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AIDS 2012: New Drugs and Formulations

August 1, 2012

At every conference we want to know about new drugs and how they might improve future care. In Washington we learnt about new integrase inhibitors and a new booster that could be an alternative to ritonavir.


New Booster -- Cobicistat as an Alternative to Ritonavir

Most protease inhibitors (PIs) need to be boosted to reach effective levels. Up until recently the only options to do this was to use low doses of another PI called ritonavir.

A new option close to approval is called cobicistat (pronounced COB-IZ-EE-STAT). Cobicistat was compared to ritonavir to boosting atazanavir in almost 700 people stating their first treatment. Everyone also used tenofovir/FTC in the combinations.

Although both boosters look similar in terms of efficacy and side effects, there is a practical advantage for the new drug. The company producing cobicistat is working with the manufacturers of darunavir and atazanavir to coformulate the PI and booster in the same pill.

This may help with fewer pills, fewer prescriptions and a slightly easier life for people taking these PIs.


New Integrase Inhibitors

Two new integrase inhibitors that are also likely to be close to approval had new studies presented at the conference. Both are once-daily meds.

Elvitegravir is a new integrase inhibitor that is included in the 4-in-1 single tablet combination called Quad. A study in Washington reported that after two years elvitegravir was similar to raltegravir in over 700 HIV positive people with drug resistance.

Elvitegravir has already been submitted to the FDA for approval as a separate drug, and shortly after the conference Quad was approved  in the US (tradename Stribild). The decision on European approval is expected by the end of 2012.

Dolutegravir is an integrase inhibitor that is being developed in a single tablet combination with abacavir and 3TC. In Washington the Spring-2 study reported dolutegravir to be similar to efavirenz in people using treatment for the first time. About 90% of people using either drug had undetectable viral load after a year.

Importantly, both raltegravir and dolutegravir have formulations for use by children that were also presented at the conference.


d4T Without the Side Effects: Early Days for a New Nuke

Finally, several studies were presented for a compound that is similar in structure to d4T.

Although these are early days this is being developed because it is unlikely to have the same side effects associated with d4T, including neuropathy and fat loss.


References

Unless stated otherwise, all references are to the Programme and Abstracts of the 19th International AIDS Society World AIDS Conference, 22–25 July 2012, Washington DC. http://www.aids2012.org.

  1. Gallant J et al. Cobicistat versus ritonavir as pharmacoenhancers in combination with atazanavir plus tenofovir disoproxil fumarate/emtricitabine: week 48 results. Oral abstract TUAB0103. http://pag.aids2012.org/Abstracts.aspx?SID=202&AID=13085
  2. Elion R et al. Efficacy and safety results from a randomized, double blind, active controlled trial of elvitegravir (once-daily) versus raltegravir (twice-daily) in treatment-experienced HIV-positive patients: long term 96-week data. Oral abstract TUAB0105. http://pag.aids2012.org/Abstracts.aspx?SID=202&AID=5823
  3. Raffi F et al. Once-daily dolutegravir (DTG; S/GSK1349572) is non-inferior to raltegravir (RAL) in antiretroviral-naive adults: 48 week results from SPRING-2 (ING113086). Late breaker oral presentation THLBB04. http://pag.aids2012.org/abstracts.aspx?aid=20990
  4. Nachman S et al. IMPAACT P1066: raltegravir (RAL) safety and efficacy in HIV+ youth two to 18 years of age through week 48. Oral Abstract TUAB0205. http://pag.aids2012.org/flash.aspx?pid=1371
  5. Hazra R et al. Pharmacokinetics, safety and efficacy of dolutegravir (DTG; S/GSK1349572) in HIV-1-positive adolescents: preliminary analysis from IMPAACT P1093. Oral abstract TUAB0203. http://pag.aids2012.org/flash.aspx?pid=1307
  6. Wang F et al. The HIV NRTI BMS-986001 does not degrade mitochondrial DNA in long term primary cultures of cells isolated from human kidney, muscle and subcutaneous fat. Poster abstract TUPE042. http://pag.aids2012.org/abstracts.aspx?aid=17957
  7. Guha M et al. Absence of renal and bone toxicity in non-clinical studies of BMS-986001, a nucleoside reverse transcriptase inhibitor (NRTI) of human immunodeficiency virus (HIV). Poster abstract TUPE041. http://pag.aids2012.org/abstracts.aspx?aid=16832




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