Conference coverage: Starting ARVS, PreP and New Booster
In the past we treated anyone with a CD4 <200 or <14%. Now the guidelines state we should offer treatment to those with CD4 <350. It is OK to treat if CD4 is <500 or anyone who won’t wear a condom so that their transmission risk is lower on antivirals. The guidelines are updated frequently and I am waiting for any changes in light of the International AIDS conference in Washington DC held in July.
Since president Reagan, the conference committee would not consider meeting in the USA when there was a travel ban on HIV patients. Many attendees around the world (physicians, researchers, industry representatives, and policy makers) are HIV positive. President Obama lifted the ban, so then the committee could consider planning the next conference in the USA and it was held recently in Washington, DC.
There is a prospective (purposeful, forward looking) randomized (to take out bias) large, multi-site clinical trial underway that will have strong evidence on when to start antivirals. It is called the START trial. Results should be ready in 2015. In the meantime there are a couple of other studies that keep shedding more light on this issue.
The HIV Prevention Treatment Network conducted a large study (052) in multiple countries with 1,761 people and found that treating early, upon first diagnosis with higher CD4s (average of 440) decreased the development of HIV complications when compared to waiting to treat when the CD4s were lower (average of 230). Early treatment also prevented transmission of HIV in 96% of the couples when the other partner was HIV negative. Taking into account the decreased complications (less medications and hospitalizations) and less transmissions treating early is cost effective for even South Africa and India at their prices.
The Cascade trial presented at the conference as is helpful too. 9,455 patients from developed countries were followed. They found that you would need to treat 34 patients for 3 years who have their CD4 between 350 and 500 to prevent one complication (AIDS or death). That is a 3% chance over 3 years for the individual. If you asked me if I was willing to take medications for 3 years when I have a 97% chance of not needing them, I might say no thanks. From a public health policy standpoint, these small percentages do help the public. Please note that this study did not address the lower transmission rates for those on medications and the complications their sex partners might have had.
The guidelines for treating HIV patients are available in updated form at http://aidsinfo.nih.gov/. There is a committee of the best minds on HIV in the USA that discusses and votes on the individual items. Sometimes they don’t agree and that is reflected in the ratings of the items. I anxiously await the next edition.
TREATMENT AS PREVENTION (TasP) AND PRE EXPOSURE PROPHYLAXIS (PREP)
The International Aids Society had a recent meeting of consumers, advocates, providers, industry representatives, and policy makers and made a consensus statement regarding these two issues.
TasP: If an HIV patient not on treatment or with inadequate treatment (missing doses so that the viral load is high) will not wear a condom consistently, then treating them earlier than usual is to be offered. Treatment lowers the risk much, and a condom lowers it 100%.
PreP: If a partner of an HIV patient is at risk and not wearing a condom, then this is better than no condom (which is 100%). I don’t like putting pills in my mouth if there is another way but I am unable to judge others. Abstinence, monogamy, condoms, low viral loads are way better at prevention than PreP.
There are challenges in many countries mentioned concerning these two strategies including: financial and resource limitations, quality and appropriateness of available drugs, ethical and human rights issues, stigma, health system and workforce capacity, potential increases in risk from poor adherence and/or risk compensation behavior (may take more risks since “protected”), need for national/global guidelines, identification of high-risk populations and ways to reach them.
BOOSTING
Protease inhibitors (PI) like Reyataz®, Prezista®, Crixivan®, Invirase®, are able to be taken less times a day and still be potent if they are boosted. Only Kaletra®, made by Abbott, has the main booster, Norvir® in it, the others need the Norvir® to be taken separately. Now a new booster is coming out, Cobisistat. Unlike Norvir®, it has no anti-HIV properties but does boost the levels of the other medications and has less side effects. The company making this has been quite the dealmaker to cooperate with the other pharmaceutical companies to make combinations beneficial for all. Abbott has, for some reason, not made these deals for these many years, causing an increase in number of pills to be taken instead of co-formulating the booster with the other PIs. At last it looks like we will have boosters imbedded into the other pills. There is a combination of a PI pill combined with Cobisistat and a new integrase inhibitor, Elvitegravir schedules to be submitted to the FDA in August, 2012. This might be the third one-pill-once-a-day to come out. Atripla® and Complera® are out but they have a non-nucleoside reverse transcriptase inhibitor instead of the Elvitegravir. Some other PIs are being studied with this new booster.
MISSING CLINIC VISITS
At the Seattle meeting in March, there was a study showing in Kaiser patients that there was a higher risk of dying because of missed office visits in the first year of seeing an HIV specialist. Those who missed more visits were more likely to be: black or latino, intravenous drug users, 18-29 years old, having a low CD4, and on public insurance.
Keep those questions coming. Be safe by heeding the advice in this article.
REFERENCES
Early ART treatment delays AIDS-related health events in HIV-infected individuals. Published on July 30, 2012 at 12:54 AM · NEWS MEDICAL
Timing of HAART Initiation and Clinical Outcomes in Human Immunodeficiency Virus Type 1 Seroconverters. Writing Committee for the CASCADE Collaboration*Arch Intern Med. 2011;171(17):1560-1569
http://www.natap.org/2012/CROI/croi_150.htm
http://www.iapac.org/tasp_prep/assets/TPSlon12_consensus.pdf
By: Daniel Pearce, D.O. FACOI, AAHIVMS