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Hepatic disorders in pregnancy
Published in Hung N. Winn, Frank A. Chervenak, Roberto Romero, Clinical Maternal-Fetal Medicine Online, 2021
Ghassan M. Hammoud, Jamal A. Ibdah
The current (2009) Federal Drug Administration (FDA)-approved therapy for HBV in nonpregnant patients include subcutaneous injection of interferon/pegylated interferon alpha and orally administered nucleoside/tide analogs such as Lamivudine, Adefovir, Entecavir, Telbivudine, and Tenofovir (21). Interferon is considered FDA category C drug in pregnancy and is not recommended. Lamivudine, an oral nucleoside analog, classified as FDA category C drug in terms of safety, is given to mothers with high HBV DNA during the second and third trimesters to reduce the risk of transmission at the time of delivery. It is generally not recommended for use against HBV in the first trimester of pregnancy. However, potential benefits may justify the potential risk. The data on adefovir, entecavir, telbivudine, and tenofovir safety are limited in pregnancy. Although HBV may be found in breast milk, a study comparing breast-fed versus non-breast-fed babies of seropositive mothers demonstrated no difference in the infection rate.
Viral hepatitis.
Published in Michael JG Farthing, Anne B Ballinger, Drug Therapy for Gastrointestinal and Liver Diseases, 2019
Eleanor Barnes, George Webster, Geoffrey M Dusheiko
Unlike hepatitis C virus infection, there is no evidence that antiviral therapy accelerates viral eradication in acute HBV infection or that it prevents chronic infection. Fulminant acute viral hepatitis is characterized by low levels of replicating virus at the time of presentation, α-IFN has not been found to be beneficial in patients with acute uncomplicated hepatitis B or in fulminant viral hepatitis. Preliminary data suggest that lamivudine is also ineffective in this setting.
Lamivudine
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
Jennifer Audsley, Michelle Giles, Sharon R. Lewin
Lamivudine is useful for the treatment of hepatitis B virus infection. Although monotherapy can provide reduction in hepatitis B viral load, this effect is not sustained, and combination therapy is required to prevent the emergence of resistance (Scott and McMahon, 2009). In a meta-analysis of 16 randomized controlled trials (considered to be underpowered) involving 4431 patients, antiviral therapy was not associated with a positive clinical outcome. Moderate quality evidence from two additional randomized controlled studies enrolling 318 patients suggested that lamivudine therapy was associated with loss of HBeAg. In further studies, pegylated interferon-alpha2a when given with lamivudine improved HBeAg loss and/or ALT normalization when compared with lamivudine alone (Shamliyan et al., 2009). In a meta-analysis of 20 randomized controlled trials (8 in HBeAg-negative and 15 in HBeAg-positive chronic HBV) treatment efficacy at 48 weeks was greatest with tenofovir in HBeAg-positive chronic hepatitis B (CHB) and tenofovir and entecavir in HBeAg-negative CHB (Woo et al., 2010). Table 228.5 summarizes the clinical trials of lamivudine use in nonpregnant adults infected with hepatitis B virus.
Pharmacological approaches to prevent vertical transmission of HIV and HBV
Published in Expert Review of Clinical Pharmacology, 2022
Emanuela Zappulo, Agnese Giaccone, Nicola Schiano Moriello, Ivan Gentile
Lamivudine is a cytidine nucleoside analogue, initially developed as an antiretroviral drug to treat HIV infection and later approved for the treatment of chronic B hepatitis infection [103]. Pharmacokinetics of lamivudine are similar in patients with HIV, HBV infection, and healthy volunteers. Lamivudine is administered in oral form and has bioavailability of about 82%; it is phosphorylated to its active form (lamivudine 5’-triphosphate) by intracellular kinases and acts by inhibiting the HBV DNA polymerase causing the early termination of the DNA chain [104]. Around 70% of lamivudine given orally is eliminated by the kidneys as an unchanged drug [110]. Lamivudine is considered to have a low genetic barrier against the B hepatitis virus and resistance develops in 53% to 76% of patients after 3 years of treatment [105]. For this reason, lamivudine is no longer considered as a first line agent to treat chronic B hepatitis, however it can still be regarded as an alternative for short therapy course in low resource settings were more expensive drugs are not available [83,84].
Development of lamivudine liposomes by three-level factorial design approach for optimum entrapment and enhancing tissue targeting
Published in Journal of Microencapsulation, 2020
Mangesh D. Godbole, Prafulla M. Sabale, Vijay B. Mathur
Unlike other viruses, the human body cannot get rid of Human immunodeficiency virus (HIV) and it remains in the body for whole life. ‘Acquired Immunodeficiency Syndrome’ (AIDS) is caused by ‘Human Immunodeficiency Virus’ (HIV), and its prevalence had been gradually increasing epidemic over last few decades. Therefore, effective antiretroviral therapy is required on a long-term basis to maintain viral suppression and reduce disease progression. Several antiretroviral agents have been developed for the control of HIV. Lamivudine (3TC) is potential hydrophilic antiretroviral agent acting as nucleoside reverse transcriptase inhibitor for treatment of acquired immunodeficiency syndrome. Lamivudine has a short biological half-life (4–6 h) and requires frequent administration for a prolonged period of time. Toxic effects due to administration for long term, inadequate bioavailability at the resident sites of HIV and emergence of drug-resistant mutants are some side effects reported with 3TC (Moyle 2000, Jain et al.2007).
Use of sorbitol as pharmaceutical excipient in the present day formulations – issues and challenges for drug absorption and bioavailability
Published in Drug Development and Industrial Pharmacy, 2019
Ranjeet Prasad Dash, Nuggehally R. Srinivas, R. Jayachandra Babu
Lamivudine, available in tablet formulation, is a nucleoside reverse transcriptase inhibitors used for the management of hepatitis B and HIV in both adults and children [21]. It is a BCS class III drug that exhibits high solubility and well-absorbed with an absolute bioavailability of 86% in adults [22,23]. However, a clinical study in children (n = 19) aged ≤4 years showed that the relative bioavailability of lamivudine oral solution was 37% lower than that of a tablet formulation [24]. This observation led to another clinical pharmacokinetic study in healthy adult subjects to evaluate the effect of sorbitol on the pharmacokinetics of lamivudine oral solution. In a cross-over study design, 16 subjects received lamivudine 300 mg (10 mg/mL) alone or with sorbitol 3.2, 10.2, or 13.4 g [25]. Pharmacokinetic analysis showed that sorbitol at doses of 3.2, 10.2, and 13.4 g decreased lamivudine Cmax by 28%, 52%, and 55% and AUC0-24 by 20%, 39%, and 44%, respectively, as shown in Table 2 [25]. The apparent clearance of lamivudine increased by 17%, 48%, and 57% corresponding to 3.2, 10.2, and 13.4 g doses of sorbitol. A nonsignificant increase in the apparent t1/2 of lamivudine when co-administered with sorbitol across all the doses was observed as compared to lamivudine alone [25].