Virologic and Immunologic Effectiveness at 48 Weeks of Darunavir–Ritonavir-Based Regimens in Treatment-Experienced Persons Living with HIV-1 Infection in Clinical Practice

Biscione, Fernando Martín; Westin, Mateus Rodrigues; Ribeiro, Karina Mota; Estevam, Denize Lotufo; Cardoso, Sandra Wagner; Tenore, Simone de Barros; Neto, Lauro Ferreira da Silva Pinto; Alencastro, Paulo Ricardo de; Suffert, Theodoro A; Moraes, Mônica Jacques de; Barbosa, Alexandre Naime; Morejón, Karen Mirna Loro; Arruda, Érico Antônio Gomes de; Silveira, Jussara María; Neto, José Luiz Andrade; Greco, Dirceu Bartolomeu; Tupinambás, Unaí

doi:10.1177/2325957413502542

Cited by 10 publications

(14 citation statements)

References 29 publications

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“…We observed that 69 % of patients reached a viral load of <50 copies/mL at week 48. This outcome was better than some other randomized clinical trials [ 5 ], but was similar to the TITAN6 and ODIN studies at 48 weeks [ 10 ] and some observational studies [ 11 , 12 ].…”

Section: Discussionsupporting

confidence: 84%

“…In that trial, HIV-1 RNA levels of <50 copies/mL were achieved at 48 weeks in 47 % of recipients of DRV/r plus an OBR, compared with 69 % of patients who received RAL and DRV/r plus an OBR; however, when we evaluated other drugs such as enfuvirtide (ENF) and maraviroc (MVC), we did not find the same result. Another observational study found that the concomitant use of RAL was strongly associated with treatment success [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness and risk factors for virological outcome of darunavir-based therapy for treatment-experienced HIV-infected patients

et al. 2015

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ObjectiveWe evaluated the effectiveness of darunavir (DRV) treatment plus an optimized background regimen in 120 HIV-1 treatment-experienced patients.DesignRetrospective cohort, multicenter study.MethodsAdults >16 years with virological treatment failure starting therapy with a DRV-containing regimen were included. Effectiveness was evaluated as the percentage of patients with an undetectable HIV-1 RNA viral load (<50 and <200 copies/mL) after 48 weeks, and changes in CD4+ cell counts. We evaluated the risk factors associated with treatment failure.ResultsOf the cohort, 83 % were men with a median age of 45 years (interquartile range, IQR 40–51). They had experienced treatment for a median of 13 years (IQR 9–17) with a median of six previous regimens (IQR 4–7), all using protease inhibitors. After treatment, 82 % (95 % confidence interval, CI 74–88 %) of patients had an HIV-1 RNA viral load <200 copies/mL and 69 % (95 % CI 60–76 %) had <50 copies/mL. The CD4+ cell count increased by 378 cells/μL (IQR 252–559; P < 0.001 vs. baseline). Risk factors associated with poor outcome were age >40 years [odds ratio, OR 0.15 (95 % CI 0.10–0.78); P = 0.015], use of raltegravir in the regimen [OR 0.37 (95 % CI 0.10–0.97); P = 0.046], and baseline CD4+ cell count <200 cells/μL [OR 2.79 (95 % CI 1.11–6.97); P = 0.028].ConclusionIn this Mexican cohort Darunavir was metabolically safe, well tolerated and achieved high rates of virological suppression in highly treatment-experienced patients infected with HIV-1.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

Effectiveness and risk factors for virological outcome of darunavir-based therapy for treatment-experienced HIV-infected patients

et al. 2015

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“…While a clinical trial may represent a select patient group, several observational studies of patients with multiclass resistant HIV treated with darunavir-based regimens have also reported virologic suppression (VL <50 copies/ml by week 48) being achieved in over 50 % of patients. This includes studies conducted in other developing countries: Brazil (83 % suppression [ 15 ] and 73 % suppression [ 16 ]) and Mexico (69 % suppression [ 17 ]). The inclusion of raltegravir in such darunavir-based regimens has been associated with improved virologic outcomes [ 16 , 18 ].…”

Section: Discussionmentioning

confidence: 99%

“…This includes studies conducted in other developing countries: Brazil (83 % suppression [ 15 ] and 73 % suppression [ 16 ]) and Mexico (69 % suppression [ 17 ]). The inclusion of raltegravir in such darunavir-based regimens has been associated with improved virologic outcomes [ 16 , 18 ].…”

Section: Discussionmentioning

confidence: 99%

Third-line antiretroviral therapy in Africa: effectiveness in a Southern African retrospective cohort study

Meintjes

Dunn²,

Coetsee³

et al. 2015

AIDS Res Ther

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Background An increasing number of patients in Africa are experiencing virologic failure on second-line antiretroviral therapy (ART) and those who develop resistance to protease inhibitors (PI) will require third-line ART, but no data on the outcomes of third-line are available from the region. We assessed the virologic outcomes and survival of patients started on salvage ART in a Southern African private sector disease management programme.Methods Retrospective observational cohort study with linkage to the national death register. Adults (≥18 years) who started salvage ART between July 2007 and December 2011 were included. Salvage ART was defined by inclusion of darunavir or tipranavir in an ART regimen after having failed another PI. For Kaplan–Meier (KM) analysis, patients were followed up until event, or censored at death (only for virologic outcomes), leaving the programme, or April 2014.Results152 patients were included. Subtype was known for 113 patients: 111 (98 %) were infected with subtype C. All 152 had a genotype resistance test demonstrating major PI resistance mutations. Salvage drugs included were: darunavir/ritonavir (n = 149), tipranavir/ritonavir (n = 3), raltegravir (n = 58), and etravirine (n = 8). Median follow-up was 2.5 years (IQR = 1.5–3.3). 82.9 % achieved a viral load ≤400 copies/ml and 71.1 % ≤50 copies/ml. By the end of the study 17 (11.2 %) of the patients had died. The KM estimate of cumulative survival was 87.2 % at 2000 days.ConclusionsVirologic suppression was comparable to that demonstrated in clinical trials and observational studies of salvage ART drugs conducted in other regions. Few deaths occurred during short term follow-up. Third-line regimens for patients with multidrug resistant subtype C HIV in Africa are virologically and clinically effective.

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“…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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Virologic and Immunologic Effectiveness at 48 Weeks of Darunavir–Ritonavir-Based Regimens in Treatment-Experienced Persons Living with HIV-1 Infection in Clinical Practice

Abstract: The use of DRV/r-based regimens for salvage therapy is an effective strategy in the clinical care setting of a developing country.

Cited by 10 publications

References 29 publications

Effectiveness and risk factors for virological outcome of darunavir-based therapy for treatment-experienced HIV-infected patients

Effectiveness and risk factors for virological outcome of darunavir-based therapy for treatment-experienced HIV-infected patients

Third-line antiretroviral therapy in Africa: effectiveness in a Southern African retrospective cohort study

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

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