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