Merck & Co. ：PifeltroDoravirine Granted Priority Review
On June 1, the CDE official website announced that Merck’s Doravirine/Islatravir Tablets are proposed to be included in priority review for the following indication: as a complete dual-drug regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen, have no history of treatment failure, and have no known mutations associated with resistance to doravirine, as a replacement for their current antiretroviral regimen.
Doravirine/Islatravir (DOR/ISL) is a non-integrase strand transfer inhibitor (INSTI)-based dual regimen. Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) that blocks HIV-1 replication through multiple mechanisms, including inhibition of reverse transcriptase translocation leading to chain termination, as well as induction of viral DNA structural changes leading to delayed chain termination. The other component, Doravirine, is a once-daily oral innovative non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds to the HIV-1 reverse transcriptase enzyme, preventing HIV-1 from converting RNA to DNA, thereby blocking HIV-1 replication. Previously, Doravirine has been approved in multiple regions worldwide for the treatment of HIV-1 infection in adults, to be used in combination with other antiretroviral agents, either as a single agent (Pifeltro) or as a component of a single-tablet regimen (Delstrigo).
In April of this year, the U.S. FDA approved Doravirine/Islatravir (DOR/ISL) for patients who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen, with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. The FDA approval of DOR/ISL was primarily based on Week 48 results from two pivotal Phase III clinical trials: MK-8591A-051 and MK-8591A-052.
MK-8591A-051 was a Phase III, open-label, randomized, active-controlled trial evaluating the efficacy and safety of switching to once-daily DOR/ISL (100 mg/0.25 mg) in virologically suppressed adults with HIV-1 infection on baseline antiretroviral therapy (bART). Data from MK-8591A-051 showed that the study met its primary efficacy endpoint. At Week 48, 1% of subjects who switched to DOR/ISL (n=366) had viral load ≥50 copies/mL, compared with 5% of those who continued bART (n=185). Secondary endpoint results at Week 48 showed that 96% of subjects who switched to DOR/ISL maintained virologic suppression (HIV-1 RNA <50 copies/mL), compared with 92% of those who continued bART.
MK-8591A-052 was a Phase III, randomized, active-controlled, double-blind trial evaluating the efficacy and safety of once-daily DOR/ISL (100 mg/0.25 mg) in virologically suppressed adults with HIV-1 infection on BIC/FTC/TAF (bictegravir/emtricitabine/tenofovir alafenamide). MK-8591A-052 also met its primary efficacy endpoint. Data showed that at Week 48, 1% of subjects who switched to DOR/ISL (n=342) had viral load ≥50 copies/mL, compared with 1% of those in the BIC/FTC/TAF group (n=171). Secondary endpoint results at Week 48 showed that 92% of subjects who switched to DOR/ISL maintained virologic suppression (HIV-1 RNA <50 copies/mL), compared with 94% of those in the BIC/FTC/TAF group.
New 96-week data from both trials demonstrated that DOR/ISL maintained high rates of virologic suppression at Week 96, with a safety profile similar to BIC/FTC/TAF and bART. As people living with HIV age, they may need to adjust their HIV treatment regimens due to comorbidities, concerns about drug toxicities, tolerability challenges, or the desire to reduce the number of medications. DOR/ISL, as a non-INSTI regimen, has the potential to provide patients with an important alternative treatment option.
Buy PifeltroDoravirine online from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.
