Estudio primario

No clasificado

Efficacy and safety of atazanavir-ritonavir plus abacavir-lamivudine or tenofovir-emtricitabine in patients with hyperlipidaemia switched from a stable protease inhibitor-based regimen including one thymidine analogue

Año 2009
Revista AIDS Patient Care and STDs
Enlaces Pubmed , DOI

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

Cargando información sobre las referencias
Mostrar resumen

Randomized, open-label, prospective clinical trial assessing efficacy and safety on hyperlipidemia of a switching from a regimen including one protease inhibitor and one thymidine analogue to atazanavir/ritonavir plus abacavir/lamivudine or tenofovir/emtricitabine. Adult HIV-infected patients on their first antiretroviral therapy (of at least 48-week duration), including one protease inhibitor and zidovudine or stavudine, with stable immunovirologic features, and having diagnosis of persisting hyperlipidemia, were randomized to replace current treatment with atazanavir/ritonavir plus abacavir/lamivudine (arm A) or tenofovir/emtricitabine (arm B), and were followed for 48 weeks. Eighty-nine patients were enrolled: 42 patients were randomized to arm A, and 47 to arm B. At the end of the 48-week follow-up, incidence of virologic failure was comparable in both arms, and associated with a poor drug compliance. Increase in CD4 lymphocyte count was significantly higher in arm A after a 24-week study period (62.5 versus 39.2×106 cells/L; p <0.05), while immunologic responses were comparable at the end of 48-week follow-up (91.5 versus 83.6; p> 0.05). A statistically significant reduction (-15.4%) in mean triglyceridaemia versus respective baseline values was reported in both groups (p <0.05), without statistically significant difference between arm A and B. Similar results were reported for total cholesterol and low-density lipoprotein (LDL) cholesterol levels. Safety and tolerability profiles were comparable in both groups. Switching from a protease inhibitor- and thymidine analogue-based antiretroviral regimen to atazanavir/ritonavir plus abacavir/lamivudine or tenofovir/emtricitabine proved effective in the management of hyperlipidemia, without significant differences in lipid-lowering effect, virologic efficacy, and safety profile between these regimens. © Copyright 2009, Mary Ann Liebert, Inc.

Mostrar resumen

Revisión sistemática

No clasificado

HLA-B*5701 screening for hypersensitivity to abacavir.

Año 2008
Revista The New England journal of medicine
Enlaces Pubmed , DOI

Sin referencias

Cargando información sobre las referencias
Mostrar resumen

BACKGROUND:

Hypersensitivity reaction to abacavir is strongly associated with the presence of the HLA-B*5701 allele. This study was designed to establish the effectiveness of prospective HLA-B*5701 screening to prevent the hypersensitivity reaction to abacavir.

METHODS:

This double-blind, prospective, randomized study involved 1956 patients from 19 countries, who were infected with human immunodeficiency virus type 1 and who had not previously received abacavir. We randomly assigned patients to undergo prospective HLA-B*5701 screening, with exclusion of HLA-B*5701-positive patients from abacavir treatment (prospective-screening group), or to undergo a standard-of-care approach of abacavir use without prospective HLA-B*5701 screening (control group). All patients who started abacavir were observed for 6 weeks. To immunologically confirm, and enhance the specificity of, the clinical diagnosis of hypersensitivity reaction to abacavir, we performed epicutaneous patch testing with the use of abacavir.

RESULTS:

The prevalence of HLA-B*5701 was 5.6% (109 of 1956 patients). Of the patients receiving abacavir, 72% were men, 84% were white, and 18% had not previously received antiretroviral therapy. Screening eliminated immunologically confirmed hypersensitivity reaction (0% in the prospective-screening group vs. 2.7% in the control group, P<0.001), with a negative predictive value of 100% and a positive predictive value of 47.9%. Hypersensitivity reaction was clinically diagnosed in 93 patients, with a significantly lower incidence in the prospective-screening group (3.4%) than in the control group (7.8%) (P<0.001).

CONCLUSIONS:

HLA-B*5701 screening reduced the risk of hypersensitivity reaction to abacavir. In predominantly white populations, similar to the one in this study, 94% of patients do not carry the HLA-B*5701 allele and are at low risk for hypersensitivity reaction to abacavir. Our results show that a pharmacogenetic test can be used to prevent a specific toxic effect of a drug. (ClinicalTrials.gov number, NCT00340080.)

Mostrar resumen

Estudio primario

No clasificado

Abacavir hypersensitivity reaction.

Año 2002
Autores Hewitt RG
Revista Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Enlaces Pubmed , DOI

Este artículo no está incluido en ninguna revisión sistemática

Cargando información sobre las referencias
Mostrar resumen

A hypersensitivity reaction occurs in association with initiation of abacavir therapy as part of combination antiretroviral therapy in approximately 3.7% of patients. The reaction is possibly the result of a combination of altered drug metabolism and immune dysfunction, which is poorly understood. White patients appear to be at higher risk and patients of African descent at lower risk of abacavir hypersensitivity. Clinical management involves supportive measures and discontinuation of abacavir therapy. Rechallenge with abacavir in a hypersensitive patient should be avoided because it might precipitate a life-threatening reaction.

Mostrar resumen

Estudio primario

No clasificado

Coming therapies: abacavir.

Año 1999
Autores Staszewski S
Revista International journal of clinical practice. Supplement
Enlaces Pubmed

Este artículo no está incluido en ninguna revisión sistemática

Cargando información sobre las referencias
Mostrar resumen

Abacavir is a nucleoside analogue reverse transcriptase inhibitor (NRTI). It has a good oral availability and penetrates the CNS. The metabolism of abacavir is not dependent on cytochrome P450 thus avoiding significant drug-drug interactions. It has an antiviral potency comparable to that of protease inhibitors (PIs) or to dual nucleoside combinations. In addition, evidence has shown that it is effective in decreasing viral load and increasing CD4 count in HIV-infected patients, especially NRTI-naïve patients. Abacavir has an acceptable tolerability profile, although hypersensitivity reactions lead to discontinuation of therapy in approximately 3% of patients. Abacavir has a potential role in first- and second-line combination regimens and as part of a PI-sparing regimen.

Mostrar resumen

Resumen estructurado de revisiones sistemáticas

No clasificado

Abacavir 600mg/lamivudine 300mg (Kivexa®) in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus infection in adults and adolescents from 12 years of age

Año 2012
Revista HTA Database
Enlaces
Cargando información sobre las referencias
Mostrar resumen

RECORD STATUS:

This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

All Wales Medicines Strategy Group (AWMSG). Abacavir 600mg/lamivudine 300mg (Kivexa®) in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus infection in adults and adolescents from 12 years of age Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 2008. 2008

Mostrar resumen

Estudio primario

No clasificado

The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial.

Año 2006
Revista Lancet
Enlaces Pubmed , DOI

Este artículo está incluido en 11 Revisiones sistemáticas Revisiones sistemáticas (11 referencias)

Cargando información sobre las referencias
Mostrar resumen

BACKGROUND:

Lopinavir-ritonavir is a preferred protease inhibitor co-formulation for initial HIV-1 treatment. Fosamprenavir-ritonavir has shown similar efficacy and safety to lopinavir-ritonavir when each is combined with two nucleoside reverse transcriptase inhibitors. We compared the two treatments directly in antiretroviral-naive patients.

METHODS:

This open-label, non-inferiority study included 878 antiretroviral-naive, HIV-1-infected patients randomised to receive either fosamprenavir-ritonavir 700 mg/100 mg twice daily or lopinavir-ritonavir 400 mg/100 mg twice daily, each with the co-formulation of abacavir-lamivudine 600 mg/300 mg once daily. Primary endpoints were proportion of patients achieving HIV-1 RNA less than 400 copies per mL at week 48 and treatment discontinuations because of an adverse event. The intent-to-treat analysis included all patients exposed to at least one dose of randomised study medication. This study is registered with ClinicalTrials.gov, number NCT00085943.

FINDINGS:

At week 48, non-inferiority of fosamprenavir-ritonavir to lopinavir-ritonavir (95% CI around the treatment difference -4.84 to 7.05) was shown, with 315 of 434 (73%) patients in the fosamprenavir-ritonavir group and 317 of 444 (71%) in the lopinavir-ritonavir group achieving HIV-1 RNA less than 400 copies per mL. Treatment discontinuations due to an adverse event were few and occurred with similar frequency in the two treatment groups (fosamprenavir-ritonavir 53, 12%; lopinavir-ritonavir 43, 10%). Diarrhoea, nausea, and abacavir hypersensitivity were the most frequent drug-related grade 2-4 adverse events. Treatment-emergent drug resistance was rare; no patient had virus that developed reduced susceptibility to fosamprenavir-ritonavir or lopinavir-ritonavir.

INTERPRETATION:

Fosamprenavir-ritonavir twice daily in treatment-naive patients provides similar antiviral efficacy, safety, tolerability, and emergence of resistance as lopinavir-ritonavir, each in combination with abacavir-lamivudine.

Mostrar resumen

Estudio primario

No clasificado

Efficacy and safety of abacavir plus lamivudine versus didanosine plus stavudine when combined with a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or both in HIV-1 positive antiretroviral-naive persons.

Año 2005
Revista HIV clinical trials
Enlaces Pubmed , DOI

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

Cargando información sobre las referencias
Mostrar resumen

PURPOSE:

The combination of abacavir + lamivudine (ABC+3TC) versus didanosine + stavudine (ddI+d4T), each combined with other classes of antiretrovirals (ARVs) in ARV-naive patients, was compared for the combined endpoint of time to plasma HIV RNA >50 copies/mL (at or after the 8-month visit) or death (primary endpoint) in a nested substudy of an ongoing multicenter randomized trial.

METHOD:

The substudy enrolled 182 patients; mean HIV RNA and CD4+ cell counts at baseline were 5.1 log10 copies/mL and 212 cells/mm3, respectively.

RESULTS:

After a median follow-up of 28 months, rates of primary endpoint were 57.2 and 67.8 per 100 person-years for the ABC+3TC and ddI+d4T groups (hazard ratio [HR]=0.81, 95% confidence interval [CI] 0.58-1.14, p=.23).

CONCLUSION:

There was a trend for treatments containing ABC+3TC to be better than treatments containing ddI+d4T with respect to HIV RNA decreases, CD4+ cell count increases, and tolerability.

Mostrar resumen

Estudio primario

No clasificado

A simplification trial switching from nucleoside reverse transcriptase inhibitors to once-daily fixed-dose abacavir/lamivudine or tenofovir/ emtricitabine in HIV-1-infected patients with virological suppression

Año 2009
Revista Journal of acquired immune deficiency syndromes (1999)
Enlaces Pubmed , DOI

Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

Cargando información sobre las referencias
Mostrar resumen

BACKGROUND:

Data comparing abacavir/lamivudine versus tenofovir/ emtricitabine in antiretroviral-naive patients are controversial. We compared 48-week efficacy and safety of these combinations as substitutes of nucleosides in patients with virological suppression.

METHODS:

We randomly assigned 333 HIV-1-infected patients on lamivudine-containing triple regimens with <200 copies per milliliter for at least 6 months to switch their nucleosides to either abacavir/lamivudine (n = 167) or tenofovir/emtricitabine (n = 166). The primary outcome was treatment failure ["switching = failure" intention to treat (ITT) analysis, noninferiority margin 12.5%]. Secondary outcomes were time to treatment failure, virological failure, adverse events, and changes in CD4 count, fasting plasma lipids, lipodystrophy, body fat, bone mineral density, and renal function.

RESULTS:

Treatment failure occurred in 32 patients (19%) on abacavir/lamivudine and 22 patients (13%) on tenofovir/emtricitabine [difference 5.9%; (95% confidence interval ĝ̂'2.1% to 14.0%), P = 0.06]. Four patients in the abacavir/lamivudine group versus none in the tenofovir/emtricitabine group developed virological failure [difference 2.4; (95% confidence interval 0.05 to 6.0), P = 0.04]. Twenty-three patients (14%) assigned to abacavir/lamivudine and 10 (6%) to tenofovir/lamivudine experienced grade 3 or 4 adverse effects (P = 0.03). CD4 counts and plasma lipids showed higher increments in the abacavir/lamivudine group than in the tenofovir/emtricitabine group.

CONCLUSIONS:

In HIV-1-infected patients with virological suppression, abacavir/lamivudine did not meet the noninferiority outcome for treatment efficacy compared with tenofovir/emtricitabine. © 2009 by Lippincott Williams & Wilkins.

Mostrar resumen

Estudio primario

No clasificado

Impact of pregnancy on abacavir pharmacokinetics.

Año 2006
Revista AIDS (London, England)
Enlaces Pubmed , DOI

Este artículo está incluido en 1 Síntesis amplia Síntesis amplias (1 referencia)

Cargando información sobre las referencias
Mostrar resumen

OBJECTIVE:

To describe abacavir pharmacokinetics during pregnancy and postpartum; physiological changes during pregnancy are known to affect antiretroviral drug disposition.

DESIGN:

The Pediatric AIDS Clinical Trials Group P1026s study is an on-going, prospective, non-blinded pharmacokinetic study of pregnant women receiving one or more antiretroviral drugs for routine clinical care, including a cohort receiving abacavir 300 mg twice daily.

METHODS:

Serial plasma samples (predose, 1, 2, 4, and 6 h postdose) obtained antepartum (30-36 weeks of gestation) and again postpartum (6-12 weeks after delivery) were assayed for abacavir concentration by reversed-phase high-performance liquid chromatography.

RESULTS:

Antepartum evaluations were available for 25 women [mean age, 28.6 years (SD, 6); mean third-trimester weight 92 kg (SD, 35.4); and race/ethnicity 52% black, 28% Hispanic, 16% white, 4% Asian], with geometric mean abacavir area under the concentration-time curve (AUC) of 5.9 mg.h/l [90% confidence interval (CI), 5.2-6.8] and maximum plasma concentration (Cmax) of 1.9 mg/l (90% CI, 1.6-2.2). Seventeen women completed postpartum sampling, and the ratios of antepartum to postpartum AUC and Cmax were 1.04 (90% CI, 0.91-1.18) and 0.79 (90% CI, 0.65-0.98), respectively.

CONCLUSIONS:

Abacavir AUC during pregnancy was similar to that at 6-12 weeks postpartum and to that for non-pregnant historical controls (5.8 mg.h/l). Consequently, pregnancy does not appear to affect overall abacavir exposure significantly or to necessitate dose adjustments.

Mostrar resumen

Estudio primario

No clasificado

Platelet Function on Abacavir and Tenofovir

Año 2018
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

Este artículo no está incluido en ninguna revisión sistemática

Cargando información sobre las referencias
Mostrar resumen

This is a small observational study aimed at observing differences in platelet function in HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation between platelet activation and cardiovascular disease- this study will act as a pilot to see if platelet activation among abacavir users may explain the correlation between abacavir and cardiovascular disease in HIV positive patients.

This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on tenofovir-based treatment. There is only one study visit which includes a blood draw, physical assessment, and review of medical history.

Mostrar resumen