Cost/efficacy analysis of preferred Spanish AIDS study group regimens and the dual therapy with lopinavir/ritonavir plus lamivudine for initial ART in HIV infected adults

Artigas, Josep M. Gatell; Arribas, José Ramón; Mercado, Pablo; Bravo, Antonio Javier Blasco

doi:10.1016/j.eimc.2015.01.018

Cited by 2 publications

(1 citation statement)

References 6 publications

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“…Three-drug combination ART has become available and widely accepted since 1996, dramatically improving the prognosis of people living with HIV (Odone et al, 2014;Sezgin et al, 2018). However, ART is a lifelong commitment, and is associated with several significant problems, including long-term toxicities, potential drug-drug interactions, and a high pill burden, which ultimately lead to a reduction in drug adherence, resulting in frequent treatment discontinuations and the development of drug resistance (Blasco et al, 2013;Tourret et al, 2013;Moyle et al, 2015;Gatell Artigas et al, 2016). Due to the increased viral potency of modern antiretroviral drugs, repositioning to a two-drug combination therapy should be considered, potentially reducing adverse events, drug-drug interactions, and cost, while maintaining an excellent sustained antiviral effect.…”

Section: Discussionmentioning

confidence: 99%

Antiretroviral Long-Term Efficacy and Resistance of Lopinavir/Ritonavir Plus Lamivudine in HIV-1-Infected Treatment-Naïve Patients (ALTERLL): 144-Week Results of a Randomized, Open-Label, Non-Inferiority Study From Guangdong, China

Guo

Chen

et al. 2021

Front. Pharmacol.

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Dual therapy with lopinavir/ritonavir (LPV/r) plus lamivudine (3TC) has been demonstrated to be non-inferior to the triple drug regimen including LPV/r plus two nucleoside reverse transcriptase inhibitors (NRTIs) in 48-week studies. However, little is known about the long-term efficacy and drug resistance of this simplified strategy. A randomized, controlled, open-label, non-inferiority trial (ALTERLL) was conducted to assess the efficacy, drug resistance, and safety of dual therapy with LPV/r plus 3TC (DT group), compared with the first-line triple-therapy regimen containing tenofovir (TDF), 3TC plus efavirenz (EFV) (TT group) in antiretroviral therapy (ART)-naïve HIV-1–infected adults in Guangdong, China. The primary endpoint was the proportion of patients with plasma HIV-1 RNA < 50 copies/ml at week 144. Between March 1 and December 31, 2015, a total of 196 patients (from 274 patients screened) were included and randomly assigned to either the DT group (n = 99) or the TT group (n = 97). In the primary intention-to-treat (ITT) analysis at week 144, 95 patients (96%) in the DT group and 93 patients (95.9%) in the TT group achieved virological inhibition with plasma HIV-1 RNA <50 copies/ml (difference: 0.1%; 95% CI, –4.6–4.7%), meeting the criteria for non-inferiority. The DT group did not show significant differences in the mean increase in CD4+ cell count (247.0 vs. 204.5 cells/mm3; p = 0.074) or the CD4/CD8 ratio (0.47 vs. 0.49; p = 0.947) from baseline, or the inflammatory biomarker levels through week 144 compared with the TT group. For the subgroup analysis, baseline high viremia (HIV-1 RNA > 100,000 copies/ml) and genotype BC did not affect the primary endpoint or the mean increase in CD4+ cell count or CD4/CD8 ratio from baseline at week 144. However, in patients with genotype AE, the DT group showed a higher mean increase in CD4+ cell count from baseline through 144 weeks than the TT group (308.7 vs. 209.4 cells/mm3; p = 0.038). No secondary HIV resistance was observed in either group. Moreover, no severe adverse event (SAE) or death was observed in any group. Nonetheless, more patients in the TT group (6.1%) discontinued the assigned regimen than those in the DT group (1%) due to adverse events. Dual therapy with LPV/r plus 3TC manifests long-term non-inferior therapeutic efficacy, low drug resistance, good safety, and tolerability compared with the first-line triple-therapy regimen in Guangdong, China, indicating dual therapy is a viable alternative in resource-limited areas.Clinical Trial Registration: [http://www.chictr.org.cn], identifier [ChiCTR1900024611].

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Section: Discussionmentioning

confidence: 99%

Antiretroviral Long-Term Efficacy and Resistance of Lopinavir/Ritonavir Plus Lamivudine in HIV-1-Infected Treatment-Naïve Patients (ALTERLL): 144-Week Results of a Randomized, Open-Label, Non-Inferiority Study From Guangdong, China

Guo

Chen

et al. 2021

Front. Pharmacol.

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show abstract

Dual Therapy with Lopinavir/Ritonavir plus Lamivudine could be a Viable Alternative for Antiretroviral-Therapy-Naive Adults with HIV-1 Infection Regardless of HIV Viral Load or Subgenotype in Resource-Limited Settings: A Randomised, Open-Label and Non-Inferiority Study from China

Lan

et al. 2018

Indian Journal of Medical Microbiology

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Cost/efficacy analysis of preferred Spanish AIDS study group regimens and the dual therapy with lopinavir/ritonavir plus lamivudine for initial ART in HIV infected adults

Cited by 2 publications

References 6 publications

Antiretroviral Long-Term Efficacy and Resistance of Lopinavir/Ritonavir Plus Lamivudine in HIV-1-Infected Treatment-Naïve Patients (ALTERLL): 144-Week Results of a Randomized, Open-Label, Non-Inferiority Study From Guangdong, China

Antiretroviral Long-Term Efficacy and Resistance of Lopinavir/Ritonavir Plus Lamivudine in HIV-1-Infected Treatment-Naïve Patients (ALTERLL): 144-Week Results of a Randomized, Open-Label, Non-Inferiority Study From Guangdong, China

Dual Therapy with Lopinavir/Ritonavir plus Lamivudine could be a Viable Alternative for Antiretroviral-Therapy-Naive Adults with HIV-1 Infection Regardless of HIV Viral Load or Subgenotype in Resource-Limited Settings: A Randomised, Open-Label and Non-Inferiority Study from China

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