highly active antiretroviral therapy (HAART) — Competitive Intelligence Brief

highly active antiretroviral therapy (HAART) (highly active antiretroviral therapy (HAART)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antiretroviral. Area: Immunology.

marketed Antiretroviral HIV enzymes and processes Immunology Small molecule

Target snapshot

highly active antiretroviral therapy (HAART) (highly active antiretroviral therapy (HAART)) — National Institute of Allergy and Infectious Diseases (NIAID). HAART combines multiple antiretroviral drugs to inhibit different stages of the HIV life cycle, thereby reducing viral replication and improving immune function.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
highly active antiretroviral therapy (HAART) TARGET	highly active antiretroviral therapy (HAART)	National Institute of Allergy and Infectious Diseases (NIAID)	marketed	Antiretroviral	HIV enzymes and processes
Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Charlotte-Paige Rolle, MD	marketed	Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Biktarvy Tab	Biktarvy Tab	Southampton Healthcare, Inc.	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase, CCR5 co-receptor
Rilpivirine + darunavir/cobicistat	Rilpivirine + darunavir/cobicistat	A.O. Ospedale Papa Giovanni XXIII	marketed	Antiretroviral combination (NNRTI + protease inhibitor + pharmacokinetic booster)	HIV reverse transcriptase, HIV protease
Ritonavir boosted Atazanavir + 2 NRTIs	Ritonavir boosted Atazanavir + 2 NRTIs	Fundacion SEIMC-GESIDA	marketed	Protease inhibitor combination antiretroviral therapy	HIV protease, HIV reverse transcriptase
Routine three-drug antiretroviral prophylaxis	Routine three-drug antiretroviral prophylaxis	University of North Carolina, Chapel Hill	marketed	Antiretroviral combination therapy
Background ARVs	Background ARVs	Hoffmann-La Roche	marketed	Antiretroviral therapy (combination regimen)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antiretroviral class)

1. A.O. Ospedale Papa Giovanni XXIII · 1 drug in this class
2. National Institute of Allergy and Infectious Diseases (NIAID) · 1 drug in this class
3. Pfizer · 1 drug in this class
4. University of Guadalajara · 1 drug in this class
5. ViiV Healthcare · 1 drug in this class