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On the experimental HIV drug front, Anthony Mills presented the latest findings on Gilead Sciences’ tenofovir alafenamide or TAF, a new formulation designed to produce higher levels of active drug in HIV-infected cells than the current tenofovir disoproxil fumarate or TDF formulation (Viread, also in the Truvada, Atripla, Complera, and Stribild combination pills).
Mills reported data from a Phase 2 study comparing a single-tablet regimen of TAF, darunavir (Prezista), cobicistat, and emtricitabine — the first one-pill-once-daily regimen containing an HIV protease inhibitor — versus a combination regimen of the same drugs with TDF in previously untreated people with HIV. After 48 weeks of treatment, 77% of participants taking the TAF regimen and 84% taking the TDF regimen had undetectable viral load. But TAF, which is taken at lower doses, had less detrimental effect on kidney function and hip and spine bone density.
Another study, presented by Susan Ford of GlaxoSmithKline, looked at the experimental HIV integrase inhibitor cabotegravir (formerly known as GSK1265744) . In previous studies it showed good antiviral activity both as a daily pill and as a long-acting injection that can be given monthly or even quarterly. Ford’s team did a population pharmacokinetic analysis of about 350 people who received an initial “loading dose” of cabotegravir followed by either 400 mg injections once-monthly, 600 mg injections every other month, or 800 mg injections every three months.
All three dosing schedules produced blood drug concentrations above target levels previously established for HIV treatment and prevention.The next-generation non-nucleoside reverse transcriptase inhibitor doravirine (formerly MK-1439) has come.They found that doravirine was as effective as efavirenz (Sustiva) and was well-tolerated across a range of doses. Based on these findings, the 100 mg dose was selected for forthcoming research.
Samit Gupta reported that an experimental thymidine nucleoside reverse transcriptase inhibitor, BMS-986001, was as effective as tenofovir when taken with efavirenz and emtricitabine in a multinational Phase 2b study.At week 48 of treatment, between 75% and 89% of people taking the new drug had undetectable viral load. A related study by Grace McComsey’s team found that BMS-986001 caused less bone loss than tenofovir .