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Session 100
Poster Abstracts Strategies of Antiretroviral Therapy Friday, 1:30 - 3:30 pm Hall A |
Background: Once-daily regimens might enhance convenience and adherence to therapy.
However, switching to these simple regimens should not compromise long-term
efficacy and safety.
Methods: In a prospective, open-label, multicenter, non-inferiority study, 355
patients receiving a protease inhibitor-based regimen with plasma HIV RNA level < 400 copies/mL were randomized to continue their
regimen (n = 177) or to switch to a once-daily combination of emtricitabine,
didanosine, and efavirenz
(n = 178). At the end of
trial (month 12), patients in the once-daily arm were asked to keep on
follow-up, up to month 36, to assess long-term efficacy and safety.
Results: The
once-daily arm was not inferior to the protease inhibitor arm according to
the virologic efficacy endpoint at month 12. Results on observed data at month 36
are shown in the table below. Reasons
for once-daily regimen discontinuation during month-12
to month-36 period were
failure in 1 patient, toxicity in 5, patient’s choice or treatment adaptation in 4, unknown in 7.
Moreover, 10 patients encountered at least 1 serious
adverse reaction (death or grade 4 or hospital admission) up to month-12 (6%),
while 5 did between month-12 and month-36 (3%): hallucination,
suicide attempt, neuropathy, abdominal distension, and
hypertriglyceridemia.
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Month 0 |
Month 12 |
Month 36 |
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Patients’ status
(n) |
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at risk |
178 |
174 |
135 |
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dead |
0 |
1 |
0 |
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withdrew consent |
3 |
0 |
12 |
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lost to follow-up |
0 |
0 |
27 |
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stopped trial regimen |
0 |
21 |
17 |
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Plasma HIV RNA < 400
copies/mL (N, n [%]) |
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intent-to-treat analysis |
174, 169 (97) |
174, 166 (95) |
128, 121 (95) |
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per-protocol analysis |
174, 169 (97) |
154, 149 (97) |
112, 108 (96) |
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Change from
M00 in CD4+
cell count (/mm3) |
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N, mean (SE) |
178, 0 (0 to 0) |
174+14 (12) |
128+43 (18) |
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Patients with
at least one sign of lipodystrophy |
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atrophy (N, n [%]) |
174, 76 (44) |
171, 75 (44) |
135, 53 (39) |
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hypertrophy (N, n [%]) |
174, 53 (30) |
171, 48 (28) |
135, 67 (50) |
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Change in HDL-cholesterol (mmol/L) |
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N, mean
(SE) |
171, 0 (0.00) |
159+0.20 (0.03) |
114+0.30 (0.04) |
Conclusions: The
substitution of a protease inhibitor-based regimen by a simplified once-daily
combination of efavirenz, emtricitabine, and
didanosine was well-tolerated and
was associated with long-term virologic suppression.
Keywords: once-daily therapy; emtricitabine; switch
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