Lamivudine 300mg / Tenofovir disoproxil 245mg tablets

BackgroundTo evaluate the effects of different types of nucleos(t)ide analogs on the survival rate of patients with hepatitis B virus-associated hepatocellular carcinoma (HBV-HCC) after radical resection through a network meta-analysis.MethodsPubMed, Embase, the Cochrane Library, and CNKI databases were searched up to 6 March 2024. The NOS was used to assess the risk of bias in cohort studies, while the ROB tool in Review Manager was employed for randomized controlled trials. Data on overall survival (OS) and recurrence-free survival (RFS) were extracted from the literature to pool hazard ratios (HRs) and corresponding 95% CrIs. Meta-analysis was performed via R.Results24 studies involving 9,787 HBV-HCC patients were included. Compared with the control group, antiviral therapies using telbivudine (HR [95% CrI] = 0.23 [0.12,0.44]), tenofovir disoproxil fumarate (HR [95% CrI] = 0.40 [0.30,0.52]), lamivudine (HR [95% CrI] = 0.50 [0.34, 0.75]), adefovir (HR [95% CrI] = 0.55 [0.38,0.79]), and entecavir (HR [95% CrI] = 0.55 [0.43,0.71]) significantly improved OS. Among these, telbivudine (98.22%) and tenofovir disoproxil fumarate (76.12%) demonstrated superior effects in improving OS. Compared with the control group, antiviral therapies using telbivudine (HR [95% CrI] = 0.45 [0.28,0.70]), tenofovir disoproxil fumarate (HR [95% CrI] = 0.52 [0.44,0.62]), entecavir (HR [95% CrI] = 0.65 [0.55,0.77]),adefovir (HR [95% CrI] = 0.79 [0.65,0.94]),and lamivudine (HR [95% CrI] = 0.82 [0.71, 0.94]) significantly improved RFS. Telbivudine (SUCRA, 93.22%) and tenofovir disoproxil fumarate (SUCRA, 85.37%) exhibited superior effects in improving RFS.ConclusionWhen compared to other nucleos(t)ide analogs, telbivudine and tenofovir disoproxil fumarate exhibited the most notable effects.Systematic reviewIdentifier CRD42024612794.

Abstract licence: CC BY

ObjectiveTo evaluate the efficacy and safety of antiretroviral therapy(ART) regimens based on tenofovir(TDF) + lamivudine(3TC) + efavirenz(EFV) in patients co-infected with Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV), thereby providing evidence-based support for clinical treatment decision-making.MethodsRelevant studies published from database inception to March 2025 were systematically retrieved from the CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, Web of Science, and Cochrane Library databases. The revised Risk of Bias tool version 2 (ROB2) was used to assess study quality, and all meta-analyses were performed using Stata 18 software.ResultsA total of 31 randomized controlled trials (RCTs) involving 2124 participants and 12 treatment interventions were included, with four outcome measures evaluated. The network meta-analysis demonstrated that the TDF + 3TC + EFV triple therapy regimen was superior to the other evaluated regimens in achieving higher HBV DNA and HIV RNA negative conversion rates. In addition, TDF+ 3TC + EFV demonstrated greater efficacy than zidovudine(AZT) + 3TC + EFV in increasing CD4 + lymphocyte counts. The surface under the cumulative ranking curve (SUCRA) analysis indicated that TDF + 3TC + EFV ranked highest in terms of efficacy. Regarding safety, several studies reported various types of adverse events. However, no statistically significant differences were observed among the treatment groups.ConclusionBased on the currently available evidence, this network meta-analysis suggests that the TDF + 3TC + EFV triple regimen demonstrates superior efficacy across multiple outcome measures in patients with HIV/HBV co-infection. Nevertheless, owing to the inherent limitations of the included studies, further high-quality studies are required to confirm its role as a preferred therapeutic option.

Abstract licence: CC BY-NC-ND

IntroductionTreatment of hepatitis B virus (HBV) infection relies on nucleos(t)ide analogues to achieve viral suppression, with tenofovir or entecavir as first-line agents. Expanding treatment, and improving its outcomes, are crucial strategies to support progress towards global viral hepatitis elimination targets. However, therapeutic drug monitoring has not been optimized for HBV therapy.MethodsWe conducted a systematic review (PROSPERO CRD420250599139) to identify studies reporting on the relationship between drug concentrations and treatment outcomes of HBV in English from PubMed, Scopus and Web of Science. Primary search included people living with HBV, with or without HIV coinfection, treated with tenofovir and/or entecavir, with drug concentrations measured and linked to treatment outcome.ResultsSix studies were identified, of which five reported on HIV/HBV coinfection, and one on HBV monoinfection. Across studies, tenofovir concentrations >800 fmol/punch in dried blood spots were typically associated with viraemic suppression for both HIV and HBV. Evidence suggests that higher tenofovir concentrations (e.g. 1000-1500 fmol/punch) may be required for consistent HBV suppression.DiscussionA therapeutic threshold cannot currently be defined for concentrations of tenofovir or entecavir in HBV. Larger cohort studies focusing on HBV monoinfection are needed to define therapeutic drug thresholds to optimize personalized care for people living with HBV.

Abstract licence: CC BY

BackgroundHepatitis B virus (HBV) remains highly endemic in many low- and middle-income countries (LMICs), where challenges such as antiviral resistance and immune/vaccine-escape mutations complicate disease management.ObjectiveThis review synthesizes current data on HBV drug resistance, including the prevalence and distribution of resistance-associated mutations (RAMs), vaccine-escape mutations (VEMs), and immune-escape mutations (IEMs) in LMICs.DesignSystematic review and meta-analysis.Data sourcesPubMed, Scopus, and Web of Science.MethodsA systematic search was conducted from 2014 to 2025 (last search date: August 04, 2025), and data were extracted from eligible studies. A random-effects meta-analysis was conducted to estimate pooled resistance rates and prevalences.ResultsA total of 43,834 participants from 47 studies conducted in 28 LMICs were included. The overall antiviral resistance rate was 7.87% (95% CI (5.13-11.11)), with very high heterogeneity (I 2 = 99.7%). Lamivudine (3TC) and telbivudine (LdT) had the highest resistance rates. Asia consistently reported the greatest resistance, with rates of 32.45% for 3TC and 51.92% for LdT. In a subgroup analysis on economic regions, Lower-middle-income countries showed the highest pooled resistance rate at 10.61% (95% CI (5.21-17.51); I 2 = 96.9%). The most frequently detected RAMs were rtM204V/I, rtV173L, and rtL180M. The pooled prevalence of vaccine-escape mutations was 8.92% (95% CI (5.02-13.64); I 2 = 78.4%). Immune-escape mutations were much more common, with a pooled prevalence of 55.66% (95% CI (28.10-81.53); I 2 = 98.1%). The most prevalent mutations were sG145R/A/K, sQ129H/R, sD144E/A, sS143L/T, and sP120S/T. The pooled estimates in this study are reported and interpreted descriptively, given the substantial heterogeneity observed.ConclusionThe remarkably high drug resistance rates and prevalence of immune and vaccine-escape mutations suggest notable burdens of resistance, especially for drugs with low genetic barriers such as lamivudine and telbivudine, underscoring the growing challenges in achieving the WHO 2030 reduction goals, and highlighting the need for enhanced surveillance, adoption of potent antiviral regimens such as tenofovir disoproxil fumarate, and continuous vaccine efficacy monitoring. However, the results should be interpreted with caution due to the very high heterogeneity observed in the study.Trial registrationInternational prospective register of systematic reviews (PROSPERO) under the ID: CRD420251030302.

Abstract licence: CC BY-NC

BackgroundDoravirine (DOR) is a nonnucleoside reverse-transcriptase inhibitor. In the phase 3 DRIVE-AHEAD trial in treatment-naive adults with human immunodeficiency virus type 1 (HIV-1) infection, DOR demonstrated noninferior efficacy compared with efavirenz (EFV) and superior profiles for neuropsychiatric tolerability and lipids at 48 weeks. We present data through week 96.MethodsDRIVE-AHEAD is a phase 3, multicenter, double-blind, noninferiority trial in antiretroviral treatment-naive adults with HIV-1 RNA ≥1000 copies/mL. Participants were randomized to a daily fixed-dose tablet of DOR (100 mg), lamivudine (3TC; 300 mg) and tenofovir disoproxil fumarate (TDF; 300 mg) (DOR/3TC/TDF) or EFV (600 mg), emtricitabine (FTC; 200 mg) and TDF (300 mg) (EFV/FTC/TDF). The efficacy end point of interest at week 96 was the proportion of participants with HIV-1 RNA levels ResultsOf 734 participants randomized, 728 received study drugs and were included in analyses. At week 96, HIV-1 RNA Clinical trials registrationNCT02403674.

Abstract licence: CC BY

BackgroundAinuovirine (ANV) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI), which was initially synthesized in Korea and later further developed in both Korea and China.MethodsA randomized, double-blind, double-dummy, positive parallel group, non-inferiority, phase 3 trial was conducted in 7 sites across China. Eligible HIV-1-positive antiretroviral therapy (ART)-naïve adults aged 18-65 years were randomly assigned in a 1:1 ratio to receive tenofovir disoproxil fumarate and lamivudine (TDF+3TC) in combination with either ANV (ANV group) or efavirenz (EFV group) for up to 48 weeks. Subsequently, participants in both groups received one of the two drug combinations according to their choice until week 96 in an observational study under an open-label setting. The primary endpoint was the proportion of participants achieving HIV RNA FindingsBetween November 27, 2018 and March 11, 2021, a total of 826 participants were screened, and 630 were finally enrolled and randomly assigned (1:1) to either ANV (n = 315) or EFV (n = 315) groups. The mean age was 30.6 ± 9.4 years and most participants were male (94.6%). At week 48, 274 (87.0%) of 315 participants in the ANV group and 288 (91.7%) of 314 in the EFV group achieved HIV-1 RNA p = 0.189). The incidence of NNRTI treatment-related adverse events (TEAEs) at week 48 was 67.6% in 315 participants in the ANV group, which was significantly lower than in 91.4% of 314 participants in the EFV group (p p InterpretationThe week 48 results indicated that the efficacy of ANV was non-inferior to EFV when combined with two NRTIs. The per-protocol risk difference at week 48 for the primary endpoint also supported non-inferiority. TEAEs in ANV treated participants were less frequent with regard to liver toxicity, dyslipidemia, neuropsychiatric symptoms and rash compared to the EFV group during the first 48 weeks of therapy. The effects were maintained during the 48-96 weeks of therapy.FundingJiangsu Aidea Pharmaceutical Co., Ltd.

Abstract licence: CC BY-NC-ND

BackgroundIn China, non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens remain widely utilized as first-line antiretroviral therapy (ART) despite issues of low resistance barriers and significant side effects, leading to frequent treatment interruptions and virologic failures. Timely drug-resistance testing is often inaccessible, complicating subsequent treatment management. This trial aims to fill this critical gap by comparing the efficacy, safety, and tolerability of the single-tablet regimen (STR) of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) with the multi-tablet regimen (MTR) of dolutegravir plus lamivudine plus tenofovir disoproxil fumarate (DTG+3TC+TDF) in people living with HIV (PLWH) experiencing virologic failure.MethodsThis multicenter, open-label, randomized controlled non-inferiority trial will enroll 374 PLWH experiencing virologic failure of first-line NNRTI-based therapy from 14 clinics across China. Participants will be randomized 1:1 to receive either a once-daily STR of BIC/FTC/TAF or a once-daily MTR of DTG+3TC+TDF. The primary endpoint is the proportion achieving viral suppression (HIV-1 RNA DiscussionThis trial aims to provide high-quality evidence for a simplified, high-barrier, STR as an optimized second-line strategy in resource-limited settings where drug resistance testing is inaccessible.Trial registrationChinese Clinical Trial Registry (Trial ID: ChiCTR2500108287). Registered on 27 August 2025. Retrospectively registered. https://www.chictr.org.cn .

Abstract licence: CC BY-NC-ND

BackgroundOptimizing efavirenz (EFV) dosing to minimize adverse events (AEs) remains a critical issue. Studies indicate that reducing the EFV dose from 600 to 400 mg daily lowers side effect intensity while maintaining virological suppression. We previously showed that 600 mg daily EFV may lead to unnecessarily high exposure in Chinese patients, but the long-term efficacy and safety of dose reduction beyond 48 weeks in this population remain unknown.MethodsWe conducted a multicenter, randomized controlled trial comparing EFV 400 vs 600 mg, each combined with lamivudine (3TC) and tenofovir (TDF), in antiretroviral therapy-naïve Chinese adults with human immunodeficiency virus (HIV)-1. The primary endpoint was virological suppression (HIV-ribonucleic acid [RNA] ResultsAt baseline, demographic and clinical characteristics were comparable between groups. At week 72, virological suppression (HIV-RNA ConclusionEFV 400 mg is noninferior to EFV 600 mg in treatment-naïve Chinese patients over 72 weeks, offering improved safety and tolerability.Trial registration#NCT04463784 on ClinicalTrials.gov, Registered by Peking Union Medical College Hospital on April 1, 2018 (URL: https://clinicaltrials.gov/study/NCT04463784).

Abstract licence: CC BY-NC-ND

BackgroundD²EFT (Dolutegravir and Darunavir Evaluation in Adults Failing Therapy) was a phase 3b/4 randomized clinical trial designed to assess second-line treatment options systematically. This substudy evaluated the distribution of drug resistance mutations (DRMs) before treatment randomization in individuals failing first-line therapy.MethodsFrom a total of 826 participants across 14 countries, 727 sequences that covered the PR-RT-INT (700), PR-RT (24), and RT (3) regions were analyzed for drug resistance. Sequences were submitted to the Stanford HIV drug resistance database to detect DRMs and assign subtypes. By adjusting for country and antiretroviral therapy regimen, we assessed the association between DRMs and country and reported DRMs.ResultsSubtype C of human immunodeficiency virus type 1 (HIV-1) accounted for most (59.3%) infections. There were extraordinarily high rates of high-level resistance to lamivudine and emtricitabine (both at 88.3%) and for efavirenz and nevirapine (92.8% and 96.8%, respectively). On average, nucleoside reverse transcriptase inhibitor mutations had the highest occurrence across countries with M184V/I detected in 86.2% of the samples, while the highest proportion of nonnucleoside reverse transcriptase inhibitor mutations was K103N at 57.8%. K103N had an increased likelihood of occurrence in African and South American countries (P ConclusionsThe regional specificity of mutations underscores the dynamic nature of HIV-1 drug resistance patterns and the importance of monitoring and understanding local mutation profiles.

Abstract licence: CC BY-NC-ND

Purpose of reviewTwo-drug regimens (2DR) for antiretroviral therapy are increasingly being recommended for people living with HIV to reduce pill burden and reduce short and long-term toxicity. The exclusion of tenofovir and lamivudine or emtricitabine has implications for acquisition of and reactivation of hepatitis B.Recent findingsA number of case-series, cohort studies and randomized-controlled trials of 2Drs have reported on the risk of HBV acquisition and HBV-reactivation (HBVr). The risk of HBVr appears negligible in those switching to 2DRs containing lamivudine, and overall low (~1%) in those switching to tenofovir and lamivudine/emtricitabine-free therapy. Even remote HBsAg positivity is associated with a significant risk of HBVr.SummaryFor people with HIV switching to 2DRs careful attention needs to be paid to preswitch HBV serological patterns. For those without previous exposure, and absence of HBsAb, vaccination is important. The risk of HBVr of switching to lamivudine-containing regimens is negligible, and low without tenofovir and lamivudine/emtricitabine. Careful monitoring and preswitch counselling is advised.

Abstract licence: CC BY