- |||||||||| NN1213 / Novo Nordisk
Trial completion date: EIT: Early Infant HIV Treatment in Botswana (clinicaltrials.gov) - Oct 20, 2022
P2/3, N=67, Active, not recruiting,
This is the first population PK model of lumefantrine in HIV-infected children and demonstrates selection for reduced lumefantrine susceptibility, a concern as we confront the threat to ACTs posed by emerging artemisinin resistance in Africa. Trial completion date: May 2022 --> Jun 2029
- |||||||||| New Data on an Autosomal Dominant Polycystic Kidney Disease (ADPKD) Treatment Option (Orange County Convention Center Exhibit Hall – West Building Level 2, Theater 2) - Oct 17, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_4586;
Inhibitors of CYP3A: Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, and conivaptan) increases tolvaptan exposure...Avoid concomitant use of JYNARQUE with strong CYP3A inducers • V2-Receptor Agonist: Tolvaptan interferes with the V2-agonist activity of desmopressin (dDAVP)...In general, JYNARQUE should be discontinued during pregnancy. Advise women not to breastfeed during treatment with JYNARQUE.
- |||||||||| artemether/lumefantrine / Generic mfg.
Association of lumefatrine pharmacokinetics and resistance selection following artemether-lumefantrine treatment in children with and without HIV in Uganda (Convention Center - Hall 4A (4th Floor); In-Person-Only) - Oct 9, 2022 - Abstract #ASTMH2022ASTMH_2419;
Using a time to event PK/PD model, more resistant (pfcrt K76) parasites were able to tolerate concentrations 3.5-fold higher than more sensitive parasites (pfcrt K76T mixed + mutant). This is the first population PK model of lumefantrine in HIV-infected children and provides evidence that wild-type K76 parasites are able withstand higher lumefantrine concentrations, which may help explain how selection is occurring in high transmission settings over repeated ACT treatments, a concern as we try to combat the recent emergence and spread of artemisinin resistance in Africa.
- |||||||||| ivermectin oral / Generic mfg.
Review: Potential limitations in systematic review studies assessing the effect of the main intervention for treatment/therapy of COVID-19 patients: An overview. (Pubmed Central) - Oct 8, 2022
All systematic reviews investigated the effectiveness, efficacy, safety, and outcome of the main intervention (Favipiravir, Remdesivir, Hydroxychloroquine, Ivermectin, Lopinavir/Ritonavir, or Tocilizumab) for the treatment of COVID-19 patients and reported the potential limitations of the included studies...As a result, stronger studies with more reliable results will be reported and disseminated. Further research on COVID-19 SRs is essential to improve research quality and also, efficiency among scientists across the world.
- |||||||||| hydroxychloroquine / Generic mfg., lopinavir/ritonavir / Generic mfg.
Enrollment change, Trial termination: COVIDAXIS: Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers (clinicaltrials.gov) - Oct 5, 2022
P3, N=118, Terminated,
Further research on COVID-19 SRs is essential to improve research quality and also, efficiency among scientists across the world. N=1200 --> 118 | Active, not recruiting --> Terminated; French authority's decision
- |||||||||| Journal: Use of Drugs Associated with QT Interval Prolongation at the Hospital Level during the COVID-19 Pandemic in Colombia. (Pubmed Central) - Oct 4, 2022
Regarding drugs initially considered against COVID-19, 2,120 patients (0.6%) received azithromycin, 802 (0.2%) received chloroquine, 517 received hydroxychloroquine (0.1%), and 265 received lopinavir/ritonavir (0.1%). The high proportion of patients treated at the hospital level who receive drugs with risk of prolonging the QT interval should alert those responsible for their care to avoid fatal outcomes, especially during the COVID-19 epidemic, when some QT drugs are being used more frequently.
- |||||||||| Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
Doravirine used as a fixed combination doravirine/lamivudine/tenofovir disoproxil, among persons living with HIV at switch and start: real-life data from the Croatian HIV cohort () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_235;
3TC, lamivudine; ABC, abacavir; BIC, bictegravir; DRV/c, darunavir with cobicistat; DRV/r, darunavir with ritonavir; DTG, dolutegravir; EFV, efavirenz; FTC, emtricitabine; LOP/r, lopinavir with ritonavir; NVP, nevirapine; RAL, raltegravir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate. In our real-life setting treatment with Delstrigo was virologically successful and well tolerated both as a switch strategy or as a first-line regimen.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Pediatric dolutegravir is highly preferred by patients/caregivers in Nigeria and Uganda at 1 month after initiation () - Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_165;
There is high self-reported acceptability to pDTG and preference over previous drug options due to better taste and easier administration and reduced nausea, which are anticipated to help improve health outcomes for children taking pDTG. This study will further evaluate the acceptability and health outcomes at 6-months follow-up to ascertain longer-term effects of pDTG.
- |||||||||| remdesivir / Generic mfg., hydroxychloroquine / Generic mfg., lopinavir/ritonavir / Generic mfg.
Clinical, Journal: Presentation and outcomes of chronic kidney disease patients with COVID-19. (Pubmed Central) - Sep 30, 2022
This study will further evaluate the acceptability and health outcomes at 6-months follow-up to ascertain longer-term effects of pDTG. In our cohort of CKD patients with COVID-19, older age, higher ferritin, and higher LDH levels were independent risk factors for mortality.
- |||||||||| FDA event, Journal: Phylogenic analysis of coronavirus genome and molecular studies on potential anti-COVID-19 agents from selected FDA-approved drugs. (Pubmed Central) - Sep 29, 2022
The Root Mean Square Deviation (RMSD), Root Mean Square Fluctuation (RMSF), Radius of gyration (Rg), and binding energy values obtained after 100 ns of MDS revealed good stability of these compounds in the binding sites of the proteins while important pharmacophore features were also identified. The study showed that COVID-19 likely originated from bat, owing to the over 90% genomic similarity observed, and that lopinavir, levofloxacin, and hydroxychloroquine might serve as potential anti-COVID-19 lead molecules for additional optimization and drug development for the treatment of COVID-19.Communicated by Ramaswamy H. Sarma.
- |||||||||| Phase classification: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - Sep 29, 2022
P=N/A, N=325, Recruiting,
The study showed that COVID-19 likely originated from bat, owing to the over 90% genomic similarity observed, and that lopinavir, levofloxacin, and hydroxychloroquine might serve as potential anti-COVID-19 lead molecules for additional optimization and drug development for the treatment of COVID-19.Communicated by Ramaswamy H. Sarma. Phase classification: P4 --> P=N/A
- |||||||||| Trial completion, Trial completion date: Antiretroviral Regime for Viral Eradication in Newborns (clinicaltrials.gov) - Sep 28, 2022
P4, N=600, Completed,
Phase classification: P4 --> P=N/A Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Dec 2021
- |||||||||| lopinavir/ritonavir / Generic mfg.
Journal: Gastrointestinal symptoms in patients with coronavirus disease 2019 (COVID-19) - friend or foe? (Pubmed Central) - Sep 23, 2022
Risk factors for GI symptoms during hospitalization in COVID-19 patients included age, Clostridioides difficile infection, and receiving certain treatment (antibiotics and lopinavir + ritonavir)...However, in the group of patients who developed GI symptoms during hospitalization, attention should be paid to concomitant treatment. The use of antibiotics should be limited because they are associated with the deterioration of the course of COVID-19; one of the reasons might be changes in the intestinal microbiome.
- |||||||||| remdesivir / Generic mfg., favipiravir / Generic mfg., lopinavir/ritonavir / Generic mfg.
Journal: Evaluation of the Costs and Outcomes of COVID-19 Therapeutic Regimens in Hospitalized Patients in Shiraz. (Pubmed Central) - Sep 23, 2022
Given the highest costs and broad usage of remdesivir, besides controversies regarding its outcomes and side effects, a stricter evaluation of remdesivir benefits seems essential. Totally, COVID-19 therapeutic protocols should be selected carefully to optimize costs and outcomes.
- |||||||||| Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
Retrospective data, Journal: The association of antiviral drugs with COVID-19 morbidity: The retrospective analysis of a nationwide COVID-19 cohort. (Pubmed Central) - Sep 21, 2022
Although several repurposed antiviral drugs have been used for the treatment of COVID-19, only a few such as remdesivir and molnupiravir have shown promising effects...Favipiravir (n = 328), lopinavir/ritonavir (n = 55), and oseltamivir (n = 761) were administered as antiviral agents, and hydroxychloroquine (HCQ, n = 1,382) and azithromycin (n = 738) were used for their immunomodulatory activity...Our findings demonstrated that antiviral drugs including lopinavir, ritonavir, and favipiravir were associated with negative clinical outcomes such as increased risks for lengthy hospital stay, ICU admission, and invasive mechanical ventilation requirement. Therefore, repurposing such agents without proven clinical evidence might not be the best approach for COVID-19 treatment.
- |||||||||| Paxlovid (nirmatrelvir and ritonavir) / Pfizer
Review, Journal: The Mechanism-Based Inactivation of CYP3A4 by Ritonavir: What Mechanism? (Pubmed Central) - Sep 18, 2022
We, therefore, propose that ritonavir markedly inactivates CYP3A through a mixed set of mechanisms. This functional redundancy may well contribute to its overall inhibitory efficacy.
- |||||||||| lopinavir/ritonavir / Generic mfg.
Trial completion date, Trial primary completion date, Real-world evidence, Real-world: Simplified Treatment of Anti-retrovirus in China (C-STAR) (clinicaltrials.gov) - Sep 14, 2022
P=N/A, N=600, Recruiting,
Further studies are needed to establish the activity of ARVs for treatment or prevention of SARS-CoV-2 infection .Communicated by Ramaswamy H. Sarma. Trial completion date: Oct 2022 --> Oct 2030 | Trial primary completion date: Dec 2021 --> Dec 2025
- |||||||||| Olumiant (baricitinib) / Incyte, Eli Lilly, Arbidol (umifenovir) / Pharmstandard
Journal: Therapeutic strategies for COVID-19 patients: An update. (Pubmed Central) - Aug 31, 2022
Baricitinib, the Janus kinase (JAK) 1/2 inhibitor, is also an attractive candidate due to its properties as a potent anti-inflammatory agent and its hypothesized offtarget antiviral effects against SARS-CoV-2...Importantly, with the number of patients increasing daily, there is an urgent need for effective therapeutic intervention. In this review, we expatiated on several strategies deployed for the treatment of COVID-19 infection.
- |||||||||| tenofovir disoproxil fumarate / Generic mfg., lopinavir/ritonavir / Generic mfg.
Journal: Chronic Kidney Disease in a Large National Human Immunodeficiency Virus Treatment Program. (Pubmed Central) - Aug 27, 2022
Tenofovir disoproxil fumarate (TDF) is associated with a risk of chronic kidney disease (CKD), especially in Asian populations...We analyzed data from patients who initiated one of the following first-line regimens: zidovudine + lamivudine + nevirapine (AZT + 3TC + NVP); zidovudine + lamivudine + efavirenz (AZT + 3TC + EFV); tenofovir + lamivudine + nevirapine (TDF + 3TC + NVP); tenofovir + lamivudine/emtricitabine + efavirenz (TDF + 3TC/FTC + EFV); and tenofovir +lamivudine +lopinavir/ritonavir (TDF + 3TC + LPV/r)...Among patients receiving TDF, compared with those receiving TDF + 3TC/FTC + EFV, the aSHR was 4.0 (95% CI 2.3-6.8) in TDF + 3TC + LPV/r and 2.3 (95% CI 1.4-3.6) in TDF + 3TC + NVP. TDF was associated with an increased risk of CKD, especially when combined with LPV/r or NVP.
- |||||||||| Zadaxin (thymalfasin) / SciClone, Arbidol (umifenovir) / Pharmstandard
Journal: SARS-CoV-2 and Plasmodium falciparum Co-Infection in a Returning Traveler. (Pubmed Central) - Aug 24, 2022
The case was administered with dihydroartemisinin and piperaquine tablets for malaria, Lopinavir and Ritonavir tablets, Arbidol, recombinant human interferon α-2b and Compound Maxing Yifei mixture for COVID-19, and Zolpidem Tartrate tablets, Diazepam, Paroxetine Hydrochloride tablets, Thymosin α1, and Lianhua Qinwen Jiaonang during the second hospitalization of the patient since the patient has a certain level of anxiety and insomnia with no evidence of inflammatory reactions...Since most countries in the sub-Saharan region have a fragile health system, co-infection for both Plasmodium and SARS-CoV-2 may not be uncommon, and raise a challenge in diagnosis, treatment, and prevention for both diseases. We add to the literature on co-infection of P. falciparum malaria and COVID-19 and offer operational advice on diagnosis, prevention, and treatment for the co-infection.
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma
Retrospective data, Journal: Efficacy of pharmacological interventions in COVID-19: A network meta-analysis. (Pubmed Central) - Aug 24, 2022
We add to the literature on co-infection of P. falciparum malaria and COVID-19 and offer operational advice on diagnosis, prevention, and treatment for the co-infection. In comparison to standard of care, dexamethasone was found to increase clinical recovery and lower mortality; remdesivir was significantly associated with a lower risk of mortality as compared to tocilizumab and higher clinical recovery and shorter time to clinical improvement as compared to hydroxychloroquine and tocilizumab; remdesivir followed by tocilizumab were found to have lesser occurrence of serious adverse events in patients with moderate to severe COVID-19.
- |||||||||| lopinavir/ritonavir / Generic mfg., adefovir dipivoxil / Generic mfg.
Review, Journal: Safety and Efficacy of Antiviral Drugs for the Treatment of COVID-19: A Systematic Review. (Pubmed Central) - Aug 21, 2022
The evaluated drugs included Ridzevir, Lopinavir/Ritonavir, Jingluwa, Fapiravi, Abidor, Danorivir, and interferon α...For critically ill patients, adefovir or more than two antiviral drugs can be used early...In view of the safety of the drug, it is necessary to consider the increase of serum uric acid caused by fapravi, the increase of bilirubin caused by abidol, and the gastrointestinal reactions of pitavir. In addition, other adverse reactions should also be noted.
- |||||||||| hydroxychloroquine / Generic mfg., dexamethasone / Generic mfg., lopinavir/ritonavir / Generic mfg.
Journal: Should RECOVERY have used response adaptive randomisation? Evidence from a simulation study. (Pubmed Central) - Aug 14, 2022
Deciding how to balance the needs of patients within a trial and future patients who have yet to fall ill is an important ethical question for the trials community to address. Response-adaptive randomisation deserves to be considered as a design feature in future trials of COVID-19 and other diseases.
- |||||||||| Olumiant (baricitinib) / Incyte, Eli Lilly, REGEN-COV (casirivimab/imdevimab) / Regeneron, Roche, Actemra IV (tocilizumab) / Roche, JW Pharma
Journal: Emerging Therapies for COVID-19: The Value of Information From More Clinical Trials. (Pubmed Central) - Aug 11, 2022
Hair zidovudine concentrations can be served as an alternative tool for clinically predicting virologic suppression among PLWH in China. Estimating the real-time value of collecting additional evidence during the pandemic can inform policy makers and clinicians about the optimal moment to implement therapies and whether to perform further research.
- |||||||||| Prezista (darunavir) / J&J
Journal: Bis(thio)carbohydrazone Luminogens with AIEE and ACQ Features and Their In Silico Investigations with SARS-CoV-2. (Pubmed Central) - Aug 10, 2022
Both the thiocarbohydrazones and the carbohydrazones, however, exhibit better binding potential at the active sites than that of some of the repurposed drugs such as chloroquine, hydroxychloroquine, lopinavir, ritonavir, darunavir and remdesivir. Also, the carbohydrazone HL can be a better bioprobe compared to HL as the former is found to have better binding potential with SARS-CoV-2 spike glycoprotein along with AIEE feature.
- |||||||||| emtricitabine/tenofovir disoproxil fumarate / Generic mfg., lopinavir/ritonavir / Generic mfg.
Trial completion, Adverse events, Metastases: Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection (clinicaltrials.gov) - Aug 10, 2022
P4, N=60, Completed,
Systematic Review Registration: [https://clinicaltrials.gov/ct2/show/NCT04351724, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001302-30/AT], identifier [NCT04351724, EUDRACT-NR: 2020-001302-30]. Unknown status --> Completed
- |||||||||| hydroxychloroquine / Generic mfg., azithromycin / Generic mfg., lopinavir/ritonavir / Generic mfg.
Trial termination: Treatment for COVID-19 in High-Risk Adult Outpatients (clinicaltrials.gov) - Aug 8, 2022
P2/3, N=289, Terminated,
Unknown status --> Completed Active, not recruiting --> Terminated; Low number of events contributing to primary outcome
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