Delving into the Latest Updates on Atazanavir Sulfate/Ritonavir with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ATZ/RTV

Target

HIV-1 pol

Mechanism

HIV-1 pol inhibitors(Human immunodeficiency virus type 1 protease inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication-

Originator Organization

Matrix Laboratories BV (Belgium)

Active Organization

Matrix Labs LLC

Emcure Pharmaceuticals Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure

Molecular FormulaC38H54N6O11S

InChIKeyDQSGVVGOPRWTKI-QVFAWCHISA-N

CAS Registry229975-97-7

View All Structures (2)

Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans.
In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients in group 2 will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days.
The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.

Start Date09 Oct 2020

Sponsor / Collaborator

Obafemi Awolowo University

[+3]

NCT04022967 / Active, not recruitingPhase 3IIT

Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz (TDF+3TC+EFV) or Dolutegravir + Lamivudine + Tenofovir (DTG+3TC+TDF) in West and Central African HIV-1 Infected Patients

MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso).
HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks.
The objective is to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks

Start Date21 Sep 2020

Sponsor / Collaborator

ANRS, Emerging Infectious Diseases

[+1]

100 Clinical Results associated with Atazanavir Sulfate/Ritonavir

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100 Translational Medicine associated with Atazanavir Sulfate/Ritonavir

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100 Patents (Medical) associated with Atazanavir Sulfate/Ritonavir

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2

Literatures (Medical) associated with Atazanavir Sulfate/Ritonavir

24 Aug 2010·AIDSQ2 · MEDICINE

Similar efficacy and tolerability of atazanavir compared with atazanavir/ritonavir, each with abacavir/lamivudine after initial suppression with abacavir/lamivudine plus ritonavir-boosted atazanavir in HIV-infected patients

Q2 · MEDICINE

Article

Author: Bellos, Nicholaos ; Young, Benjamin ; Shaefer, Mark S. ; Patel, Lisa G. ; Murphy, Daniel ; Zhao, Henry H. ; Squires, Kathleen E. ; Wannamaker, Paul G. ; De Jesus, Edwin ; Ross, Lisa L.

BACKGROUNDTreatment simplification strategies involving induction with a ritonavir (RTV)-boosted (/r) protease inhibitor regimen followed by simplification (without RTV) are appealing because they may offer sustained virologic suppression while minimizing potential long-term adverse effects associated with RTV.METHODSThis open-label, randomized, noninferiority study enrolled 515 antiretroviral therapy-naive patients to receive abacavir/lamivudine plus atazanavir/RTV (ATV/r) followed by randomization at week 36 (N = 419) to maintain or discontinue RTV for an additional 48 weeks. Eligibility for randomization required confirmed HIV RNA level below 50 copies/ml and no virologic failure. Protocol-defined virologic failure after week 36 was confirmed rebound of HIV RNA level at least 400 copies/ml. The primary endpoint was the proportion of patients with HIV RNA level below 50 copies/ml at week 84 (time to loss of virologic response). This study is registered with ClinicalTrials.gov number NCT00440947.RESULTSAt week 84, noninferiority of ATV to ATV/r (95% confidence interval around the treatment difference -1.75 to 12.48%) was demonstrated with 181 of 210 (86%) patients in the ATV group and 169 of 209 (81%) in the ATV/r group maintaining HIV RNA level below 50 copies/ml. During the randomized phase (weeks 36-84), 10 versus 14% of patients in the ATV and ATV/r arms, respectively, experienced a drug-related grades 2-4 adverse event with hyperbilirubinemia being the most frequently reported (4 versus 10%). The overall rate of protocol-defined virologic failure was 2%; no patient had virus that developed a major protease inhibitor mutation.CONCLUSIONATV in combination with abacavir/lamivudine is a potent and well tolerated regimen in patients who have achieved initial suppression on an induction regimen and represents a viable treatment simplification strategy.

01 Jun 2008·HIV Clinical Trials

Once-Daily Abacavir/Lamivudine and Ritonavir-Boosted Atazanavir for the Treatment of HIV-1 Infection in Antiretroviral-Naïve Patients: A 48-Week Pilot Study

Article

Author: Edwin deJesus ; William Towner ; Richard Elion ; Linda Yau ; Gary Richmond ; Marty St. Clair ; Daniel Berger ; Michael Sension ; Belinda Ha

PURPOSETo assess the efficacy and safety of a once-daily (QD) regimen consisting of the co-formulation of abacavir/lamivudine (ABC/3TC) and atazanavir plus ritonavir (ATV-RTV) in antiretroviral (ART)-naïve patients with plasma HIV-1 RNA >5,000 copies/mL.METHODThis open-label, multicenter study conducted between September 2004 and June 2006 included 112 patients who received ABC 600 mg/3TC 300 mg and ATV 300 mg-RTV 100 mg QD. Drug switches were permitted for ABC hypersensitivity and ATV-related hyperbilirubinemia. Primary endpoints were proportion of patients achieving HIV-1 RNA <50 copies/mL at Week 48 and treatment discontinuation due to study drugs.RESULTSA total of 111 patients were treated. At Week 48, the proportion of patients achieving HIV-1 RNA <50 copies/mL was 77% (85/111) by intent-to-treat (ITT) missing=failure, switch included response rate. Drug substitutions occurred in 8 (7%) patients for suspected ABC hypersensitivity reaction (HSR) and in 6 (5%) patients for ATV-related toxicities; only 1 patient discontinued study due to ABC HSR. Four patients met confirmed virologic nonresponse (HIV RNA >or= 400 copies/mL). Treatment-emergent drug resistance was rare, and no patient had virus that developed reduced susceptibility to ATV. Median change from baseline (95% confidence interval) in fasting lipids at Week 48 was 39 (26-66) mg/dL for triglycerides, 28 (22-38) mg/dL for total cholesterol (C), 14 (10.5-16) mg/dL for HDL-C, and 8 (2-16.5) mg/dL for LDL-C.CONCLUSIONABC/3TC and ATV-RTV QD is an effective and well-tolerated regimen in ART-naïve patients through 48 weeks, with a modest impact on fasting lipids.

100 Deals associated with Atazanavir Sulfate/Ritonavir

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	NDA/BLA	US	Matrix Labs LLC	-
HIV Infections	NDA/BLA	US	Emcure Pharmaceuticals Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04459286 (NACOVID, Pubmed)	Phase 2	COVID-19	57	nitazoxanide (Standard of care)	(luxjdlyewi): aHR = 0.948 (95% CI, 0.341 - 2.636), P-Value = 0.919 View more	Negative	01 Jan 2022
				Nitazoxanide + Atazanavir/Ritonavir
ARIA study (IAS2020)	Not Applicable	-	495	DTG/ABC/3TC	(gehgnnngvh) = hyziwoxygw dkuqyfrkot (pytihvncav ) View more	-	01 Jan 2020
				Atazanavir/ritonavir + tenofovir disoproxil + emtricitabine	(gehgnnngvh) = pbpqxdphht dkuqyfrkot (pytihvncav ) View more
NCT01307488 (SALT, Pubmed \| J Antimicrob Chemother) Manual	Phase 3	HIV Infections	286	lamivudine+Atazanavir/Ritonavir	otnemehmrr(xalwzcrfac) = zlpxmvjeyn czlmhkbwbf (xkjdtocncq ) View more	Non-inferior	01 Jan 2017
				2NUCs+Atazanavir/Ritonavir	otnemehmrr(xalwzcrfac) = ilbktfkpzc czlmhkbwbf (xkjdtocncq ) View more
PHACS Adolescent Master Protocol Study (IAS2017)	Not Applicable	HIV Infections	47	Atazanavir/ritonavir	(yvbzlgivjh) = tdvhxwopxf corywavlsw (fmdcvxhaxd )	-	01 Jan 2017
				Older PI-based ART	(yvbzlgivjh) = neqykovirw corywavlsw (fmdcvxhaxd )
NCT00532168 (Advanz-3, Pubmed)	Phase 4	HIV Infections	108	Efavirenz	(xpzfdohian) = elpfrjutbw atdbijiocd (dymwxvyums, 129 - 349) View more	-	01 Jun 2015
				Atazanavir/Ritonavir	(xpzfdohian) = twoflccscj atdbijiocd (dymwxvyums, 146 - 238) View more
WAVES Study (IAS2015)	Not Applicable	HIV Infections	575	Elvitegravir (EVG) / cobicistat (COBI) / emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF)	(ojdwbqtlhy) = gxbnpkfrgt xjhiecatcj (unqbiimndc )	Positive	01 Jan 2015
				ritonavir (RTV) boosted atazanavir (ATV) plus FTC/TDF	(ojdwbqtlhy) = zxrqqguwhu xjhiecatcj (unqbiimndc )
NCT01274780 (Pubmed \| HIV Med)	Phase 4	HIV Infections	180	Atazanavir/ritonavir	(agehdyrsbd) = vyxqdelfvj bkahkaoeyn (rhoqlbetel ) View more	-	01 Jul 2014
				Darunavir/ritonavir	(agehdyrsbd) = kcxbqgosod bkahkaoeyn (rhoqlbetel )
ACTG 5202 (IAS2014)	Not Applicable	HIV Infections First line	-	Tenofovir/emtricitabine+Efavirenz	xtobesxfke(vootnvpcxm) = ccediyqixo yeelhcvkvc (rsdkljcwfd )	-	01 Jan 2014
				Tenofovir/emtricitabine+Atazanavir/ritonavir	xtobesxfke(vootnvpcxm) = gjjsnptlbr yeelhcvkvc (rsdkljcwfd )
IAS2013	Not Applicable	First line	2,167	ritonavir-boosted atazanavir (ATV/r)	kroffwdcgl(crwtdkroct) = velmnfpqsc mfldavwnrk (gqhpiytxxh ) View more	-	01 Jan 2013
				efavirenz (EFV)	kroffwdcgl(crwtdkroct) = unebupvdwh mfldavwnrk (gqhpiytxxh ) View more
A5202 (IAS2012)	Not Applicable	Acquired Immunodeficiency Syndrome	928	Atazanavir/ritonavir	xntiuwdinj(vqsmiuanhn): HR = 3.49 (95% CI, 1.24 - 9.84), P-Value = p0.003	-	01 Jan 2012
				Efavirenz