HIV-1 genital shedding in HIV-infected patients randomized to second-line lopinavir/ritonavir monotherapy versus tenofovir/lamivudine/lopinavir/ritonavir.
BACKGROUND
HIV-1 shedding in genital secretions is associated with HIV transmission risk. Limited data exist on the effect of second-line lopinavir/ritonavir monotherapy (mLPV/r) on genital secretion of HIV RNA.


METHODS
We measured HIV-1 in genital secretions of HIV-infected adults at time of failure from non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens and at 48 weeks after being randomized to second-line mLPV/r versus tenofovir/lamivudine/LPV/r (TDF/3TC/LPV/r). Plasma and genital secretion (semen, vaginal swab) HIV RNA was quantified by the CobasAmpliprep/TaqMan assay.


RESULTS
Forty enrolled (15 on mLPV/r and 25 on TDF/3TC/LPV/r). Median age was 37.8 years and 35% were male. Median baseline CD4(+) T-cell count was 222 cells/mm(3), plasma HIV RNA was 4.1 log10 copies/ml and genital secretion HIV RNA was 2.3 log10 copies/ml. At week 48, the proportion of patients with plasma HIV RNA<50 copies/ml was 13/15 (87%) in mLPV/r and 21/25 (84%) in TDF/3TC/LPV/r arms. Median genital HIV RNA was significantly decreased from baseline in both arms (P=0.009 in mLPV/r and P=0.001 in TDF/3TC/LPV/r). In subjects with suppressed plasma HIV RNA, 12/34 (35%; 6/13 [46%] in the mLPV/r and 6/21 [29%] in the TDF/3TC/LPV/r arms) had detectable HIV RNA (range 74-957 copies/ml) in the genital secretions (P=0.41). By multivariate analysis, the only predictor of having genital HIV RNA>50 copies/ml at week 48 was baseline genital secretion HIV RNA>50 copies/ml (P=0.049).


CONCLUSIONS
LPV/r either given alone or in combination with TDF/3TC as second-line treatment achieved high genital secretion HIV RNA suppression rate. Genital secretion HIV RNA remained detectable at low levels in one-third of patients with suppressed plasma viraemia.
HIV-NAT, the Thai Red Cross AIDS Research Centre, Bangkok, Thailand. torsak.b@hivnat.org.
Torsak
T
Bunupuradah
Chureeratana
C
Bowonwattanuwong
Supunnee
S
Jirajariyavej
Warangkana
W
Munsakul
Virat
V
Klinbuayaem
Jiratchaya
J
Sophonphan
Apicha
A
Mahanontharit
Bernard
B
Hirschel
Kiat
K
Ruxrungtham
Jintanat
J
Ananworanich
D000225:Adenine / Q000031:analogs & derivatives; D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D005500:Follow-Up Studies; D005835:Genitalia / Q000821:virology*; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects / Q000502:physiology*; D006801:Humans; D019259:Lamivudine; D061466:Lopinavir; D008297:Male; D063065:Organophosphonates; D012307:Risk Factors; D019438:Ritonavir; D000068698:Tenofovir; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D017201:Virus Shedding
D019380:Anti-HIV Agents; D063065:Organophosphonates; D061466:Lopinavir; D019259:Lamivudine; D000068698:Tenofovir; D000225:Adenine; D019438:Ritonavir