A Controlled Trial of Valganciclovir as Induction Therapy for Cytomegalovirus Retinitis
This randomized trial involved 160 patients with the acquired immunodeficiency syndrome (AIDS) and newly diagnosed cytomegalovirus retinitis. After four weeks, the response to induction therapy was satisfactory in 72 percent of patients who received oral valganciclovir, as compared with 77 percent o...
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| Published in: | The New England journal of medicine Vol. 346; no. 15; pp. 1119 - 1126 |
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| Main Authors: | , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Boston, MA
Massachusetts Medical Society
11-04-2002
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| Abstract | This randomized trial involved 160 patients with the acquired immunodeficiency syndrome (AIDS) and newly diagnosed cytomegalovirus retinitis. After four weeks, the response to induction therapy was satisfactory in 72 percent of patients who received oral valganciclovir, as compared with 77 percent of those who received intravenous ganciclovir. The median time to progression of retinitis was 160 days for the valganciclovir group and 125 days for the ganciclovir group.
Cytomegalovirus retinitis remains the leading cause of visual loss in patients with the acquired immunodeficiency syndrome (AIDS).
1
–
3
Induction therapy with intravenous ganciclovir,
4
,
5
foscarnet,
5
,
6
or cidofovir,
7
,
8
followed by maintenance therapy, can effectively make cytomegalovirus retinitis inactive. If recovery of immune function is not possible, indefinite treatment is needed, and an indwelling catheter and daily intravenous medication may be required. The cost, the risk of sepsis, and the adverse effect on the quality of life associated with an indwelling catheter spurred the development of an oral formulation of ganciclovir.
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When administered orally, ganciclovir requires three doses (up to . . . |
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| AbstractList | BACKGROUNDValganciclovir is an orally administered prodrug that is rapidly hydrolyzed to ganciclovir. We compared the effects of oral valganciclovir with those of intravenous ganciclovir as induction therapy for newly diagnosed cytomegalovirus retinitis in 160 patients with the acquired immunodeficiency syndrome (AIDS).METHODSThe primary end point was photographically determined progression of cytomegalovirus retinitis within four weeks after the initiation of treatment. Secondary end points included the achievement of a prospectively defined satisfactory response to induction therapy and the time to progression of cytomegalovirus retinitis. After four weeks, all patients received valganciclovir as maintenance therapy.RESULTSEighty patients were randomly assigned to each treatment group. Of the patients who could be evaluated, 7 of 70 assigned to intravenous ganciclovir (10.0 percent) and 7 of 71 assigned to oral valganciclovir (9.9 percent) had progression of cytomegalovirus retinitis during the first four weeks (difference in proportions, 0.1 percentage point; 95 percent confidence interval, -9.7 to 10.0). Forty-seven of 61 patients (77.0 percent) assigned to intravenous ganciclovir and 46 of 64 (71.9 percent) assigned to valganciclovir had a satisfactory response to induction therapy (difference in proportions, 5.2 percentage points; 95 percent confidence interval, -20.4 to 10.1). The median times to progression of retinitis were 125 days in the group assigned to intravenous ganciclovir and 160 days in the group assigned to oral valganciclovir. The mean values for the area under the curve for the ganciclovir dosage interval were similar at both induction doses and maintenance doses. The frequency and severity of adverse events were similar in the two treatment groups.CONCLUSIONSOrally administered valganciclovir appears to be as effective as intravenous ganciclovir for induction treatment and is convenient and effective for the long-term management of cytomegalovirus retinitis in patients with AIDS. This randomized trial involved 160 patients with the acquired immunodeficiency syndrome (AIDS) and newly diagnosed cytomegalovirus retinitis. After four weeks, the response to induction therapy was satisfactory in 72 percent of patients who received oral valganciclovir, as compared with 77 percent of those who received intravenous ganciclovir. The median time to progression of retinitis was 160 days for the valganciclovir group and 125 days for the ganciclovir group. Cytomegalovirus retinitis remains the leading cause of visual loss in patients with the acquired immunodeficiency syndrome (AIDS). 1 – 3 Induction therapy with intravenous ganciclovir, 4 , 5 foscarnet, 5 , 6 or cidofovir, 7 , 8 followed by maintenance therapy, can effectively make cytomegalovirus retinitis inactive. If recovery of immune function is not possible, indefinite treatment is needed, and an indwelling catheter and daily intravenous medication may be required. The cost, the risk of sepsis, and the adverse effect on the quality of life associated with an indwelling catheter spurred the development of an oral formulation of ganciclovir. 9 When administered orally, ganciclovir requires three doses (up to . . . Valganciclovir is an orally administered prodrug that is rapidly hydrolyzed to ganciclovir. We compared the effects of oral valganciclovir with those of intravenous ganciclovir as induction therapy for newly diagnosed cytomegalovirus retinitis in 160 patients with the acquired immunodeficiency syndrome (AIDS). The primary end point was photographically determined progression of cytomegalovirus retinitis within four weeks after the initiation of treatment. Secondary end points included the achievement of a prospectively defined satisfactory response to induction therapy and the time to progression of cytomegalovirus retinitis. After four weeks, all patients received valganciclovir as maintenance therapy. Eighty patients were randomly assigned to each treatment group. Of the patients who could be evaluated, 7 of 70 assigned to intravenous ganciclovir (10.0 percent) and 7 of 71 assigned to oral valganciclovir (9.9 percent) had progression of cytomegalovirus retinitis during the first four weeks (difference in proportions, 0.1 percentage point; 95 percent confidence interval, -9.7 to 10.0). Forty-seven of 61 patients (77.0 percent) assigned to intravenous ganciclovir and 46 of 64 (71.9 percent) assigned to valganciclovir had a satisfactory response to induction therapy (difference in proportions, 5.2 percentage points; 95 percent confidence interval, -20.4 to 10.1). The median times to progression of retinitis were 125 days in the group assigned to intravenous ganciclovir and 160 days in the group assigned to oral valganciclovir. The mean values for the area under the curve for the ganciclovir dosage interval were similar at both induction doses and maintenance doses. The frequency and severity of adverse events were similar in the two treatment groups. Orally administered valganciclovir appears to be as effective as intravenous ganciclovir for induction treatment and is convenient and effective for the long-term management of cytomegalovirus retinitis in patients with AIDS. Background Valganciclovir is an orally administered prodrug that is rapidly hydrolyzed to ganciclovir. We compared the effects of oral valganciclovir with those of intravenous ganciclovir as induction therapy for newly diagnosed cytomegalovirus retinitis in 160 patients with the acquired immunodeficiency syndrome (AIDS). Methods The primary end point was photographically determined progression of cytomegalovirus retinitis within four weeks after the initiation of treatment. Secondary end points included the achievement of a prospectively defined satisfactory response to induction therapy and the time to progression of cytomegalovirus retinitis. After four weeks, all patients received valganciclovir as maintenance therapy. Results Eighty patients were randomly assigned to each treatment group. Of the patients who could be evaluated, 7 of 70 assigned to intravenous ganciclovir (10.0 percent) and 7 of 71 assigned to oral valganciclovir (9.9 percent) had progression of cytomegalovirus retinitis during the first four weeks (difference in proportions, 0.1 percentage point; 95 percent confidence interval, -9.7 to 10.0). Forty-seven of 61 patients (77.0 percent) assigned to intravenous ganciclovir and 46 of 64 (71.9 percent) assigned to valganciclovir had a satisfactory response to induction therapy (difference in proportions, 5.2 percentage points; 95 percent confidence interval, -20.4 to 10.1). The median times to progression of retinitis were 125 days in the group assigned to intravenous ganciclovir and 160 days in the group assigned to oral valganciclovir. The mean values for the area under the curve for the ganciclovir dosage interval were similar at both induction doses and maintenance doses. The frequency and severity of adverse events were similar in the two treatment groups. Conclusions Orally administered valganciclovir appears to be as effective as intravenous ganciclovir for induction treatment and is convenient and effective for the long-term management of cytomegalovirus retinitis in patients with AIDS. Valganciclovir is an orally administered prodrug that is rapidly hydrolyzed to ganciclovir. We compared the effects of oral valganciclovir with those of intravenous ganciclovir as induction therapy for newly diagnosed cytomegalovirus retinitis in 160 patients with the acquired immunodeficiency syndrome (AIDS). The primary end point was photographically determined progression of cytomegalovirus retinitis within four weeks after the initiation of treatment. Secondary end points included the achievement of a prospectively defined satisfactory response to induction therapy and the time to progression of cytomegalovirus retinitis. After four weeks, all patients received valganciclovir as maintenance therapy. Eighty patients were randomly assigned to each treatment group. Of the patients who could be evaluated, 7 of 70 assigned to intravenous ganciclovir (10.0 percent) and 7 of 71 assigned to oral valganciclovir (9.9 percent) had progression of cytomegalovirus retinitis during the first four weeks (difference in proportions, 0.1 percentage point; 95 percent confidence interval, -9.7 to 10.0). Forty-seven of 61 patients (77.0 percent) assigned to intravenous ganciclovir and 46 of 64 (71.9 percent) assigned to valganciclovir had a satisfactory response to induction therapy (difference in proportions, 5.2 percentage points; 95 percent confidence interval, -20.4 to 10.1). The median times to progression of retinitis were 125 days in the group assigned to intravenous ganciclovir and 160 days in the group assigned to oral valganciclovir. The mean values for the area under the curve for the ganciclovir dosage interval were similar at both induction doses and maintenance doses. The frequency and severity of adverse events were similar in the two treatment groups. Orally administered valganciclovir appears to be as effective as intravenous ganciclovir for induction treatment and is convenient and effective for the long-term management of cytomegalovirus retinitis in patients with AIDS. |
| Author | Walmsley, Sharon Wolitz, Richard A Georgiou, Panos Sierra-Madero, Juan Martin, Daniel F Macey, Katherine Robinson, Charles A Stempien, Mary Jean |
| Author_xml | – sequence: 1 givenname: Daniel F surname: Martin fullname: Martin, Daniel F – sequence: 2 givenname: Juan surname: Sierra-Madero fullname: Sierra-Madero, Juan – sequence: 3 givenname: Sharon surname: Walmsley fullname: Walmsley, Sharon – sequence: 4 givenname: Richard A surname: Wolitz fullname: Wolitz, Richard A – sequence: 5 givenname: Katherine surname: Macey fullname: Macey, Katherine – sequence: 6 givenname: Panos surname: Georgiou fullname: Georgiou, Panos – sequence: 7 givenname: Charles A surname: Robinson fullname: Robinson, Charles A – sequence: 8 givenname: Mary Jean surname: Stempien fullname: Stempien, Mary Jean |
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| ContentType | Journal Article |
| Copyright | Copyright © 2002 Massachusetts Medical Society. All rights reserved. 2002 INIST-CNRS |
| Copyright_xml | – notice: Copyright © 2002 Massachusetts Medical Society. All rights reserved. – notice: 2002 INIST-CNRS |
| CorporateAuthor | Valganciclovir Study Group |
| CorporateAuthor_xml | – name: Valganciclovir Study Group |
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| DOI | 10.1056/NEJMoa011759 |
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| Keywords | Human Immunopathology Cytomegalovirus Retinopathy Valganciclovir Herpesviridae Treatment efficiency Oral administration Retroviridae AIDS Betaherpesvirinae Immune deficiency Lentivirus Immunomodulator Infection Virus Eye disease Association Viral disease Antiviral Clinical trial Retinitis Human immunodeficiency virus |
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| References | N Engl J Med 2002 Sep 12;347(11):862 Lalezari JP (r007) 1997; 126 r010 r001 r012 (r005) 1994; 101 Palestine AG (r006) 1991; 115 Martin DF (r011) 1994; 112 r018 Kuppermann BD (r002) 1993; 115 r009 r013 r003 r014 r004 r015 r016 Ferris FL (r017) 1982; 94 (r008) 1997; 126 |
| References_xml | – volume: 115 start-page: 665 year: 1991 ident: r006 publication-title: Ann Intern Med doi: 10.7326/0003-4819-115-9-665 contributor: fullname: Palestine AG – ident: r014 doi: 10.1177/00912709922008452 – volume: 94 start-page: 91 year: 1982 ident: r017 publication-title: Am J Ophthalmol doi: 10.1016/0002-9394(82)90197-0 contributor: fullname: Ferris FL – ident: r012 doi: 10.1056/NEJM199707103370203 – volume: 126 start-page: 257 year: 1997 ident: r007 publication-title: Ann Intern Med doi: 10.7326/0003-4819-126-4-199702150-00001 contributor: fullname: Lalezari JP – ident: r009 doi: 10.1056/NEJM199509073331002 – volume: 101 start-page: 1250 year: 1994 ident: r005 publication-title: Ophthalmology doi: 10.1016/S0161-6420(94)31181-X – ident: r010 doi: 10.1016/S1386-6532(01)00229-3 – ident: r003 doi: 10.1093/infdis/166.6.1223 – ident: r001 doi: 10.1056/NEJM199312233292604 – ident: r016 doi: 10.1128/AAC.44.10.2811-2815.2000 – volume: 126 start-page: 264 year: 1997 ident: r008 publication-title: Ann Intern Med doi: 10.7326/0003-4819-126-4-199702150-00002 – volume: 115 start-page: 575 year: 1993 ident: r002 publication-title: Am J Ophthalmol doi: 10.1016/S0002-9394(14)71453-9 contributor: fullname: Kuppermann BD – ident: r015 doi: 10.2165/00003088-199937020-00005 – ident: r004 doi: 10.1093/infdis/168.3.557 – volume: 112 start-page: 1531 year: 1994 ident: r011 publication-title: Arch Ophthalmol doi: 10.1001/archopht.1994.01090240037023 contributor: fullname: Martin DF – ident: r013 doi: 10.1056/NEJM199904083401402 – ident: r018 doi: 10.2307/2281868 |
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| Snippet | This randomized trial involved 160 patients with the acquired immunodeficiency syndrome (AIDS) and newly diagnosed cytomegalovirus retinitis. After four weeks,... Valganciclovir is an orally administered prodrug that is rapidly hydrolyzed to ganciclovir. We compared the effects of oral valganciclovir with those of... Background Valganciclovir is an orally administered prodrug that is rapidly hydrolyzed to ganciclovir. We compared the effects of oral valganciclovir with... BACKGROUNDValganciclovir is an orally administered prodrug that is rapidly hydrolyzed to ganciclovir. We compared the effects of oral valganciclovir with those... |
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| SubjectTerms | Acquired Immunodeficiency Syndrome - complications Administration, Oral Adult AIDS-Related Opportunistic Infections - drug therapy AIDS-Related Opportunistic Infections - pathology Antiviral Agents - blood Antiviral Agents - pharmacokinetics Antiviral Agents - therapeutic use Biological and medical sciences Catheters Clinical trials Cytomegalovirus Cytomegalovirus - isolation & purification Cytomegalovirus Retinitis - drug therapy Cytomegalovirus Retinitis - pathology Diabetic retinopathy Disease Progression Eye Female Ganciclovir - analogs & derivatives Ganciclovir - blood Ganciclovir - pharmacokinetics Ganciclovir - therapeutic use HIV HIV - isolation & purification Human immunodeficiency virus Humans Injections, Intravenous Male Medical sciences Pharmacology. Drug treatments Prodrugs - pharmacokinetics Prodrugs - therapeutic use Viral Load |
| Title | A Controlled Trial of Valganciclovir as Induction Therapy for Cytomegalovirus Retinitis |
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