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Aprovaedo (FDA) Unique "Genvoya" Pill Scheme With Tenofovir Alafenamid

genoyaThe US Food and Drug Administration (FDA) announced on 5 November approval of Gilead Sciences "Genvoya, a new drug with a dosage of a single tablet containing the inhibitor elvitegravir integrase, the cobicistat booster, emtricitabine and tenofovir alafenamide (TAF ) - a new formulation that is easier to be assimilated by the kidneys and the bones that older treatment with tenofovir disoproxil fumarate (TDF).

"Today's approval of a fixed dose combination containing a new form of tenofovir provides another effective way, a therapeutic SCHEMATIC a single tablet once a day for patients with HIV-1," said Edward Cox, director of the FDA's office of antimicrobial products, said in aFDA press release.

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

One of the most widely used antiretrovirals, TDF is considered generally safe and well tolerated, but it can cause a small amount of bone loss immediately after initiation of treatment and can lead to kidney disease in susceptible individuals this. TAF produces appropriate intracellular levels of drugs at lower doses, which means lower concentration in the blood and reduced exposure to the drug 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 been approved for use by patients without prior therapy, HIV-positive adults and children of all ages to 12 years of age and weighing at least 35 kg (about 77 pounds), and adult coming from a stable suppressive antiretroviral regimen that They have no previous history of treatment failure.

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 were not observed cases of Fanconi syndrome or proximal renal tubulopathy, 2 types of severe kidney disease, among people with normal renal function at baseline (eGFR> 50 ml / minute). While TAF is active against hepatitis B virus (HBV), Genvoya is not recognized as a treatment for hepatitis B which can lead to sudden worsening of hepatitis B.

First-Line Genvoya

Two international studies (Study 104º and study 111º) made-head comparison of first-line treatment using Genvoya or Stribild. Together them signed up 1733 virgins participants from treatment renal function close to normal.As described in this year's Conference on Retroviruses and Opportunistic Infections{Link opens in another tab, and another site in English}, after weeks of treatment 48 92% of people dealing with Genvoya and 90% taking Stribild had an undetectable viral load.Aconforme 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 less negative effects on the kidneys and bones. Several laboratory tests of renal function favored the usandoo scheme scheme with TAF. The Genvoya people having had significantly lower mean reduction of bone mineral density in the spine and hip bone mineral density in 96 weeks.The total LDL and HDL cholesterol were the largest increases in TAF arm estudoo (a known side effect of tenofovir) but the relationship with total cholesterol HDL remained stable.

Other studies have shown that Genvoya was safe and effective for patients not previously treated.Persons with pre-existing renal insufficiency{link in another tab, another site, in English) (eGFR 30-69 mL / min) Search (112) and the naive adolescent treatment with HIV (106º study). Switch to Genvoya Another study phase 3 (the 109º study) showed that people who switched from a combined regimen containing TDF with Genvoya had maintained viral suppression and see improvement in kidney and bone markers. As discussed in this year's Conference on Retroviruses and infections opportunistic {link to another tab, another site, in English}, Tony Mills of the Society of Men group Doctors and colleagues of Southern California studied 5074 treatment experienced people with normal renal function at baseline had a stable viral suppression, and Stribild; Efavirenz / TDF / emtricitabine coformulation (Atripla); or atazanavir (Reyataz) boosted with ritonavir or cobicistat plus TDF / emtricitabine (Truvada). They were randomly assigned to remain on their current regimen containing TDF or switch to 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.

The overall safety and tolerability levels were good in both treatment groups, with few dropouts due to adverse events. People who switched to Genvoya showed improvements in markers of renal function, while those who stayed on the regimen containing TDF schemes worsened. The mineral density of the spine and hip bone structure went up in Genvoya arm while falling among those who stayed in their existing schemes, and people who changed seen significant improvements for the treatment of osteoporosis. Again, lipid abnormalities in the blood were higher with the regime containing regimen FAT- and more people taking Genvoya began modifying the lipid medication of consequence.

TAF going forward

Besides Genvoya, Gilead has also requested the approval of other medications containing TAF single tablet regimen containing NNRTI rilpivirine (which could be a Complera successor) stilldual coformulation of TAF and emtricitabine(successor of Truvada). And monotherapy TAF is being developed as a treatment for hepatitis B.

But above all, tenofovir alafenamide has not been adequately studied for pre-exposure prophylaxis (PrEP), which potentially may not perform as well as PTO why not create much present in body tissues. Asked about the role of TAF for HIV prevention at the eleventh, Marshall Fordyce Gilead said the company is cooperating with the disease control and prevention centers on a study of TAF and emtricitabine PrEP in monkeys.

"As the population ages patient with HIV increases the risk of developing age-related and treatment of comorbid conditions including low bone mineral density and renal impairment. This is due to the combination of HIV infection, antiretroviral therapy, and the natural process of aging, "study 104 / 111 lead researcher David Wohl of the University of North Carolina at Chapel Hill, in aGilead 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."

11/5/15

Sources

US Food and Drug Administration. FDA approves new treatment for HIV.Press release. November 5, 2015.

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.

Gilead Sciences. US Food and Drug Administration Approves Gilead's Single Tablet Regimen Genvoya (Elvitegravir, cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV Infection 1.Press release. November 5, 2015.

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