Indirect Treatment Comparisons of Lenacapavir Plus Optimized Background Regimen Versus Other Treatments for Multidrug-Resistant Human Immunodeficiency Virus

Chatzidaki, Iro; Curteis, Tristan; Luedke, Hannah; Mezzio, Dylan J; Rhee, Martin S; McArthur, Eve; Eddowes, LA

doi:10.1016/j.jval.2022.12.011

Cited by 9 publications

(9 citation statements)

References 45 publications

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“…This phenomenon is seen in heavily treatment-experienced HIV-1 infected patients and limits the effectiveness of ART [ 26 ]. Accordingly, these patients have limited treatment options and are at a higher risk of morbidity and mortality [ 3 ]. Long-acting anti-HIV drugs can improve the quality of life of this class of HIV-1 patients and can combat the MDR HIV-1 infection [ 44 ].…”

Section: Discussionmentioning

confidence: 99%

“…LEN is a long-acting and patient compliant (oral/subcutaneous administration and less frequent dosing schedule) first-in-class HIV-1 capsid inhibitor approved by the USFDA, Health Canada, and EMA for the treatment of MDR HIV-1 infection ( Table 1 ) [ 11 , 12 , 13 ]. LEN demonstrated a low level of drug-related mutations, is active against MDR HIV-1 infection and does not demonstrate cross-resistance to ARTs due to its novel mechanism of action ( Figure 4 ) [ 3 , 66 , 67 ]. LEN is also an excellent drug for patients having difficult or limited access to healthcare facilities [ 68 , 69 ].…”

Section: Discussionmentioning

confidence: 99%

“…AIDS is characterized by a CD4+ T-cell count of <200 cells per microliter or HIV infection with associated diseases (tuberculosis, cryptococcal meningitis, lymphomas, Kaposi’s sarcoma, etc.). The increased viral load of HIV-1 and decreased CD4+ T-cell count are the principal markers of HIV-1 infection progression or treatment failure [ 3 ]. When left untreated, HIV-1 infection or AIDS can also lead to death after a latency period of various lengths.…”

Section: Introductionmentioning

confidence: 99%

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Highlights on the Development, Related Patents, and Prospects of Lenacapavir: The First-in-Class HIV-1 Capsid Inhibitor for the Treatment of Multi-Drug-Resistant HIV-1 Infection

Dzinamarira,

Almehmadi,

Alsaiari

et al. 2023

Medicina

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The multidrug-resistant (MDR) human immunodeficiency virus 1 (HIV-1) infection is an unmet medical need. HIV-1 capsid plays an important role at different stages of the HIV-1 replication cycle and is an attractive drug target for developing therapies against MDR HIV-1 infection. Lenacapavir (LEN) is the first-in-class HIV-1 capsid inhibitor approved by the USFDA, EMA, and Health Canada for treating MDR HIV-1 infection. This article highlights the development, pharmaceutical aspects, clinical studies, patent literature, and future directions on LEN-based therapies. The literature for this review was collected from PubMed, authentic websites (USFDA, EMA, Health Canada, Gilead, and NIH), and the free patent database (Espacenet, USPTO, and Patent scope). LEN has been developed by Gilead and is marketed as Sunlenca (tablet and subcutaneous injection). The long-acting and patient-compliant LEN demonstrated a low level of drug-related mutations, is active against MDR HIV-1 infection, and does not reveal cross-resistance to other anti-HIV drugs. LEN is also an excellent drug for patients having difficult or limited access to healthcare facilities. The literature has established additive/synergistic effects of combining LEN with rilpivirine, cabotegravir, islatravir, bictegravir, and tenofovir. HIV-1 infection may be accompanied by opportunistic infections such as tuberculosis (TB). The associated diseases make HIV treatment complex and warrant drug interaction studies (drug–drug, drug–food, and drug–disease interaction). Many inventions on different aspects of LEN have been claimed in patent literature. However, there is a great scope for developing more inventions related to the drug combination of LEN with anti-HIV/anti-TB drugs in a single dosage form, new formulations, and methods of treating HIV and TB co-infection. Additional research may provide more LEN-based treatments with favorable pharmacokinetic parameters for MDR HIV-1 infections and associated opportunistic infections such as TB.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Highlights on the Development, Related Patents, and Prospects of Lenacapavir: The First-in-Class HIV-1 Capsid Inhibitor for the Treatment of Multi-Drug-Resistant HIV-1 Infection

Dzinamarira,

Almehmadi,

Alsaiari

et al. 2023

Medicina

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“…Two drugs regimens are now common in order to avoid NRTIs or boosted-PI [ 10 ]. LEN plus optimal backbone ARVs (OBR) has shown superior virological efficacy compared to other regimens, in particular FTR + OBR, in heavily treatment-experienced (HTE) patients failing their regimen [ 11 ]. As experienced by our patient, the most prevalent side effect of LEN is injection site pain and induration.…”

Section: Discussionmentioning

confidence: 99%

Lenacapavir with Fostemsavir in a Multidrug-Resistant HIV-Infected Hemodialysis Patient

Bigirimana,

Van den Wijngaert,

Fosso

et al. 2023

Case Reports in Infectious Diseases

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We report a hemodialysis MDR HIV-infected patient switched to fostemsavir with lenacapavir plus lamivudine for more than a year. She maintained a suppressed viral replication and did not present any clinical or biological drug-related side effects. The combination of lenacapavir plus fostemsavir looks promising in terms of safety and efficacy even in patients with end-stage renal disease awaiting renal transplant. Both drugs are first in class ARVs so that there is no cross resistance with previous drugs, maintaining their efficacy against MDR HIV.

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“…A feasibility assessment was conducted to evaluate studies of people who are HTE with HIV-1 infection for indirect treatment comparisons. 10 Analyses were based on population characteristics, interventions, comparators, and outcomes of interest. Results demonstrated LEN plus OBT had 6.57 times higher odds of virologic suppression at weeks 24 to 28 than fostemsavir plus OBT (95% CI, 1.34 to 32.28), 8.93 times higher odds of virologic suppression than ibalizumab plus OBT (95% CI, 2.07 to 38.46), and 12.74 times higher odds of virologic suppression than OBT alone (95% CI, 1.70 to 95.37).…”

Section: Phase 2 Trialsmentioning

confidence: 99%

Lenacapavir: A Novel Long-Acting Capsid Inhibitor for HIV

et al. 2023

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Objective: To review the efficacy, safety, and role of lenacapavir (LEN) in the treatment of HIV-1 infection. Data Sources: A literature search was performed using PubMed and Google Scholar (through March 2023) with the search term LEN and GS-6207. Other resources included abstracts presented at recent conferences, the manufacturer’s Web site, and prescribing information. Study Selection and Data Extraction: All relevant articles, trial updates, and conference abstracts in the English language were included. Data Synthesis: Lenacapavir represents a new class of antiretrovirals (ARVs) with a novel mechanism of action as a capsid inhibitor and a unique twice-a-year subcutaneous administration schedule. Lenacapavir when combined with other ARVs has proven to benefit heavily treatment-experienced (HTE) patients with HIV-1 infection in achieving viral suppression and immune restoration. Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs: Lenacapavir is a new treatment option that patients who are HTE can consider adding as part of an ARV regimen. Conclusions: Lenacapavir is an effective and well-tolerated option for HTE patients which is a valuable addition to the arsenal of ARVs.

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Indirect Treatment Comparisons of Lenacapavir Plus Optimized Background Regimen Versus Other Treatments for Multidrug-Resistant Human Immunodeficiency Virus

Cited by 9 publications

References 45 publications

Highlights on the Development, Related Patents, and Prospects of Lenacapavir: The First-in-Class HIV-1 Capsid Inhibitor for the Treatment of Multi-Drug-Resistant HIV-1 Infection

Highlights on the Development, Related Patents, and Prospects of Lenacapavir: The First-in-Class HIV-1 Capsid Inhibitor for the Treatment of Multi-Drug-Resistant HIV-1 Infection

Lenacapavir with Fostemsavir in a Multidrug-Resistant HIV-Infected Hemodialysis Patient

Lenacapavir: A Novel Long-Acting Capsid Inhibitor for HIV

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