Genital shedding of HIV after scheduled treatment interruption.

This study assessed genital shedding of HIV in patients on intermittent combination antiretroviral therapy (cART) and assessed predictors of having detectable genital HIV RNA in 156 Thai patients with CD4 > 350 cells/µL and HIV RNA ≤50 copies/mL who were randomized to continuous therapy (CT, n = 65) or CD4-guided cART (n = 91). There were 383 matched genital and plasma HIV RNA samples (CT: 158, CD4 guided: 225). In 14 samples collected within eight weeks of treatment interruption, detectable HIV RNA was present in 29% of genital samples and 71% of plasma samples. In 55 samples collected after eight weeks of treatment interruption, detectable HIV RNA was present in 60% of genital samples and 98% of plasma samples. In 110 samples collected up to 96 weeks after treatment re-initiation, detectable genital HIV RNA was found in 8% of samples and all of these were within the first 17 weeks. Independent predictors of detectable genital HIV RNA were increasing age and increasing concentrations of HIV RNA in plasma. These findings support the role of cART in maintaining undetectable HIV RNA in genital secretions.

The 48-week efficacy of once-daily saquinavir/ritonavir in patients with undetectable viral load after 3 years of antiretroviral therapy.

OBJECTIVES: To evaluate the efficacy and safety of once-daily saquinavir-soft-gel-capsules/ritonavir (SQV-SGC/RTV) 1600 mg/100 mg plus dual nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected patients with plasma viral load (pVL) <50 HIV-1 RNA copies/mL following 3 years of antiretroviral therapy. METHODS: A total of 69 patients with pVL <50 copies/mL after 162 weeks of antiretroviral treatment started SQV-SGC/RTV 1600 mg/100 mg once-daily while continuing dual NRTIs. Previous treatment consisted of 66 weeks of treatment with a half/full dose of zidovudine (ZDV)/zalcitabine (ddC), followed by 2 years of SQV-SGC twice a day (bid) plus ZDV/lamivudine (3TC) or didanosine (ddI)/stavudine (d4T). Efficacy (pVL), safety and immunological changes (CD4 cell counts) were evaluated after 48 weeks in this open-label, single-arm prospective study. RESULTS: SQV-SGC/RTV once-daily was well tolerated. No patient changed regimens or was lost to follow-up. After 48 weeks, 63 of 69 patients (91%) had pVL <50 copies/mL (five of the six remaining patients had pVL <400 copies/mL, and one patient had an unexplained rise to 39 500 copies/mL, which decreased to <50 copies/mL 12 weeks later). Median CD4 count increased from 534 cells/muL at the start of the SQV-SGC/RTV once-daily treatment to 664 cells/muL (P<0.001). Compared to the preceding 48 weeks on bid SQV-SGC, the CD4 cell count improved significantly on once-daily SQV-SGC/RTV (P<0.001). CONCLUSIONS: These data support the use of SQV-SGC/RTV 1600 mg/100 mg once-daily with two NRTIs as a convenient, safe and cost-saving regimen to maintain viral suppression and CD4 counts for 48 weeks in this preselected cohort on highly active antiretroviral therapy (HAART) with pVL <50 copies/mL. The CD4 count rise may be a result of continued immune reconstitution in patients with well-controlled infection.