2015 Elsevier Ltd. Background Tenofovir disoproxil fumarate can cause renal and bone toxic effects related to high plasma tenofovir concentrations. Tenofovir alafenamide is a novel tenofovir prodrug with a 90% reduction in plasma tenofovir concentrations. Tenofovir alafenamide-containing regimens can have improved renal and bone safety compared with tenofovir disoproxil fumarate-containing regimens. Methods In these two controlled, double-blind phase 3 studies, we recruited treatment-naive HIV-infected patients with an estimated creatinine clearance of 50 mL per min or higher from 178 outpatient centres in 16 countries. Patients were randomly assigned (1:1) to receive once-daily oral tablets containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide (E/C/F/tenofovir alafenamide) or 300 mg tenofovir disoproxil fumarate (E/C/F/tenofovir disoproxil fumarate) with matching placebo. Randomisation was done by a computer-generated allocation sequence (block ...
Lamivudine and tenofovir disoproxil fumarate - Get up-to-date information on Lamivudine and tenofovir disoproxil fumarate side effects, uses, dosage, overdose, pregnancy, alcohol and more. Learn more about Lamivudine and tenofovir disoproxil fumarate
TY - JOUR. T1 - Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide-naïve chronic hepatitis B patients in Korea. T2 - data from the clinical practice setting in a single-center cohort. AU - Ahn, Sung S.oo. AU - Chon, Young E.un. AU - Kim, Beom K.yung. AU - Kim, Seung U.p.. AU - Kim, Do Y.oung. AU - Ahn, Sang H.oon. AU - Han, Kwang Hyub. AU - Park, Jun Y.ong. PY - 2014/9/1. Y1 - 2014/9/1. N2 - BACKGROUND/AIMS: This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to 12 months in Korean treatment-naïve chronic hepatitis B (CHB) patients.METHODS: A total of 411 treatment-naïve CHB patients who had been treated with TDF for at least 3 months (median 5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinely assessed every 3 months.RESULTS: The median age was 51.3 years, 63.0% of the patients were male, 49.6% were HBeAg (+), and 210 patients had liver cirrhosis. The median baseline HBV ...
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A Randomized, Phase II, Controlled Trial Comparing the Efficacy of Adefovir Dipivoxil and Tenofovir Disoproxil Fumarate for the Treatment of Lamivudine-Resistant Hepatitis B Virus in Subjects Who Are Co-Infected With HIV ...
Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) in the open-label period ...
BACKGROUND: Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen for the treatment of HIV-1 infection in ART-naive adults.. METHODS: We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Both drug regimens were administered orally. We masked participants and investigators to treatment ...
This study is to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. Safety, tolerability, and efficacy will also be evaluated through Week 48.. A total of 50 adolescent participants (12 to , 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows:. ...
Background: Off-target renal and bone side effects may occur with tenofovir disoproxil fumarate (TDF) use. Compared with TDF, tenofovir alafenamide (TAF) results in significantly reduced plasma tenofovir (TFV) and may have less renal and bone toxicity.. Methods: Treatment naïve HIV-1+ adults were randomized 1:1 to a single tablet regimen of E/C/F/TAF or E/C/F/TDF once daily in two double blind studies. Assessments included measures of renal function and bone mineral density (BMD). Four pre-specified secondary safety endpoints were tested: serum creatinine, treatment-emergent proteinuria, spine and hip BMD. Week 48 off-target side effects data are described.. Results: Combined, the two studies randomized and treated 1,733 subjects. Plasma TFV was ,90% lower (mean [%CV] AUCtau 297 (20) vs. 3,410 (25) nghr/mL) in the E/C/F/TAF arm, compared to the E/C/F/TDF arm. Serum creatinine (mean [SD] change: +0.08 [0.124] vs +0.11 [0.217] mg/dL, p,0.001), quantified proteinuria (UPCR, median [Q1, Q3] % ...
Medication Guide TRUVADA (tru-vah-dah) (emtricitabine and tenofovir disoproxil fumarate) Tablets Read this Medication Guide before you start taking TRUVADA and each time you get a refill. There may be
Learn about Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate) may treat, uses, dosage, side effects, drug interactions, warnings, patient labeling, reviews, and related medications.
Learn about Complera (Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Tablets) may treat, uses, dosage, side effects, drug interactions, warnings, patient labeling, reviews, and related medications.
Professional guide for Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate. Includes: pharmacology, pharmacokinetics, contraindications, interactions, adverse reactions and more.
On June 8, 2017, the Food and Drug Administration approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, ...
This study compared the efficacy and tolerability of entecavir versus tenofovir disoproxil fumarate in patients with chronic hepatitis B.
Brand Name: Cimduo Other Names: 3TC/TDF, Lamivudine/Tenofovir Disoproxil Fumarate Drug Class: Nucleoside Reverse Transcriptase Inhibitors WARNING:Cimduo can cause serious, life-threatening side effec
Background. The efficacy of tenofovir disoproxil fumarate (TDF) as part of combination antiretroviral treatment (ART) has been demonstrated in several randomized, controlled trials. However, an increasing number of case reports suggest that TDF use may be associated with significant nephrotoxicity. Our objective was to determine the renal safety of TDF-containing ART regimens for HIV-infected individuals.. Methods. MEDLINE, EMBASE, Global Health, Scopus, Biosis Previews, Cochrane Library, Web of Science, and existing systematic reviews were searched. Prospective studies comparing TDF-containing with non-TDF containing ART regimens were selected for inclusion. We extracted data on study characteristics, participant characteristics, therapeutic interventions, renal function, bone density, and fracture rates.. Results. A total of 17 studies (including 9 randomized, controlled trials) met the selection criteria. Median sample size was 517 participants. Constituent ART regimens were diverse. There ...
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Lim, S.G., Marcellin, P., Tassopoulos, N., Hadziyannis, S., Chang, T.T., Tong, M., Sievert, W., Hu, P., Arterburn, S., Brosgart, C.L. (2007). Clinical trial: Effects of adefovir dipivoxil therapy in Asian and Caucasian patients with chronic hepatitis B. Alimentary Pharmacology and Therapeutics 26 (10) : 1419-1428. [email protected] Repository. https://doi.org/10.1111/j.1365-2036.2007.03506. ...
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is a once-daily, single-tablet regimen for treatment of HIV-1 infection. The efficacy/safety of switching to D/C/F/TAF versus continuing boosted protease inhibitor (bPI) + emtricitabine/tenofovir disoproxil fumarate (control) were demonstrated in a phase 3, randomized study (EMERALD) of treatment-experienced, virologically suppressed adults through week 48. The objective of this analysis was to evaluate EMERALD outcomes across subgroups of patients based on demographic characteristics, prior treatment experience, and baseline antiretroviral regimen. EMERALD patients were virologically suppressed (viral load [VL] | 50 copies/mL for ≥ 2 months at screening). Prior non-darunavir virologic failure (VF) was allowed. Primary endpoint was proportion of patients with virologic rebound (confirmed VL ≥ 50 copies/mL) cumulative through week 48. Virologic response was VL | 50 copies/mL (FDA snapshot). Safety was assessed by
FOSTER CITY, Calif. & WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Aug. 11, 2006--Gilead Sciences, Inc. (Nasdaq: GILD) and Merck & Co., Inc. (NYSE: MRK) today announced that the companies have established an agreement for the distribution of ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily, single tablet regimen for the treatment of HIV-1 infection in adults, in developing countries around the world.. ATRIPLA contains 600 mg of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, both nucleoside reverse transcriptase inhibitors (NRTIs). Efavirenz is marketed by Merck under the tradename Stocrin(R) in all territories outside of the United States, Canada and certain European countries (where it is commercialized by Bristol-Myers Squibb under the tradename Sustiva(R)). Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences under ...
This retrospective single-center analysis included 212 people taking TDF with ritonavir-boosted protease inhibitors (PIs), 176 with nonnucleosides, 46 with dolutegravir or raltegravir, and 76 with elvitegravir/cobicistat. Tenofovir troughs proved significantly higher with elvitegravir/cobicistat or with boosted PIs than with nonnucleosides or integrase inhibitors (P < 0.01). Multivariate regression analysis with tenofovir trough concentration as the dependent variable indicated significantly higher tenofovir troughs with elvitegravir/cobicistat than with ritonavir-boosted PIs (beta 0.27, P = 0.001). In the same analysis, women had higher tenofovir troughs than men (beta 0.20, P = 0.004). Older age and lower weight were also associated with higher tenofovir troughs ...
The addition of adefovir dipivoxil (ADV) to ongoing lamivudine therapy is effective against lamivudine-resistant virus in patients with hepatitis B virus (HBV) infection. We studied 39 patients who received ADV added to lamivudine for breakthrough hepatitis. We determined early viral changes (12 wee …
Emtricitabine & Tenofovir - Get up-to-date information on Emtricitabine & Tenofovir side effects, uses, dosage, overdose, pregnancy, alcohol and more. Learn more about Emtricitabine & Tenofovir
Introduction: More than a million people acquire HIV infection annually. Pre-exposure prophylaxis (PrEP) using antiretrovirals is currently being investigated for HIV prevention. Oral and topical formulations of tenofovir have undergone preclinical and clinical testing to assess acceptability, safety and effectiveness in preventing HIV infection. Areas covered: The tenofovir drug development pathway from compound discovery, preclinical animal model testing and human testing were reviewed for safety, tolerability and efficacy. Tenofovir is well tolerated and safe when used both systemically or applied topically for HIV prevention. High drug concentrations at the site of HIV transmission and concomitant low systemic drug concentrations are achieved with vaginal application. Coitally applied gel may be the favored prevention option for women compared with the tablets, which may be more suitable for prevention in men and sero-discordant couples. However, recent contradictory effectiveness outcomes ...
Tenofovir belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (NtRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people. Tenofovir is currently in late-stage clinical trials for the treatment of hepatitis B. Tenofovir disoproxil fumarate is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate. Tenofovir requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylations by cellular enzymes to form tenofovir diphosphate. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases α, β, and mitochondrial DNA polymerase γ ...
BACKGROUND: Reproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type 1 (HIV-1) infection. METHODS: We conducted a randomized, placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate (TDF), oral tenofovir-emtricitabine (TDF-FTC), or 1% tenofovir (TFV) vaginal gel as preexposure prophylaxis against HIV-1 infection in women in South Africa, Uganda, and Zimbabwe. HIV-1 testing was performed monthly, and plasma TFV levels were assessed quarterly.
... - Product Developed Through Joint Venture Between Bristol-Myers Squib... Gilead Sciences the First of Its Kind in HIV Treatment - ...PRINCETON N.J. and FOSTER CITY Calif. Dec. 17 FirstCall... Historically HIV treatment regimens have been a challenge for manyp...,European,Commission,Approves,ATRIPLA(R),(efavirenz,600,mg/emtricitabine,200,mg/tenofovir,disoproxil,fumarate,300,mg),,the,First,Once-Daily,Single,Tablet,Regimen,for,Virologically,Suppressed,Adults,With,HIV-1,Infection,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health
Tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) are prodrugs of the HIV-1 nucleotide reverse transcriptase inhibitor tenofovir (TFV). In vivo, TAF achieves ,4-fold-higher intracellular levels of TFV diphosphate (TFV-DP) compared to TDF. Since thymidine analog-associated mutations (TAMs) in HIV-1 confer reduced TFV susceptibility, patients with TAM-containing HIV-1 may benefit from higher TFV-DP levels delivered by TAF. Moreover, the presence of the M184V mutation increases TFV susceptibility during TDF- or TAF-based therapy. The susceptibilities to antiviral drugs of site-directed mutants (SDMs) and patient-derived mutants containing combinations of TAMs (M41L, D67N, K70R, L210W, T215Y, and K219Q) with or without the M184V mutation (TAMs±M184V) were evaluated using either 5-day multicycle (MC; n = 110) or 2-day single-cycle (SC; n = 96) HIV assays. The presence of M184V in TAM-containing HIV-1 SDMs (n = 48) significantly increased TAF sensitivity compared to SDMs without ...
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FOSTER CITY, Calif.--(BUSINESS WIRE)--March 8, 2006--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted traditional approval status to its once-daily antiretroviral Viread(R) (tenofovir disoproxil fumarate) and its fixed-dose product Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), which combines the companys two antiretrovirals Emtriva(R) (emtricitabine) and Viread in a single daily tablet. Traditional approval status was granted following FDA review of 48-week data from Study 934, the second confirmatory pivotal study for Viread. The FDA previously granted accelerated approval for Viread and Truvada in October 2001 and August 2004, respectively.. As part of traditional approval, the U.S. prescribing information for Viread and Truvada now include 48-week data from Study 934, a Phase III open-label trial comparing a once-daily regimen of Viread, Emtriva and efavirenz to twice-daily Combivir(R) (lamivudine/zidovudine) and ...
Consumer information about the medication EMTRICITABINE/TENOFOVIR - ORAL (Truvada), includes side effects, drug interactions, recommended dosages, and storage information. Read more about the prescription drug EMTRICITABINE/TENOFOVIR - ORAL.
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Phosphonates represent an important class of organophosphorus compounds. Their use as reagents in organic synthesis is prevalent, and there is a plethora of examples of biologically active compounds possessing the phosphonate moiety. To further our exploration of phosphonates as both reagents and biologically active compounds we have developed a one-flask protocol for the direct synthesis of phosphonates from benzylic and allylic alcohols. This transformation is unprecedented and is applicable to a range of substrates. Both electron rich and electron deficient benzylic alcohols react under the conditions developed. Furthermore, good yields are achieved when converting allylic alcohols to the corresponding allylic phosphonates. In at least one case, the one-flask protocol allows for phosphonate formation that was not achievable under the standard conditions. Bisphosphonates represent a significant subclass of phosphonates. Several nitrogenous bisphosphonates have found use in the clinic as treatments for
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This study will test the safety, side effects and antiviral activity of different doses of tenofovir DF in children and adolescents with human immunodef
A Phase 2 Randomized Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in combination with Tenofovir Disoproxil Fumarate (TDF) for the treatment of subjects with chronic hepatitis B and who are currently not on treatment
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Likewise to currently marketed STRs, Gilead remains the major player with multiple combinations under development. Most notably, pipeline combinations include their nucleotide reverse transcriptase inhibitor tenofovir alafenamide (TAF). (Table 2) TAF has demonstrated in phase III trials an improved renal and bone safety profile as well as high antiviral efficacy at a dose 10 times lower than Gileads tenofovir disoproxil fumarate, which is used in their current STRs.[3] Gilead is also inclined to promote TAF use over TDF as the patent protection for TDF is set to expire in July 2017.[2]. First and closest to launch is Genvoya, which consists of emtricitabine/elvitegravir/tenofovir alafenamide + cobicistat. The European Commission and the FDA have granted marketing authorization in November 2015[4][5], and the STR will likely be marketed as a replacement for Gileads Stribild regimen. Second is Gileads yet unnamed emtricitabine/rilpivirine/tenofovir alafenamide STR that has been submitted to the ...
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Patrick Marcellin1, Maria Buti2, Edward Gane3, Naoky Tsai4, William Sievert5, Ira M. Jacobson6, George Germanidis7, Phillip Dinh8, John F. Flaherty8, Kathryn M. Kitrinos8, John G. McHutchison8, Nezam H. Afdhal9 1H pital Beaujon, Clichy, France; 2Hospital General Universitari Vall dHebron and Ciberehd, Barcelona, Spain; 3Auckland City Hospital, Auckland, New Zealand; 4University of Hawaii at Manoa, Honolulu, HI, United States; 5Monash University and Monash Medical Centre, Melbourne, VIC, Australia; 6Weill Cornell Medical College, New York, NY, United States; 7AHEPA University Hospital, Aristotle University Medical School, Thessaloniki, Greece; 8Gilead Sciences, Inc., Foster City, CA, United States; 9Beth Israel Deaconess Medical Center, Boston, MA, United States ...
Because TAF is rapidly converted to tenofovir, and tenofovir exposure in rats and mice is lower after TAF administration compared to tenofovir disoproxil fumarate (TDF) administration, carcinogenicity studies were performed with TDF. Long-term oral carcinogenicity studies of tenofovir in mice and rats were carried out at 167 times (mice) and 55 times (rats) tenofovir exposure compared to that seen after TAF administration at recommended doses in humans. In female mice, liver adenomas were increased. In rats, no carcinogenic findings were observed.1,2 Reproduction/Fertility ...
In a United Kingdom cohort of 71 pregnant women receiving TDF, retrospective analysis of serum creatinine and estimated glomerular filtration rate (eGFR) measured throughout pregnancy and 6 weeks after delivery revealed no decline in renal function during pregnancy and normal renal function(,90 mL/min) 6 weeks postpartum (one womans postpartum eGFR was 60 mL/min).19. Among 382 pregnancies occurring in 302 women in Uganda and Zimbabwe participating in the DART trial-approximately two-thirds of whom received TDF through more than 90% of their pregnancies-there were no differences noted in mortality, birth defects, or growth.20 In the Pediatric HIV/AIDS Cohort Study from the United States, 449 (21%) of the 2,029 HIV-exposed but uninfected infants had in utero exposure to TDF, and there was no difference at birth between those exposed to combination drug regimens with or without TDF in low birthweight, small-for-gestational-age, and newborn length-for-age and head circumference-for-age z-scores ...
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Published Thursday, 21 November 2013 00:00Written by Liz Highleyman. A new formulation of tenofovir that can be taken at lower doses demonstrated potent activity against hepatitis B virus (HBV) similar to that of the existing formulation in a 28-day study, but with less effect on kidney function, researchers reported at the 64thAASLD Liver Meeting this month in Washington, DC.. Gilead Sciences tenofovir disoproxil fumarate (TDF, brand name Viread) - the currently marketed formulation - is one of the most effective antiviral drugs for hepatitis B as well as one of the most widely used antiretrovirals for HIV. TDF is generally safe and well-tolerated, but it can cause kidney toxicity in susceptible individuals and is also associated with bone loss.. A new pro-drug formulation known as tenofovir alafenamide (TAF, formerly GS-7340) produces 5-fold higher concentrations of active tenofovir diphosphate in lymphoid cells that harbor HIV, but is more stable in plasma and results in lower blood drug ...
The aim of this manuscript is to highlight challenges in the implementation of maternal tenofovir disoproxil fumarate (tenofovir) for prevention of mother to child transmission (PMTCT) of hepatitis B virus (HBV) in resource limited setting. Current preventive strategies in resource-limited settings fail mainly due to prohibitive costs of hepatitis B immunoglobulin (HBIG) and a high proportion of homebirths, meaning both HBIG and hepatitis B birth dose vaccine are not given. A new strategy for PMTCT without the necessity of HBIG, could be daily tenofovir commenced early in gestation. Implementation challenges to early tenofovir for PMTCT can provide insight to elimination strategies of HBV as the burden of disease is high in resource-limited settings. Challenges encountered during implementation of a study of tenofovir for PMTCT before 20 weeks gestation in rural and resource-limited areas on the Thailand-Myanmar border were identified informally from trial study logbooks and formally from comments from
Volume 4, Issue 12.. Our guest author is Chloe Thio, MD, Professor of Medicine, Divison of Infectious Diseases at the Johns Hopkins University School of Medicine.. Take our post-test to claim CME credits ...