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cobicistat + darunavir (G006 / Rezolsta / Prezcobix)

✓ Approved

Johnson & Johnson Services, Inc. · CYP3A4 · Small Molecule

What is cobicistat + darunavir?

cobicistat + darunavir is a small molecule developed by Johnson & Johnson Services, Inc.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesG006, Rezolsta, Prezcobix
CompanyJohnson & Johnson Services, Inc.
Drug ClassSmall Molecule
Molecular TargetCYP3A4,
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Johnson & Johnson Services, Inc.

Mechanism of Action

Molecular Targets

cobicistat + darunavir acts on 2 molecular targets:

CYP3A4cytochrome P450 family 3 subfamily A member 4 (CP33, HLP)
gag-pol, HIV-1 (gag-pol)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

cobicistat + darunavir is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsAcquired immunodeficiency syndrome✓ Approved

Related Research Articles

PubMedIDCases2026-09-20

Therapeutic drug monitoring uncovering incorrect antiretroviral drug intake in a patient with swallowing difficulties.

Carrozzo Giorgia G, Cattaneo Dario D, Giacomelli Andrea A, Gori Andrea A et al.

A woman living with HIV reported swallowing difficulties that interfered with oral antiretroviral therapy. Treatment with darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza®) was initiated, with the patient choosing to chew the tablet before swallowing because of her swallowing difficulties. Therapeutic drug monitoring, performed because of this non-standard administration, revealed unexpectedly low darunavir trough concentrations despite reported adherence and maintained virological suppression. A structured pharmacological assessment revealed that the patient had been consistently taking the medication in the fasting state, despite initial counselling to take it with food. After correction of the drug intake conditions, darunavir exposure increased to therapeutic levels. This case highlights the clinical value of therapeutic drug monitoring in identifying medication intake errors and optimising antiretroviral therapy in patients with swallowing difficulties.

PMID 42763503
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PubMedSynthesis2026-09-19

Late-stage Diversification of HIV-1 Protease Inhibitor via SuFEx Click Chemistry.

Khanal Bipin B, Yamanushkin Pavel P, Gold Brian B

The global HIV/AIDS epidemic continues to demand durable antiretroviral therapies. HIV-1 protease (HIV-PR) remains a central target, and although darunavir (DRV) exhibits exceptional resilience, resistance evolution necessitates continued innovation. Building on DRV's success, structural modifications at key positions have yielded promising derivatives. In this work, we report the design and synthesis of over 20 DRV derivatives incorporating pyrazole and amino acid motifs at the P2' position. These substituents were introduced to strengthen interactions within the protease active site and expand opportunities for resistance coverage. Sulfur(VI) fluoride exchange (SuFEx) chemistry was employed as a robust late-stage diversification strategy, enabling efficient coupling and rapid library generation. This approach highlights the potential to access structurally diverse HIV-1 protease inhibitors, laying the groundwork for the development of next-generation therapeutics.

PMID 42761751
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PubMedThe Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases2026-09-15

Older people living with HIV: a population with high prevalence and severity of metabolic dysfunction-associated steatotic liver disease ‒ A cross-sectional study.

Peixoto Rafaella Italiano RI, Batista Andrea Dória AD, de Oliveira Armando Ykaro Soares AYS, Domingues Ana Lúcia Coutinho ALC et al.

Among People Living With Human immunodeficiency virus (PLWH) chronic liver disease is a major cause of non-HIV-related death. Factors related to HIV and its treatment may amplify the impact of metabolic risk factors and aging, thus leading to a high frequency of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) among this population. This study aimed to evaluate the frequency and associated factors of MASLD and its severity in older PLWH, and secondarily, to assess the frequency of MASLD-related fibrosis. This cross-sectional study included older PLWH followed at a referral center in northeastern Brazil. Hepatic steatosis was assessed by abdominal ultrasonography and liver fibrosis by point Shear-Wave Elastography (pSWE). Multivariable Poisson regression was performed to identify factors independently associated with hepatic steatosis and steatosis severity. Ninety-two older PLWH were included. Hepatic steatosis was identified in 53.3% (n = 49) of participants, of whom 29 (53%) had moderate-to-severe steatosis. Significant fibrosis (F2 or greater) was identified in 10.6% of participants with steatosis who underwent elastography. Increased waist circumference, higher body mass index, metabolic syndrome, higher HbA1c and triglyceride levels were associated with hepatic steatosis. In multivariate analysis, increased waist circumference remained the factor most strongly associated with hepatic steatosis (PR = 4.69; 95% CI 1.53-14.38; p = 0.007). Factors associated with moderate-to-severe steatosis included metabolic and social factors, higher Alanine Aminotransferase (ALT) levels, dolutegravir use, absence of darunavir exposure and higher CD4 nadir. After adjustment, lipodystrophy (aPR = 1.63; 95% CI 1.04-2.56; p = 0.033) and higher Alanine Aminotransferase (ALT) levels (aPR = 1.03; 95% CI 1.01-1.04; p = 0.001) remained independently associated with greater steatosis severity. MASLD was highly prevalent among older PLWH, with a substantial proportion presenting moderate-to-severe steatosis and significant fibrosis. Metabolic and adiposity-related factors were independently associated with hepatic steatosis, while lipodystrophy and higher ALT levels were associated with greater steatosis severity.

PMID 42743598
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PubMedInfectious diseases and therapy2026-09-13

Prevalence and Severity of Potential Drug-Drug Interactions in People Living with HIV on Antiretroviral Therapy in the United States.

Fleming Sean P SP, Lee Kyung Min KM, Prajapati Girish G, Quan Wenying W et al.

As people living with HIV (PLWH) age, the risk for polypharmacy and potential drug-drug interactions (pDDIs) will likely increase, which may pose clinical challenges and contribute to increased healthcare burden. This retrospective study used administrative claims data (1/1/19-1/31/25) from Optum's de-identified Clinformatics® Data Mart Database and included adults with ≥ 1 antiretroviral therapy (ART) claim from 1/1/24-12/31/24 (index date: earliest ART claim). The prevalence and severity of pDDIs between ART and each non-ART comedication the PLWH received during the 30-day post-index period were quantified at the ART agent and ART regimen levels. DDI severity was categorized using the University of Liverpool HIV Drug Interactions Resource scale: contraindicated, major, minor, or no interaction. Prevalence of pDDIs was reported as the proportion of PLWH with any pDDI by severity category. Overall, 22,412 PLWH were included; 44.2% had ≥ 1 pDDI classified as contraindicated, major, or minor. At the ART regimen level, contraindicated pDDIs were most prevalent for darunavir/cobicistat/emtricitabine/tenofovir alafenamide (14.4%) and elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (14.0%). Major pDDIs were observed in up to 66.4% of PLWH receiving certain boosted ART, whereas contraindicated pDDIs were uncommon (< 7%) among PLWH on non-boosted integrase inhibitor- and non-nucleoside reverse transcriptase inhibitor-based regimens. Across commonly prescribed ART regimens, 61.5% to 69.7% of PLWH had either no comedications or only comedications classified as having no interaction, with lower proportions observed for boosted regimens, and major pDDIs were predominantly associated with antidiabetic medications and statins. In this large, real-world claims analysis, pDDIs between ART and non-ART medications were not uncommon in routine clinical practice. As the HIV population continues to age, systematic screening for drug interactions (particularly with comedications for chronic conditions such as diabetes and cardiovascular disease) and thoughtful, individualized ART selection may help mitigate interaction risk and support safe, effective long-term HIV management.

PMID 42728472
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PubMedInternational journal of microbiology2026-09-08

Comparative and Subtractive Genomics Analysis of Multidrug-Resistant Klebsiella pneumoniae Strains for Novel Target Identification and Drug Repurposing Strategies.

Bora Manasi M, Paul Prokriti P, Rajkhowa Sanchaita S, Sonar Harshita H et al.

The rapid rise of multidrug-resistant (MDR) Klebsiella pneumoniae has created a major global health challenge due to the limited availability of conserved therapeutic targets effective across diverse resistant strains. In this study, an integrative computational target-discovery and drug-repurposing framework was applied to six clinically relevant K. pneumoniae strains. Comparative genomic analysis identified 3012 conserved genes, which were subsequently filtered to nine essential, non-host homologous proteins. Among these, three conserved cytoplasmic proteins (accD, cpxR, and mraZ) were prioritized for functional analysis, with acetyl-CoA carboxylase subunit beta (accD) emerging as the most promising therapeutic target based on sequence conservation, predicted essentiality, subcellular localization, and pathway association. Structural assessment supported the reliability of the predicted accD model, whereas consensus binding-site analysis identified key residues suitable for ligand interaction. Virtual screening of FDA-approved drugs followed by molecular docking identified several compounds with favorable binding profiles toward accD. Subsequent molecular dynamics simulations, including root mean square deviation (RMSD), root mean square fluctuation (RMSF), radius of gyration (Rg), hydrogen-bond occupancy, principal component analysis (PCA), and PCA-based free energy landscape (FEL) analyses, consistently identified tenapanor, micafungin, deferoxamine, and cobicistat as the most stable protein-ligand complexes, with tenapanor exhibiting the most favorable overall structural and thermodynamic stability profile. These findings identify accD as a promising therapeutic target in MDR K. pneumoniae and suggest several FDA-approved compounds as potential candidates for drug repurposing. Although experimental validation is needed to confirm their biological activity and therapeutic potential, this study demonstrates the potential of integrating comparative genomics with molecular dynamics analyses to support antimicrobial target identification and drug repurposing against MDR bacterial pathogens.

PMID 42707355
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PubMedIDCases2026-09-06

Multiclass HIV drug resistance: Case series of treatment-experienced PLHIV with resistance to all antiretroviral classes in Northern Uganda.

Kayinda Francis F, Bakunzi Lillian Betty LB, Okello Edmund E, Jurua Charity C et al.

Multiclass HIV drug resistance (HIVDR) is an emerging public health challenge in Uganda, especially among treatment-experienced individuals with long antiretroviral therapy (ART) histories. Resistance across nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI), and integrase strand transfer inhibitors (INSTI) limits treatment options and threatens program sustainability. This study describes three cases of multiclass HIVDR in West-Nile region of Uganda. A descriptive case series was conducted among people living with HIV (PLHIV) with documented virological failure and confirmed resistance to all four ART classes between January 2023 and December 2024. HIVDR testing used next-generation sequencing, and resistance mutations were interpreted with Stanford HIVDR database. Clinical data were abstracted and analyzed descriptively. Three cases were identified: two females (20 and 42 years) and one male (14 years), after approximately 10 years on ART. Shared factors included delayed viral load (VL) monitoring, prolonged exposure to failing regimens, delayed resistance testing and adherence challenges related to stigma and psychosocial barriers. All had been exposed to dolutegravir (DTG)-based regimens and developed intermediate-to-high level resistance to DTG alongside mutations in the other classes. Two cases achieved viral suppression < 1000 copies/ml on salvage therapy. These cases demonstrate that high-barrier drugs like DTG and Darunavir remain vulnerable when virological failure persists and adherence is suboptimal. Strengthening VL monitoring, access to genotypic testing and adherence support is essential to prevent Multiclass HIVDR.

PMID 42699134
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