Patient Survey on Lipodystrophy

 

 

 

 

Patient Survey on Lipodystrophy

 

 

 

 

HIV drug usage in the past ten years

 

Updated Facial Wasting Options Table

 

HIV Lipodystrophy has decreased in the past 4 years

 

Tenofovir Dosing for patients with kidney dysfunction

I have seen some confusion about Tenofovir (Viread, which is in Truvada and Atripla) dosing in those with kidney problems in my pozhealth at yahoogroups.com list, so I am posting this information.

So far, most of the problems with tenofovir and kidney function have been reported in treatment experienced patients on boosted protease inhibitors, african americans, people with diabetes, or those using other medications that may affect the kidneys. Naive patients on Atripla seem to be doing just fine.

By the way, for those of you who have not calculated your creatinine clearance, ask your doctor if that value is included in your lab report. If not , ask him or her to include it. You can also calculate it here:

http://cpsc.acponline.org/enhancements/212creatinineCalc.html


From
http://www.medscape.com/druginfo/monograph?cid=med&drugid=22106&drugname=Viread+Oral&monotype=monograph&secid=3


Special Populations
Dosage of tenofovir should be adjusted in adults with creatinine clearances less than 50 mL/minute. The manufacturer and some experts recommend that adults with creatinine clearances of 30 to 49 mL/minute should receive 300 mg of tenofovir once every 48 hours and those with clearances of 10 to 29 mL/minute should receive 300 mg twice weekly. Adults undergoing hemodialysis should receive 300 mg of tenofovir once every 7 days (based on 3 hemodialysis sessions per week, each lasting approximately 4 hours) or 300 mg after a total of approximately 12 hours of dialysis; the dose should be administered following completion of a dialysis session. Because safety and efficacy of these dosages have not been evaluated in clinical studies, clinical response to treatment and renal function should be closely monitored. The manufacturer states that dosage recommendations cannot be made for adults with creatinine clearances less than 10 mL/minute who are not undergoing hemodialysis since the pharmacokinetics of the drug have not been studied in such patients.
The usual dosage of the fixed-combination preparation containing emtricitabine and tenofovir disoproxil fumarate (Truvada®) can be used in adults with creatinine clearances of 50 mL/minute or greater. The manufacturer of the fixed-combination preparation recommends a dosage of one tablet (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) every 48 hours in adults with creatinine clearances of 30–49 mL/minute; response to therapy and renal function should be monitored in these patients since this dosing recommendation has not been evaluated in clinical studies. The fixed-combination preparation should not be used in adults with creatinine clearances less than 30 mL/minute, including those undergoing dialysis.

The usual dosage of the fixed-combination preparation containing tenofovir disoproxil fumarate, emtricitabine, and efavirenz (Atripla®) can be used in adults with creatinine clearances of 50 mL/minute or greater. The fixed-combination preparation should not be used in adults with creatinine clearances less than 50 mL/minute.

Dosage adjustment is not necessary in patients with hepatic impairment

37.5 percent of US patients skip AIDS/HIV treatment due to side effects.

FROM: http://pharmexec.findpharma.com/pharmexec/article/articleDetail.jsp?id=534038


A new study released at the 17th International AIDS Conference in Mexico City on Monday detailed the disconcerting fact that 37.5 percent of US interviewees skip AIDS/HIV treatment due to side effects.

AIDS Treatment for Life (ATLIS) polled approximately 3,000 HIV-positive patients from 18 countries to get a better understanding of their treatment regimens. Surprisingly, side effects trumped cost of treatment as the top reason for skipping treatment, with 55.4 percent of respondents admitting that they changed or stopped taking their medicine due to adverse reactions. Also, 27.3 percent of respondents said that they chose not to begin treatment because they felt that the treatments cause too many side effects.

"There are a fair amount of patients who are experiencing side effects from their treatments severe enough to change, stop, or avoid treatment," said Martin Markowitz, clinical director and staff investigator, Aaron Diamond AIDS Research Center. "That underlies the importance of treating patients with regimens that they can tolerate, and educating them about the side effects."

The top side effects that concerned interviewees were physical changes to body and face, liver problems, fatigue, and anemia.

Resistance to treatments is also an issue of concern. More than 28 percent of respondents in the US and 53 percent worldwide said that they were unaware of how resistance to antiretroviral drugs develops. "Treatment interruption without medical monitoring may result in accelerated disease progression," said Markowitz. "It is imperative that physicians and patients address concerns about side effects openly, and evaluate different treatment options that may be more tolerable."

On a positive note for domestically, a significantly higher ratio of US patients said that they were aware of treatment options: 32.9 percent, compared with a 69.4 percent worldwide.

"There is a need to increase the educational and treatment awareness programs that were very active early on, but that have since petered out," said Jose M. Zuniga, president and CEO of the International Association for Physicians in AIDS Care. "The fact that so many patients don?t understand resistance—even in the US—points to the fact that not enough is being done to increase HIV literacy."

MY COMMENTS:


In the past, many doctors would follow the mantra " don't fix it if it is not broken" referring to only CD4s and viral load. Patients had to be very assertive to convince docs to switch them to "friendlier" meds when their viral load was undectable, no matter how bad their quality of life was.

Actually, now more than ever I see an improving trend from doctors that are no longer following just CD4 cells and viral load in their decision to switch medications on patients. Many doctors waited too long to switch people from Zerit to Tenofovir or Abacavir, but most did by 2005. Presently, there are a lot of patients being switched from Kaletra to Reyataz to decrease lipids and diarrhea, or from all norvir-based protease inhibitors to raltegravir to also decrease lipids and/or diarrhea. I still see patients suffering from depression after months on Sustiva and being kept on this drug while being prescribed antidepressants to feel better and to clonazepam to sleep, which is creating a huge poly-pharmacy for them.

However, it is becoming increasingly difficult to educate the community about side effect management. Now that most companies are using their own employees to give patient lectures, some of us in the treatment education field are left with fewer funding sources to give unbiased information to patients who do not have Internet access.

S-Adenosyl-L-Methionine (SAMe) for Treatment of Depression, Osteoarthritis, and Liver Disease

I am convinced this supplement works for depression and fatigue. I have taken 400 mg twice a day and can definitely feel a difference the first day. Something else that I have noticed is that my hairy leukoplakia goes away within days. It can also decrease liver enzymes. However, it is contraindicated for those with bipolar disorder. It is not cheap. I get mine from Jarrow at the Houston Buyers Club.

Here is a summary of studies

http://www.healthyplace.com/Communities/Depression/treatment/alternative/sam-e.asp

I am attaching a study done in HIV

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=535560

Is Exercise Important for People with HIV?

We need more programs around the Unites States and the world that provide supervised exercise programs for people with HIV!

Association between Exercise and HIV Disease Progression in a Cohort of Homosexual Men . Annals of Epidemiology , Volume 9 , Issue 2 , Pages 127 - 131 T . Mustafa



Having exercised was associated with slower progression to AIDS at 1 year (); hazard ratios (HR) at 2, 3, and 4 years were 0.96, 1.18, and 1.36, respectively. Having exercised was also associated with slower progression to death with AIDS at 1 year (HR = 0.37, 90% CI: 0.14–0.94) with hazard ratios at 2, 3, and 4 years of 0.68, 0.98, and 1.27, respectively, suggesting a protective effect close to the time exercise was assessed, but an increased risk after 2 years. Exercising 3–4 times/week had a more protective effect than daily exercise. Exercisers in the HIV positive group showed an increase in CD4 count during a year by a factor of 1.07.



Testosterone Replacement and Resistance Exercise in HIV-Infected Men With Weight Loss and Low Testosterone Levels

Shalender Bhasin, MD; Thomas W. Storer, PhD; Marjan Javanbakht, MPH; Nancy Berman, PhD; Kevin E. Yarasheski, PhD; Jeffrey Phillips, MD; Marjorie Dike, PhD; Indrani Sinha-Hikim, PhD; Ruoquing Shen, MD; Ron D. Hays, PhD; Gildon Beall, MD

JAMA. 2000;283:763-770.



Our data suggest that testosterone and resistance exercise promote gains in body weight, muscle mass, muscle strength, and lean body mass in HIV-infected men with weight loss and low testosterone levels. Testosterone and exercise together did not produce greater gains than either intervention alone.



A pilot study of exercise training to reduce trunk fat in adults with HIV-associated fat redistribution.

AIDS. 13(11):1373-1375, July 30, 1999.
Roubenoff, Ronenn abc; Weiss, Lauren c; McDermott, Ann c; Heflin, Tanya ac; Cloutier, Gregory J. d; Wood, Michael ac; Gorbach, Sherwood ab


Exercise training may reduce trunk fat mass in HIV-positive men with fat redistribution.


Resistance Exercise and Supraphysiologic Androgen Therapy in Eugonadal Men With HIV-Related Weight Loss -A Randomized Controlled Trial


Alison Strawford, PhD; Theresa Barbieri; Marta Van Loan, PhD; Elizabeth Parks, PhD; Don Catlin, MD; Norman Barton, MD, PhD; Richard Neese, PhD; Mark Christiansen, MD; Janet King, RD, PhD; Marc K. Hellerstein, MD, PhD

JAMA. 1999;281:1282-1290.



A moderately supraphysiologic androgen regimen that included an anabolic steroid, oxandrolone, substantially increased the lean tissue accrual and strength gains from PRE, compared with physiologic testosterone replacement alone, in eugonadal men with HIV-associated weight loss. Protease inhibitors did not prevent lean tissue anabolism.



Supervised exercise training improves cardiopulmonary fitness in HIV-infected persons.

Medicine & Science in Sports & Exercise. 25(6):684-688, June 1993.
MACARTHUR, RODGER D.; LEVINE, SHELDON D.; BIRK, THOMAS J.



We attempted to measure cardiopulmonary effects, CD4 counts, and perceived sense of well-being in 25 individuals moderately to severely immunocompromised from HIV infection (mean entry CD4 count = 144-[mu]l-1) before and after a 24-wk program of exercise training. Only six subjects completed the 24-wk program. All six showed evidence of a training effect. Statistically significant improvements were seen in maximal oxygen consumption (VO2max), oxygen pulse, and minute ventilation. Submaximal exercise performance improved significantly by 12 wk in the 10 individuals available for testing: decreases were seen in heart rate, rate pressure product, and rate of perceived exertion. White blood cell counts and T-lymphocyte subsets were stable at 12 and 24 wk in the subjects available for testing. High depression/anxiety scores on a mental health inventory (General Health Questionnaire) correlated with low CD4 counts. Scores did not correlate with compliance with the exercise program. There was a trend (P < 0.10) for scores to improve over time among those individuals who attended >=80% of scheduled exercise sessions. We conclude that exercise training is feasible and beneficial for some HIV-infected individuals.





Aerobic exercise: effects on parameters related to fatigue, dyspnea, weight and body composition in HIV-infected adults. AIDS. 15(6):693-701, April 13, 2001.
Smith, Barbara A. a; Neidig, Judith L. b,d; Nickel, Jennie T. e; Mitchell, Gladys L. c; Para, Michael F. b; Fass, Robert J. b



We conclude that supervised aerobic exercise training safely decreases fatigue, weight, BMI, subcutaneous fat and abdominal girth (central fat) in HIV-1-infected individuals. It did not appear to have an effect on dyspnea.



Exercise intervention attenuates emotional distress and natural killer cell decrements following notification of positive serologic status for HIV-1
Applied Psychophysiology and Biofeedback


Volume 15, Number 3 / September, 1990

Arthur R. LaPerriere, Michael H. Antoni, Neil Schneiderman, Gail Ironson, Nancy Klimas, Panagiota Caralis and Mary Ann Fletcher

Abstract The impact of aerobic exercise training as a buffer of the affective distress and immune decrements which accompany the notification of HIV-1 antibody status in an AIDS risk group was studied. Fifty asymptomatic gay males with a pretraining fitness level of average or below (determined by predicted VO2 max) were randomly assigned to either an aerobic exercise training program or a no-contact control condition. After five weeks of training, at a point 72 hours before serostatus notification, psychometric, fitness and immunologic data were collected on all subjects. Psychometric and immunologic measures were again collected one-week postnotification. Seropositive controls showed significant increases in anxiety and depression, as well as decrements in natural killer cell number following notification whereas, seropositive exercisers showed no similar changes and in fact, resembled both seronegative groups. These findings suggest that concurrent changes in some affective and immunologic measures in response to an acute stressor might be attenuated by an experimentally manipulated aerobic exercise training intervention.





Resistance exercise training reduces hypertriglyceridemia in HIV-infected men treated with antiviral therapy
J Appl Physiol 90: 133-138, 2001; Vol. 90, Issue 1, 133-138, January 2001
Kevin E. Yarasheski1, Pablo Tebas2, Barbara Stanerson1, Sherry Claxton1, Donna Marin2, Kyongtae Bae3, Michael Kennedy2, Woraphot Tantisiriwat2, and William G. Powderly2



Hypertriglyceridemia, peripheral insulin resistance, and trunk adiposity are metabolic complications recently recognized in people infected with human immunodeficiency virus (HIV) and treated with highly active antiretroviral therapy (HAART). These complications may respond favorably to exercise training. Using a paired design, we determined whether 16 wk of weight-lifting exercise increased muscle mass and strength and decreased fasting serum triglycerides and adipose tissue mass in 18 HIV-infected men. The resistance exercise regimen consisted of three upper and four lower body exercises done for 1-1.5 h/day, 4 days/wk for 64 sessions. Dual-energy X-ray absorptiometry indicated that exercise training increased whole body lean mass 1.4 kg (P = 0.005) but did not reduce adipose tissue mass (P = NS). Axial proton-magnetic resonance imaging indicated that thigh muscle cross-sectional area increased 5-7 cm2 (P < 0.005). Muscle strength increased 23-38% (P < 0.0001) on all exercises. Fasting serum triglycerides were decreased at the end of training (281-204 mg/dl; P = 0.02). These findings imply that resistance exercise training-induced muscle hypertrophy may promote triglyceride clearance from the circulation of hypertriglyceridemic HIV-infected men treated with antiviral therapy.



Effects of exercise training and metformin on body composition and cardiovascular indices in HIV-infected patients.

AIDS. 18(3):465-473, February 20, 2004.
Driscoll, Susan D ; Meininger, Gary E ; Lareau, Mark T ; Dolan, Sara E ; Killilea, Kathleen M ; Hadigan, Colleen M ; Lloyd-Jones, Donald M c; Klibanski, Anne ; Frontera, Walter R ; Grinspoon, Steven K



Exercise training in combination with metformin significantly improves cardiovascular and biochemical parameters more than metformin alone in HIV-infected patients with fat redistribution and hyperinsulinemia. Combined treatment was safe, well tolerated and may be a useful strategy to decrease cardiovascular risk in this population.



The effect of acute exercise on lymphocyte subsets, natural killer cells, proliferative responses, and cytokines in HIV-seropositive persons.Ullum H, Palmø J, Halkjaer-Kristensen J, Diamant M, Klokker M, Kruuse A, LaPerriere A, Pedersen BK. J Acquir Immune Defic Syndr. 1994 Nov;7(11):1122-33.



Copenhagen Muscle Research Center, Department of Infectious Diseases, Rigshospitalet, Denmark.

Eight healthy men infected with human immunodeficiency virus, type 1 (HIV) and eight HIV seronegative age- and sex-matched controls exercised on a bicycle ergometer (75% of VO2max, 1 h). The percentages of CD4+, CD4+45RA+, and CD4+45RO+ cells did not change, whereas the absolute number of CD4+ cells increased twofold during exercise and fell below prevalues 2 h after. The neutrophil count increase was more pronounced after exercise in the controls compared with in HIV-seropositive subjects. The percent CD16+ cells, and the natural killer (NK) and lymphokine activated killer (LAK) cell activity increased during exercise, but this increase was significantly less pronounced in the HIV-seropositive group. The results suggest that in response to physical stress, HIV-seropositive subjects have an impaired ability to mobilize neutrophils, NK and LAK cells to the blood. Furthermore, because the total number of CD4+ cells, but not the percentage of CD4+ cells, changed in response to exercise, this study further strengthens the idea that the percentage of CD4+ cells is preferable to the number of CD4+ cells in monitoring patients seropositive for HIV.


Cardiopulmonary and CD4 cell changes in response to exercise training in early symptomatic HIV infection. Med. Sci. Sports Exerc., Vol. 31, No. 7, pp. 973-979, 1999.

Approximately 61% of exercise-assigned participants complied (> 50% attendance) with the exercise program, and analyses of exercise relapse data indicated that obesity and smoking status, but not exercise-associated illness, differentiated compliant from noncompliant exercisers. Compliant exercisers significantly improved peak oxygen consumption ( O2peak; 12%), oxygen pulse (O2pulse; 13%), tidal volume (TV; 8%), ventilation ( E; 17%), and leg power (25%) to a greater degree than control participants and noncompliant exercisers (all P < 0.05). Although no group differences in health status were found, a significant interaction effect indicated that noncompliant exercisers' CD4 cells declined (18%) significantly, whereas compliant exercisers' cell counts significantly increased (13%; P < 0.05).



Moderate and high intensity exercise training in HIV-1 seropositive individuals: a randomized trial. Int J Sports Med. 1999 Feb;20(2):142-6. Terry L, Sprinz E, Ribeiro JP.

HIV-infected individuals are frequently active, but guidelines for exercise in this population lack scientific support, since studies on the effects of exercise training on immunologic variables of HIV-1 positive individuals have shown conflicting results. Exercise capacity, immunologic markers (CD4, CD8 and CD4:CD8 ratio), anthropometric measurements, and depression scores were evaluated to compare the effects of two intensities of aerobic exercise on HIV-1 seropositive individuals. Twenty-one healthy subjects (14 men, 7 women), carriers of the HIV-1 virus (CD4>200 cells x mm(-3)), and inactive for at least 6 months, completed a 12 week exercise training program (36 sessions of 1 h, 3 times per week), in a moderate intensity group (60+/-4% of maximal heart rate) or a high intensity group (84+/-4% of maximal heart rate). Exercise capacity estimated by treadmill time was increased significantly in both moderate intensity (680+/-81 s before; 750+/-151 s after) and high intensity (651+/-122 s before; 841+/-158 s after) groups, but the high intensity group presented a significantly larger increment (p<0.01). There were no significant changes in the immunologic variables, anthropometric measurements or depression scores. Thus, HIV-seropositive individuals that participate in moderate and high intensity exercise programs are able to increase their functional capacity without any detectable changes in immunologic variables, anthropometric measurements or depression scores.



Aerobic Exercise Training for Depressive Symptom Management in Adults Living With HIV Infection . Journal of the Association of Nurses in AIDS care , Volume 14 , Issue 2 , Pages 30 - 40 J . Neidig , B . Smith , D . Brashers



Aerobic exercise training may help prevent or reduce depressive symptoms experienced by persons living with HIV infection. However, the psychological effects of aerobic exercise have not been studied extensively. This study evaluated the effects of an aerobic exercise training program on self-reported symptoms of depression in HIV-infected adults and examined the convergent validity of two widely used depressive symptom scales. Sixty HIV-infected adults participated in a randomized, controlled trial of a supervised 12-week aerobic exercise training program. As compared to study controls, exercise participants showed reductions in depressive symptoms on all indices, and total depressive symptoms scores were highly correlated. Additional study of the psychological effects of aerobic exercise programs in the target population is recommended.





The effect of exercise training on aerobic fitness, immune indices, and quality of life in HIV+ patients.

Medicine & Science in Sports & Exercise. 30(1):11-16, January 1998.
STRINGER, WILLIAM W.; BEREZOVSKAYA, MARINA; O'BRIEN, WILLIAM A.; BECK, C. KEITH; CASABURI, RICHARD



Exercise training resulted in a substantial improvement in aerobic function while immune indices were essentially unchanged. Quality of life markers improved significantly with exercise. Exercise training is safe and effective in this patient group and should be promoted for HIV+ patients

The Coming Crisis in HIV Drug Development

Excellent article by Paul Dalton

Project Inform
The Coming Crisis in HIV Drug Development
By Paul Dalton

June 16, 2008

The last few years have seen tremendous progress in treating people with advanced and drug-resistant HIV. Four powerful drugs became available that either overcame drug resistance (Prezista [darunavir, TMC-114], Intelence [etravirine, TMC-125]) or were from entirely new classes [Selzentry (maraviroc), Isentress (raltegravir)].

This marked an important and unique moment in HIV drug development. Never before have so many new and effective drugs come out so close together. People with extensive experience taking HIV drugs have been able to put together powerful regimens with two or more fully active agents -- often for the first time.

Project Inform took pains to highlight both the tremendous promise of these new drugs as well as the importance of using them correctly -- emphasizing that this moment, or anything resembling it, is unlikely to recur. Our message was clear: 'Seize this opportunity, use the new drugs carefully, and don't waste this once-in-a-lifetime chance'.

As good as some of these newer drugs have looked in studies, there are emerging signs of trouble in the real world. Dr. Steven Deeks, a prominent HIV physician and researcher says, "Although the current generation of drugs are generally doing great, many patients are not responding in a durable manner. We are now following about 25 individuals who have failed all six drug classes. The key now is to design regimens to maintain immunologic and clinical stability while we wait for more drugs. I am concerned, however, as it will likely be a few years before we have another shot at getting the virus under control. We desperately need a second generation integrase inhibitor that works against viruses resistant to raltegravir."

Dr. Deeks' experience is far from typical. He follows many of the most treatment experienced people in the San Francisco Bay Area, many of whom have been on therapy since 1987. Although not typical, his experiences have been reported elsewhere, if in smaller numbers.

This suggests a burgeoning problem of people beginning to run out of treatment options, as has happened a couple of times during the epidemic. Project Inform is concerned that the most vulnerable people living with HIV will be left with few or no viable treatment options, possibly for many years.

One of the unintended effects of the recent successes in drug development is that fewer people are available for studies of experimental drugs aimed at treatment experienced folks. We saw this coming and have been counseling drug companies and the Food and Drug Administration (FDA) that the era of 'TORO-like' studies was coming to a close. These studies give volunteers optimized background therapy (the best combination of HIV drugs chosen with resistance test results) with either the experimental drug or a placebo. The design allows regulators, scientists and activists to clearly see the benefit of the new drug. (Some call these studies 'TORO-like' after those that led to the approval of Fuzeon [enfuvirtide, T20]).

This contrasts with how studies of first line treatment are done. When studying HIV drugs as first line, the basic model is head-to-head non-inferiority studies, which are designed to tease out the relative contribution of the entire regimens rather than the individual drugs. (Non-inferiority means that one drug or regimen is equivalent or 'close enough' to another.)

The FDA has allowed non-inferiority studies for drugs being studied as first line, but has insisted on placebo controlled superiority studies for treatment experienced studies. This made a good deal of sense when there were many people signing up for these studies. The situation is now quite different.

While there aren't enough people signing up for these kinds of studies, there's still a sizeable need for studying new HIV drugs. This, combined with the thin drug pipeline and the current difficulty recruiting for studies, may add up to real trouble down the line.

In meetings with many drug companies Project Inform has warned of this impending problem and recommended that they adopt new ways of studying their drugs. The reaction has been mixed. While some companies have been quite open to new ideas, it's fair to say that most would prefer to stick with models that have proven successful.

We have struggled to argue -- to the companies and the FDA -- that ways of studying and developing drugs are both necessary and possible. Gilead Sciences is one of the first to grapple with this. When it came time to do large, pivotal studies of their experimental integrase inhibitor, elvitegravir, there simply were not enough people in the US to enroll a typical study for treatment experienced people. Project Inform had warned Gilead, and others, of this eventuality and argued for studies that would more closely resemble the head-to-head, non-inferiority studies used for studying first-line drugs.

Over time Gilead came to agree that this was the way forward and submitted such a plan to the FDA. The FDA eventually allowed Gilead to move forward with this study design for elvitegravir. This is a great victory for people living with HIV. There is a great need for new treatments to be developed and for the FDA and companies to think and act creatively to ensure this happens.




An Overview of the Current State of HIV Drug Development
The Industry
As a whole, pharma has done a tremendous job developing HIV drugs. However, many visible signs are showing their fading commitment to HIV. Fewer new companies are getting into HIV, and some well established ones are either cutting back or eliminating their drug development plans. The marketplace for HIV drugs is both crowded and competitive. The scientific hurdles for developing new HIV drugs have also grown more difficult, making it a less attractive market for companies.

The FDA
The FDA is responsible for ensuring that drugs are safe and effective before they become available outside clinical studies. Recent media stories that focused on drug safety, particularly on Vioxx and Heparin, have created a somewhat fearful climate inside the FDA where new ideas are met skeptically. Their recent decision to green light elvitegravir's development shows that at least its antiviral division is open to creative drug development plans.

The Current Pipeline
All in all, the pipeline is both thin and unimpressive. There are a few 'me too' drugs (slight changes in existing drugs) which are helpful but not game changing. A few novel compounds may prove promising down the line, but they're struggling right now, due to either study results or in one case the company being bought by a company that doesn't want to work in HIV.

As for those drugs in human studies, the closest to approval is rilpivarine (TMC-278), an NNRTI for first line treatment being studied against Sustiva. Vicriviroc, Schering's CCR5 drug, continues to flounder but is still viable. Bevirimat, a maturation inhibitor from Panacos, has been hamstrung by formulation problems. Other drugs we are following are Pharmasset's racivir, and Avexa's apricitabine.

The Bottom Line
The past two years have been a boon to people with extensive treatment experience. Four successful new drugs, including two new classes, have meant most people can put together powerful, effective and tolerable regimens, even if they've never been able to get to undectable before. However, this period is now over, and we're experiencing a major downturn in the number of promising drugs in the pipeline.

This reinforces the importance of using the current crop of new drugs correctly. Your best chance at getting to and staying undetectable is to start a regimen with at least two and hopefully three fully active drugs. If you're able to do this and get your HIV level to undetectable, good adherence is the best way of keeping it there.

This also points to the need for treatment activists, like Project Inform, to continue to work with the companies, scientists and regulators to ensure that new drugs are developed.
Lastly, this situation points toward the need for a cure. It is only going to become more difficult to keep the companies, their researchers and the general public interested in HIV drugs. There's a growing sense that HIV is not that much of a problem anymore, at least not in wealthy countries.

The only real solution is a cure. While some may discount its possibility, we do not. Many promising approaches are under study, as well as a resurgence in community activism aimed at cure research. A conscientious program mounted by academia, industry, government and community is necessary to reach this goal.