Dual treatment with atazanavir–ritonavir plus lamivudine versus triple treatment with atazanavir–ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial

Perez-Molina, José A.; Rubio, Rafael; Rivero, Antonio; Pasquau, Juan; Suárez-Lozano, Ignacio; Riera, Melcior; Estébanez, Miriam; Santos, Jesús; Sanz-Moreno, José; Troya, Jesús; Mariño, Ana; Antela, Antonio; Navarro, Jordi; Esteban, Herminia; Moreno, Santiago

doi:10.1016/s1473-3099(15)00097-3

Cited by 121 publications

(62 citation statements)

References 31 publications

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“…The drug combination was presented as a possible alternative and discussed individually according to clinical needs. The possibility to use the dual combination was discussed according to available data [40] and to results obtained with similar dual therapies [15, 16]. Alternatives were presented according to the specific clinical situation and comprehended (but were not limited to): a) possible alternative regimens such as for example 3TC + ATV/r or more complex combinations (either with 2 or 3 active agents e.g.…”

Section: Methodsmentioning

confidence: 99%

Lamivudine/dolutegravir dual therapy in HIV-infected, virologically suppressed patients

et al. 2017

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BackgroundLittle is known about the applicability of dual treatments based on integrase inhibitors. We explored the combination of lamivudine + dolutegravir as an option when switching from standard cART in virologically suppressed patients.MethodsIn this prospective cohort we enrolled patients previously switched to 3TC + DTG who were 18 years or older, with no previous resistance mutations to the used drugs, having a HIV-RNA <50 copies/ml for 6 months or longer, negative for HBsAg and on a stable (>6 months) cART.ResultsNinety-four individuals were included. They were mostly men (77.7%) with a mean age of 53 years. They presented 159 co-morbidities including cardiovascular, bone, hepatic, kidney, and CNS diseases. Because of these pathologies, they took 207 non-ARV drugs (mean 2.2 per patient). Median duration of viral suppression was 77.5 months (IQR 61). All subjects were prospectively followed up to week 24 and all remained on dual therapy during the whole period. Neither virological failure, nor viral blip was detected.The median CD4 count rose from 658 cells/mcl (IQR 403) to 724 cells/mcl (IQR 401) (P = 0.006) without a significant (P = 0.44) change in the CD4/CD8 ratio. A significant (P < 0.0001) increment of median creatinine from 0.87 mg/dl (IQR 0.34) to 0.95 mg/dl (IQR 0.29) was observed in the first 2 months but thereafter leveled on these values (1.00 mg/dl; IQR 0.35) (P = 0.111 compared to 2 months). The lipid profile slightly improved. The daily cost of cART was significantly (P < 0.0001) reduced of 6.89 euros (SD 6.10).DiscussionSwitching to a dual cART regimen based on lamivudine + dolutegravir maintains virological efficacy up to week 24, and is associated to slight improvements of the immunologic and metabolic status. The strategy allows to freely using concomitant medications for associated pathologies. The dual therapy is less expensive in economic terms.ConclusionAlthough still limited evidence exists, a dolutegravir-based dual therapy in combination with lamivudine shows promising results to be confirmed in larger controlled trials.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-017-2311-2) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Lamivudine/dolutegravir dual therapy in HIV-infected, virologically suppressed patients

et al. 2017

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“…99–102 Although trials provide some support for this approach, it remains investigational, and induction maintenance strategies are not recommended at this time (evidence rating BIIa).…”

Section: When and How To Switchmentioning

confidence: 99%

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Günthard

Saag

Benson

et al. 2016

JAMA

558

313

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“…Keeping in mind that salvage regimens are mainly based on the use of PIs and that darunavir/cobicistat can be used in patients without darunavir RAMs, rescue regimens with a low burden of pills and once-daily posology are now a reality 3. Furthermore, in an attempt to avoid long-term toxicities related to the use of some NRTIs, there have been some studies that have shown a great efficacy with a dual therapy combining a boosted PI plus lamivudine as a simplification strategy,34,35 although with ritonavir as the booster. Finally, darunavir/cobicistat FDC could become a STR treatment in the selected group of patients receiving a PI monotherapy.…”

Section: Use Of Darunavir/cobicistat In the Clinical Practicementioning

confidence: 99%

Profile of once-daily darunavir/cobicistat fixed-dose combination for the treatment of HIV/AIDS

Navarro¹,

Curran²

2016

HIV

Self Cite

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Efficacy is the main objective of antiretroviral treatment and adherence is one of the cornerstones to achieve it. For this reason, treatment simplification is of key importance with regard to antiretroviral regimens. Rezolsta® (darunavir/cobicistat) is the first fixed-dose combination containing a protease inhibitor approved for HIV treatment. This coformulation includes darunavir, a protease inhibitor that has shown its efficacy and safety in naïve and treatment-experienced patients, and cobicistat, the new pharmacokinetic enhancer that is expected to replace ritonavir. Bioequivalence between ritonavir and cobicistat as darunavir boosters has been shown in studies involving healthy volunteers. Furthermore, efficacy and safety of darunavir/cobicistat observed in phase III studies, including naïve and pretreated patients without darunavir-associated resistance mutations, are comparable to historical data of darunavir/ritonavir 800/100 mg once-daily formulation. Adverse events with darunavir/cobicistat are scarce and mild, and basically include skin reactions and gastrointestinal disturbances. Although small increases in plasma creatinine are expected in patients receiving cobicistat due to the inhibition of creatinine transporters in kidney tubules, actual glomerular filtrate rate remains unaltered. Cobicistat does not have an inducer effect on metabolic pathways and shows much more selective inhibition than ritonavir. Therefore, isoenzyms different from CYP3A4 are supposed to be less affected by cobicistat, and thus fewer drug–drug interactions are expected.

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Dual treatment with atazanavir–ritonavir plus lamivudine versus triple treatment with atazanavir–ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial

Cited by 121 publications

References 31 publications

Lamivudine/dolutegravir dual therapy in HIV-infected, virologically suppressed patients

Lamivudine/dolutegravir dual therapy in HIV-infected, virologically suppressed patients

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Profile of once-daily darunavir/cobicistat fixed-dose combination for the treatment of HIV/AIDS

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