Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial

Arribas, José Ramón; Pialoux, Gilles; Gathe, Joseph; Perri, Giovanni Di; Reynes, Jacques; Tebas, Pablo; Nguyen, Thai; Ebrahimi, Ramin; White, Kirsten; Piontkowsky, David

doi:10.1016/s1473-3099(14)70782-0

Cited by 109 publications

(118 citation statements)

References 19 publications

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“…The study included patients with VL <50 copies/ml on ART containing a PI/r/TDF/FTC for at least 6 months, no history of virologic failure, no documented resistance to study drugs and creatinine clearance (CrCl) ‡70 ml/min. At week 48, EVG/ COBI/TDF/FTC showed superior efficacy in maintaining VL <50 copies/ml than PI/r/TDF/FTC (93.8 [n = 272/290] vs 87.1% [n = 121/139]; difference 6.7%, 95% CI: 0.4 to 13.7%; p = 0.025) [49]. STRATEGY-NNRTI trial had the same study design as STRATEGY-PI, except that it evaluated the efficacy of EVG/COBI/TDF/FTC as an NNRTI-sparing agent.…”

Section: Efficacymentioning

confidence: 99%

Review of integrase strand transfer inhibitors for the treatment of human immunodeficiency virus infection

Mohamed

Kalabalik

Sharma

2015

Expert Review of Anti-infective Therapy

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Integrase strand transfer inhibitors (INSTIs) are oral antiretroviral agents used against HIV infection. There are three agents available, including raltegravir, elvitegravir and dolutegravir, some of which are available as combination medications with other antiretroviral drugs. The efficacy and safety of INSTIs in treatment-naïve and experienced HIV-infected patients have been established by multiple studies. Based on the current practice guidelines, INSTI-based regimens are considered as one of the first-line therapies for treatment-naïve HIV-infected patients. There are new INSTIs in development to improve the resistance profile and to decrease the frequency of drug administration.

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Section: Efficacymentioning

confidence: 99%

Review of integrase strand transfer inhibitors for the treatment of human immunodeficiency virus infection

Mohamed

Kalabalik

Sharma

2015

Expert Review of Anti-infective Therapy

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“…In terms of safety, switching from PI/r (essentially ATV/r, DRV/r or LPV/r) to TDF/FTC/COBI/EVG has been virologically superior, and some switch patients experienced improvement in the rates of gastrointestinal disturbance. These are results from the STRATEGY-PI study [80], a 96-week, international, multicentre, randomized, open-label, phase 3b trial.…”

Section: Switching From a Pi-based Regime To An Insti-based Regimementioning

confidence: 99%

Switching antiretroviral regimes for the treatment of HIV: safety implications

Utrillo

Vidal

Puig

et al. 2016

Expert Opinion on Drug Safety

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Switching cART has been a popular strategy to address safety issues throughout the antiretroviral era. The myriad of switching studies have paralleled the study and release into clinical practice of new antiretroviral drugs with different and often improved safety profiles. Most of them have been successful in improving antiretroviral toxicity while keeping HIV replication under control. However, it should be taken into account that, whenever a new drug is given, there is a possibility of new drug-related toxicity. Notwithstanding that, an increase in cART switching is foreseen, given the fact that we have a wide antiretroviral drug armamentarium and that people living with HIV are ageing and thus more prone to developing age-related co-morbidities whose therapies may entail new interactions and eventually new toxicities.

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“…In published studies comparing the safety and effectiveness of DRV/COBI or EVG/COBI, patients were treated with a triple therapy with two NRTIs following the recommendations of the current ART guidelines [12,14].…”

Section: Introductionmentioning

confidence: 99%

One Year Follow-Up of Darunavir/Cobicistat Monotherapy in Pretreated HIV Patients

Yunquera-Romero¹,

Diez²,

Rio-Valencia³

et al. 2017

J AIDS Clin Res

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IntroductionThe availability of antiretroviral treatment (ART) has made it possible to consider HIV-1 infection as a chronic disease. This has led to a change in the objectives of ART with a greater importance in improving the patient's quality of life and more efficient use of the resources, without compromising the effectiveness of treatments. In ART naive patients, on the first and successive lines after ART failure, preferred regimens remain the combination of three active drugs against HIV: Two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), a protease inhibitor (PI) with a pharmacokinetic (PK) enhancer (booster) (cobicistat or ritonavir), integrase strand transfer inhibitor (INSTI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI) [1][2][3].Currently, boosted protease inhibitor monotherapy (PI/r): Darunavir/ritonavir (DRV/r) or Lopinavir/ritonavir (LPV/r) is only contemplated in the main treatment guidelines in pretreated patients to avoid toxicity associated with NRTIs, reduce costs and simplify ART. PI/r monotherapy with Atazanavir/ritonavir (ATV/r) is not recommended because of the worst results obtained in clinical trials. To initiate monotherapy based on PI/r, the patient must meet the following criteria: absence of chronic hepatitis B, plasma HIV-RNA viral load <50 copies/mL for at least 6 months and absence of mutations in the protease gene or virological failures (VF) prior to PI/r. PI/r are drugs that have a high genetic barrier and are used in monotherapy to maintain virological suppression in most patients, but with lower rates than triple therapy. The use of monotherapy with Lopinavir/ritonavir (LPV/r) and Darunavir/ritonavir (DRV/r) is associated with a higher frequency of "blips", defined as isolated and transient viral load values between 50 and <200 copies/mL. The "blips", although in most studies are not related to the increased risk of virological failure, do recommend re-evaluation of ART (degree of adhesion and genetic barrier) and in some patients may select resistant mutants [1]. Virological failure occurs when, in a patient with strict adherence and optimal tolerability to ART, there are any of the following two situations: a) Viral load detectable after 24 weeks of initiation of ART; B) if after reaching undetectability, th e viral load returns to >50 copies/mL in two consecutive determinations (separated by 2-4 weeks), excluding intercurrent vaccinations or infections (they may produce transient elevations of viral load). Virologic a l failure is AbstractIntroduction: Boosted protease inhibitor monotherapy (PI/r ) : Darunavir/ritonavir (DRV/r) or Lopinavir/ritonavir (LPV/r) monotherapy is only provided in the major treatment guidelines in pre-treated HIV patients to prevent toxicity associated with nucleoside/nucleotide reverse transcriptase inhibitor (NRTIs), reduce costs and simplify antiretroviral treatment. To start PI/r monotherapy, according to GESIDA g uidelines 2016, patients need to meet the following criteria: absence of chronic hepatitis B, pla...

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Cited by 109 publications

References 19 publications

Review of integrase strand transfer inhibitors for the treatment of human immunodeficiency virus infection

Review of integrase strand transfer inhibitors for the treatment of human immunodeficiency virus infection

Switching antiretroviral regimes for the treatment of HIV: safety implications

One Year Follow-Up of Darunavir/Cobicistat Monotherapy in Pretreated HIV Patients

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