Clinical utility of HIV-1 genotyping and expert advice: the Havana trial

Tural, Cristina; Ruiz, Lı́dia; Holtzer, Christopher; Schapiro, Jonathan; Viciana, Pompeyo; González, Juan; Domingo, Peré; Boucher, Charles A.; Rey-Joly, Celestino; Clotet, Bonaventura

doi:10.1097/00002030-200201250-00010

Cited by 284 publications

(215 citation statements)

References 26 publications

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“…Nevertheless, the advantage of genotyping information was lost after 12 months. These findings were similar to results from previous randomized studies [5][6][7][8][9], indicating that resistance testing helps to choose more effective regimens in patients failing previous antiretroviral regimens. Although group 2 patients had fewer mutations and viral samples with no mutations (wild type virus, Table 5), this group received less active drugs (Figure 2), thus emphasizing the importance of genotyping in salvage therapy.…”

Section: Discussionsupporting

confidence: 88%

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Treatment switch guided by HIV-1 genotyping in Brazil

Tupinambás¹,

Ribeiro²,

Aleixo³

et al. 2006

Braz J Infect Dis

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We assessed the performance of HIV-1 genotyping tests in rescue therapy. Patients were divided into two groups: group 1 (genotyped), included those switching to new antiretroviral drugs based on HIV-1 genotyping data, and group 2 (standard of care -SOC), comprised those in rescue therapy who had not used this test. This was an open and non-randomized study, with 74 patients, followed up for a mean period of 12 months, from February 2002 to May 2003. The groups differed in the duration of antiretroviral use, experience with diverse drug classes (non-nucleoside reverse transcriptase inhibitors and protease inhibitors) and viral load <2.6 log 10 copies/mL at any time during treatment. In 23 patients (group 1), the switch in antiretroviral (ARV) regimen was based on genotyping data; this test was not used for 51 patients (group 2). Two CD 4 + lymphocyte counts and viral load counts were made for each patient during the study. Data from the pharmacy where patients received antiretroviral agents, medical charts, and direct interviews with patients to assess compliance to treatment, were analyzed. In the genotyped group, the average drop in viral load was 2.8 log 10 , compared with a 1.5 log 10 difference in group 2; the difference was significant in the first assessment performed six months after switching (p=0.001). Considering the patients with viral load < 2.6 log 10 (400 copies/mL) after switching, the patients in group 1 had a better performance in the first assessment (73.9% versus 31.1% in groups 1 and 2, respectively); this difference was significant (p=0.001). In multivariate analysis, the variables associated with a greater drop in viral load in the first assessment were the patients whose switching was based on genotyping (group 1), those with a past history of viral load < 2.6 log 10 and correct use of antiretroviral agents. In conclusion, the genotyping test and adherence were found to be independent factors for success in the management of patients who failed treatment.

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Section: Discussionsupporting

confidence: 88%

“…Among others, the GART [6] and the NARVAL [7] studies demonstrated the usefulness of HIV genotyping, compared to phenotyping. The Argenta [8] and Havana [9] studies evaluated the effects of compliance and expert advice on HIV-1 genotyping.…”

mentioning

confidence: 99%

Treatment switch guided by HIV-1 genotyping in Brazil

Tupinambás¹,

Ribeiro²,

Aleixo³

et al. 2006

Braz J Infect Dis

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“…Similar results were obtained in another prospective study where 326 HIV-1-infected patients on stable ART and with treatment failure were randomized to receive salvage ART guided by GRT (161 patients) versus salvage ART guided by clinical judgment (165 patients). The proportion of patients with plasma HIV-1 RNA <400 copies/mL at 24 weeks was lower for those guided by GRT than for those guided by clinical judgment (48.5 and 36.2%, respectively; P < 0.05) (10). In addition, these two studies have suggested that the benefit of resistance testing is increased when expert interpretation of the resistance test results is used to guide therapy changes (8,10).…”

Section: Discussionmentioning

confidence: 97%

“…No benefit regarding the clinical parameters was observed in those patients submitted to ART change based on the routine access to HIV-1 genotype testing associated with expert recommendations when compared to those patients whose ART had been changed based on their previous history of ART use. Several previously published prospective studies have shown a benefit associated with resistance testing (8)(9)(10)20). In a prospective controlled trial, 153 HIV-1-infected patients failing on combination drug regimens were randomized to receive salvage ART guided by GRT with expert advice (78 patients) versus salvage ART guided by clinical judgment (75 patients).…”

Section: Discussionmentioning

confidence: 99%

“…HIV-1 genetic polymorphisms associated with drug resistance have been retrospectively shown to be associated with treatment failure, the development of AIDS, and death (3)(4)(5)(6)(7). Prospective studies have shown shortterm improvement in virus load suppression when genotype testing was used to guide therapy in naive and experienced patients (8)(9)(10)(11). Other recent studies have shown either transient improvement (12) or no benefit (13,14) associated with the use of genotype testing, i.e., resistance assays.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of genotype resistance testing for salvage antiretroviral therapy at AIDS care centers from Ribeirão Preto, São Paulo, Brazil

Neto

Colares

Fonseca

2008

Braz J Med Biol Res

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The availability of HIV-1 genotype resistance testing (GRT) to clinicians has been insufficiently studied outside randomized clinical trials. The present study evaluated the outcome of salvage antiretroviral therapy (ART) recommended by an expert physician based on GRT in a non-clinical trial setting in Ribeirão Preto, Brazil. A prospective, open, nonrandomized study evaluating easy access to GRT at six Brazilian AIDS Clinics was carried out. This cooperative study analyzed the efficacy of treatment recommended to patients whose salvage ART was guided by GRT with that of treatment with ART based only on previous ART history. A total of 112 patients with ART failure were included in the study, and 77 of them were submitted to GRT. The median CD4 cell count and viral load for these 77 patients at baseline were (mean ± SD) 252.1 ± 157.4 cells/µL and 4.60 ± 0.5 log 10 HIV RNA copies/mL, respectively. The access time, i.e., the time elapsed between ordering the GRT and receiving the result was, on average, 71.9 ± 37.3 days. The study results demonstrated that access to GRT followed by expert recommendations did not improve the time to persistent treatment failure when compared to conventional salvage ART. Access to GRT in this Brazilian community health care setting did not improve the long-term virologic outcomes of HIV-infected patients experiencing treatment failure. This result is probably related to the long time required to implement ART guided by GRT.

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