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Retinopathy associated with interferon alpha therapy - case report
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I eos/lO9 I S E X U A L D I S T U R B A N C E S IN PATIENTS W I T H C H R O N I C H E P A TITIS B J. Juszczyk t, Z. Bielan 1Department o f Infectious Diseases, K a r o l Marcinkowski University School o f Medical Sciences in Poznan, Poland. A d a m Mickiewicz University o f Poznan, Poland.
Aim. To investigate if chronic hepatitis B have any influence on sexual activity.Matedal. 30 men aged 20-49 years, with history of chronic hepatitis (1-4 y.), HBsAg pos., HBV-DNA pos., and histological (liver biopsy) diagnosis of chronic persistent (65%) and chronic agressive hepatitis (15%) not treated anti-viral. Methods. MelI-Krat score, modifflcated by Lew-Starowicz questionaire (13 - spheres of sexual activity graded from 0-4), 2 consecutive investigations and interview. Results (selected). The statistically significant differences (Chi.sq. test) between sexual activity were present in 10/13 spheres. In average the grad of sexual activity was 2,9 before and 1,5 at the course of the disease. Conclusion. Chronic hepatitis B has an influence on the diminished sexual activity. Psychotherapeutic support should be considered.
[ C06/110
I
I C06/111 I RIBAVIRIN A N D I N T E R F E R O N A L F A T H E R A P Y IN PATIENTS WITH CHRONIC HEPATITIS C - PRELIMINARY OBSERVATION W. Warunek, M. Zejc-Bajsarowicz, T. Zyrkowska-Bieda, M. Librant-Suska, U. Janas-Skulina, T. M a c h Dept. o f Infectious Diseases, Jagiellonian University, K r a k t w , Poland. AIM: to estimate 1) the influence of the combination therapy of interferon and ribavirin on the course of chronic hepatitis C and 2) the safety of this therapy. PATIENTS AND METHODS: We studied 30 patients ( 23 males, 7 females; age 2559 years; mean 42,5) with histologically proven chronic hepatitis and seropositive for HCV. In this group 5 pts had compensated liver cirrhosis. All pts were treated with combination therapy of interferon alfa ( 5 MIU thrice weekly, s.c.) end ribavirin ( 1000rag/day for pts weighing < 75 kg, 1200 nag/day for pts weighting > 75 k$, orally). The pts were divided into three groups: I - naive pts ( n = 17), II - retherapy post previous course of interferon monotherapy ( n = 13); with subdivision into: IIA pts wih relapses ( n = 8) and lib - nonrosponders (n=5). The virologic response was defined as al~senc~of saturn HCV RNA ( assessed by RT-PCR assay) and biochemical response as normalisation of serum aminotransferase (ALT). RESULTS AND CONCLUSIONS: After 24 weeks of treatmeat 16 of 30 !0ts( 53,3% ) had virsr clearance ( seronegative for HCV RNA) with normalisation of the scram ALT. In group 1 9 of 17 pB ( 52,9%); in group I17 of 13 pts (58,3%), in group IIA 6 of 8 pts (75%) and of group lib 1 of 5 pts (20%) were negative for HCV - RNA with normal ALT. Four of 30 pts had normal ALT without loss of saturn HCV RNA. Seven of 30 pts had completed 48 weeks combination therapy ( 3 pts ofl group; 2 pts of both IIA and liB groups), the other pts are still under observation. Two of 3 from I group achieved biochemical and virologic response at the end of treatment; one remained viremic at weeks 24 and 48 and had abnormal ALT at 48 week. Two of 2 pts from IIA group achieved biochemical and virologic response at the end of treatment. In group II one patient had normal ALT with loss of serum HCV RNA at 24 week with subsequent relapse ( at week 48 was viramic again with ALT above normal), and 1 patient had elevated serum ALT value and was viremic at 24 and 48 weeks. Dose of ribavirin had been reduced in 1 patient because of decreasa of haemoglobin level below 10 g/dl. We did not observed any significant side effects of the therapy which should required cessation of it. During treatment the mean maximum haemoglobin decrease was 2,19 g/dl from baseline and mean bilirubin increase was 5,6 umol/I.. The most often side effects were: fatigue (80%), dyspepsia ( 76,7%), loss of appstite (66,7%), pruritus (40%), psychiatric events ( most commonly insomnia, depression and irritability; they cecurred in 21,9% of pts). One patient develop thyroid abnormalities. Several pts included to this study are still under observat on n order to compete 48 week therapy.
I C061112 I
RETINOPATHY ASSOCIATED WITH INTERFERON ALPHA THERAPY - CASE REPORT
HEMATOLOGIC SIDE EFFECTS OF INTERFERON ALPHA AND R1BAVIRIN T H E R A P Y O F C H R O N I C ACTIVE H E P A T I T I S C
A. Dzierbicki, Z. Michalska, J. Stolarczvk Infectious Diseases D e p a r t m e n t , Medical University in Gdafisk, Poland.
P. Stalke, K. Witczak-Malinowska, E. Lakomv, Z. Michalska, A. Dzierbicki Infectious Diseases D e p a r t m e n t , Medical University in Gdafisk, Poland.
There are few reports of potential ophtalmologic side effects of interferon (INF) alpha therapy. Among 200 patients who received treatment with IFN alpha for chronic viral hepatitis in our center, one presented with acute retinopathy. The" patient was 20 years old with history of chronic renal failure as a result of recurrent pyelonephritis, bilateral nephrectomy, 6 years hemodialysis therapy, well-controlled hypertension, and mild hypertensive retinopathy. Asymptomatic HBV and HCV infection were detected 5 and 2 years respectively, prior to referral for IFN treatment. On admission the markers of HBV and HCV infection were as follows: HBsAg (+), HBeAg (-), HBVDHA (+), anti-HCV (+), HCV RNA (+). Liver function tests were moderately elevated (ALT 206U/1, AST 81U/I). Liver biopsy revealed chronic active hepatitis, grading 1, staging 2. Initial tolerance of IFN alpha therapy (6MU tiw) was good. During the 12th week of treatment acute remittent visual disturbances began. The patient reported decreased visual acuity and transient lack of vision. In fundoscopic examination blurred borders of the optic disc on nasal sides, focal oedema with punctuate hemorrhages were noted in addition to previously present hypertensive retinopathy. Angiography revealed focal hypoperfusion. Because the symptoms reappeared during the continued IFN treatment the therapy was stopped. Within 2 months after cessation of IFN therapy both clinical and fundoscopic abnormalities disappeared.
204
A i m o f t h e s t u d y - description of dynamics of hematologic side effects of combination therapy of chronic active hepatitis C, and identification of period of maximal toxicity. M e t h o d s - 15 patients (5 females, 10 males) treated with IFN alpha (5MU tiw) and ribavirin (1000-1200mg/d) for 24 weeks. All patients had documented plasma HCVRNA, ALT>2xnormal, and normal or slightly decreased hemoglobin levels at baseline (>llmg/dl). Hematologic toxicity assessment was performed at week 2,4,8,12,18, and 24. Resluts - the therapy was generally well tolerated. All patients completed the 24weeks therapy. WBC, RBC and Hb levels showed greatest decline in the first 4 weeks of therapy. A mild decline continued thereafter reaching its nadir at week 12. The average relative decline of WBC, RBC and Hb at week 12 were 35%, 19%, and 17% of baseline levels respectively. The average WBC, RBC and Hb values at week 12 were 3.6thsn/mm3, 3.groin/ram3, and 11.7g/d I respectively. The PLT values remained relatively stable in the first 4 weeks of therapy, then a marked decline was observed between weeks 4 and 8, followed by slow increase in subsequent weeks. The nadir levels at week 8 were on average 87% of baseline values. Condusions - Combination therapy is generally well tolerated. Complete blood count should be closely monitored (especially) during the initial 4 weeks of therapy.
I eos/lO9 I S E X U A L D I S T U R B A N C E S IN PATIENTS W I T H C H R O N I C H E P A TITIS B J. Juszczyk t, Z. Bielan 1Department o f Infectious Diseases, K a r o l Marcinkowski University School o f Medical Sciences in Poznan, Poland. A d a m Mickiewicz University o f Poznan, Poland.
Aim. To investigate if chronic hepatitis B have any influence on sexual activity.Matedal. 30 men aged 20-49 years, with history of chronic hepatitis (1-4 y.), HBsAg pos., HBV-DNA pos., and histological (liver biopsy) diagnosis of chronic persistent (65%) and chronic agressive hepatitis (15%) not treated anti-viral. Methods. MelI-Krat score, modifflcated by Lew-Starowicz questionaire (13 - spheres of sexual activity graded from 0-4), 2 consecutive investigations and interview. Results (selected). The statistically significant differences (Chi.sq. test) between sexual activity were present in 10/13 spheres. In average the grad of sexual activity was 2,9 before and 1,5 at the course of the disease. Conclusion. Chronic hepatitis B has an influence on the diminished sexual activity. Psychotherapeutic support should be considered.
[ C06/110
I
I C06/111 I RIBAVIRIN A N D I N T E R F E R O N A L F A T H E R A P Y IN PATIENTS WITH CHRONIC HEPATITIS C - PRELIMINARY OBSERVATION W. Warunek, M. Zejc-Bajsarowicz, T. Zyrkowska-Bieda, M. Librant-Suska, U. Janas-Skulina, T. M a c h Dept. o f Infectious Diseases, Jagiellonian University, K r a k t w , Poland. AIM: to estimate 1) the influence of the combination therapy of interferon and ribavirin on the course of chronic hepatitis C and 2) the safety of this therapy. PATIENTS AND METHODS: We studied 30 patients ( 23 males, 7 females; age 2559 years; mean 42,5) with histologically proven chronic hepatitis and seropositive for HCV. In this group 5 pts had compensated liver cirrhosis. All pts were treated with combination therapy of interferon alfa ( 5 MIU thrice weekly, s.c.) end ribavirin ( 1000rag/day for pts weighing < 75 kg, 1200 nag/day for pts weighting > 75 k$, orally). The pts were divided into three groups: I - naive pts ( n = 17), II - retherapy post previous course of interferon monotherapy ( n = 13); with subdivision into: IIA pts wih relapses ( n = 8) and lib - nonrosponders (n=5). The virologic response was defined as al~senc~of saturn HCV RNA ( assessed by RT-PCR assay) and biochemical response as normalisation of serum aminotransferase (ALT). RESULTS AND CONCLUSIONS: After 24 weeks of treatmeat 16 of 30 !0ts( 53,3% ) had virsr clearance ( seronegative for HCV RNA) with normalisation of the scram ALT. In group 1 9 of 17 pB ( 52,9%); in group I17 of 13 pts (58,3%), in group IIA 6 of 8 pts (75%) and of group lib 1 of 5 pts (20%) were negative for HCV - RNA with normal ALT. Four of 30 pts had normal ALT without loss of saturn HCV RNA. Seven of 30 pts had completed 48 weeks combination therapy ( 3 pts ofl group; 2 pts of both IIA and liB groups), the other pts are still under observation. Two of 3 from I group achieved biochemical and virologic response at the end of treatment; one remained viremic at weeks 24 and 48 and had abnormal ALT at 48 week. Two of 2 pts from IIA group achieved biochemical and virologic response at the end of treatment. In group II one patient had normal ALT with loss of serum HCV RNA at 24 week with subsequent relapse ( at week 48 was viramic again with ALT above normal), and 1 patient had elevated serum ALT value and was viremic at 24 and 48 weeks. Dose of ribavirin had been reduced in 1 patient because of decreasa of haemoglobin level below 10 g/dl. We did not observed any significant side effects of the therapy which should required cessation of it. During treatment the mean maximum haemoglobin decrease was 2,19 g/dl from baseline and mean bilirubin increase was 5,6 umol/I.. The most often side effects were: fatigue (80%), dyspepsia ( 76,7%), loss of appstite (66,7%), pruritus (40%), psychiatric events ( most commonly insomnia, depression and irritability; they cecurred in 21,9% of pts). One patient develop thyroid abnormalities. Several pts included to this study are still under observat on n order to compete 48 week therapy.
I C061112 I
RETINOPATHY ASSOCIATED WITH INTERFERON ALPHA THERAPY - CASE REPORT
HEMATOLOGIC SIDE EFFECTS OF INTERFERON ALPHA AND R1BAVIRIN T H E R A P Y O F C H R O N I C ACTIVE H E P A T I T I S C
A. Dzierbicki, Z. Michalska, J. Stolarczvk Infectious Diseases D e p a r t m e n t , Medical University in Gdafisk, Poland.
P. Stalke, K. Witczak-Malinowska, E. Lakomv, Z. Michalska, A. Dzierbicki Infectious Diseases D e p a r t m e n t , Medical University in Gdafisk, Poland.
There are few reports of potential ophtalmologic side effects of interferon (INF) alpha therapy. Among 200 patients who received treatment with IFN alpha for chronic viral hepatitis in our center, one presented with acute retinopathy. The" patient was 20 years old with history of chronic renal failure as a result of recurrent pyelonephritis, bilateral nephrectomy, 6 years hemodialysis therapy, well-controlled hypertension, and mild hypertensive retinopathy. Asymptomatic HBV and HCV infection were detected 5 and 2 years respectively, prior to referral for IFN treatment. On admission the markers of HBV and HCV infection were as follows: HBsAg (+), HBeAg (-), HBVDHA (+), anti-HCV (+), HCV RNA (+). Liver function tests were moderately elevated (ALT 206U/1, AST 81U/I). Liver biopsy revealed chronic active hepatitis, grading 1, staging 2. Initial tolerance of IFN alpha therapy (6MU tiw) was good. During the 12th week of treatment acute remittent visual disturbances began. The patient reported decreased visual acuity and transient lack of vision. In fundoscopic examination blurred borders of the optic disc on nasal sides, focal oedema with punctuate hemorrhages were noted in addition to previously present hypertensive retinopathy. Angiography revealed focal hypoperfusion. Because the symptoms reappeared during the continued IFN treatment the therapy was stopped. Within 2 months after cessation of IFN therapy both clinical and fundoscopic abnormalities disappeared.
204
A i m o f t h e s t u d y - description of dynamics of hematologic side effects of combination therapy of chronic active hepatitis C, and identification of period of maximal toxicity. M e t h o d s - 15 patients (5 females, 10 males) treated with IFN alpha (5MU tiw) and ribavirin (1000-1200mg/d) for 24 weeks. All patients had documented plasma HCVRNA, ALT>2xnormal, and normal or slightly decreased hemoglobin levels at baseline (>llmg/dl). Hematologic toxicity assessment was performed at week 2,4,8,12,18, and 24. Resluts - the therapy was generally well tolerated. All patients completed the 24weeks therapy. WBC, RBC and Hb levels showed greatest decline in the first 4 weeks of therapy. A mild decline continued thereafter reaching its nadir at week 12. The average relative decline of WBC, RBC and Hb at week 12 were 35%, 19%, and 17% of baseline levels respectively. The average WBC, RBC and Hb values at week 12 were 3.6thsn/mm3, 3.groin/ram3, and 11.7g/d I respectively. The PLT values remained relatively stable in the first 4 weeks of therapy, then a marked decline was observed between weeks 4 and 8, followed by slow increase in subsequent weeks. The nadir levels at week 8 were on average 87% of baseline values. Condusions - Combination therapy is generally well tolerated. Complete blood count should be closely monitored (especially) during the initial 4 weeks of therapy.