A Clinical Observation Of Valaciclovir For The Prevention Of HCMV Infenction After Renal Transplantation

Objective:To observe the efficacy and safety of low-dose valaciclovir prophylaxis against cytomegalovirus infection in renal transplant recipients,aiming at providing a good method for the prevention of cytomegalovirus infection after renal transplantation.Method:47 CMV–seronegative recipients who received a CMV–seropositive kidney(D+/R-)and 59 CMV–seronepositive recipients(D±/R+)were randomly divided into valaciclovir prophylaxis group and comparison group.The prophylaxis group received 0.6g of valaciclovir orally 3 times per day for 90 days since the third day after renal transplantation,in contrast the comparison group received none antivirus prophylaxis.The diagnosis of CMV infection and CMV disease was according to the CMV-pp65 antigenemia and clinical symptoms.In the trial phase,neither group received any antivirus therapy unless CMV diease were diagnosed.After the clinical trial,the incidence and time of CMV infection and CMV disease,the incidence of acute rejection and side effects of valaciclovir were to be evaluated. Results:1.Valaciclovir reduced the incidence of primary CMV infection after renal transplantation: In D+/R- recipients,8 of 25 (25.0%) prophylaxis-group recipients versus 15 of 22(25.0%) comparison-group recipients were found CMV-pp65 antigenemia (p<0.05),of which 3 of 8 (37.5%) versus 11 of 15 (73.3%) recipients were diagnosed CMV disease(P<0.05). 2.Valaciclovir reduced the incidence of CMV reactivation after renal transplantation: In D±/R+ recipients,11 of 32 (34.4%) prophylaxis-group recipients versus 19 of 27 (70.4%) comparison-group recipients were found CMV-pp65 antigenemia (p<0.05),of which 5 of 11 (45.5%) versus 13 of 19 (68.4%) recipients were diagnosed CMV disease(P<0.05). 3.Valaciclovir delayed the CMV infection and CMV disease:In all the CMV infection recipients ,the first time of CMV-pp65 antigenemia was 29.37±15.65 versus 10.03±9.83 days after transplantation in comparison or prophylaxis group(p<0.01),and the time of CMV diease was 62.63±25.58 virsus 30.38±20.43 days after transplan tation(p<0.01). 4.Valaciclovir reduced and delayed the peak value of electropositive leucocyts of CMV-pp65 antigen:In comparison-group and prophylaxis- group, the occurrenc time of peak value of electropositive leucocyts of CMV-pp65 antigen was 41.95±21.72 versus 28.91±17.28 days after transplantation (p<0.01),and the average peak value was 16.79±10.97 versus 20.76±6.77 per 5×104WBC(p<0.05);5.Valaciclovir reduced the incidence of acute rejection:The incidence of AR was 28.07%(16/57) in prophylaxis group virsus 46.94%(23/49) in comparison group(p<0.05). 6. The side effects of valaciclovir were gentle and reversable:In 90 days of valaciclovir prophylaxis,the main side effects of valaciclovir were represented in nerve system,including 7 cases of insomnias and 1 of hallucination.Another 2 cases arised diarrhea.All the symptoms disappeared when the dosage of valaciclovir was reduced. And the indexes of blood examination were not distinctly affected (p>0.05). 7.CMV disease after renal transplantation had a high mortality and was difficult to be cured,so early prophylaxis was important: 8 of 32 (25%) cases were dead of CMV disease,including 7 cases of CMV pneumonia and 1 case of hepatitis. CMV pneumonia had a especially high mortality,and 7 of 16 (43.75%) cases were dead of CMV pneumonia in our test. The clinical symptoms of other 24 cases of CMV disease disappeared after antivirus therapy,and the CMV-pp65 antigenemia disappeared in only 20 cases(62.50%).Conclusion:Low dose valaciclovir can prevent CMV primary infection or reactivation and reduce the incidence of CMV disease efficiently.It can also delay the CMV infection and CMV disease as well as reduce the incidence of AR, and almost has no ill or toxic effect. Early diagnosis and prophylaxis of CMV high-risk group are the key points for preventing CMV infection after renal transplantation. To D+/R- or D±/R+ recipients using valaciclovir for 90 days is a safe and efficient method for preventing CMV infection.