- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
Final week 192 results from the ADVANCE trial: first-line TAF/FTC/DTG, TDF/FTC/DTG vs TDF/FTC/EFV () - Jul 2, 2022 - Abstract #AIDS2022AIDS_3932;
In the ADVANCE trial, participants taking TAF/FTC+DTG experienced greater weight gain and clinical obesity than TDF/FTC/DTG by Week 192, particularly in women, but no significant differences in HIV RNA suppression or renal or bone-related adverse events. Both TAF/FTC/DTG and TDF/FTC/DTG had significantly higher rates of HIV RNA suppression than TDF/FTC/EFV at Week 192 in the main ITT analysis.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Adherence and resistance to ART among postpartum women with HIV in KwaZulu-Natal, South Africa () - May 12, 2022 - Abstract #AIDS2022AIDS_877;
Adherence to ART needs to be addressed to prevent failure of newer first line regimens, including Dolutegravir containing regimens, and second line regimens. Self-reported adherence tools may have limited benefit in assessing adherence to ART showing the need for early treatment support for all WWH.
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg., emtricitabine/tenofovir disoproxil fumarate / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Journal: The making of the one pill-Developing single tablet regimens for HIV and for HCV. (Pubmed Central) - May 9, 2022
A fixed-dose combination of ledipasvir and sofosbuvir was developed and approved in 2014 to be the first complete daily single tablet regimen for CHC genotype 1 infection. A spray-drying process for particle morphology engineering in a polymer matrix was used for improving bioavailability.
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Journal: The transformation of HIV therapy: One pill once a day. (Pubmed Central) - May 9, 2022
A co-formulated, one pill once a day antiretroviral regimen (single-tablet regimen), containing efavirenz, emtricitabine, and tenofovir disoproxyl fumarate (Atripla), revolutionized the antiretroviral therapy landscape...Given the many excellent options available now, single-tablet regimens are the preferred choice for initiating antiretroviral therapy in almost all patients with rare exceptions for drug interactions and pregnancy, and for simplification of more complex antiretroviral therapy to a single-tablet regimen. In this special commemorative article, we celebrate this astounding advancement in antiretroviral therapy, championed by John C. Martin while CEO of Gilead Sciences, and its transformative impact on HIV care nationally and globally.
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
Journal: Anti-HIV Drugs Cause Mitochondrial Dysfunction in Monocyte-Derived Macrophages. (Pubmed Central) - Apr 22, 2022
Collectively, our data demonstrate that cART, independent of HIV, alters the MDM phenotype. This suggests that cART may contribute to cell dysregulation in PLWH that subsequently results in increased susceptibility to comorbidities.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Journal: CYP2B6 Genotype and Weight Gain Differences Between Dolutegravir and Efavirenz. (Pubmed Central) - Mar 15, 2022
CYP2B6 metaboliser genotype was associated with weight gain in PLWH starting efavirenz-based ART. Weight gain was similar between CYP2B6 extensive metabolizers in the efavirenz arm and in the dolutegravir arm, suggesting that impaired weight gain among CYP2B6 slow or intermediate metabolizers could explain the increased weight gain on dolutegravir compared with efavirenz observed in ADVANCE and other studies.
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Journal: Bone and fat hormonal crosstalk with antiretroviral initiation. (Pubmed Central) - Mar 12, 2022
Weight gain was similar between CYP2B6 extensive metabolizers in the efavirenz arm and in the dolutegravir arm, suggesting that impaired weight gain among CYP2B6 slow or intermediate metabolizers could explain the increased weight gain on dolutegravir compared with efavirenz observed in ADVANCE and other studies. The current study demonstrates bone-fat crosstalk in cART initiating PLWH.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
ADVERSE OUTCOMES IN SUBSEQUENT PREGNANCIES IN THE IMPAACT 2010 TRIAL ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_1192;
Women were randomized to start ART with dolutegravir (DTG) plus emtricitabine (FTC)/tenofovir alafenamide (TAF); DTG+FTC/tenofovir disoproxil fumarate (TDF); or efavirenz (EFV)/FTC/TDF...Nineteen (3%) of 643 women had 20 subsequent pregnancies on-study and were taking the following ART at conception: DTG+FTC/TAF (3), DTG+FTC/TDF (2), EFV/FTC/TDF (11, 1 woman with 2 pregnancies), non-study ART (2) and no ART (1)...This finding should be considered in analyses of incident pregnancies occurring in trial participants. Data from larger similar cohorts of women are needed, to elucidate factors associated with adverse pregnancy outcomes in WLHIV.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
RISK-BENEFIT TRADE-OFF FOR PREGNANCY AND INFANT OUTCOMES: DTG, EFV, TAF, AND TDF ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_1191;
Overall, DTG+FTC/TAF provided the best and clearest risk-benefit trade-off when more severe outcomes were given more weight. Similarly, DTG+FTC/TDF had a better risk-benefit profile than EFV/FTC/TDF.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
PREGNANCY HEMOGLOBIN A1c AND GLUCOSE WITH DTG VS EFV, TDF VS TAF: IMPAACT 2010 ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_942;
In IMPAACT 2010, a trial comparing 3 antiretroviral treatment (ART) regimens initiated in pregnancy, dolutegravir (DTG)–particularly in combination with tenofovir alafenamide (TAF)–was associated with more weight gain but better pregnancy outcomes than ART containing efavirenz (EFV) or tenofovir disoproxil fumarate (TDF)...348 mothers and 65 infants had HbA1c and/or glucose result available (114 in the DTG+FTC/TAF; 116 in the DTG+FTC/TDF; and 118 in the EFV/FTC/TDF arms); 78% enrolled in Africa...Mean infant glucose levels ?48 hours of birth were similar by arm. In this randomized trial with modest sample sizes of participants assessed for HbA1c and random glucose, we did not observe significant differences in maternal HbA1C by ART regimen, nor clinically meaningful differences in maternal or infant random glucose.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
RESUPPRESSION AFTER VIROLOGICAL FAILURE IN DOLUTEGRAVIR AND EFAVIRENZ-BASED REGIMENS ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_634;
In ADVANCE and NAMSAL, participants taking DTG regimens with HIV RNA >1,000 copies/mL after being suppressed were more likely to resuppress without a change in treatment with low rates of resistance. EFV based regimens were more likely to show sustained viremia and higher resistance compared to DTG based regimens.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
GROWTH OF INFANTS WITH PERINATAL EXPOSURE TO MATERNAL DTG VS EFV AND TDF VS TAF ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_266;
Pregnant women with HIV in 9 countries were randomized 1:1:1 to start open-label maternal ART with dolutegravir (DTG) plus emtricitabine (FTC)/tenofovir alafenamide (TAF), DTG+FTC/tenofovir disoproxil fumarate (TDF), or efavirenz (EFV)/FTC/TDF at 14-28 weeks’ gestation...There were no apparent mean differences between DTG+FTC/TAF and DTG+FTC/TDF arms in LAZ or WAZ at Weeks 26 or 50...Rates of severe stunting were high across all arms, and present in one in five EFV/FTC/TDF-exposed 1-year old infants. Infant growth should be factored into choice of optimal maternal ART regimen during pregnancy and breastfeeding.
- |||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Clinical, Retrospective data, Journal, Real-world evidence: Durability of single tablet regimen for patients with HIV infection in Southern Taiwan: data from a real-world setting. (Pubmed Central) - Jan 12, 2022
This probably driven by the more frequently sexual health education and counseling when patients had syphilis infection. Treatment with ABC/DTG/3TC was associated with higher risk of treatment failure. The STR durability was dependent on the drug toxicity/intolerance, age and syphilis infection.
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Nephrotoxicity monitoring and risk factors evaluation in HIV patients receiving ART (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_668;
Risk of ART induced renal toxicity is higher in patients, receiving tenofovir containing regimens , and increases after 12–18 months of treatment. Progressive stage of HIV, Low CD4+ , HCV and TB co-infections significantly increase the risk of kidney damage.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
Week 144 body composition results from the ADVANCE trial (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_602;
Participants taking TAF/FTC+DTG showed greater rises in weight, with significantly higher changes in women compared to men. These results confirm previous findings from the ADVANCE trial, and participants continue to gain weight to week 144.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan, Tivicay (dolutegravir) / ViiV Healthcare
Week 192 bone and renal markers from the ADVANCE trial (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_600;
Fifteen bone fractures occurred during the study period, none attributed to the study drugs. Between baseline and week 48, hip BMD decreased significantly in all treatment groups, with, greater reductions in the TDF-containing groups versus the TAF-containing group (P < 0.001).
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Nephrotoxicity monitoring and risk factors evaluation in HIV patients receiving ART (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_201;
Risk of ART induced renal toxicity is higher in patients, receiving tenofovir containing regimens , and increases after 12–18 months of treatment. Progressive stage of HIV, Low CD4+ , HCV and TB co-infections significantly increase the risk of kidney damage.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan
Week 144 body composition results from the ADVANCE trial (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_135;
Participants taking TAF/FTC+DTG showed greater rises in weight, with significantly higher changes in women compared to men. These results confirm previous findings from the ADVANCE trial, and participants continue to gain weight to week 144.
- |||||||||| dolutegravir/emtricitabine/tenofovir alafenamide (DTG/FTC/TAF) / Mylan, Tivicay (dolutegravir) / ViiV Healthcare
Week 192 bone and renal markers from the ADVANCE trial (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_133;
Fifteen bone fractures occurred during the study period, none attributed to the study drugs. Between baseline and week 48, hip BMD decreased significantly in all treatment groups, with, greater reductions in the TDF-containing groups versus the TAF-containing group (P < 0.001).
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Journal: The estimation of transmitted drug resistance mutation strains probability in the treatment of HIV using the beta-binomial model. (Pubmed Central) - Aug 20, 2021
The transition probability matrices corresponding to the ARV drugs combinations TDF+ETC+NVP, TDF+FTC+EFV, AZT+3TC+NVP, AZT+3TC+EFV, D4T+3TC+NVP, and D4T+3TC+EFV provide an upper triangular matrix of probabilities...The transmission probabilities play a major role in aiding the physicians make an informed decision to prescribe an optimal ARV drugs combination. We suggest a TDRM test to be done to all newly diagnosed HIV individuals before prescribing any of the ARV drugs combination.
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
Journal: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide discontinuation and return to normal weight. (Pubmed Central) - Aug 12, 2021
Identifying who is at greatest risk and whether the unintended weight gain is reversible remain unanswered questions. We report a return to baseline weight after switching back to tenofovir disoproxil/emtricitabine/efavirenz (Atripla®) in a woman who had profound weight gain due to tenofovir alafenamide/emtricitabine/cobicistat/elvitegravir (Genvoya®).
- |||||||||| Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco, NN1213 / Novo Nordisk
Trial completion, Trial primary completion date: SABES: HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women (clinicaltrials.gov) - Jul 14, 2021
P4, N=223, Completed,
However, predictive tools have not been validated in the HIV-positive and black African population. Active, not recruiting --> Completed | Trial primary completion date: Mar 2019 --> Nov 2020
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Journal: Impact of pre-existing drug resistance on risk of virological failure in South Africa. (Pubmed Central) - Jul 11, 2021
In a South African cohort, the presence of majority DRMs increased the risk of VF, especially for participants receiving <2 active drugs. The detection of drug-resistant MVs alone did not predict an increased risk of VF, but their inclusion with majority DRMs affected the sensitivity/specificity of predicting VF.
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Clinical, Journal: Bone methabolic disorders in HIV positive patients: a case report. (Pubmed Central) - Jun 30, 2021
Chronic infection with HIV likely contributes to increased systemic inflammation, which has been associated with increased rates of fracture. We report a case of a 56-year-old male (HIV + in treatment with Atripla) heavy worker, at the beginning affected by intra-articular proximal humerus fracture treated with endoprosthesis replacement and later by periprosthetic fracture treated with plate, screws and cerclages...Bone metabolism disorders in HIV patients lead to low BMD values, changes in bone turnover markers, and histomorphometric abnormalities, especially when HIV is present along with HCV or other hepatopathies. Additional therapy with bisphosphonate and Vitamin D should always be carried out when possible to prevent such types of orthopaedic complications.
- |||||||||| efavirenz / Generic mfg.
Clinical, Journal: Efavirenz-Induced Vanishing Bile Duct Syndrome: A Case Report. (Pubmed Central) - May 15, 2021
To our knowledge, this is the first reported case of probable efavirenz-induced VBDS in a patient living with HIV. Recognition and awareness of this adverse drug reaction by clinicians for quick diagnosis, discontinuation of therapy, and management are important in patients receiving this regimen.
- |||||||||| efavirenz/emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Clinical, Journal: Will differentiated care for stable HIV patients reduce healthcare systems costs? (Pubmed Central) - May 13, 2021
The standard of care for stable patients has already been "differentiated" for years in South Africa, prior to the roll out of the new adherence guidelines. AC and DMD models of care, when implemented as envisioned in the guidelines, are unlikely to generate substantive reductions or increases in provider costs of care.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults (clinicaltrials.gov) - May 11, 2021
P4, N=30, Completed,
AC and DMD models of care, when implemented as envisioned in the guidelines, are unlikely to generate substantive reductions or increases in provider costs of care. Recruiting --> Completed | N=200 --> 30 | Trial completion date: Oct 2021 --> Sep 2020 | Trial primary completion date: Sep 2021 --> Aug 2020
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