Shots: The 2 P-III ILLUMINATE SWITCH A & B trials evaluate doravirine/islatravir (100/0.75mg, qd, PO) in a ratio (1:1) in 672 & 641 patients with HIV-1 who are virologically suppressed […]readmore
Tags : HIV-1 Infection
Shots: The US FDA approved Vocabria (30mg, tablet formulation) in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated […]readmore
Shots: The approval is based on P-III ATLAS, FLAIR and ATLAS-2M studies assessing Vocabria (cabotegravir injection and tablets) + Janssen’s Rekambys (rilpivirine inj.) or Edurant (rilpivirine tablets) in 1200+ patients […]readmore
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 […]readmore
Shots: The P-III BRIGHTE study involves assessing of fostemsavir + OBT vs PBO in 371 patients in a ratio (3:1) with HIV-1 infection who were resistant, intolerable and contraindicated to […]readmore
Regulatory
Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval
Shots: The approval is based on four P-III 1489 and 1490 & 1844 and 1878 studies result assessing Biktarvy vs PBO in 2,415 naive patients with HIV-1 infected & virologically […]readmore
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/ […]readmore
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) […]readmore
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., […]readmore