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2. Nonnucleoside Reverse-transcriptase Inhibitor- vs Ritonavir-boosted Protease Inhibitor-based Regimens for Initial Treatment of HIV Infection:A Systematic Review and Metaanalysis of Randomized Trials

Author

Borges, Álvaro H, Lundh, Andreas, Tendal, Britta, Bartlett, John A, Clumeck, Nathan, Costagliola, Dominique, Daar, Eric S, Echeverría, Patrícia, Gisslén, Magnus, Huedo-Medina, Tania B, Hughes, Michael D, Huppler Hullsiek, Katherine, Khabo, Paul, Komati, Stephanus, Kumar, Princy, Lockman, Shahin, MacArthur, Rodger D, Maggiolo, Franco, Matteelli, Alberto, Miro, Jose M, Oka, Shinichi, Petoumenos, Kathy, Puls, Rebekah L, Riddler, Sharon A, Sax, Paul E, Sierra-Madero, Juan, Torti, Carlo, Lundgren, Jens D, Borges, Álvaro H, Lundh, Andreas, Tendal, Britta, Bartlett, John A, Clumeck, Nathan, Costagliola, Dominique, Daar, Eric S, Echeverría, Patrícia, Gisslén, Magnus, Huedo-Medina, Tania B, Hughes, Michael D, Huppler Hullsiek, Katherine, Khabo, Paul, Komati, Stephanus, Kumar, Princy, Lockman, Shahin, MacArthur, Rodger D, Maggiolo, Franco, Matteelli, Alberto, Miro, Jose M, Oka, Shinichi, Petoumenos, Kathy, Puls, Rebekah L, Riddler, Sharon A, Sax, Paul E, Sierra-Madero, Juan, Torti, Carlo, and Lundgren, Jens D

Abstract

BACKGROUND: Previous studies suggest that nonnucleoside reverse-transcriptase inhibitors (NNRTIs) cause faster virologic suppression, while ritonavir-boosted protease inhibitors (PI/r) recover more CD4 cells. However, individual trials have not been powered to compare clinical outcomes.METHODS: We searched databases to identify randomized trials that compared NNRTI- vs PI/r-based initial therapy. A metaanalysis calculated risk ratios (RRs) or mean differences (MDs), as appropriate. Primary outcome was death or progression to AIDS. Secondary outcomes were death, progression to AIDS, and treatment discontinuation. We calculated RR of virologic suppression and MD for an increase in CD4 cells at week 48.RESULTS: We included 29 trials with 9047 participants. Death or progression to AIDS occurred in 226 participants in the NNRTI arm and in 221 in the PI/r arm (RR, 1.03; 95% confidence interval, .87-1.22; 12 trials; n = 3825), death in 205 participants in the NNRTI arm vs 198 in the PI/r arm (1.04; 0.86-1.25; 22 trials; n = 8311), and progression to AIDS in 140 participants in the NNRTI arm vs 144 in the PI/r arm (1.00; 0.80-1.25; 13 trials; n = 4740). Overall treatment discontinuation (1.12; 0.93-1.35; 24 trials; n = 8249) and from toxicity (1.21; 0.87-1.68; 21 trials; n = 6195) were comparable, but discontinuation due to virologic failure was more common with NNRTI (1.58; 0.91-2.74; 17 trials; n = 5371). At week 48, there was no difference between NNRTI and PI/r in virologic suppression (RR, 1.03; 0.98-1.09) or CD4(+) recovery (MD, -4.7 cells; -14.2 to 4.8).CONCLUSIONS: We found no difference in clinical and viro-immunologic outcomes between NNRTI- and PI/r-based therapy.

Published
2016

3. An HIV-1 clade A/E DNA prime, recombinant fowlpox virus boost vaccine is safe, but non-immunogenic in a randomized phase 1/11a trial in Thai volunteers at low risk of HIV infection

Author

Hemachandra, Atchriya, Puls, Rebekah L, Sirivichayakul, Sunee, Kerr, Stephen, Thantiworasit, Pattarawat, Ubolyam, Sasiwimol, Cooper, David A, Emery, Sean, Phanuphak, Praphan, Kelleher, Anthony, and Ruxrungtham, Kiat

Subjects
AIDS Vaccines, Adult, CD4-Positive T-Lymphocytes, Male, Drug Carriers, Vaccines, Synthetic, Fowlpox virus, Genetic Vectors, Immunization, Secondary, HIV Infections, CD8-Positive T-Lymphocytes, Middle Aged, Thailand, Injections, Intramuscular, Placebos, Human Experimentation, Double-Blind Method, Vaccines, Subunit, HIV-1, Vaccines, DNA, Cytokines, Humans, Female, Immunization, Research Paper
Abstract

Previously demonstrated safe and highly immunogenic in non-human primates, this study assessed DNA (pHIS-HIV-AE) prime, recombinant fowlpox (rFPV-HIV-AE) boost vaccines in humans.Eight participants (6 active vaccine, 2 placebo) received all vaccinations; local and systemic reactions were mild to moderate. The percentage CD4(+) and CD8(+) T cells responding to HIV-1 Gag antigens by ICS (mean ± SD) was 0.16 ± 0.12 and 0.10 ± 0.12 for active and 0.01 ± 0.01 and 0.00 ± 0.00 for placebo vaccine respectively. The percentage of T cells responding did not reach pre-defined thresholds to be considered positive responses. Consequently, the Data Safety Monitoring Board recommended cessation of further recruitment. Existing volunteers were followed to 52 weeks.Vectors expressing homologous HIV-1 clade A/E gag, pol, env and regulatory genes or matched placebo were administered intramuscularly at weeks 0, 4, 8 (6 mg pHIS-HIV-AE) and week 12 (3.0 x 10(8) pfu rFPV-HIV-AE) in this randomized, double-blind, placebo-controlled phase I/IIa study in healthy Thai adults at low risk of HIV infection. Immunogenicity was determined by interferon-gamma and IL-2 expression using intracellular cytokine staining assay (ICS), 13 weeks after randomization. Interim analysis was performed when eight volunteers reached 16 weeks follow-up.Vaccine candidates were generally well tolerated, but showed limited immunogenicity. Better vaccines and delivery systems are required.

Published
2010

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