A Controlled Trial of Valganciclovir as Induction Therapy for Cytomegalovirus Retinitis

• Published in: The New England journal of medicine Vol. 346; no. 15; pp. 1119 - 1126
• Main Authors: Martin, Daniel F, Sierra-Madero, Juan, Walmsley, Sharon, Wolitz, Richard A, Macey, Katherine, Georgiou, Panos, Robinson, Charles A, Stempien, Mary Jean
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 11-04-2002
• Subjects: 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; 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
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa011759

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 . . .