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Efficacy, safety and tolerability of enfuvirtide in a population of Portuguese HIV-1 chronically infected patients

Purpose of the study

To assess efficacy, safety and tolerability of enfuvirtide (ENF), as part of an antiretroviral (ARV) regimen, in a heavily pre-treated, non-selected Portuguese population with chronic HIV-1 infection, without previous exposure to fusion inhibitors.


Multicenter, retrospective, 48-week (wk) observational study. Inclusion criteria allowed adults with HIV-1 infection, with virologic failure and resistance to at least one drug of each ARV class (N(t)RTI, NNRTI, PI) who completed ≥ 48 wks of ENF, during the first half of study period.

Summary of results

93 patients were included and started ENF as a component of an optimized antiretroviral regimen. Baseline characteristics (median values): 80% male, age 45 years (25–70), 72% acquired HIV infection through sexual contact and 22% by intravenous drug use. Time since diagnosis 9 yrs (1–22), 69% had AIDS criteria, previous exposure to 10 ARVs (3–19) and 9 (1–16) yrs of treatment. Baseline median TCD4+ was 167/mcl (6–600), with sustained increase during the 48-wk study period and final gain of 150/mcl (2–742)(ITT).

The median HIV-1 RNA decrease, at wk 12, was 2.2 log10. At this time, 23.8% of patients presented with HIV-1 RNA <50 cp/ml, and by the end of study 53.2% were suppressed. Comparing with the predictive factors of treatment response identified in TORO trials, we did not find a statistically significant difference in the immunological response between the group of patients with previous exposure to <10 or ≥10 ARVs. Patients with baseline TCD4+<100/mcl showed better immunological responses, compared to those with higher values. Nevertheless, at wk 48, the difference was not statistically significant (p = 0.065).

Those patients with baseline viral load<100,000 cp/ml revealed a trend to better immunological response, but at wk 48 the difference did not reach statistical significance (p = 0.128).

Median Genotypic Susceptibility Score of the ARV regimen containing ENF was 1.5 (0–3).

20/93 (23%) of patients had to change ARV regimen and 17/93 (18%) interrupted treatment with ENF mostly due to: injection site reactions (n = 5), poor adherence (n = 7) and virologic failure (n = 6).


These data from a real-life setting confirm ENF efficacy, safety and good tolerability in a non-selected patient population. Compared to TORO trials, this population achieved a better virological response, probably explained by the favorable baseline characteristics previously defined as predictive factors of successful treatment.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Miranda, A., Almeida, I., Mendez, J. et al. Efficacy, safety and tolerability of enfuvirtide in a population of Portuguese HIV-1 chronically infected patients. JIAS 11 (Suppl 1), P51 (2008).

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