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Effectiveness and safety of HAART regimens containing tenofovir DF + saquinavir or fosamprenavir in HIV patients: sub-analysis from PROTECTION study

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Journal of the International AIDS Society200811 (Suppl 1) :P78

  • Published:


  • Protease Inhibitor
  • Renal Impairment
  • Tenofovir
  • Good Tolerability
  • Saquinavir

Purpose of the study

The concomitant use of tenofovir DF (TDF) in combination with different protease inhibitors (PIs) has been widely investigated, especially in treatment-naïve patients. Although some data exist in treatment-experienced patients receiving TDF with the commonly used PIs, such as atazanavir or lopinavir, data from other TDF+PI combinations are lacking.


The PROTECTION cohort included retrospective data from 1,428 HIV patients treated with different TDF+PI combinations from 80 HIV clinics in Spain. We have performed a sub-analysis of those patients whose HAART regimens included at TDF in combinations including saquinavir (SQV) or fosamprenavir (FPV).

Summary of results

Tables 1 and 2.
Table 1

Baseline characteristics.


FPV Cohort (n = 105)

SQV Cohort (n = 98)

% Male



Mean Age (years)



Primary HIV risk factor (%)

IVDU (53%)

IVDU (53%)

CDC C status (%)



Main reasons for TDF based regimen (%)

Virological failure (59%)

Virological failure (48%)


Toxicity management (19%)

Simplification (20%)

Previous time on ARV; Months. Median (IQR)

70 (21–111)

73 (34–111)

Most common acompanying NRTIs

3TC or FTC (36%)

3TC or FTC (65%)


AZT or d4T (26%)

AZT or d4T (7%)


ddI (11%)

ddI (13%)

Median BL HIV RNA, c/mL (log)



Mean BL CD4 count (cell/mm3)



BL = Baseline; ARV = antiretrovirals.

Table 2

Efficacy outcomes.


FPV Cohort (n = 105)

SQV Cohort (n = 98)

% viral failure



Mean time of follow-up (months)



Mean CD4 count increase*

+84 cells/mm3

+12 cells/mm3

*In those subjects with 48 week data available (n = 36 and 26 for FPV and SQV cohorts, respectively).

The most prevalent adverse event was diarrhoea in the SQV cohort (11%) and hypertrigliceridaemia in the FPV cohort (4%). Only four patients (2%) withdrew their treatment due to an adverse event. One patient (0.5%) with baseline mild renal impairment (GFR: 63 mL/min) withdrew his treatment due to a grade 1 GFR decrease.


In this cohort, concomitant use of TDF with SQV or FPV was associated with good tolerability and an adequate rate of viral effectiveness, suggesting these combinations are suitable as rescue therapy in highly treatment-experienced patients.

Authors’ Affiliations

Hospital Son Dureta, Palma de Mallorca, Spain
Hospital Univ Gregorio Marañón, Madrid, Spain
Hospital Virgen de las nieves, Granada, Spain
Hospital de Granollers, Barcelona, Spain
Medical Department Gilead Sciences, Madrid, Spain


© Abdon et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.