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H. Green - One of the best experts on this subject based on the ideXlab platform.

  • Lamivudine abacavir maintains virological superiority over zidovudine Lamivudine and zidovudine abacavir beyond 5 years in children
    AIDS, 2007
    Co-Authors: H. Green, K Butler, A Compagnucci, Della Negra M, Guido Castelligattinara, A. S. Walker, Diana M. Gibb, Fatima Candeias, Deenan Pillay, De Rossi A
    Abstract:

    To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial.PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART).128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo.Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V).Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

  • Lamivudine/abacavir maintains virological superiority over zidovudine/Lamivudine and zidovudine/abacavir beyond 5 years in children
    AIDS, 2007
    Co-Authors: H. Green, Pillay D, Butler K, Candeias F, Castelli-gattinara G, Compagnucci A, Della Negra M, A. S. Walker, Diana M. Gibb, De Rossi A
    Abstract:

    To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial.PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART).128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo.Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V).Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

  • Lamivudine/abacavir maintains virological superiority over zidovudine/Lamivudine and zidovudine/abacavir beyond 5 years in children
    AIDS (London England), 2007
    Co-Authors: H. Green, K Butler, A Compagnucci, A. S. Walker, Diana M. Gibb, Fatima Candeias, Deenan Pillay, G Castelli-gattinara, M Della Negra, A. De Rossi
    Abstract:

    OBJECTIVE: To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial. DESIGN: PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART). METHODS: 128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo. RESULTS: Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V). CONCLUSIONS: Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

D.f. Gray - One of the best experts on this subject based on the ideXlab platform.

  • adefovir dipivoxil alone or in combination with Lamivudine in patients with Lamivudine resistant chronic hepatitis b
    Gastroenterology, 2004
    Co-Authors: Marion G. Peters, Marc Bourliere, Kris V Kowdley, Jenny E Heathcote, Peter Buggisch, Christian Trepo, Hie-won Hann, Robert H. Rubin, Paul Martin, D.f. Gray
    Abstract:

    Abstract Background & Aims: Adefovir dipivoxil possesses potent in vitro and in vivo antiviral activity in wild-type hepatitis B. This study assessed the safety and efficacy of adefovir dipivoxil alone and in combination with Lamivudine compared with ongoing Lamivudine therapy in patients with chronic hepatitis B with compensated liver disease and Lamivudine-resistant hepatitis B virus (HBV). Methods: Fifty-nine hepatitis B e antigen (HBeAg)-positive patients with genotypic evidence of Lamivudine-resistant HBV, serum alanine aminotransferase (ALT) level ≥1.2 times the upper limit of normal, and serum HBV DNA level ≥6 log 10 copies/mL despite ongoing treatment with Lamivudine were randomized to adefovir dipivoxil 10 mg, Lamivudine 100 mg, or addition of adefovir dipivoxil to ongoing Lamivudine daily. The primary end point was the time-weighted average change from baseline in serum HBV DNA level (DAVG) up to week 16. Results: Rapid reductions in serum HBV DNA level were seen by 4 weeks in all recipients of adefovir dipivoxil; DAVG 16 was −0.07 in the Lamivudine group compared with −2.45 and −2.46 log 10 copies/mL in the adefovir dipivoxil/Lamivudine and adefovir dipivoxil monotherapy groups, respectively ( P 10 copies/mL in the Lamivudine, adefovir dipivoxil/Lamivudine, and adefovir dipivoxil groups, respectively. ALT level normalized in 10 of 19 (53%) and 9 of 18 (47%) recipients of adefovir dipivoxil/Lamivudine and adefovir dipivoxil, respectively, compared with 1 of 19 (5%) recipients of Lamivudine. Three patients receiving adefovir dipivoxil or adefovir dipivoxil/Lamivudine and none receiving Lamivudine monotherapy were HBeAg negative at week 48 and one became hepatitis B surface antigen negative. Conclusions: These data, limited to patients with compensated liver disease, indicate that adefovir dipivoxil alone or in combination with ongoing Lamivudine therapy provides effective antiviral therapy in patients with Lamivudine-resistant HBV.

  • Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis b infection a randomised trial
    Gut, 2000
    Co-Authors: Solko W. Schalm, Bernard Willems, Jenny Heathcote, J Cianciara, G Farrell, Mark Sherman, Amar P Dhillon, A Moorat, Judy Barber, D.f. Gray
    Abstract:

    BACKGROUND, AIM, AND METHODS—Alpha interferon is the generally approved therapy for HBe antigen positive patients with chronic hepatitis B, but its efficacy is limited. Lamivudine is a new oral nucleoside analogue which potently inhibits hepatitis B virus (HBV) DNA replication. To investigate the possibility of an additive effect of interferon-Lamivudine combination therapy compared with interferon or Lamivudine monotherapy, we conducted a randomised controlled trial in 230 predominantly Caucasian patients with hepatitis B e antigen (HBeAg) and HBV DNA positive chronic hepatitis B. Previously untreated patients were randomised to receive: combination therapy of Lamivudine 100 mg daily with alpha interferon 10 million units three times weekly for 16 weeks after pretreatment with Lamivudine for eight weeks (n=75); alpha interferon 10 million units three times weekly for 16 weeks (n=69); or Lamivudine 100 mg daily for 52 weeks (n=82). The primary efficacy end point was the HBeAg seroconversion rate at week 52 (loss of HBeAg, development of antibodies to HBeAg and undetectable HBV DNA). RESULTS—The HBeAg seroconversion rate at week 52 was 29% for the combination therapy, 19% for interferon monotherapy, and 18% for Lamivudine monotherapy (p=0.12 and p=0.10, respectively, for comparison of the combination therapy with interferon or Lamivudine monotherapy). The HBeAg seroconversion rates at week 52 for the combination therapy and Lamivudine monotherapy were significantly different in the per protocol analysis (36% (20/56) v 19% (13/70), respectively; p=0.02). The effect of combining Lamivudine and interferon appeared to be most useful in patients with moderately elevated alanine aminotransferase levels at baseline. Adverse events with the combination therapy were similar to interferon monotherapy; patients receiving Lamivudine monotherapy had significantly fewer adverse events. CONCLUSIONS—HBeAg seroconversion rates at one year were similar for Lamivudine monotherapy (52 weeks) and standard alpha interferon therapy (16 weeks). The combination of Lamivudine and interferon appeared to increase the HBeAg seroconversion rate, particularly in patients with moderately elevated baseline aminotransferase levels. The potential benefit of combining Lamivudine and interferon should be investigated further in studies with different regimens of combination therapy. Keywords: chronic hepatitis B; hepatitis B virus; nucleoside analogue; Lamivudine; alpha interferon; combination therapy; HBeAg seroconversion

  • a one year trial of Lamivudine for chronic hepatitis b
    The New England Journal of Medicine, 1998
    Co-Authors: Chinglung Lai, Judy Barber, Tingtsung Chang, R N Chien, N W Y Leung, R Guan, D I Tai, Julie C Dent, S L Stephenson, D.f. Gray
    Abstract:

    Background and Methods In preliminary trials, Lamivudine, an oral nucleoside analogue, has shown promise for the treatment of chronic hepatitis B. We conducted a one-year, double-blind trial of Lamivudine in 358 Chinese patients with chronic hepatitis B. The patients were randomly assigned to receive 25 mg of Lamivudine (142 patients), 100 mg of Lamivudine (143), or placebo (73) orally once daily. The patients underwent liver biopsies before entering the study and after completing the assigned treatment regimen. The primary end point was a reduction of at least two points in the Knodell necroinflammatory score. Results Hepatic necroinflammatory activity improved by two points or more in 56 percent of the patients receiving 100 mg of Lamivudine, 49 percent of those receiving 25 mg of Lamivudine, and 25 percent of those receiving placebo (P<0.001 and P=0.001, respectively, for the comparisons of Lamivudine treatment with placebo). Necroinflammatory activity worsened in 7 percent of the patients receiving 10...

  • a one year trial of Lamivudine for chronic hepatitis b
    The New England Journal of Medicine, 1998
    Co-Authors: R N Chien, Judy Barber, Tingtsung Chang, N W Y Leung, R Guan, Julie C Dent, S L Stephenson, K Y Ng, P C Wu, D.f. Gray
    Abstract:

    BACKGROUND AND METHODS: In preliminary trials, Lamivudine, an oral nucleoside analogue, has shown promise for the treatment of chronic hepatitis B. We conducted a one-year, double-blind trial of Lamivudine in 358 Chinese patients with chronic hepatitis B. The patients were randomly assigned to receive 25 mg of Lamivudine (142 patients), 100 mg of Lamivudine (143), or placebo (73) orally once daily. The patients underwent liver biopsies before entering the study and after completing the assigned treatment regimen. The primary end point was a reduction of at least two points in the Knodell necroinflammatory score. RESULTS: Hepatic necroinflammatory activity improved by two points or more in 56 percent of the patients receiving 100 mg of Lamivudine, 49 percent of those receiving 25 mg of Lamivudine, and 25 percent of those receiving placebo (P<0.001 and P=0.001, respectively, for the comparisons of Lamivudine treatment with placebo). Necroinflammatory activity worsened in 7 percent of the patients receiving 100 mg of Lamivudine, 8 percent of those receiving 25 mg, and 26 percent of those receiving placebo. The 100-mg dose of Lamivudine was associated with a reduced progression of fibrosis (P=0.01 for the comparison with placebo) and with the highest rate of hepatitis B e antigen (HBeAg) seroconversion (loss of HBeAg, development of antibody to HBeAg, and undetectable HBV DNA) (16 percent), the greatest suppression of HBV DNA (98 percent reduction at week 52 as compared with the base-line value), and the highest rate of sustained normalization of alanine aminotransferase levels (72 percent). Ninety-six percent of the patients completed the study. The incidence of adverse events was similar in all groups, and there were few serious events. CONCLUSIONS: In a one-year study, Lamivudine was associated with substantial histologic improvement in many patients with chronic hepatitis B. A daily dose of 100 mg was more effective than a daily dose of 25 mg.

A. S. Walker - One of the best experts on this subject based on the ideXlab platform.

  • Lamivudine abacavir maintains virological superiority over zidovudine Lamivudine and zidovudine abacavir beyond 5 years in children
    AIDS, 2007
    Co-Authors: H. Green, K Butler, A Compagnucci, Della Negra M, Guido Castelligattinara, A. S. Walker, Diana M. Gibb, Fatima Candeias, Deenan Pillay, De Rossi A
    Abstract:

    To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial.PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART).128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo.Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V).Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

  • Lamivudine/abacavir maintains virological superiority over zidovudine/Lamivudine and zidovudine/abacavir beyond 5 years in children
    AIDS, 2007
    Co-Authors: H. Green, Pillay D, Butler K, Candeias F, Castelli-gattinara G, Compagnucci A, Della Negra M, A. S. Walker, Diana M. Gibb, De Rossi A
    Abstract:

    To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial.PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART).128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo.Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V).Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

  • Lamivudine/abacavir maintains virological superiority over zidovudine/Lamivudine and zidovudine/abacavir beyond 5 years in children
    AIDS (London England), 2007
    Co-Authors: H. Green, K Butler, A Compagnucci, A. S. Walker, Diana M. Gibb, Fatima Candeias, Deenan Pillay, G Castelli-gattinara, M Della Negra, A. De Rossi
    Abstract:

    OBJECTIVE: To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial. DESIGN: PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART). METHODS: 128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo. RESULTS: Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V). CONCLUSIONS: Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

Diana M. Gibb - One of the best experts on this subject based on the ideXlab platform.

  • Lamivudine abacavir maintains virological superiority over zidovudine Lamivudine and zidovudine abacavir beyond 5 years in children
    AIDS, 2007
    Co-Authors: H. Green, K Butler, A Compagnucci, Della Negra M, Guido Castelligattinara, A. S. Walker, Diana M. Gibb, Fatima Candeias, Deenan Pillay, De Rossi A
    Abstract:

    To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial.PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART).128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo.Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V).Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

  • Lamivudine/abacavir maintains virological superiority over zidovudine/Lamivudine and zidovudine/abacavir beyond 5 years in children
    AIDS, 2007
    Co-Authors: H. Green, Pillay D, Butler K, Candeias F, Castelli-gattinara G, Compagnucci A, Della Negra M, A. S. Walker, Diana M. Gibb, De Rossi A
    Abstract:

    To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial.PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART).128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo.Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V).Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

  • Lamivudine/abacavir maintains virological superiority over zidovudine/Lamivudine and zidovudine/abacavir beyond 5 years in children
    AIDS (London England), 2007
    Co-Authors: H. Green, K Butler, A Compagnucci, A. S. Walker, Diana M. Gibb, Fatima Candeias, Deenan Pillay, G Castelli-gattinara, M Della Negra, A. De Rossi
    Abstract:

    OBJECTIVE: To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial. DESIGN: PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART). METHODS: 128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo. RESULTS: Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V). CONCLUSIONS: Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.

De Rossi A - One of the best experts on this subject based on the ideXlab platform.

  • Lamivudine abacavir maintains virological superiority over zidovudine Lamivudine and zidovudine abacavir beyond 5 years in children
    AIDS, 2007
    Co-Authors: H. Green, K Butler, A Compagnucci, Della Negra M, Guido Castelligattinara, A. S. Walker, Diana M. Gibb, Fatima Candeias, Deenan Pillay, De Rossi A
    Abstract:

    To describe the long-term efficacy over 5 years of regimens including combinations of abacavir, Lamivudine and/or zidovudine in previously untreated children in the PENTA 5 trial.PENTA 5 was a 48-week randomised controlled trial comparing three dual nucleoside reverse transcriptase inhibitor (NRTI) combinations as part of first triple antiretroviral therapy (ART).128 ART-naive children were randomised to zidovudine\Lamivudine (n = 36), zidovudine\abacavir (45) or Lamivudine\abacavir (47). Asymptomatic children (n = 55) were also randomised to nelfinavir or placebo; all other children received open-label nelfinavir. Analyses are intent-to-treat and adjusted for minor baseline imbalances and receipt of nelfinavir/placebo.Median follow-up was 5.8 years. By 5 years, 17 (47%), 28 (64%) and 18 (39%) children had changed their randomised NRTIs in the zidovudine\Lamivudine, zidovudine\abacavir and Lamivudine\abacavir groups respectively, but 18%, 50% and 50% of these changes were either early single drug substitutions for toxicity or switches with viral suppression (HIV-1 RNA < 400 copies/ml; e.g. to simplify regimen delivery). At 5 years, 55%/32% zidovudine\Lamivudine, 50%/25% zidovudine\abacavir and 79%/63% Lamivudine\abacavir had HIV-1 RNA < 400/< 50 copies/ml respectively (p = 0.03/p = 0.003). Mean increase in height-for-age 0.42, 0.68, 1.05 (p = 0.02); weight-for-age 0.03, 0.13, 0.75 (p = 0.02). Reverse transcriptase resistance mutations emerging on therapy differed between the groups: zidovudine\Lamivudine (M41L, D67N, K70R, M184V, L210W, T215Y); zidovudine\abacavir (M41L, D67N, K70R, L210W, T215F/Y, K219Q); Lamivudine\abacavir (K65R, L74V, Y115F, M184V).Five year data demonstrate that Lamivudine\abacavir is more effective in terms of HIV-1 RNA suppression and growth changes, with lower rates of switching with detectable HIV-1 RNA than zidovudine\Lamivudine or zidovudine\abacavir, and should be preferred as first-line NRTI backbone.