “Drive-Ahead,” 728 patients were treated with either Delstrigo or Gilead’s Atripla for 48 weeks.

At the end of the study, viral suppression rates were similar with Delstrigo reaching 84% and Atripla achieving 81% suppression.

In addition to edging Atripla on viral suppression, Delstrigo patients saw better results regarding LDL cholesterol and non-HDL cholesterol.

The Delstrigo group also experienced lower incidence of neuropsychiatric adverse issues like sleep problems, dizziness and being able to concentrate more clearly.

While there is currently no cure for HIV/AIDS, the Centers for Disease Control have previously announced that when HIV+ folks stay on their prescribed medications on a daily basis, not only are viral loads lowered to ‘undetectable,’ but ‘undetectable’ means the virus is untransmittable.

(h/t PharmaPhorum)

New Study: Gay Men On Anti-Retroviral Meds Have "Pretty Much" Zero Chance Of Infecting Others

Results of a new large-scale study of gay men presented this week at the 9th International AIDS Conference on HIV Science in Paris shows HIV+ people taking regular antiretroviral medication have “pretty much” a zero chance of infecting others during either gay or straight sex.

From the Washington Blade:

In the largest-ever trial on HIV transmission risk among gay men, Australian researchers explored the sex lives and HIV rates of more than 350 homosexual couples where one person is HIV positive. The couples were from Brazil, Thailand and Australia, CNN reports.

Each couple reported their sexual activity when visiting clinics involved in the trial and HIV-negative partners were regularly tested to diagnose any new infections, CNN reports. The couples participating reported having sex almost 17,000 times without condoms between them over four years, and none of those times resulted in new infections.

”There was not a single linked HIV infection in these couples,” said Andrew Grulich, professor of epidemiology at the University of New South Wales in Australia, who led the study. “Nobody became infected from their partner,” CNN quoted him as having said.