Tags : HIV-1 Infection

ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives MHLW’s Approval to Treat HIV

Shots: The approval is based on GEMINI 1 & 2 studies assessing dual drug regimen (dolutegravir 50 mg/lamivudine 300 mg) vs dolutegravir + two NRTIs [tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)] in 1400 patients with HIV-1 infection aged> 12yrs. weighing at least 40kg  The GEMINI 1 & 2 study results demonstrated non-inferior efficacy based on plasma HIV-1 […]Read More

Gilead’s Descovy (Emtricitabine, Tenofovir Alafenamide) Receives NMPA ‘s (CFDA) Approval

Shots: The approval is based on three P-III study (104,111 & 109) results assessing Genvoya (elvitegravir/ cobicistat /emtricitabine /tenofovir alafenamide /150 / 150/ 200/ 10mg, E/C/F/TAF) vs Stribild (E/C/F/TDF,150 mg/ 150 mg/ 200 mg/tenofovir disoproxil fumarate 300 mg) in adults for 144 wks. The pooled study demonstrated non-inferiority data, meeting 1EPs compared with Stribild and […]Read More

Merck’s Delstrigo (doravirine / lamivudine / tenofovir disoproxil fumarate) &

Shots: The approval is based on the results of P-III DRIVE-AHEAD and DRIVE-FORWARD trial assessing Delstrigo vs efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) & Pifeltro vs darunavir + ritonavir (DRV+r) + FTC/TDF or abacavir (ABC)/3TC respectively for a duration of 48/96 wks. DRIVE-AHEAD and DRIVE-FORWARD results: suppression of HIV-1 RNA @ 48 wks. (84%, 83% […]Read More

Merck’s Delstrigo and Pifeltro Receives CHMP Approval for the Treatment

Shots: • CHMP approval is based on two P-III trials i.e. DRIVE-AHEAD and DRIVE-FORWARD assessing (Delstrigo vs efavirenz (EFV)/emtricitabine (FTC)/TDF) and (Pifeltro vs darunavir +ritonavir +FTC/TDF/abacavir (ABC)/3TC)) for 48 wks., showing its safety and efficacy • On 30 Aug, 2018 the US FDA approved Delstrigo and Pifeltro for the treatment of HIV-1 infection in adult […]Read More