- Efficacy and safety of TDF/FTC-containing first-line HAART in clinical practice – 2-year data from the German Outpatient Cohort (2008)
- Poster presentation: Purpose of the study First-line HAART with tenofovir DF (TDF) and FTC in pivotal trials has been associated with high efficacy and good tolerability. However, real-life clinical practice often differs from clinical trials due to co-morbidities, co-infections, and less intensive clinical monitoring. To evaluate efficacy and safety of first-line HAART in a day-to-day setting, this Gilead-sponsored non-interventional cohort was established. Methods Between July 2005 and August 2006, 533 HIV-1 infected antiretroviral-naïve patients from 50 German centres enrolled in this non-interventional cohort. All patients were followed every 3 months for 3 years to monitor efficacy (viral load [VL], CD4), tolerability, renal safety, regimen changes and resistance profile. All patients received TDF+FTC as a single tablet (Truvada, TVD) in combination with either an NNRTI or PI/r as their first antiretroviral regimen. Summary of results As of June 2008, 2 years of therapy have been documented for 330/533 (62%) patients. At treatment initiation, 81% were male; median age was 39 years; clinical AIDS diagnosis was documented in 22%; 47% started therapy with CD4 <200 cells/mm3. TVD was combined with an NNRTI (43%) or a PI/r (57%). After 24 months, in an As-Treated (AT) analysis, 85% patients achieved a VL <50 copies/ml (VL <500 copies/ml: 97%), median CD4 count increased from 217 at baseline to 450 cells/mm3 (IQR: 325–608). Truvada showed a good safety profile; 76 adverse events (AEs) of any grade were reported in 66/533 patients (12%); six of these were judged serious. Fourteen (2.6%) patients discontinued TVD due to AEs. Renal abnormalities of any grade were reported in 10 patients (1.9%). Virological failure was documented in nine patients, of which eight were genotyped; M184V/I was detected in three, K65R in two patients. Conclusion During 2 years of follow-up, the overall safety of TVD was good; renal AEs of any grade were reported in 1.9% of patients. K65R was detected in two patients. First-line HAART with TVD plus an NNRTI or PI/r in clinical practice showed comparable efficacy to that observed in controlled clinical trials.
- Once-daily saquinavir (SAQ)/ritonavir (RTV) (2000/100 mg) with abacavir/lamivudine (600/300 mg) or tenofovir/emtricitabine (245/300 mg) in naïve patients (2008)
- Poster presentation: Background In the past years, once-daily (QD) dosing of antiretroviral combination therapy has become an increasingly available treatment option for HIV-1+ patients. Methods Open label study in which HIV-1+ patients treated with SAQ/RTV (1000/100 mg BID) and two NRTIs with HIV-RNA-PCR < 50 copies/ml were switched to SAQ/RTV(2000/100 mg QD) with unchanged NRTI-backbone. CD4-cells, HIV-RNA-PCR, SAQ and RTV drug-levels and metabolic parameters were compared. Summary of results 17 patients (15 male, 42 years), median CD4 456 ± 139/micro l were included so far. The median follow-up time is 4 months. The HIV-RNA-PCR remained <50 copies/ml for all patients. Fasting metabolic parameters remained unchanged. The SAQ AUC 0–12 h were significantly higher when given QD vs. BID (median 29,400 vs. 18,500 ng*h/ml; p = 0.009), whereas the Cmin, Cmax and AUC was lower for RTV when given QD vs. BID (7,400 vs. 11,700 ng*h/ml; p = 0.02). Conclusion In this ongoing study SAQ/RTV (2000/100 mg QD) was well tolerated and demonstrated higher SAQ and lower RTV drug levels as compared to the BID dosing schedule. (Table 1 and Figure 1.)
- Virological and immunological response to three boosted protease inhibitor regimens (2008)
- Poster presentation: Purpose of the study To compare the virological, immunological and clinical response to three boosted double protease inhibitor (PI) regimens of saquinavir and ritonavir in combination with lopinavir (LOPSAQ), atazanavir (ATSAQ) or fosamprenavir (FOSAQ) without reverse transcriptase inhibitors (RTI) in HIV-positive patients with limited RTI treatment options. ...
- Nevirapine (NVP), tenofovir (TDF) and lamivudine (3TC) or emtricitabine (FTC) is effective and well tolerated in naïve HIV-1 infected patients (2008)
- Poster presentation: Background The combination of stavudine (d4T), 3TC and NVP was the WHO recommended first-line regimen for the treatment of naïve HIV-1 infected patients in resource-limited settings. But peripheral polyneuropathy, lipoatrophy and symptomatic hyperlactatemia are frequent and treatment-limiting adverse events associated with stavudine, especially when combined with antituberculous drugs. Tenofovir combined with lamivudine and efavirenz has proven excellent efficacy, but there is little experience when given with NVP. Methods Retrospective analysis of all patients receiving TDF, NVP and 3TC or FTC as first-line treatment in the Frankfurt HIV cohort. Summary of results 70 patients (15 female) with a median CD4 cell count of 210/micro l (47–949) and HIV-RNA PCR of 140,000 copies/ml (2,500–2,000,000) at baseline received TDF, NVP and 3TC/FTC, and were treated for a median of 68 weeks (16–278). CD4 cells rose up to cells/micro l 322 (119–1075) and 75% of the patients remained on treatment. All patients on treatment at week 48 were <50 c/ml, even those starting with CD4 cells of <200 cells/micro l or a HIV-RNA PCR >100,000 c/m. Reasons for discontinuation (24%) were mainly adverse events (13%), with rash (7%) and liver toxicity (6%) being the two most common, whereas virologic failure, drug interaction and non-adherence were all relatively rare (each 3%). Conclusion The combination of NVP, TDF and 3TC or FTC is effective and well tolerated in previously naïve HIV-1 infected patients even when started with low CD4 cell counts (<200/ml) and high viral loads (>100,000 c/ml). In the latest amendment of the WHO guidelines TDF, instead of d4T, is the recommended first-line treatment in resource-limited settings.