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Meds, Mind, Body & Benefits => Research News & Studies => Topic started by: Jim Allen on August 31, 2018, 07:43:17 am

Title: FDA Approves Merck’s Delstrigo and Pifeltro to Treat HIV
Post by: Jim Allen on August 31, 2018, 07:43:17 am
Cool another combination approved.

Full writeup: https://www.poz.com/article/fda-approves-mercks-delstrigo-pifeltro-treat-hiv

FDA Approves Merck’s Delstrigo and Pifeltro to Treat HIV

Quote
The Food and Drug Administration (FDA) has approved Merck’s Pifeltro (doravirine), a new non-nucleoside reverse transcriptase inhibitor (NNRTI), as well as Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate), which includes Pifeltro in a three-drug, single-tablet antiretroviral (ARV) regimen. Both tablets are indicated for the treatment of HIV among those beginning an ARV regimen for the first time. Pifeltro should be taken in combination with other HIV medications.

The approval of both tablets is based upon the randomized, multicenter, double-blind, active-controlled Phase III trials DRIVE-AHEAD and DRIVE-FORWARD.

DRIVE-AHEAD included 728 people not previously treated for HIV who were randomized to receive either Delstrigo or Atripla (efavirenz/tenofovir disoproxil fumarate/emtricitabine). After 48 weeks of treatment, viral suppression rates were comparable between the two study groups, indicating that Delstrigo was noninferior to, or as effective as, Atripla.

Those receiving Delstrigo had superior results compared with those receiving Atripla with regard to LDL cholesterol and non-HDL cholesterol, although the trial did not demonstrate a clinical benefit of this difference. Those taking Delstrigo also had lower rates of neuropsychiatric adverse health events, including dizziness, sleep problems and an altered ability to think clearly and concentrate
Title: Delstrigo Is Safe and Effective
Post by: Jim Allen on October 10, 2018, 12:45:06 pm
Well at least I can pronounce this one.

https://www.poz.com/drug/delstrigo
Generic Name: doravirine + tenofovir disoproxil fumarate + lamivudine
Pronunciation: del-STREE-go

Poz.com
https://www.poz.com/article/switching-mercks-new-hiv-regimen-delstrigo-safe-effective

Switching to Merck’s New HIV Regimen Delstrigo Is Safe and Effective
According to 48-week data from a recent study, Delstrigo posted good marks against other HIV treatments.


Quote
Switching from a variety of antiretroviral regimens to Merck’s newly approved Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) is safe and effective at treating HIV, aidsmap reports.

Presenting their findings at the IDWeek conference in San Francisco, researchers from the open-label, active-controlled noninferiority Phase III DRIVE-HEAD trial enrolled 670 people with HIV who had a fully suppressed viral load for at least six months. The participants were taking two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) plus a Norvir (ritonavir)-boosted protease inhibitor, Vitekta (elvitegravir), or a non-nucleoside reverse transcriptase inhibitor (NNRTI).

The participants had no history of virologic failure on any HIV regimen and had virus that was not resistant to any of the three drugs in Delstrigo.

Previous results from the study were presented at the 9th International AIDS Society Conference on HIV Science in Paris (IAS 2017).

The participants were randomized two to one to switch from their current HIV regimen to taking Delstrigo (447 people were in this immediate-start group) or to switch to Delstrigo after 24 weeks (223 were in the delayed-start group).

A total of 84.5 percent of the participants were male; 76.4 percent were white. The average age was 43 years old.

At week 24 of the study, 93.7 percent (419 of 447) of those in the immediate-start group and 94.6 percent (211 of 223) of those in the delayed-start group had a fully suppressed viral load. At this time, 1.8 percent of each group had a viral load of at least 50.

At week 48 of the study, 90.8 percent (406 of 447) of those in the immediate start group had a fully suppressed viral load. (In their analysis, the study authors also compared this rate with the viral suppression rate of 94.6 percent of those in the delayed start group at the 24-week mark.) At the 48-week mark, 1.6 percent of those in the immediate start group had a viral load of 50 or greater.

Among those who started the trial taking boosted Vitekta, the average changes in LDL cholesterol and non-HDL cholesterol at week 24 were significantly lower in the immediate-start group compared with the delayed-start group.

At the 24-week mark, rates of any adverse health event and drug-related adverse health events were higher in the immediate- versus the delayed-start group. Among those in the immediate-start group who experienced any adverse health events, these events were mild for 64 percent of these participants and were mild for 80 percent of those who experienced drug-related adverse health events.

The study authors concluded that Delstrigo was noninferior to, or as effective as, the comparison regimens and also demonstrated acceptable safety compared with continuing on the other regimens.
Title: Re: FDA Approves Merck’s Delstrigo and Pifeltro to Treat HIV
Post by: Jim Allen on January 23, 2019, 10:34:01 am
Currently approved for those starting HIV treatment for the first time. Merck is now seeking approval for the medications to be use among those switching from other ARV regimens

Write-up from POZ.com
https://www.poz.com/article/merck-files-fda-expanded-approval-pifeltro-delstrigo
Merck Files With FDA for Expanded Approval of Pifeltro and Delstrigo