Budget impact analysis of the simplification to atazanavir + ritonavir + lamivudine dual therapy of HIV-positive patients receiving atazanavir-based triple therapies in Italy starting from data of the Atlas-M trial

Restelli, Umberto; Fabbiani, Massimiliano; Giambenedetto, Simona Di; Nappi, Carmela; Croce, Davide

doi:10.2147/ceor.s127097

Cited by 10 publications

(3 citation statements)

References 21 publications

(24 reference statements)

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“…If dual regimes are going to be proved non-inferior to triple combination therapy in the ART-naïve population, a single tablet of this dual regimen will likely be developed. Thus, as a consequence of the publication of the results of these studies, in order to save toxicities and resources, we could see a shift in drug production and clinical use of dual therapies [ 12 , 13 ]. However, it has been recently shown that virological suppression and CD4 cell count fail to protect from the major causes of death of persons living with HIV (PLWHIV), which are mainly non-AIDS-related events, also known as serious non-AIDS events (SNAEs) [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Switching to dual/monotherapy determines an increase in CD8+ in HIV-infected individuals: an observational cohort study

Mussini

Lorenzini

Cozzi‐Lepri

et al. 2018

BMC Med

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BackgroundThe CD4/CD8 ratio has been associated with the risk of AIDS and non-AIDS events. We describe trends in immunological parameters in people who underwent a switch to monotherapy or dual therapy, compared to a control group remaining on triple antiretroviral therapy (ART).MethodsWe included patients in Icona who started a three-drug combination ART regimen from an ART-naïve status and achieved a viral load ≤ 50 copies/mL; they were subsequently switched to another triple or to a mono or double regimen. Standard linear regression at fixed points in time (12-24 months after the switch) and linear mixed model analysis with random intercepts and slopes were used to compare CD4 and CD8 counts and their ratio over time according to regimen types (triple vs. dual and vs. mono).ResultsA total of 1241 patients were included; 1073 switched to triple regimens, 104 to dual (72 with 1 nucleoside reverse transcriptase inhibitor (NRTI), 32 NRTI-sparing), and 64 to monotherapy. At 12 months after the switch, for the multivariable linear regression the mean change in the log10 CD4/CD8 ratio for patients on dual therapy was −0.03 (95% confidence interval (CI) –0.05, –0.0002), and the mean change in CD8 count was +99 (95% CI +12.1, +186.3), taking those on triple therapy as reference. In contrast, there was no evidence for a difference in CD4 count change. When using all counts, there was evidence for a significant difference in the slope of the ratio and CD8 count between people who were switched to triple (points/year change ratio = +0.056, CD8 = −25.7) and those to dual regimen (ratio = −0.029, CD8 = +110.4).ConclusionsWe found an increase in CD8 lymphocytes in people who were switched to dual regimens compared to those who were switched to triple. Patients on monotherapy did not show significant differences. The long-term implications of this difference should be ascertained.Electronic supplementary materialThe online version of this article (10.1186/s12916-018-1046-2) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Switching to dual/monotherapy determines an increase in CD8+ in HIV-infected individuals: an observational cohort study

Mussini

Lorenzini

Cozzi‐Lepri

et al. 2018

BMC Med

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“…Over a 3-year period, ART cost decreased between € 23.1 million and € 44.3 million considering different scenarios. A third analysis was conducted to evaluating the impact of treatment simplification of atazanavir (ATV) + ritonavir (r) + lamivudine (3TC) in virologically suppressed patients receiving ATV + r + 2 nucleoside reverse transcriptase inhibitors (NRTIs) [10]. The perspective of the Italian National Health Service (NHS) was considered.…”

Section: Discussionmentioning

confidence: 99%

The cost of a combination Anti-Retroviral Therapy (cART) optimization pathway as maintenance therapy in HIV-1 infected patients

Ravasio¹,

Rigo²,

Lattuada³

et al. 2017

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BACKGROUND: In order to reduce/prevent combination Anti-Retroviral Therapy (cART)-related toxicity, while maintaining its therapeutic effectiveness over time, the optimization of the antiretroviral therapy could be performed. AIM: To estimate the economic impact on the Italian National Health Service (NHS) of a cART optimization pathway as maintenance therapy in HIV-1 infected patients over one-year period. METHODS: Patient data were retrieved from the electronic medical record system in use (year 2015) in a reference HIV Center in Northern Italy. The analysis considered naïve patients and non-naïve patients. To estimate the actual ART expenditure charged to the Center we calculated the cost of cART received during 12 months for each patient. Subsequently, referring to the same patients, a "potential" cART expenditure was estimated. This potential expenditure was estimated taking in consideration the adoption of a specific optimization pathway aimed at maintaining over the time the cART efficacy. Lastly, to assess the sustainability of the optimization pathway, we compared the actual cART expenditure with the potential one. We considered only drug costs (ex-factory prices, included all discounts and VAT) from the perspective of the Italian NHS. RESULTS: In the 2015, the total expenditure for 564 enrolled HIV-1 patients treated with cART was € 4,042,983. The mean treatment cost per patient was € 7,168. If the Center adopted a specific optimization pathway, the total expenditure would be € 3, 914,855 (-€ 128,128). CONCLUSIONS: From the Italian NHS's perspective, the adoption of a specific cART optimization pathway represents a cost-saving option as maintenance antiretroviral therapy in HIV-1 infected patients. KeywordsCombination Italian National Health System The cost of a combination Anti-Retroviral Therapy (cART) optimization pathway as maintenance therapy in HIV-1 infected patients ORIgInAl ReseARCHFarmeconomia. Health economics and therapeutic pathways 2017; 18(1): [83][84][85][86][87][88][89][90][91][92] https://doi.org/10.7175/fe.v18i1.1325

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“…In recent years, the availability of more potent drugs with a high genetic barrier [17] has renewed the interest for simpler HIV regimens. Several drugsparing strategies have been investigated both in ART-naïve patients and, more extensively, in virologically suppressed patients receiving three-drug regimens, in order to achieve and maintain viral suppression and immunological control, improving tolerability, and adherence, and limiting at the same time pill burden and costs [18].…”

Section: Introductionmentioning

confidence: 99%

Risk of failure in dual therapy versus triple therapy in naïve HIV patients: a systematic review and meta-analysis

Pisaturo

Onorato

Russo

et al. 2021

Clinical Microbiology and Infection

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Objectives: Several attempts have been made to test different drug-sparing strategies to reduce the drugburden and drug-related toxicities. The objective of this meta-analysis was to evaluate the relative risk (RR) of failure of dual therapies compared to triple therapies in HIV-naïve patients. Methods: We searched MEDLINE, Google Scholar and the Cochrane Library. The following criteria were used: present data from original articles comparing the two treatment regimens; published from January 2007 up to January, 2020. No language or study design restriction was applied. Subjects were HIVpositive naïve patients treated with dual or triple antiretroviral therapy (ART). A systematic review and meta-analysis was performed. Treatment failure (TF) was the primary outcome evaluated; heterogeneity was assessed using the Q statistic and I 2 . Results: Fourteen studies were included, allowing a meta-analysis on 5205 patients. The meta-analysis performed on studies that presented data at 48 weeks showed that the RR of TF (RR > 1 favouring triple therapy) in 10 studies was 1.20 (95% confidence interval (CI): 0.91e1.59, I 2 : 49.2%); the RR of virological failure (VF) in eight studies was 1.54 (95% CI: 0.84e2.86, I 2 : 54%); the RR of adverse drug reaction leading to discontinuation of the regimen at 48 weeks in eight studies was 0.76 (95% CI: 0.43e1.33, I 2 : 17.7%). In patients with less than 200 CD4þ, the RR of TF in two studies without maraviroc was 2.09 (95% CI: 1.05e4.17, I 2 : 0.0%). Regarding the studies at 96 weeks there was no difference except in rate of development of resistance, RR 1.94 (95% CI: 1.06e3.53, I 2 : 6.2%). Conclusion: Dual therapies are as effective as those with three drugs, showing no difference according to the different dual therapies, except in patients with less than 200 CD4; however, they are associated with a higher selection of resistance-associated mutations at 96 weeks of therapy.

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Budget impact analysis of the simplification to atazanavir + ritonavir + lamivudine dual therapy of HIV-positive patients receiving atazanavir-based triple therapies in Italy starting from data of the Atlas-M trial

Cited by 10 publications

References 21 publications

Switching to dual/monotherapy determines an increase in CD8+ in HIV-infected individuals: an observational cohort study

Switching to dual/monotherapy determines an increase in CD8+ in HIV-infected individuals: an observational cohort study

The cost of a combination Anti-Retroviral Therapy (cART) optimization pathway as maintenance therapy in HIV-1 infected patients

Risk of failure in dual therapy versus triple therapy in naïve HIV patients: a systematic review and meta-analysis

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