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NEW ORLEANS—The antiviral agent maribavir has shown activity against cytomegalovirus (CMV) in a phase 2 trial.
The trial included transplant recipients with a CMV infection that was resistant or refractory to prior treatment with (val)ganciclovir or foscarnet.
Sixty-seven percent of patients treated with varying doses of maribavir for up to 24 weeks had no detectable levels of CMV in their plasma within 6 weeks of starting treatment.
However, CMV infection did recur in some of these patients.
Dysgeusia was the most commonly reported treatment-emergent adverse event (AE), and one patient died of an AE that was considered possibly related to maribavir.
These results were presented at IDWeek 2016 (abstract 78). The study was sponsored by Shire.
“Cytomegalovirus infection that is resistant or refractory to standard therapy in transplant patients is associated with significant complications and high mortality,” said study investigator Genovefa Papanicolaou, MD, of Memorial Sloan Kettering Cancer Center in New York, New York.
“The phase 2 findings support further research to confirm these results among patients who have limited options to combat the infection.”
Maribavir is a member of a class of drugs called benzimidazole ribosides. Maribavir is thought to inhibit viral DNA assembly and egress of viral capsids from the nucleus of infected cells. The drug has not been shown to affect the maturation of viral DNA or affect the viral DNA polymerase.
This phase 2 study of maribavir included 120 patients ages 12 and older with CMV infection (≥1000 DNA copies/mL of blood plasma) that was resistant or refractory to (val)ganciclovir or foscarnet.
Forty-seven of the patients had received a hematopoietic stem cell transplant, and 73 had a solid organ transplant. The patients’ median age was 55 (range, 18 to 74).
The patients were randomized to 1 of 3 twice-daily oral doses of maribavir—400 mg, 800 mg, or 1200 mg—for up to 24 weeks of treatment.
Efficacy
The study’s primary efficacy endpoint was the proportion of patients with confirmed undetectable plasma CMV DNA within 6 weeks of treatment.
Overall, 67% (80/120) of patients met the primary efficacy endpoint. This included 70% (n=28) of patients in the 400 mg group, 63% (n=25) in the 800 mg group, and 67% (n=27) in the 1200 mg group.
CMV infection recurred in 30 patients, including 7 in the 400 mg group, 11 in the 800 mg group, and 12 in the 1200 mg group.
Safety
The primary safety analysis was focused on the incidence of treatment-emergent AEs. The incidence was 78% (n=93) overall, including 78% (n=31) in the 400 mg group, 80% (n=32) in the 800 mg group, and 75% (n=30) in the 1200 mg group.
Twenty-seven percent of patients died due to any AE, 1 of which (multi-organ failure) was considered possibly related to maribavir.
Forty-one patients (34%) discontinued treatment with maribavir due to an AE, including 17 patients who discontinued due to CMV infection.
Dysgeusia was the most common treatment-emergent AE and led to treatment discontinuation in 1 patient. Dysgeusia occurred in 65% (n=78) of all patients, including 60% (n=24) in the 400 mg group, 63% (n=25) in the 800 mg group, and 73% (n=29) in the 1200 mg group.
Other treatment-emergent AEs (occurring in at least 20% of patients) for all doses included nausea, vomiting, CMV infection, diarrhea, fatigue, and anemia. Immunosuppressant drug level increases were reported as an AE in 10% of all patients. 
NEW ORLEANS—The antiviral agent maribavir has shown activity against cytomegalovirus (CMV) in a phase 2 trial.
The trial included transplant recipients with a CMV infection that was resistant or refractory to prior treatment with (val)ganciclovir or foscarnet.
Sixty-seven percent of patients treated with varying doses of maribavir for up to 24 weeks had no detectable levels of CMV in their plasma within 6 weeks of starting treatment.
However, CMV infection did recur in some of these patients.
Dysgeusia was the most commonly reported treatment-emergent adverse event (AE), and one patient died of an AE that was considered possibly related to maribavir.
These results were presented at IDWeek 2016 (abstract 78). The study was sponsored by Shire.
“Cytomegalovirus infection that is resistant or refractory to standard therapy in transplant patients is associated with significant complications and high mortality,” said study investigator Genovefa Papanicolaou, MD, of Memorial Sloan Kettering Cancer Center in New York, New York.
“The phase 2 findings support further research to confirm these results among patients who have limited options to combat the infection.”
Maribavir is a member of a class of drugs called benzimidazole ribosides. Maribavir is thought to inhibit viral DNA assembly and egress of viral capsids from the nucleus of infected cells. The drug has not been shown to affect the maturation of viral DNA or affect the viral DNA polymerase.
This phase 2 study of maribavir included 120 patients ages 12 and older with CMV infection (≥1000 DNA copies/mL of blood plasma) that was resistant or refractory to (val)ganciclovir or foscarnet.
Forty-seven of the patients had received a hematopoietic stem cell transplant, and 73 had a solid organ transplant. The patients’ median age was 55 (range, 18 to 74).
The patients were randomized to 1 of 3 twice-daily oral doses of maribavir—400 mg, 800 mg, or 1200 mg—for up to 24 weeks of treatment.
Efficacy
The study’s primary efficacy endpoint was the proportion of patients with confirmed undetectable plasma CMV DNA within 6 weeks of treatment.
Overall, 67% (80/120) of patients met the primary efficacy endpoint. This included 70% (n=28) of patients in the 400 mg group, 63% (n=25) in the 800 mg group, and 67% (n=27) in the 1200 mg group.
CMV infection recurred in 30 patients, including 7 in the 400 mg group, 11 in the 800 mg group, and 12 in the 1200 mg group.
Safety
The primary safety analysis was focused on the incidence of treatment-emergent AEs. The incidence was 78% (n=93) overall, including 78% (n=31) in the 400 mg group, 80% (n=32) in the 800 mg group, and 75% (n=30) in the 1200 mg group.
Twenty-seven percent of patients died due to any AE, 1 of which (multi-organ failure) was considered possibly related to maribavir.
Forty-one patients (34%) discontinued treatment with maribavir due to an AE, including 17 patients who discontinued due to CMV infection.
Dysgeusia was the most common treatment-emergent AE and led to treatment discontinuation in 1 patient. Dysgeusia occurred in 65% (n=78) of all patients, including 60% (n=24) in the 400 mg group, 63% (n=25) in the 800 mg group, and 73% (n=29) in the 1200 mg group.
Other treatment-emergent AEs (occurring in at least 20% of patients) for all doses included nausea, vomiting, CMV infection, diarrhea, fatigue, and anemia. Immunosuppressant drug level increases were reported as an AE in 10% of all patients.
NEW ORLEANS—The antiviral agent maribavir has shown activity against cytomegalovirus (CMV) in a phase 2 trial.
The trial included transplant recipients with a CMV infection that was resistant or refractory to prior treatment with (val)ganciclovir or foscarnet.
Sixty-seven percent of patients treated with varying doses of maribavir for up to 24 weeks had no detectable levels of CMV in their plasma within 6 weeks of starting treatment.
However, CMV infection did recur in some of these patients.
Dysgeusia was the most commonly reported treatment-emergent adverse event (AE), and one patient died of an AE that was considered possibly related to maribavir.
These results were presented at IDWeek 2016 (abstract 78). The study was sponsored by Shire.
“Cytomegalovirus infection that is resistant or refractory to standard therapy in transplant patients is associated with significant complications and high mortality,” said study investigator Genovefa Papanicolaou, MD, of Memorial Sloan Kettering Cancer Center in New York, New York.
“The phase 2 findings support further research to confirm these results among patients who have limited options to combat the infection.”
Maribavir is a member of a class of drugs called benzimidazole ribosides. Maribavir is thought to inhibit viral DNA assembly and egress of viral capsids from the nucleus of infected cells. The drug has not been shown to affect the maturation of viral DNA or affect the viral DNA polymerase.
This phase 2 study of maribavir included 120 patients ages 12 and older with CMV infection (≥1000 DNA copies/mL of blood plasma) that was resistant or refractory to (val)ganciclovir or foscarnet.
Forty-seven of the patients had received a hematopoietic stem cell transplant, and 73 had a solid organ transplant. The patients’ median age was 55 (range, 18 to 74).
The patients were randomized to 1 of 3 twice-daily oral doses of maribavir—400 mg, 800 mg, or 1200 mg—for up to 24 weeks of treatment.
Efficacy
The study’s primary efficacy endpoint was the proportion of patients with confirmed undetectable plasma CMV DNA within 6 weeks of treatment.
Overall, 67% (80/120) of patients met the primary efficacy endpoint. This included 70% (n=28) of patients in the 400 mg group, 63% (n=25) in the 800 mg group, and 67% (n=27) in the 1200 mg group.
CMV infection recurred in 30 patients, including 7 in the 400 mg group, 11 in the 800 mg group, and 12 in the 1200 mg group.
Safety
The primary safety analysis was focused on the incidence of treatment-emergent AEs. The incidence was 78% (n=93) overall, including 78% (n=31) in the 400 mg group, 80% (n=32) in the 800 mg group, and 75% (n=30) in the 1200 mg group.
Twenty-seven percent of patients died due to any AE, 1 of which (multi-organ failure) was considered possibly related to maribavir.
Forty-one patients (34%) discontinued treatment with maribavir due to an AE, including 17 patients who discontinued due to CMV infection.
Dysgeusia was the most common treatment-emergent AE and led to treatment discontinuation in 1 patient. Dysgeusia occurred in 65% (n=78) of all patients, including 60% (n=24) in the 400 mg group, 63% (n=25) in the 800 mg group, and 73% (n=29) in the 1200 mg group.
Other treatment-emergent AEs (occurring in at least 20% of patients) for all doses included nausea, vomiting, CMV infection, diarrhea, fatigue, and anemia. Immunosuppressant drug level increases were reported as an AE in 10% of all patients.