Searched for: in-biosketch:true
person:panc01
Entecavir Safety and Effectiveness in a National Cohort of Chronic Hepatitis B Patients in the United States - the ENUMERATE study [Meeting Abstract]
Ahn, Joseph; Lee, Hannah; Lim, Joseph K; Pan, Calvin Q; Nguyen, Mindie H; Kim, WRay; Trinh, Huy N; Tran, Tram T; Chu, Danny; Min, Albert; Do, Son T; Woog, Jocelyn; Mannalithara, Ajitha; Lok, Anna S
ISI:000344483804433
ISSN: 1527-3350
CID: 1383952
Efficacy and safety of tenofovir disoproxil fumarate in asian-americans with chronic hepatitis B in community settings
Pan, Calvin Q; Trinh, Huy; Yao, Alan; Bae, Ho; Lou, Lillian; Chan, Sing
BACKGROUND AND AIMS: Chronic hepatitis B (CHB) disproportionately affects the Asian-American population in the USA. Tenofovir disoproxil fumarate (TDF) has demonstrated potent antiviral activity in clinical trials, but data in Asian-Americans from community studies are lacking. METHODS: Adult Asian-American patients with CHB from private medical and community-based practices were prospectively enrolled and treated with open-label TDF 300 mg once daily in a single-arm study for 48 weeks. After Week 48, patients had the option to transition to commercially available CHB therapy. The primary efficacy endpoint was hepatitis B virus (HBV) DNA <400 copies/mL at Week 48. Secondary endpoints were safety and tolerability, serologic and biochemical responses, liver fibrosis by FibroTest, and the development of drug-resistant mutations. RESULTS: Of the 90 patients enrolled, 53 (58%) were hepatitis B e antigen (HBeAg)-positive at baseline. At Week 48, 74 patients (82% overall; 70% HBeAg-positive and 100% HBeAg-negative) had HBV DNA <400 copies/mL. Six (12%) HBeAg-positive patients achieved HBeAg loss/seroconversion. The percentage of patients with alanine aminotransferase in the normal range increased from 26% at baseline to 66% at Week 48. The percentage of patients with F0 (no or minimal) fibrosis by FibroTest increased from 48% to 51%, and those with F4 (severe) fibrosis decreased from 4% to 1%. No resistance to TDF developed. Treatment was well tolerated. Most adverse events were mild in severity and considered unrelated to study drug. CONCLUSIONS: TDF is effective and well tolerated in Asian-American CHB patients in community clinic-based settings, consistent with larger registration trials. Improvement in liver fibrosis was seen in a proportion of patients. No resistance to TDF developed through 48 weeks of treatment. TRIAL REGISTRATION: Clinicaltrial.gov identifier NCT00736190.
PMCID:3942404
PMID: 24594870
ISSN: 1932-6203
CID: 829722
Cesarean section reduces perinatal transmission of hepatitis B virus infection from hepatitis B surface antigen-positive women to their infants
Pan, Calvin Q; Zou, Huai-Bin; Chen, Yu; Zhang, Xiaohui; Zhang, Hua; Li, Jie; Duan, Zhongping
BACKGROUND & AIMS: Despite appropriate passive and active immunization, perinatal transmission of hepatitis B virus (HBV) still occurs in 5%-10% of infants born to women with high levels of viremia who test positive for the hepatitis B e antigen (HBeAg). We evaluated the effects of cesarean section delivery on perinatal transmission of HBV from women who tested positive for the hepatitis B surface antigen (HBsAg). METHODS: We analyzed data from 1409 infants born to HBsAg-positive mothers through vaginal delivery (VD) (n = 673), elective caesarean section (ECS) (n = 496), or urgent cesarean section (UCS) (n = 240) who completed appropriate immunization against HBV. The prevention was assumed to have failed for infants who were HBsAg positive when they were 7-12 months old; this information was used to assess transmission rates. RESULTS: HBV infection was transmitted to a smaller percentage of infants born by ECS (1.4%) than by VD (3.4%, P < .032) or UCS (4.2%, P < .020). UCS had no effect on vertical transmission, compared with VD (4.2% vs 3.4%, P = .593). Infants born by ECS had a significantly lower rate of vertical transmission than those born by non-ECS (1.4% vs 3.6%, P = .017). Women with HBV DNA levels <1,000,000 copies/mL did not transmit the infection to their infants, regardless of method of delivery. There were no differences in maternal or infant morbidity and mortality among the groups. CONCLUSIONS: There is a significantly lower rate of vertical transmission of HBV infection to infants delivered by ECS, compared with those delivered vaginally or by UCS. Elective cesarean sections for HBeAg-positive mothers with pre-delivery levels of HBV DNA >/=1,000,000 copies/mL could reduce vertical transmission.
PMID: 23639606
ISSN: 1542-3565
CID: 551662
The efficacy of lamivudine use in the second vs. third trimester of pregnancy in preventing vertical transmission of HBV in highly viremic mothers [Meeting Abstract]
Yi, W; Liu, M; Chen, A; Pan, C
Backgrounds: Despite the use of timely immunoprophylaxis, vertical transmission (VT) occurs in 10% infants born to highly viremic mothers with chronic hepatitis B. We evaluated if lamivudine use in the 2nd trimester (2T) vs. 3rd trimester (3T) improves the VT rate in treatment naive HBeAg+ mothers with HBV DNA > 6 log10copies/mL. Methods: HBV mono-infected mothers with lamivudine use (100 mg/day) at the 2T or 3T during 5/2008-1/2013 were retrospectively enrolled and compared to cases with similar maternal baseline from untreated mothers. All infants received appropriate immunoprophylaxis. Infants' HBsAg and HBV DNA status at 28 weeks was used to determine VT rate. Results: 155 consecutive mothers treated with lamivudine (2T/3T=61/94) and 89 match cases selected from untreated mothers were enrolled with comparable maternal baseline values (Table 1). Prior to delivery, maternal HBV DNA mean (SD) levels were 4.15 (0.98), 4.68 (0.90), 7.16 (0.52) log10 copies/mL in the 2T, 3T and control group, respectively (F=327.207, p< 0.001). At birth, HBsAg positivity from venous blood was found in 21.31% (13/61), 31.91% (30/94), and 32.58% (29/89) [p=0.268] of newborns in the 2T, 3T and control group, respectively. At the age of 28 weeks, infants with HBsAg+ or detectable HBV DNA were 0% (0/61 and 0/94) in the 2T and 3T groups vs. 5.62% (5/89) in the control group (p=0.012); all infants in lamivudine-treated groups seroconverted to anti-HBs with undetectable DNA (< 500 copies/mL). There was no significantly difference in VT rates between the groups of lamivudine initiated in the 2T and 3T. 126 lamivudine-treated mothers discontinued therapy at week 4 postpartum. ALT flares during pregnancy (5 x ULN) were observed 6.45% (10/155) and 1.12% (1/89) in lamivudine and control arms respectively (p=0.054), but severe hepatitis exacerbation (ALT>10XULN) was uncommon (lamivudine:control=1/126:5/45, p=0.001). No lamivudine discontinuations from adverse events or genotypic resistance were reported. !
EMBASE:71236861
ISSN: 0270-9139
CID: 670612
Safety of Telaprevir Treatment in Asian-American Adults with Genotype 1 Chronic Hepatitis C Virus Infection [Meeting Abstract]
Pan, Calvin; Zeng, Zheng; Ouyang, Elsa
ISI:000330178100479
ISSN: 0002-9270
CID: 816042
Safety of Tenofovir Disoproxil Fumarate Treatment in Late Pregnancy in Highly Viremic Mothers with Chronic Hepatitis B [Meeting Abstract]
Pan, Calvin; Ta, Anita; Zeng, Zheng
ISI:000330178100530
ISSN: 0002-9270
CID: 816322
Safety of Tenofovir Disoproxil Fumarate (TDF) treatment for the entire pregnancy in mothers with active chronic hepatitis B or cirrhosis [Meeting Abstract]
Pan, Calvin; Liu, Min; Cai, Haodong; Yi, Wei
ISI:000330252203045
ISSN: 0270-9139
CID: 833492
Three-year outcomes of tenofovir disoproxil fumarate (TDF) treatment in Asian-American adults with chronic hepatitis B in real-life practice in the US: A prospective open label study [Meeting Abstract]
Pan, Calvin; Zeng, Zheng; Bae, Ho; Trinh, Huy N.; Ma, Xiaoli; Mi, Li-Jun; Leduc, Truong-Sinh; Chan, Sing; Hu, Ke-Qin
ISI:000330252203180
ISSN: 0270-9139
CID: 833522
Antiviral therapy for chronic hepatitis B in pregnancy
Pan, Calvin Q; Lee, Hannah M
The management of chronic hepatitis B (CHB) during pregnancy remains a challenge and involves various aspects of maternal-fetal care. Despite the standard immunoprophylaxis, a significant portion of infants born to highly viremic mothers remain infected with hepatitis B virus (HBV). Emerging data suggest that antiviral therapy in the third trimester can prevent immunoprophylaxis failure. To minimize fetal exposure to antiviral agents, antiviral therapy during pregnancy should be reserved for mothers with advanced disease or who are at risk for hepatic decompensation. Current safety data suggest that lamivudine, telbivudine, or tenofovir may be used during pregnancy. However, the timing in initiating antiviral therapy requires careful assessment of risks and benefit. The authors provide a systematic review of the features of HBV during pregnancy, risk factors for vertical transmission, and evidence-based data on antiviral use during pregnancy. They propose an algorithm to assess the need of antiviral treatment and monitor mothers with CHB.
PMID: 23749670
ISSN: 0272-8087
CID: 408662
Hepatitis Outreach Network: a practical strategy for hepatitis screening with linkage to care in foreign-born communities
Perumalswami, Ponni V; Factor, Stephanie H; Kapelusznik, Luciano; Friedman, Scott L; Pan, Calvin Q; Chang, Charissa; Di Clemente, Frances; Dieterich, Douglas T
BACKGROUND & AIMS: Many foreign-born persons in the US are at high risk of chronic hepatitis B (HBV) and C (HCV) infections, yet are not aware of their infection, and lack healthcare coverage or linkage to care. METHODS: A unique partnership, the Hepatitis Outreach Network, combines the expertise and resources of the Mount Sinai School of Medicine, the NYC Department of Health and Mental Hygiene, and community-based organizations, to provide education, screening and link to care in communities with high prevalence of chronic viral hepatitis. Comprehensive HBV and HCV screening identifies infected patients, who then receive further evaluation from either local or Mount Sinai physicians, combined with patient-navigators who organize follow-up visits. RESULTS: Of 1603 persons screened, 76 had HBV and 75 had HCV. Importantly, screening for HCV based on traditional risk factors would have missed 67% of those who tested positive. Of the 76 persons with HCV infection, 49 (64%) received a medical evaluation (26 with local providers and 23 at Mount Sinai). Of the 49 HCV-infected persons evaluated, treatment was recommended in 11 and begun in 8 (73%). Of the 76 persons with HBV infection, 43 (57%) received a medical evaluation (31 with local providers and 12 at Mount Sinai). Of the 43 HBV-infected persons evaluated, treatment was recommended and begun in 5 (100%). CONCLUSIONS: Hepatitis Outreach Network has successfully established novel proof of concept for identifying HBV and HCV infections in foreign-born persons through use of several unique elements that effectively link them to care.
PMID: 23333446
ISSN: 0168-8278
CID: 551642