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• W2321905088 abstract "Co-formulated zidovudine, lamivudine and abacavir was used in seven therapy-naive patients with advanced HIV-1 (four mycobacterial infection, two Pneumocystis,one lymphoma). The median viral load was 180 000 copies/mm3 and the median CD4 cell count was 27 cells/mm3. All achieved viral loads of less than 80 copies/ml by week 24 and survived beyond 48 weeks. Six had sustained viral suppression over 12–18 months and CD4 cell increases were 198 cells/mm3 (111–308 cells/mm3) supporting the use of this combination in patients with advanced disease. Concern over toxicity and adherence to antiretroviral therapy and drug–drug interactions has led to the development of simpler antiretroviral regimes including the triple nucleoside combination of zidovudine, lamivudine and abacavir. The simplification of protease inhibitor-based therapy with the triple nucleoside combination has been demonstrated to improve serum lipids significantly and ease dosing regimes [1,2]. In therapy-naive patients triple nucleoside therapy appears to be well tolerated and adherence is enhanced [3,4]. In an observational study of 108 therapy-naive, incarcerated patients without AIDS and with CD4 cell counts greater than 50 cells/mm3, directly observed therapy with combivir (lamivudine and zidovudine) and abacavir led to viral load suppression below 400 copies/ml in 85% of patients by week 24 (intention to treat analysis) [3]. In a randomized controlled trial, treatment-naive patients with viral loads of less than 100 000 copies/ml, who received the combination form of zidovudine and lamivudine in addition to abacavir and placebo (thrice daily regime), demonstrated an equivalent virological response to a regime in which abacavir was substituted by indinavir [4]. Patients with high baseline viral loads responded less well in the abacavir group although improvements in CD4 cell counts were equivalent [4]. More recent data suggest that improved adherence to a two tablet twice a day triple nucleoside regime (with no placebo) resulted in equivalent virological and immunological response to an indinavir-based thrice-daily regime even at high baseline viral loads [5]. To date, trials of this triple nucleoside regime have excluded patients presenting with life-threatening complications of HIV infection or low CD4 cell counts (< 100 cells/mm3). As part of the expanded use programme we have used the co-formulated preparation of zidovudine, lamivudine and abacavir (Trizivir) in a number of antiretroviral-naive patients, largely because of drug interactions, but also in view of the ease of administration for patients (one capsule twice a day). A retrospective review of all patients with HIV-1 infection, naive to antiretroviral therapy and presenting with an AIDS-defining illness to our unit between October 2000 and April 2001 was performed. Patients who had received at least one dose of Trizivir and had a baseline CD4 cell count of less than 100 cells/mm3 or a viral load greater than 100 000 (5.0 log) were included. Age, sex, ethnicity and mode of transmission of HIV were recorded. Baseline and follow-up viral loads, CD4 cell counts, presenting and subsequent opportunistic infections, adverse events, clinical, virological and immunological outcomes were recorded for all patients. A total of seven patients met the inclusion criteria. Of these, six received Trizivir as first-line therapy and one further patient (number 7, Table 1) received Trizivir within 2 weeks of the initiation of nevirapine/combivir, which had been discontinued because of liver toxicity. Patient characteristics at baseline are shown in Table 1. All presented with an AIDS-defining illness [three tuberculosis (one with concomitant cytomegalovirus encephalitis), one Mycobacterium avium complex infection, two Pneumocystis carinii pneumonia and one high-grade non-Hodgkin's lymphoma] and commenced Trizivir within one month of presentation. The median age was 37 years (range 26–60 years). At presentation the median viral load was 180 000 copies/mm3 (5.26 log) and in five the viral load was greater than 100 000 copies/mm3. The median CD4 cell count was 27 cells/mm3 and in six the CD4 cell count was below 100 cells/mm3.Table 1: Characteristics of patients before and after the initiation of Trizivir (zidovudine/lamivudine/abacavir).Trizivir was well tolerated and no adverse effects were recorded. All patients have survived beyond 48 weeks and there have been no further opportunistic infections. All patients gained weight, with a median gain of 14 kg (3–22 kg) and all patients achieved an undetectable (< 80 copies/ml) viral load by 24 weeks. Six have had a sustained virological response to date (follow-up range 12–18 months). Median CD4 cell count increases were by 198 cells/mm3 (range 111–308 cell/mm3). Virological failure occurred in patient 4; the initial viral load was 84 000 copies/mm3. By week 24 the viral load was recorded as less than 80 copies/mm3, but rebound to 2500 copies/mm3 occurred by week 36. The patient subsequently admitted to poor adherence to therapy. Genotypic resistance testing showed D67N, K70R and M184V reverse transcriptase codon mutations, with retained susceptibility to all protease inhibitors and non-nucleoside reverse transcriptase inhibitors. Despite virological failure, the patient achieved a sustained improvement in well-being, CD4 cell count (+134 cells/mm3), and further treatment options were not compromised. Two further patients have experienced viral load ‘blips'. With patient 3 the viral load increased to 8400 copies/mm3 at the time of discontinuation of tuberculous therapy, but virological control was rapidly re-established without changing therapy. In patient 5, who presented with non-Hodgkin's lymphoma the baseline viral load was 1 100 000 copies/mm3 decreasing to less than 80 copies/mm3 by week 12. Viral load ‘blips'of 710 and 230 copies/mm3 occurred at 6 and 7 months. Virological control was regained without recourse to an alteration in therapy and was sustained at 12 months. Although these are clinical observations on a small number of patients, this does reflect our early experience of this new combination therapy in patients with advanced HIV infection. These clinical data add to clinical trial data in which such patients have been excluded because of low CD4 cell counts, opportunistic infections and potential drug interactions with comparator agents [3–5]. The data support the use of Trizivir in patients with a high viral load, low CD4 cell counts and opportunistic infections, particularly when there are concerns over pill burden and when there is the potential for serious drug–drug interactions. In particular, Trizivir may prevent further AIDS-related events and mortality in patients with tuberculosis and low CD4 cell counts when commenced within the initial phase of antituberculous therapy, as has been shown for highly active antiretroviral therapy in general [6]." @default.
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• W2321905088 title "Effect of co-formulated zidovudine, lamivudine and abacavir (Trizivir) on antiretroviral-naive patients presenting with advanced HIV-1 infection" @default.
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• W2321905088 doi "https://doi.org/10.1097/00002030-200302140-00021" @default.
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