Efficacy and safety of darunavir (Prezista®) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study

Benea, Otilia Elisabeta; Streinu-Cercel, Adrian; Dorobăț, Carmen; Rugină, Sorin; Negrutiu, L.; Cupşa, Augustin; Duiculescu, Dan; Chiriac, Carmen; Itu, Corina; Prisăcariu, Liviu Jany; Iosif, Ionel

doi:10.11599/germs.2014.1057

Cited by 3 publications

(5 citation statements)

References 16 publications

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“…The effectiveness, tolerability, and persistence data reported in this study are in agreement with those from other real-world studies. 21 – 24 The body of evidence suggests that DRV-based therapy administered in routine care settings is associated with proportions of virological suppression similar to those seen in randomized controlled trials in most treatment-experienced patients with HIV-infection 14 , 18 This is true even in patients who have been treated for many years using several different ART regimens and who were failing current therapy due to lack of response or tolerability issues.…”

Section: Discussionmentioning

confidence: 89%

“…The persistence of DRV/r in terms of both durability of virological response and number of patients remaining on treatment (discontinuation rate) was also evaluated because treatment failure is common in the real-world setting for a number of reasons, including lack of efficacy, loss of virological response, resistance to treatment, adverse reactions, drug adherence, and patient preference. 25 Furthermore, to investigate whether previous clinical trial data 10 – 18 , 26 – 28 translate into the setting of routine clinical practice, 21 – 24 virological response with DRV/r in previously DRV-treated, ARV-experienced DRV-naïve, and ARV-naïve patients was assessed. Immuno-virological responses were analyzed according to VL at study entry.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study

Antinori¹,

Meraviglia²,

Monforte³

et al. 2016

DDDT

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Current antiretroviral (ARV) therapy for the treatment of human immunodeficiency virus (HIV-1)-infected patients provides long-term control of viral load (VL). Darunavir (DRV) is a nonpeptidomimetic protease inhibitor approved for use with a ritonavir booster (DRV/r). This study evaluated the effectiveness of DRV/r in combination with other ARV agents in routine clinical practice in Italy. In this descriptive observational study, data on utilization of DRV/r, under the conditions described in the marketing authorization, were collected from June 2009 to December 2012. Effectiveness (VL <50 copies/mL), tolerability, and durability in four patient groups (two DRV/r-experienced, one ARV-experienced DRV/r-naïve, and one ARV-naïve) were analyzed. Secondary objectives included immunological response, safety, and persistence/discontinuation rates. In total, 875 of 883 enrolled patients were included in the analysis: of these, 662 (75.7%) completed the follow-up until the end of 2012 and 213 (24.3%) withdrew from the study earlier. Initial DRV dose was 600 mg twice daily (67.1%) or 800 mg once daily (32.9%). Only 16 patients (1.8%) withdrew from the study due to virological failure. Virological response proportions were higher in patients virologically suppressed at study entry versus patients with baseline VL ≥50 copies/mL in each ARV-experienced group, while there was no consistent difference across study groups and baseline VL strata according to baseline CD4+ cell count. CD4+ cell count increased from study entry to last study visit in all the four groups. DRV/r was well tolerated, with few discontinuations due to study-emergent nonfatal adverse events (3.0% overall, including 2.1% drug-related) or deaths (3.0% overall, all non-drug-related); 35.3% of patients reported ≥1 adverse events. These observational data show that DRV/r was effective and well tolerated in the whole patient population described here. The DRV/r-containing regimen provided viral suppression in a high percentage of patients in all groups, with low rates of discontinuation due to virological failure.

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Section: Discussionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study

Antinori¹,

Meraviglia²,

Monforte³

et al. 2016

DDDT

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“…The efficacy and safety of DRV/r have been extensively demonstrated in different clinical trials and current HIV treatment guidelines considered DRV/r in combination with tenofovir/emtricitabine as a recommended regimen for treatment‐naïve patients [DHHS, ; EACS, ]. However, there are few studies evaluating the long‐term efficacy and safety of DRV/r in the real‐life setting, and all of them only include treatment‐experienced patients [Young et al, ; Benea et al, ; Biscione et al, ; Ribeiro et al, ].…”

Section: Discussionmentioning

confidence: 99%

“…However, few studies have evaluated the long‐term efficacy and safety of regimens including DRV/r in the real life and outside clinical trials [Young et al, ; Benea et al, ; Biscione et al, ; Ribeiro et al, ]. Herein, we assessed the clinical experienced with DRV/r based on efficacy, safety and tolerability parameters in a large cohort of HIV+ patients in Northwest Spain since its approval since 2007 until nowadays.…”

Section: Introductionmentioning

confidence: 99%

Long‐term clinical experience with darunavir (2007–2015) in a large cohort of HIV‐infected patients in Spain

Pernas

Grandal

Tabernilla

et al. 2016

Journal of Medical Virology

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The clinical experience with the protease inhibitor darunavir/ritonavir (DRV/r) was retrospectively evaluated in a cohort of 173 HIV+ patients who initiated antiretroviral treatment including DRV/r (period 2007-2015). The 43.2% had a CD4 nadir ≤100 cells/mm , 64.1% were treatment-experienced, and 36.5% had failed to >3 lines of antiretroviral therapy. Nonetheless, the rate of virological suppression (HIV-RNA <50 copies/ml) in naïve patients was 63%, 66.7%, and 63.6% at 48, 96, and 144 weeks, respectively. The rate of virological suppression in treatment-experienced patients was 62.7%, 78.7%, and 79.1% at 48, 96, and 144 weeks, respectively. No differences were observed according to the immunovirological status neither dosage of DRV/r. Most of them (82.6%) maintained DRV/r treatment. Causes for DRV/r discontinuation were mainly gastrointestinal and cutaneous adverse events (10.5%), switch to simplification treatment strategies (3.5%) and virological failure (1.7%). These findings demonstrate the prolonged efficacy and tolerability of DRV/r even in multi-treated HIV+ patients with an unfavorable immunovirological status. J. Med. Virol. 88:2125-2131, 2016. © 2016 Wiley Periodicals, Inc.

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“…For initial antiretroviral therapy (ART), combining boosted DRV and other antiretrovirals (ARVs) is currently recommended [ 5 ]. The safety and effectiveness of boosted DRV has been confirmed in several post-marketing clinical studies [ 6 7 8 9 ]. However, it is unclear whether the same profiles exist in the Korean population.…”

Section: Introductionmentioning

confidence: 98%

Safety and Effectiveness of Darunavir in Korean Patients with Human Immunodeficiency Virus 1 Infection: A Post-Marketing Observational Study

Kim¹,

Kim²,

Kang

2021

Infect Chemother

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We aimed to evaluate the safety and effectiveness of darunavir (DRV) in the treatment of human immunodeficiency virus-1 (HIV-1) infection in Korea. From October 29, 2010, 225 eligible patients with HIV-1 infection receiving DRV were enrolled. DRV was administered with other antiretroviral agents, and followed for 24 weeks. The primary objective was safety evaluation, and effectiveness was assessed by viral load and CD4 T cell counts after 12 weeks and 24 weeks. Adverse drug reactions occurred in 18 patients (9.2%); diarrhea was the most common. Viral load was controlled (<400 copies/mL) in 90.9% of patients. CD4 T cell counts were increased 45.0/mm 3 significantly at Week 12 ( P = 0.0002), and 70.5/mm 3 at Week 24 ( P <0.0001). DRV safety and effectiveness was consistent with previous studies.

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Efficacy and safety of darunavir (Prezista®) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study

Abstract: Conclusion DRV/r administered in combination with other ARV medications in subtype F HIV-1 infected subjects in naturalistic settings proved to be an effective and safe treatment in Romania.Trial registration NCT01253967

Cited by 3 publications

References 16 publications

Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study

Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study

Long‐term clinical experience with darunavir (2007–2015) in a large cohort of HIV‐infected patients in Spain

Safety and Effectiveness of Darunavir in Korean Patients with Human Immunodeficiency Virus 1 Infection: A Post-Marketing Observational Study

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