ViiV Healthcare, a global HIV specialist with a majority of GlaxoSmithKline plc, in partnership with Pfizer Inc. and Shionogi Limited, today announced the presentation of 12 abstracts that include data regarding its diverse portfolio of innovative options for treatment and prevention. of HIV, already authorized or currently in development, at the International Aids Society Conference 2021 (Ias 2021), in progress in virtual mode until 21 July. Kimberly Smith, Head of Research & Development ViiV Healthcare commented, “We are thrilled to present a broad range of data from ViiV Healthcare’s diverse portfolio and drug pipeline at IAS 2021. No single medicine will work for all people living. with HIV or are at risk of contracting the virus – he stressed – which is why we are developing innovative long-acting regimens and 2-drug combinations that are changing the treatment paradigm. We look forward to sharing these advances. including results on long-term efficacy and safety, a sign of the implementation of science and preferences that define the prospects of the HIV community, “concluded Smith. The most relevant data – reports a note – include: results at the 48th week of the Phase III ‘Salsa’ study evaluating the switch to the dolutegravir / lamivudine 2-drug regimen versus continuation with the corrected antiretroviral regimen nte (Car) of at least 3 drugs. Virologic and metabolic well-being outcomes at week 144 of the ‘Tango’ study evaluating the dolutegravir / lamivudine 2-drug regimen in virologically suppressed adults living with HIV-1. The phase III study ‘Tango’ – details the note – was conducted to evaluate the switch to dolutegravir / lamivudine compared to the continuation of therapy with a regimen of ≥3-drugs (TAF-based regimen, Tbr) that included tenofovir alafenamide ( TAF) in adults virologically suppressed with HIV-1. After three years of therapy, dolutegravir / lamivudine maintained non-inferior virological efficacy compared to Tbr, with no virological-related interruptions or development of resistance detected in the dolutegravir / lamivudine treatment arm. The alterations found in metabolic parameters were similar in the dolutegravir / lamivudine and Tbr arms, with changes in lipid parameters generally continuing to favor the dolutegravir / lamivudine arm. Weight changes, insulin resistance and metabolic syndrome occurred to a comparable extent between both treatment arms. Overall adverse event rates (Ea) were similar between groups through week 144, with overall Ea finding 91% of participants in the dolutegravir / lamivudine arm, and 90% in the Car arm. The most frequent AEs were nasopharyngitis, diarrhea, back pain, upper respiratory tract infection, syphilis and arthralgia, and were reported in similar proportions between treatment groups. And again: viral replication data in the ‘Tango’ studies and ‘Gemini-1 & 2’ for the dolutegravir / lamivudine 2-drug regimen and dolutegravir (Dtg) plus lamivudine in virologically suppressed and treatment-naïve adults living with HIV-1, respectively. In the ‘Tango’ study at 96 weeks of treatment, the dolutegravir / lamivudine and Tbr arms demonstrated similar proportions of participants with target not detected (Tnd) viral load (73% vs 69%, respectively), considered a sensitive measurement of viral load. Dolutegravir / lamivudine data showed higher rates of participants with Tnd at all study visits through week 96 with no difference between all groups by baseline viraemia, at 37% versus 31% for the Tbr arm. The occurrence of elevated viral loads greater than 50 copies / mL was lower in the dolutegravir / lamivudine arm (6%) than in the Tbr arm (10%). Furthermore, changes in inflammatory parameters were minimal and comparable between treatment arms during 96 weeks of treatment. The ‘Gemini-1 & 2’ studies are identically designed Phase III non-inferiority studies evaluating a 2-drug regimen of Dtg plus lamivudine versus a 3-drug regimen of Dtg + Ftc / Tdf in al-naïve adults. treatment living with HIV. The results continued to demonstrate the efficacy and durability of Dtg plus lamivudine over time in treatment-naïve adults, as demonstrated by the proportion of participants with similar viral load Tnd through week 144 in the Dtg plus lamivudine and Dtg + Ftc arms. / Tdf (Population Snapshot Analysis Intention to Treat-Exposed (ITT-E): 63% vs 65%, respectively; observed population: 77% vs 78%, respectively). Additionally, the frequency of viral load blips (Vl) through week 144 was found to be similar in both arms when assessed early from Day 1 or week 48 (Day 1 through week 144: 14.6% of participants in the Dtg plus lamivudine vs 19.5% in the Dtg + Ftc / Tdf arm). Data presented above showed that overall adverse event rates at week 144 were similar in both study arms, with lower drug-related AE rates in participants who received Dtg plus lamivudine than those who received DTG. + FTC / TDF (20% [146/716] vs 27% [192/717], respectively). The company also presents results at week 48 of the ‘Stat’ study evaluating the dolutegravir / lamivudine 2-drug regimen for rapid onset of treatment after diagnosis in adults with HIV-1. The Phase IIIb study was designed to evaluate the feasibility, efficacy and safety of using dolutegravir / lamivudine as a first-line regimen in a Test and Treat model of care that is increasingly seen in clinical practice. with treatment initiated within 14 days of diagnosis prior to the availability of hepatitis B virus (Hbv) co-infection status, renal function and resistance test results. At week 48, regardless of therapy, 82% (107/131) of all participants and 97% (107/110) of those with available data achieved HIV-1 Rna <50 c / mL. Dolutegravir / lamivudine was well tolerated, with low rates of grade 2-5 drug-related adverse events (2%) and serious adverse events (2%). The most common adverse events were headache, diarrhea, depression and nausea. Again: results at week 124 from the 'Flair' study evaluating cabotegravir and long-acting rilpivirine administered monthly for the treatment of HIV-1. The phase III study was designed to evaluate the non-inferiority of the monthly cabotegravir / rilpivirine regimen compared to the daily oral formulation of abacavir / dolutegravir / lamivudine. The data presented showed that the long-acting regimen maintained virologic suppression (HIV-1 RNA <50 copies / mL) in 80.2% (n = 227/283) of the study participants and that it is a long-lasting, effective and well-tolerated maintenance therapy for people with HIV who have received treatment with this regimen for up to 124 weeks. Since week 48, only one participant has experienced virological failure. Injection site reactions were the most common drug-related adverse event; most were grade 1 or 2 (99.5%). The safety and tolerability results are consistent with previous results at week 48 and week 96.Update virological and efficacy results of 'Hptn 084', a study sponsored by the US National Institute of Allergy and Infectious Diseases (Niaid), controlled and randomized double-blind study to evaluate the efficacy and safety of investigational long-acting injectable cabotegravir for pre-exposure prophylaxis (Cab-La) for HIV prevention in African women aged 18 to 45 years . The comparator was emtricitabine / tenofovir disoproxil fumarate (Ftc / Tdf) given oral once daily; there was no placebo control arm. La (Long Acting) administration of Cab and Ftc / Tdf tablets were both well tolerated during the study, with most adverse events being mild or moderate, and with a widely balanced frequency between both treatment arms. . Injection site reactions were more frequent in the Cab-La arm. No major integrase mutations or infections were reported during oral lead-in or PK tail phases. When prevailing infections were excluded, the incidence of HIV (95% CI) in the Cab-La arm was 0.15 (0.03-0.45) per person per year and the unadjusted hazard ratio for Cab-La vs. Ftc / Tdf was 0.08 (95% CI 0.03, 0.27) leading to a 92% reduction in infections compared to Ftc / Tdf, which had an unadjusted hazard ratio of 1.85. estimated long duration of action in the 'Hptn 084' cohort using a model-based HIV incidence in the absence of PrEP. For ethical reasons - presicsa the note - the efficacy of new HIV prevention products such as injectable long-acting cabotegravir for pre-exposure prophylaxis (Cab-La) must be compared with an approved PrEP product such as Ftc / Tdf. A hypothetical placebo control, using data from the placebo arm from previous trials to predict the cumulative incidence of HIV over one year of follow-up, suggests that Cab-La and daily oral Ftc / Tdf have efficacy against acquisition. HIV by 91% (95% int. cred. 76% -97%) and 15% (95% int. cred. -26% -44%), respectively when considering the efficacy data of the study from both experimental arms. This model-based comparison provides further assurance that Cab-La continues to demonstrate high rates of efficacy compared to a hypothetical placebo arm. With the aim of understanding participants' experiences and preferences in an injectable PrEP trial, it was conducted 'Hptn 083', sponsored by Niaid, an international, randomized, double-blind clinical trial of investigational long-acting injectable cabotegravir (Cab-La) versus oral Ftc / Tdf for HIV prevention among cisgender and transgender women who have sexual relations with males (Msm / Tgw). Previous results demonstrated a 66% reduction in HIV incidence in participants randomized to Cab-La compared to Ftc / Tdf. Cab-la injection and Ftc / Tdf tablets were both well tolerated during the study, with most adverse events mild or moderate in nature and balanced between treatment arms. And again, the results of the survey are presented at IAS 2021 on the interest in a long-acting injectable option for HIV prevention and preferences for implementation among U.S. males who have sex with children. males (MSM). Data from the annual American Men's Internet Survey of more than 10,000 men included questions about willingness to use a long-acting injectable medicine (Lai) for pre-exposure prophylaxis (PrEP) as well as perceived facilitators and barriers to its adoption. . Among MSMs, a group potentially at higher risk of contracting the virus, 72% said their use of Lai-PrEP was quite likely or very likely. Adoption facilitators included dosing every 2 months, but preference was expressed for even longer dosing intervals and emphasis was placed on optimizing adherence, persistence and reducing clinical impact. The barriers to adoption included the cost (52%) and a product with perceived severe side effects (30%). ViiV Healthcare - the note concludes - will participate in an IAS symposium on the most recent discoveries in the field of HIV care, presenting a summary of the work done as part of his collaboration with the University of North Carolina at Chapel Hill, including an update on approaches that induce latent HIV and reduce viral load.