Published in the Bulletin of Experimental Treatments for AIDS June 1997 issue, by the San Francisco AIDS Foundation.

June 1997 Table of Contents

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The 1592 Controversy

by Ronald Baker, PhD

Community treatment activists are focusing on efforts to secure early access to 1592 (also known as abacavir), the promising new anti-HIV drug from Glaxo Wellcome Inc. 1592 is now entering pivotal Phase III studies in medical centers in the U.S., Canada, Europe and Australia. In response to community demands for access to the drug prior to FDA approval, Glaxo has announced plans for a 2,500-person compassionate use program with a July 1997 start date. Glaxo is considering a plan to increase to 5,000 the number of people served worldwide by the compassionate use program. The company says it hopes to establish a large expanded access program for 1592 by March 1998.

Activists want Glaxo to accomplish more with 1592 sooner. They point out that the immediate need for 1592 probably exceeds 10,000 patients worldwide, primarily people with AIDS who are without treatment options. For the growing number of people who have failed all the FDA-approved antiretrovirals, 1592 represents their only viable treatment option. Having exhausted the benefit from currently available anti-HIV therapies, these individuals require new drugs such as 1592 for use in combination regimens. The hope is that, as part of a combination regimen, 1592 will help to delay disease progression until other effective drugs become available.

Community Groups Send Letter to Glaxo

Following discussions among community representatives nationwide, a coalition of treatment advocacy groups that includes the San Francisco AIDS Foundation (SFAF) sent a letter to Glaxo on June 17 calling on the company to take specific actions regarding 1592. The letter includes the following requests:

Compassionate Use Program

• make a good faith effort to significantly increase the size of the 1592 compassionate use program, preferably to 10,000 people worldwide
• design the program to ensure that patients in the greatest need receive the drug first
• provide monthly progress reports to designated community representatives regarding drug production and patient enrollment
• create procedures to ensure equity of access and avoidance of preferential acceptance of patients
• provide 1592 to patients who cannot travel to any of the medical centers that will offer the compassionate use program

Expanded Access Program

• start an expanded access program for 1592 before the end of 1997
• set up a mechanism for community input into the design of the expanded access program

Accelerated Approval

• apply to FDA for accelerated approval of 1592 no later than March 1998

The letter to Glaxo concludes that "promising new therapies such as 1592 must become available as soon as possible to people without treatment options who face disease progression or death. Community advocates and activists call on Glaxo Wellcome and all AIDS drug manufacturers to recognize that people with advanced disease have a basic right to speedy access to new experimental therapies when all other treatment options have failed."

Members of the 1592 Access Coalition:

Ron Baker, Bill Bahlman, Peter Cashman, Sally Cooper, Paul Davis, Martin Delaney, Jeff Getty, David Gilden, Linda Grinberg, John Iverson, Cleve Jones, Kate Krauss, James Learned, Jules Levin, Andrew Lipschitz, Joel Martinez, Eileen Mitzman, Leigh Paidolfino-Danas, Lili Rundback, Matthew Sharp, Theo Smart.

Over 20 community-based AIDS organizations have already endorsed the letter to Glaxo. If your organization wants to sign on, please fax your endorsement to Linda Grinberg at 310-471-4565.

Activists Consider Boycott of Glaxo's Zantac, Civil Disobedience and Demonstrations

ACT UP chapters in the U.S., Europe and Australia have been vocal about their belief that Glaxo has the capacity to increase the size of the 1592 compassionate use program now, but is unwilling to do so for financial reasons. On May 31, 1997, about 250 activists from ACT UP chapters in Philadelphia, New York and Cleveland and their supporters staged a "die in" and demonstration against Glaxo at the Life Expo AIDS Trade show in New York City, an event sponsored by POZ magazine. Glaxo canceled its exhibit after learning of the planned demonstration.

"A nationwide boycott against Glaxo Wellcome is imminent unless there is further commitment to make 1592 available to those who need it," said David Mahon of ACT UP/Golden Gate in San Francisco. Glaxo's Zantac, now an over-the-counter medication, has been mentioned as a possible target for an international boycott initiated by ACT UP chapters. A press statement from ACT UP/Golden Gate announced that the group will target Glaxo sales representatives in the field and will organize demonstrations against Glaxo that involve civil disobedience.

Expanded Access for AIDS Drugs

The issue of early access to promising AIDS drugs goes beyond the 1592 controversy. Many in the AIDS community believe that drug companies have a fundamental obligation to provide promising new drugs to people with AIDS through expanded access and/or compassionate use programs early in the drug development process, once basic safety information is known. Historically, new anti-HIV drugs have become available through this mechanism to thousands of AIDS patients outside of clinical trials. For example, Glaxo operated a 30,000-person expanded access program for 3TC early in that drug's development. Bristol-Myers Squibb also operated large expanded access programs for ddI (20,000 people) and d4T (12,000) prior to FDA accelerated approval of these drugs. With the advent of the protease inhibitor drugs in late 1995 and early 1996, several drug manufacturers broke with the tradition of large expanded access programs. The expanded access programs for Merck's indinavir (Crixivan) and Abbott's ritonavir (Norvir) each accepted fewer than 1,500 people worldwide. The saquinavir (Invirase) expanded access program from Hoffmann-La Roche provided that drug to about 3,000 people worldwide.

The Bottom Line on 1592

The primary area of disagreement between Glaxo and activists is not whether individuals without treatment options should be offered 1592, but how soon and how many people? Unfortunately for many people with AIDS who are desperate for treatment options, waiting equals death.

New HIV Treatment Recommendations

The U.S. Department of Health and Human Services (DHHS) has finally released new HIV treatment guidelines, the first HIV therapy recommendations from the government since 1993. Long overdue (the initial expected release date was early 1997), these new guidelines offer the most comprehensive and up-to-date information available on treatment for HIV infection. Although directed primarily to physicians, these recommendations offer a wealth of important information to patients.The text of the guidelines appears in this issue of BETA. BETA Live! will present a free, interactive telephone conference call on the new guidelines on July 30 at 12 noon Pacific Time. Call 1-800-707-BETA to register for that program.

These new HIV treatment recommendations offer valuable guidance to HIV positive individuals and their physicians. SFAF encourages patients and their physicians to set aside time together to review the new recommendations as part of a strategy to define individual treatment goals and objectives.

FDA Warns of Diabetes Risk from Protease Inhibitors

On June 11, FDA issued a warning to physicians notifying them that use of protease inhibitor drugs may lead to increases in blood sugar (hyperglycemia) and diabetes. FDA has received reports of 83 such cases, including 27 that were serious enough to require hospitalization. In many of the cases, diabetes was controlled using oral medication or insulin. FDA believes that the side effect is uncommon, and does not recommend that people avoid protease inhibitors. Diabetes has been reported in people taking indinavir, nelfinavir, ritonavir and saquinavir. Package inserts for these drugs will be revised to reflect the new information. FDA recommends that physicians closely monitor the blood glucose levels of people taking protease inhibitors. The warning signs of hyperglycemia include increased thirst and hunger, more frequent urination, dry skin and fatigue. FDA urges healthcare professionals to report new cases of protease inhibitor-related diabetes to the MEDWATCH program at 1-800-FDA-1088 (fax 1-800-FDA-0178).

Treatment for Primary HIV Infection: Can Very Early Therapy Eradicate HIV?

The widespread availability of HIV RNA (viral load) testing and powerful new anti-HIV drug regimens has created the opportunity to detect and treat HIV very early in infection. It is critically important for physicians and patients to recognize the signs of primary HIV infection (PHI) and to consider starting treatment during this very early stage.

Primary HIV infection generally refers to the first 6 weeks following exposure to and infection with HIV. This period is characterized by active HIV replication and transient immune suppression. During PHI, 50-80% of HIV-infected individuals experience the "acute retroviral syndrome" (ARS), which manifests as a flu-like illness that may include fever, rash, and gastrointestinal and neurological symptoms. ARS persists on average for 1-3 weeks, but may last up to 8 weeks. Twenty to fifty percent of HIV-infected individuals have no symptoms of ARS following exposure to HIV. PHI is further characterized by an 8-12 week period before the body produces antibodies against HIV.

The University of California's Universitywide AIDS Research Program (UARP) has allocated $1 million to initiate focused studies to discover whether early treatment during PHI can eradicate HIV or slow or completely prevent progression to AIDS and the transmission of the virus. These are vitally important questions, and the San Francisco AIDS Foundation commends and supports the UARP effort. Following a 1-day meeting in San Francisco of researchers, clinicians and AIDS community representatives, UARP prepared a written report on California's research agenda for primary HIV infection. The executive summary of that report appears of this issue.

Postexposure Prophylaxis: Treatment to Prevent HIV Infection Following Exposure to the Virus

Postexposure prophylaxis (PEP) for HIV refers to drug treatment started within hours following accidental exposure to the virus. Four weeks of treatment with AZT monotherapy after accidental needlestick exposure to HIV among healthcare workers decreased the chance of their becoming infected by 79%, according to the results of a recent U.S. government study. Given this high rate of success in preventing HIV infection among healthcare workers, the question naturally arises as to whether PEP also can abort HIV infection among individuals exposed to the virus through sexual contact or injection drug use. Although the answer is not yet known, some clinicians are already prescribing 2- or 3-drug therapy to patients exposed to HIV through sex or injection drug use.

The objective of PEP is to eradicate HIV from the body and to prevent HIV infection of cells. The following treatment recommendation for PEP is the new, preliminary regimen from the U.S. Centers for Disease Control and Prevention (CDC) for healthcare workers accidentally exposed to HIV:

• double combination treatment with AZT (200 mg 3 times daily) plus 3TC (150 mg twice daily) for 4 weeks
• if the "source" individual has advanced AIDS, the protease inhibitor nelfinavir (750 mg 3 times daily) should be added to the AZT/3TC regimen
• if the "source" individual has failed on AZT/3TC therapy (e.g., no benefit or intolerance), d4T plus ddI should be used instead of AZT/3TC

Individuals considering PEP following accidental sexual or injection drug use exposure may want to consider using 3-drug therapy that includes a protease inhibitor such as nelfinavir, regardless of the status of the "source" individual. The rationale for using a 3-drug regimen (e.g., AZT/3TC/nelfinavir) is based on data showing that triple combination therapy using 2 nucleoside analogs plus a potent protease inhibitor is more effective in reducing viral replication than double combination regimens comprised of 2 nucleoside analogs (e.g., AZT/3TC).

HIV negative individuals who believe they have been exposed to HIV very recently should contact their physician as soon as possible after exposure to discuss the pros and cons of starting PEP. In order to maximize the chances of successful abortion of HIV infection, the CDC recommends starting drug therapy within 72 hours of exposure to the virus.

Beginning in Fall 1997, the San Francisco Department of Public Health will offer PEP for HIV to qualified individuals at certain public health clinics. For more information on PEP, see "Postexposure Treatment of People Exposed to the Human Immunodeficiency Virus through Sexual Contact or Injection Drug Use" in the April 10, 1997 issue of The New England Journal of Medicine. A detailed review of that article appears in Research Notes in this issue of BETA.

Reflections on the New Formulation of Saquinavir

Numerous published articles and the impending availability of a new soft-gel capsule formulation of saquinavir from Hoffmann-La Roche raise important issues for people with HIV who are currently taking or considering taking saquinavir (Invirase). The Scientific Advisory Committee (SAC) of the San Francisco AIDS Foundation has prepared the following summary of information regarding saquinavir formulations and dosing:

1. Hoffmann-La Roche recognized the need for and developed a new soft-gel capsule (SGC) formulation of saquinavir; FDA approval is pending.

2. The oral bioavailability (blood level after taking pills) of the new SGC formulation is 12-36%, or 3-9 times greater than that of the currently approved hard-gel capsule (HGC) formulation, which is 4% [1]. The other FDA-approved protease inhibitors have an oral bioavailability of approximately 20-80% [2].

3. The FDA-approved 1,800 mg daily dosage of saquinavir HGC leads to lesser decreases in HIV RNA viral load and lesser increases in CD4 cell counts than any of the other 3 currently approved protease inhibitors: nelfinavir (Viracept), indinavir (Crixivan) and ritonavir (Norvir) [3].

4. HIV positive persons started on combinations containing the standard dose of saquinavir HGC have been switched to combinations containing other protease inhibitors due to lack of benefits (insignificant viral load reductions) more commonly than those who were started on combinations containing other protease inhibitors [9,10,14].

5. A monotherapy study of 40 patients who took either double (3,600 mg) or quadruple (7,200 mg) the current daily dosage of saquinavir HGC [4] showed:

• greater and more sustained HIV RNA viral load reductions
• greater and more sustained CD4 count increases
• a trend towards a delay in and lower rate of saquinavir resistance
• increases in side effects, yet little or no dose-limiting toxicity

6. Similar dose-dependent decreases in HIV protease inhibitor resistance have been reported with other protease inhibitors [5,6].

7. HIV drug resistance is more likely to occur when a subtherapeutic (low) level of protease inhibitor exists in the blood, due to continued HIV replication in the presence of selective pressure from the drug [3,7].

8. Blood levels of saquinavir SGC are increased:

• 500% (5-fold) by the concurrent administration of nelfinavir [12]

Blood levels of saquinavir HGC are increased:

• 1,800% (18-fold) by concurrent administration of ritonavir [13], requiring that lower dosages of each be used [19,20]
• 500% (5-fold) by the concurrent administration of delavirdine (Rescriptor) 400 mg, 3-times daily [11] ¥ 150% by concurrent administration of ketoconazole [11]
• by concurrent administration of concentrated grapefruit juice [24]

9. When compared to monotherapy, HIV drugs used in combination are significantly more likely to achieve optimal results in each of the following areas [3,8]:

• decreases in HIV RNA viral load
• durability of HIV RNA viral load reductions
• increases in CD4 cell count
• durability of CD4 cell count increases
• reductions in the development of HIV drug resistance

10.The approximate annual wholesale cost of the standard 1,800 mg daily dosage of saquinavir HGC (9 capsules daily) is $5,800, while the 7,200 mg dosage (36 capsules daily) is $23,000. Corresponding annual retail prices are $7,600 and $30,400, respectively [3,15]

Scientific Advisory Committee Recommendations

The SAC has concerns about an HIV positive person who is newly starting HIV combination therapy including saquinavir HGC at the FDA-approved dosage of 1,800 mg daily because he/she may be receiving subtherapeutic drug levels that may be associated with an increased risk of any of the following:

• suboptimal HIV viral load reductions
• suboptimal duration of anti-HIV benefits
• suboptimal likelihood of avoiding the development of saquinavir-resistant HIV strains

Furthermore, such persons and their physicians should be aware that:

• a new soft-gel formulation that results in higher blood levels of saquinavir will be available by the end of 1997, according to Hoffmann-La Roche
• there may be advantages to starting with a higher dosages (3,600-7,200 mg) of saquinavir HGC than the FDA-approved dose of 1,800 mg daily if cost is not a primary consideration. While there are no studies indicating that an increased dosage of saquinavir HGC in combination therapy is more effective than the standard dosage, a monotherapy study did reveal greater reductions of HIV viral load with higher dosages of saquinavir HGC
• co-administration of saquinavir with any of several medications or with grapefruit juice will increase blood levels of saquinavir (see 8. above)
• there is preliminary unpublished data indicating that saquinavir SGC, when used in combination therapy, can achieve HIV viral load reductions and CD4 cell count increases similar to those that occur with combination therapies containing other currently available protease inhibitors
• approximately 2,000 patients will be eligible to enroll in studies using saquinavir SGC in various combinations in the next 3 months or so
• other protease inhibitor options are available until the new formulation saquinavir SGC is approved by FDA and available by prescription

The SAC recommends that an HIV positive person who is currently taking HIV combination therapy including saquinavir HGC at the FDA-approved dosage of 1,800 mg daily should discuss with his/her physician that he/she may have subtherapeutic drug levels that may be associated with an increased risk of:

• suboptimal HIV viral load reductions
• suboptimal duration of anti-HIV benefits and/or
• suboptimal likelihood of avoiding the development of saquinavir-resistant HIV strains

Furthermore, such persons and their physicians should be aware that:

• if the desired endpoint of HIV viral load reduction has not been attained with combination therapy including saquinavir HGC at 1,800 mg daily, or if the viral load has returned toward baseline level, then a change of at least 2 HIV drugs is indicated, according to current guidelines [16,17,18,23]
• a person who has very recently (within the past 2 weeks) started on combination HIV therapy including saquinavir HGC at 1,800 mg daily may benefit from a higher dose (3,600-7,200 mg daily) if cost is not a primary consideration
• co-administration of saquinavir with any of several medications or with grapefruit juice will increase blood levels of saquinavir (see 8. above)
• it is quite possible that at some time in the future, saquinavir HGC will no longer be available from the manufacturer

There are several unknowns regarding saquinavir SGC at this time. Future information will help to clarify these issues. BETA will keep readers informed.

Scientific Advisory Committee of the San Francisco AIDS Foundation: Ronald Baker, PhD, Kirstin Balano, PharmD, Harvey S. Bartnof, MD, Mark Bowers, MA, Gregory Pauxtis, MD, Mary Romeyn, MD

References

1. Invirase (saquinavir mesylate) package insert. Hoffmann-La Roche, Inc. Nutley, NJ.

2. Moyle G and Gazzard B. Current knowledge and future prospects for the use of HIV protease inhibitors. Drugs 51(5):701-712. May 1996.

3. Deeks SG and others. HIV-1 protease inhibitors, a review for clinicians. Journal of the American Medical Association 277:145-153. January 8, 1997.

4. Schapiro JM and others. The effect of high-dose saquinavir on viral load and CD4+ T-cell counts in HIV-infected patients. Annals of Internal Medicine 124(12):1039-1050. June 15, 1996.

5. Emini E and others. Maintenance of long-term virus suppression in patients treated with the HIV-1 protease inhibitor, Crixivan (indinavir). In: Program and Abstracts of the XI International Conference on AIDS. Vancouver, BC, July 7-12, 1996. Abstract #Mo.B.170.

6. Korneyeva M and others. Clinical and virological responses to ritonavir, an inhibitor of HIV protease. In: Program and Abstracts of the XI International Conference on AIDS. Vancouver, BC, July 7-12, 1996. Abstract #Mo.B.1137.

7. Molla A and others. Ordered accumulation of mutations in HIV-1 protease confers resistance to ritonavir. Nature Medicine 2:760-766, 1996.

8. Condra JH and others. Bidirectional inhibition of HIV-1 drug resistance selection by combination therapy with indinavir and reverse transcriptase inhibitors. In: Program and Abstracts of the XI International Conference on AIDS. Vancouver, BC, July 7-12, 1996. Abstract #Th.B.932.

9. Valette M and others. Kaplan-Meier analysis of interruption probability of a protease inhibitor, saquinavir, indinavir or ritonavir in 177 patients receiving a combination of protease inhibitors and reverse transcriptase inhibitors. In: Program and Abstracts of the 4th Conference on Retroviruses and Opportunistic Infections. Washington, DC, January 22-26, 1997. Abstract #197.

10. Johnson D and Currier JS. Protease inhibitor therapy in women: experience from clinical practice. In: Program and Abstracts of the National Conference on Women and HIV. Pasadena, CA, May 4-7, 1997. Oral presentation and abstract #227.7.

11. Cox SR and others. Evaluation of the pharmacokinetic interaction between saquinavir and delavirdine in healthy volunteers. In: Program and Abstracts of the 4th Conference on Retroviruses and Opportunistic Infections. Washington, DC, January 22-26, 1997. Abstract #372.

12. Kravcik S and others. Nelfinavir mesylate increases saquinavir-soft gel capsule exposure in HIV+ patients. In: Program and Abstracts of the 4th Conference on Retroviruses and Opportunistic Infections. Washington, DC, January 22-26, 1997. Abstract #371.

13. Norbeck D and others. Ritonavir and saquinavir: potential for 2-dimensional synergy between HIV protease inhibitors. In: Program and Abstracts of the 35th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, September 17-20, 1995. Late breaker abstract #LB-7.

14. Gerard Y and others. Efficacy of proteinase inhibitors in combination with reverse transcriptase inhibitors: study in 177 HIV-1 infected patients in the North France AIDS Reference Center. In: Program and Abstracts of the 4th Conference on Retroviruses and Opportunistic Infections. Washington, DC, January 22-26. Abstract #243.

15. Bartlett J. Protease inhibitors for HIV infection. Annals of Internal Medicine 124(12):1086-1088. June 15, 1996.

16. Saag M and others. HIV viral load markers in clinical practice. Nature Medicine 2(6):625-629. June 1995.

17. Carpenter CCJ and others. Antiretroviral therapy of HIV infection in 1996, recommendations of an international panel. Journal of the American Medical Association 76(2):146-154. July 10, 1996.

18.BHIVA Guidelines Coordinating Committee. Consensus statement: British HIV Association guidelines for antiretroviral treatment of HIV seropositive individuals. The Lancet 349:1086-1092. April 12, 1997.

19. Cameron DW and others. Combination use of ritonavir and saquinavir in HIV-infected patients: preliminary safety and activity data. In: Program and Abstracts of the XI International Conference on AIDS. July 7-12, 1996; Vancouver, British Columbia. Abstract and oral presentation Th.B.934.

20. Cohen C and others. Ritonavir-saquinavir combination treatment in HIV-infected patients. In: Program and Abstracts of the 35th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). September 15-18, 1996; New Orleans, Louisiana. Late breaker abstract and oral presentation LB-7b.

21. Barbour CO. Efficacy and safety of quadruple combination therapy in treatment experienced HIV/AIDS patients. In: Program and Abstracts of the 4th Conference on Retroviruses and Opportunistic Infections. January 22-26, 1997; Washington, D.C. Abstract and poster presentation #245.

22. BETA: Bulletin of Experimental Treatment for AIDS. March 1997: 38-41; December 1996: 29-30, 35; September 1996: 27-28.

23. BETA. December 1996: 41-42; September 1996: 31; June 1996: 9-11, 39-42.

24. James J. Grapefruit juice and saquinavir. AIDS Treatment News 235. November 17, 1997.

Roche Responds

The following response to the SAC statement was received from Hoffmann-La Roche:

"Reflections on the New Formulation of Saquinavir" raises important points about how best to use the current, hard gelatin capsule formulation in the period before the new, soft gelatin capsule is available to patients.

Invirase received full marketing clearance from the FDA when a clinical endpoint trial with 940 patients demonstrated that Invirase in combination with Hivid (ddC) prolongs life and delays time to disease progression. Since that time, data from an exploratory study at Stanford University have demonstrated that higher doses of Invirase produce a more profound antiviral effect.

Exploratory data from clinical trials demonstrate that other antiretrovirals including ritonavir, nelfinavir and delavirdine raise saquinavir levels. Ritonavir extensively inhibits the metabolism of saquinavir resulting in greatly increased saquinavir plasma concentrations. Coadministration of ritonavir 400 or 600 mg b.i.d. [twice daily] regimens produced greater than 20-fold increases in steady-state dose-normalized saquinavir concentrations in healthy subjects. The appropriate doses for this combination, with respect to activity and safety, have not been established.

In a pharmacokinetic clinical trial, the interaction between delavirdine (400 mg t.i.d. [three times daily]) and saquinavir (600 mg t.i.d.) in 7 healthy volunteers resulted in a 5-fold increase in saquinavir area under the curve. While there are limited safety and no efficacy data available from the use of this combination, hepatocellular [liver] enzymes ALT/AST should be monitored frequently if this combination is prescribed.

In addition, a small pharmacokinetic study in healthy volunteers demonstrated that giving 1 glass of double-strength grapefruit juice (reconstituted from the frozen concentrate but with less water) with saquinavir followed by a second glass 1 hour later more than doubles the blood levels of saquinavir.

"Reflections on the New Formulation of Saquinavir" implies that the use of the current formulation of saquinavir may expedite the emergence of reduced sensitivity. However, in a clinical trial combining Invirase with Hivid, the incidence of a mutation at codon 90, which is typically associated with resistance to saquinavir, at 1 year, is only 21%. In addition, the convenient 3-times-daily dosing of saquinavir with meals enhances compliance, a key to minimizing resistance to protease inhibitor therapy.

To maximize the potential of saquinavir, Roche is currently developing a new, soft gelatin capsule formulation. The new formulation shows a potent antiviral response in combination with other antiretrovirals and provides 10 times the drug exposure of the current formulation. The soft gelatin capsule formulation is expected to be available to patients by the end of 1997.

References

Invirase (saquinavir mesylate) package insert. Hoffmann-La Roche, Inc. Nutley, NJ.

Schapiro JM and others. The effect of high-dose saquinavir on viral load and CD4 T-cell counts in HIV-infected patients. Annals of Internal Medicine 124(12):1039-1050. June 15, 1996.

Kravcik S and others. Nelfinavir mesylate (NFV) increases saquinavir-soft gel capsule (SQV-SGC) exposure in HIV+ patients. Abstracts presented at the 4th Conference on Retroviruses and Opportunistic Infections. Washington, DC, January 22-26, 1997.

Rescriptor (delavirdine mesylate) package insert. Pharmacia and Upjohn, Inc. Kalamazoo, MI.

James J. Grapefruit juice and saquinavir. AIDS Treatment News pp 5-6. October 17, 1995.

Race E and others. Poster 15 presented at Third International Congress on Drug Therapy in HIV Infection. Birmingham, England, November 3-7, 1996.

Ronald Baker, PhD, is Director of Treatment Education and Advocacy at the San Francisco AIDS Foundation.

Page last updated 2 July 1997

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