OK For Genvoya and Tenofovir-Alafenamide Single Pill Scheme

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The Almighty FDA Gave Its OK For Genvoya and Tenofovir-Alafenamide Single Pill Scheme

First Gilead squeezed the Truvada until you did not come out of the box any more. Then, after cases and cases, and more cases of osteoporosis, kidney failure they release the Genvoya that makes me think even in noia !!!

Single tablet of Genvoya and Tenofovir was released by US Food and Drug Administration (FDA) announced the approval of the drug created by "Gilead Sciences", O Genvoya, a new remedy with a single tablet dosage containing the integrase inhibitor elvitegravir, booster cobicistat, emtricitabine and tenofovir alafenamide (TAF) - a new formulation that is easier to be assimilated by the kidneys and bones than the older ones treatments with tenofovir disoproxil fumarate (TDF). What about PEP?

"Today, the approval of a fixed dose combination containing a new form of tenofovir provides another effective form, in a therapeutic regimen of a single tablet once a day for patients with HIV-1 infection, "Said Edward Cox, director of the FDA Office of Antimicrobial Products, said in a FDA Press release (I had to kill the link, the FDA has no commitment to maintaining its documentation đŸ˜ŁđŸ˜ŁđŸ˜ đŸ˜€).

Yes, this girl who helps me on Instagram and sometimes even makes me smile, is a great friend!!!

With This OK For Genvoya and Tenofovir-Alafenamide Single Pill Scheme

Genvoya is the first approved product containing TAF, a pro-drug that delivers the active agent, tenofovir diphosphate, to HIV-infected cells more efficiently than current formulations with TDF (Viread and Truvada, also at Atripla, Complera, and Stribild) . The new co-formulation is similar to Stribild, but with 10mg of TAF replacing 300mg from TDF.

One of the most widely used antiretroviral drugs, TDF is considered generally safe and well tolerated, but it can cause a small amount of bone loss soon after beginning treatment and can lead to kidney problems in individuals susceptible to it. TAF produces drugs at appropriate intracellular levels at lower doses, which means lower blood concentrations and less drug exposure to the kidneys, bones and other organs and tissues.

Genvoya FDA approval was based on data from the Phase 3, in randomized clinical trials enrolling more than 3.000 participants, which showed that investigated various schemes containing several works, as well as regimens containing TDF to suppress HIV replication, but with less renal toxicity and bone. Nausea was the most common side effect observed in these studies.

Genvoya has been approved for use by untreated patients, HIV-positive adults and children of all ages up to 12 years of age and weighing at least 35 kg (about 77 pounds), and for adults coming from a stable suppressive antiretroviral regimen that have no prior history of treatment failure.

Even if late this OK For Genvoya And Tenofovir-Alafenamide Single Pill Scheme Is A Relief

Genvoya is not recommended for people with severe impairment of renal function (eGFR 30 mL / min), but it can be used by people with moderate impairment. In clinical trials with Genvoya, no cases of Fanconi Syndrome or proximal renal tubulopathy, 2 types of severe renal disease, were observed among persons with normal renal function at baseline (eGFR> 50 ml / min). While TAF is active against the hepatitis B virus (HBV), Genvoya is not recognized as a treatment for hepatitis B which can lead to sudden worsening of hepatitis B.

Treatment With Genoya Is First Line

Two international studies (the 104 study and the 111 study) made the head-of-comparison first-line treatment using Genvoya or Stribild. Together, they enrolled 1733 treatment-naive participants with near-normal renal function. As described in this year's Conference on Retroviruses and Opportunistic Infections {Link opens on another tab, another website, and in English), after 48 weeks of treatment 92% of people dealing with Genvoya and 90% having Stribild had undetectable viral load. As reported in a European congress in Barcelona on AIDS96 weeks .In response rates were 87 85% and% respectively. The virological results do not differ by age, sex, race / ethnicity, geographic region, baseline viral load, or CD4.

Treatment was generally safe and well tolerated, with low rates of serious adverse events and discontinuation due to adverse events, but TAF had fewer negative effects on the kidneys and bones. Several laboratory tests of renal function favored the scheme using the TAF scheme. People taking Genvoya had significantly lower mean reduction in bone mineral density of the spine and bone mineral density of the hip in 96 weeks. The total LDL and HDL-cholesterol were the largest increases in the TAF arm of the study (a known side effect of tenofovir) , but the relationship with total HDL cholesterol remained stable.

Other studies have shown that Genvoya has been shown to be safe and effective for previously untreated patients. Persons with pre-existing renal insufficiency {link em outra aba, outro site, em inglĂȘs) (eGFR 30-69 mL/min) Pesquisa (112) e para o tratamento de ingenuidade adolescente com HIV ( 106Âș estudo).

Mudar para Genvoya Pode Ser Uma Ótima Opção

Outro estudo Fase 3 (o 109Âș estudo) mostrou que as pessoas que mudaram de um esquema combinado contendo TDF com Genvoya tinham mantida a supressĂŁo viral e vĂȘ melhoria nos rins e nos marcadores Ăłsseos. Conforme descrito na edição deste ano da ConferĂȘncia sobre retrovĂ­rus e infecçÔes oportunistas {link para outra aba, outro site, em inglĂȘs}, Tony Mills da Sociedade de Homens MĂ©dicos do grupo e colegas CalifĂłrnia do Sul estudaram 1436 tratamentos de pessoas experientes com função renal normal que no inĂ­cio do estudo tinham uma estĂĄvel supressĂŁo viral, tendo Stribild; o efavirenz/TDF/emtricitabina coformulation (Atripla); ou atazanavir (Reyataz), impulsionado com ritonavir ou cobicistat, mais TDF/emtricitabina (Truvada). Eles foram aleatoriamente designados para permanecer sobre a seu regime atual contendo TDF ou mudar para Genvoya.

After 48 weeks, virologic response rates were high in both groups - 97% with Genvoya and 93% with the existing regime, showing that changing Genvoya was non-inferior to replace TDF-containing regimen. People who switched from Atripla or atazanavir had significantly better responses, while those who changed their Stribild achieved the same result as before.

Tenofovir Ended My Cervical Spine Because Of A Damn Osteoporosis

Osteoporosis is with six hundred thousand devils, who also took my left arm off! (I.e.

Overall levels of safety and tolerability were good in both treatment groups, with HIV-positive patients discontinuing due to adverse events. People who moved to Genvoya showed improvements in renal function markers, while those who stayed in the regimen containing TDF schemes worsened. The mineral density of the spine and hip bone structure rose in the Genvoya arm while falling among those who stayed in their existing schemes, and people who changed saw significant improvements for the treatment of osteoporosis. Again, lipid changes in blood were greater with the regime regimen containing FAT- and more people taking Genvoya began to modify the lipids as a consequence of the medication. Cliqie here to know another medicine, a Protease Inhibitor, the DARUNAVIR

: https://soropositivo.org/2015/08/24/pro-140-injecao-com-anticorpos-amplamente-neutralizantes-pode-esta-disponivel-no-inicio-de-2017/

TAF going forward

In addition to Genvoya, Gilead has also requested approval of another TAF-containing medication from a single tablet regimen containing NNRTI rilpivirine (which could be a successor to Complera) dual co-formulation of TAF and emtricitabine (Truvada's successor). And a monotherapy with TAF is being developed as a treatment for hepatitis B.

But most importantly, tenofovir alapenamide has not yet been adequately studied for pre-exposure prophylaxis (PrEP), and that potentially may not work as well as TDF because it does not create as much presence in body tissues. Asked about the role of TAF for HIV prevention in the eleventh, Marshall Fordyce of Gilead said the company is collaborating with the Centers for Disease Control and Prevention on a study of TAF and Emtricitabine PrEP in monkeys.

"As the population of people living with HIV get older, increases the risk of development of age - and the treatment of related comorbidities, including low bone mineral density and renal impairment. This is due to the combination of HIV infection, antiretroviral treatments, and the natural aging process, "104 / 111 study led researcher David Wohl of the University of North Carolina at Chapel Hill in a Gilead Press release. "Given its proven efficacy and safety profile, Genvoya represents an important new treatment option for a number of patients who are new to therapy or who choose to change treatments."



        1. US Food and Drug Administration. FDA approves new treatment for HIV. Press release. November 5, 2015. (I had to kill the link by generating page not found)
        2. Klein R, K Struble, S and Morin, the US Food and Drug Administration. FDA approved GENVOYA as a complete regimen for the treatment of HIV-infection 1. FDA alert. November 15, 2015.
        3. Gilead Sciences. US Food and Drug Administration Approaches Gilead's Single Tablet Genvoya Regimen (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection. Press release (This link does not respond correctly and I deleted it). November 5, 2015.


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