post-exposure prophylaxis (PEP) combination of FTC/tenofovir (Truvada) with lopinavir/ritonavir (Kaletra) tablets is safe and generally
well-tolerated, French investigators report in the online edition of the Journal of Acquired Immune Deficiency
Syndromes. The researchers recommend that this combination should be the
standard PEP regimen.
patients stopped taking their treatment because of side-effects. However, the
investigators found that women were more likely to report gastrointestinal
side-effects than men.
this good tolerability, the low discontinuation rate, the ease of use,
TDF/FTC+LPV/r tablet formulation should be considered as the standard of care
concerning HIV PEP”, comment the investigators.
In France – as in the United Kingdom and
many other countries – the recommended treatment for both occupational and
non-occupational PEP is two nucleoside reverse transcriptase inhibitors (NRTIs)
and a ritonavir-boosted protease inhibitor.
are one of the main reasons why patients fail to complete the recommended four
weeks of therapy with PEP. It is therefore important to investigate which
combinations are more tolerable.
therefore performed a prospective, observational study involving 249 patients
who accessed PEP between November 2006 and June 2008. All these patients
commenced treatment within 48 hours of their potential exposure to HIV. Most
(82%) of the patients took PEP because of possible sexual exposure, and overall
60 of the source patients were known to be HIV-positive. A total of 23 patients
had taken a previous course of PEP.
were performed prior to the initiation of PEP to determine baseline full blood
count, kidney and liver function, and lipid levels. These tests were repeated
after 14 days and again after the completion of therapy on day 48. Patients
were asked to report any side-effects they had experienced at these study
patients stopped treatment after it was established that the source individual
was HIV-negative or because the possible exposure was considered to involve a
very low risk of HIV transmission.
Of the 188
patients who should have completed PEP, a total of 22 stopped treatment because
of side-effects. This included two patients with skin rashes and one individual
with abnormal kidney function.
166 patients completed therapy. The majority of these (96) said they had
tolerated their treatment well. Moderate tolerability was reported by 59
individuals, and only eleven patients said that tolerability had been poor.
was reported by 70% of patients, with 27% telling investigators that they had
missed one or two doses and 4% three or more doses.
A total of
92 patients reported side-effects. The most common were diarrhoea (78%), sleep
problems (78%), nausea and vomiting (59%) and headache (38%).
problems and insomnia were more likely to be reported by women than men (p <
0.001 and p < 0.05 respectively).
abnormalities were generally mild. The most common were elevated triglycerides
(35%) or cholesterol (17%). Three patients had moderate increases in their
phosphate levels, with three patients also having abnormal liver function, their
ALT levels being moderately elevated.
analysis showed that women were significantly more likely to stop treatment
because of side-effects than men (p < 0 .02) and to report poorer
tolerability. Patients who had taken a previous course of PEP were more likely
to discontinue therapy than those who were taking treatment for the first time
(p < 0.03).
investigators limited their analysis to patients who were taking PEP following
a possible sexual exposure to HIV, they found that gay men were less likely to
discontinue therapy or report poor tolerability than heterosexuals (p <0.012 and p < 0.002 respectively).
the investigators compared the tolerability of this PEP regimen to those
previous used in France.
They found that the rate of discontinuation was significantly lower for
patients taking the Truvada/Kaletra regimen.
None of the
patients became infected with HIV.
is associated with a higher risk of PEP interruption and with poorer
tolerability”, comment the investigators, “these findings are important because
a preventative treatment of these specific adverse events in this selected
population could be necessary and help to increase HIV PEP completion rates.”
the investigators recommend the Truvada/Kaletra combination as the standard of
care for PEP, noting that there were significantly fewer discontinuations with
this regime than with alternatives.