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

Mata‐Marín, José Antonio; Huerta-García, Gloria; Domínguez-Hermosillo, Juan Carlos; Chavez-García, Marcelino; Banda-Lara, Marco Isaac; Nuñez-Rodríguez, Nohemí; Cruz-Herrera, Javier Enrique; Sandoval-Ramírez, Jorge Luis; Iván, Martínez-Abarca; Villagómez-Ruiz, Alfredo; Manjarrez-Tellez, Bulmaro; Gaytán-Martı́nez, Jesús

doi:10.1186/s12981-015-0072-9

Cited by 12 publications

(14 citation statements)

References 15 publications

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“…Our data demonstrated the effectiveness of third-line ART in a programme where the predominant subtype was C. Our findings are in line with other studies from the region that demonstrated good virological suppression rates among patients receiving third-line ART [11,12,23]. Findings from studies in resource limited settings have demonstrated that virologic suppression is a realistic endpoint for most treatment-experienced patients who begin a darunavir-based third-line therapy outside the controlled conditions of a randomized trial, at routine care settings [24][25][26]. NC has a very intense program to help prepare patients for thirdline ART which includes a six-week enhanced adherence support program.…”

Section: Plos Onesupporting

confidence: 88%

Zimbabwe’s national third-line antiretroviral therapy program: Cohort description and treatment outcomes

Chimbetete

Shamu²,

Keiser

2020

PLoS ONE

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Background In 2015, Zimbabwe introduced third-line antiretroviral therapy (ART) through four designated treatment centers; three government clinics in Harare and Bulawayo, and Newlands Clinic (NC), operated by a private voluntary organization in Harare. We describe characteristics of patients receiving third line ART and analyzed treatment outcomes in this national programme as of 31 December 2018. Methods We described the population using proportions for categorical variables, and medians and interquartile ranges for continuous variables. Patients from NC, where data were more complete, were followed from the date of starting third-line ART until death, transfer, loss to follow up or 31 December 2018. Results A total of 209 patients had ever received third-line ART: 124 at NC and 85 from the three government clinics. HIV genotype results were available for 89 (72%) patients at NC and fourteen (16.5%) patients in the government clinics. Median duration of third line ART (years) in the government clinics was 2.3 (IQR:0.6-3.4), 1.3 (IQR: 0.7-1.7) and 1 (0.6-1.9). Of the 67 patients who received third line ART in the government clinics for at least six months, 53 (79%) had most recent viral load (VL) < 1000 copies/ml. Data on other treatment outcomes from government clinics were incomplete. From NC: a total of 109 (88%) patients were still in care, 13 (10.5%) had died and 2 (1.5%) were transferred. Median duration of third-line ART was 1.4 years (IQR: 0.6-2.8). Among the 111 NC patients who had received third-line ART for at least 6 months, 83 (75%) had a VL <50 copies/ml and 106 (95.5%) had a VL <1000 copies/ml.

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Section: Plos Onesupporting

confidence: 88%

Zimbabwe’s national third-line antiretroviral therapy program: Cohort description and treatment outcomes

Chimbetete

Shamu²,

Keiser

2020

PLoS ONE

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“…Although married participants were more restrained in sexual activity than those that were not married, this was likely not the reason for TDF resistance as no other ART drug resistance was related to marital status. Previous studies showed baseline CD4 count was a risk factor of DR [ 7 ], but others revealed no significant difference [ 23 , 24 ]. This study did not find an association of baseline CD4 count with DR occurrence.…”

Section: Discussionmentioning

confidence: 99%

An analysis of drug resistance among people living with HIV/AIDS in Shanghai, China

et al. 2017

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BackgroundUnderstanding the mechanisms of drug resistance can facilitate better management of antiretroviral therapy, helping to prevent transmission and decrease the morbidity and mortality of people living with HIV/AIDS. However, there is little data about transmitted drug resistance and acquired drug resistance for HIV/AIDS patients in Shanghai.MethodsA retrospective cohort study of HIV-infected patients who visited the Department of Infectious Disease from June 2008 to June 2015 was conducted in Shanghai, China. Logistic regression analysis was performed to analyze risk factors for drug resistance among HIV-infected people with virological failure. The related collected factors included patient age, gender, marital status, infection route, baseline CD4 count, antiretroviral therapy regimens, time between HIV diagnosis and initiating antiretroviral therapy. Factors with p<0.1 in the univariate logistic regression test were analyzed by multivariate logistic regression test.ResultsThere were 575 subjects selected for this study and 369 participated in this research. For the antiretroviral therapy drugs, the rates of transmitted drug resistance and acquired drug resistance were significantly different. The non-nucleoside reverse transcriptase inhibitor (NNRTI) had the highest drug resistance rate (transmitted drug resistance, 10.9%; acquired drug resistance, 53.3%) and protease inhibitors (PIs) had the lowest drug resistance rate (transmitted drug resistance, 1.7%; acquired drug resistance, 2.7%). Logistic regression analysis found no factors that were related to drug resistance except marital status (married status for tenofovir: odds ratio = 6.345, 95% confidence interval = 1.553–25.921, P = 0.010) and the time span between HIV diagnosis and initiating antiretroviral therapy (≤6M for stavudine: odds ratio = 0.271, 95% confidence interval = 0.086–0.850, P = 0.025; ≤6M for didanosine: odds ratio = 0.284, 95% confidence interval = 0.096–0.842, P = 0.023; ≤6M for tenofovir: odds ratio = 0.079, 95% confidence interval = 0.018–0.350,P<0.001).ConclusionNNRTI had a higher DR rate compared with nucleoside reverse transcriptase inhibitor (NRTI) and PIs, consequently, LPV/r was a reasonable choice for patients with NNRTI drugs resistance in China. Only married status and a time span≤6 month between the HIV confirmed date and the time initiating antiretroviral therapy were risk factors for TDF drug resistance. Both baseline HIV-RNA load and resistance test is crucial for TDR diagnosis, and frequent monitoring of HIV-RNA load is crucial for ADR identification and intervention. Treatment adherence still plays a positive role on the outcome of ART.

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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%

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

Cited by 12 publications

References 15 publications

Zimbabwe’s national third-line antiretroviral therapy program: Cohort description and treatment outcomes

Zimbabwe’s national third-line antiretroviral therapy program: Cohort description and treatment outcomes

An analysis of drug resistance among people living with HIV/AIDS in Shanghai, China

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

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