Bictegravir Sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate and Tetracycline Hydrochloride

• Generic Name: bictegravir / emtricitabine / tenofovir alafenamide
• Dosage Forms: n.a.
• Other Brand Names: Biktarvy

Treatment of HIV-1 infection in antiretroviral-naive (have not previously received antiretroviral therapy) or antiretroviral-experienced (previously treated) adults.

Fixed combination of BIC/FTC/TAF used alone as a complete regimen for treatment of HIV-1 infection; concomitant use with other antiretrovirals not recommended.

For initial treatment in antiretroviral-naive adults, experts state BIC/FTC/TAF is a recommended INSTI-based regimen for most adults.

For antiretroviral-experienced adults, manufacturer states BIC/FTC/TAF can be used to replace the current antiretroviral regimen in those with plasma HIV-1 RNA levels <50 copies/mL on a stable antiretroviral regimen for ≥3 months who have no history of treatment failure and are infected with HIV-1 with no known substitutions associated with resistance to the antiretroviral components of the fixed combination (i.e., bictegravir, emtricitabine, tenofovir).

• Generic Name: tetracycline
• Dosage Forms: n.a.
• Other Brand Names: Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap, Tetracon, Robitet 500, Emtet-500

Treatment of respiratory tract infections caused by Mycoplasma pneumoniae.

Treatment of respiratory tract infections caused by Haemophilus influenzae, Streptococcus pneumoniae, or Klebsiella. Should only be used for treatment of infections caused by these bacteria when in vitro susceptibility tests indicate the organism is susceptible.

Acne

Adjunctive treatment of moderate to severe inflammatory acne. Not indicated for treatment of noninflammatory acne.

Actinomycosis

Treatment of actinomycosis caused by Actinomyces israelii; oral tetracyclines (usually doxycycline or tetracycline) used as follow-up after initial parenteral penicillin G.

Amebiasis

Adjunct to amebicides for treatment of acute intestinal amebiasis. Tetracyclines not included in current recommendations for treatment of amebiasis caused by Entamoeba.

Anthrax

Alternative to doxycycline for postexposure prophylaxis to reduce the incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax). Initial drug of choice for such prophylaxis is ciprofloxacin or doxycycline; doxycycline is the preferred tetracycline because of ease of administration and proven efficacy in monkey studies.

Alternative to doxycycline for treatment of inhalational anthrax when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting). A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is preferred for treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.

Balantidiasis

Treatment of balantidiasis caused by Balantidium coli; drug of choice.

Bartonella Infections

Treatment of bartonellosis caused by Bartonella bacilliformis.

Brucellosis

Treatment of brucellosis; tetracyclines (usually doxycycline or tetracycline) considered drugs of choice. Used in conjunction with other anti-infectives (e.g., streptomycin or gentamicin and/or rifampin), especially for severe infections or when there are complications (e.g., endocarditis, meningitis, osteomyelitis).

Burkholderia Infections

Treatment of glanders caused by Burkholderia mallei. Experience is limited regarding treatment of human cases; optimum regimens not identified. Some clinicians suggest streptomycin used in conjunction with tetracycline or chloramphenicol or imipenem monotherapy. Other clinicians suggest that, pending results of in vitro susceptibility tests, regimens used for treatment of melioidosis can be used for initial empiric treatment of glanders. Doxycycline is the preferred tetracycline for treatment of melioidosis caused by susceptible B. pseudomallei.

Campylobacter Infections

Treatment of infections caused by Campylobacter. Tetracyclines (usually doxycycline) are alternatives, not drugs of choice for C. jejuni.

Chancroid

Treatment of chancroid caused by Haemophilus ducreyi. Not included in CDC recommendations for treatment of chancroid; CDC and others recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin.

Chlamydial Infections

Treatment of uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis. Doxycycline is the preferred tetracycline for treatment of these infections, including presumptive treatment of chlamydial infections in patients with gonorrhea.

Treatment of trachoma and inclusion conjunctivitis caused by C. trachomatis. Consider that anti-infectives may not eliminate C. trachomatis in all cases of chronic trachoma.

Treatment of lymphogranuloma venereum (genital, inguinal, or anorectal infections) caused by C. trachomatis. Doxycycline is the preferred tetracycline for these infections.

Treatment of psittacosis (ornithosis) caused by C. psittaci. Doxycycline and tetracycline are drugs of choice. For initial treatment of severely ill patients, use IV doxycycline.

Clostridium Infections

Alternative for treatment of infections caused by Clostridium. Tetracyclines are alternatives to metronidazole or penicillin G for adjunctive treatment of C. tetani infections.

Dientamoeba fragilis Infections

Treatment of Dientamoeba fragilis infections. Drugs of choice are iodoquinol, paromomycin, tetracycline, or metronidazole.

Enterobacteriaceae Infections

Treatment of infections caused by susceptible Escherichia coli, Enterobacter aerogenes, Klebsiella, or Shigella. Only use for treatment of infections caused by these common gram-negative bacteria when other appropriate anti-infectives are contraindicated or ineffective and when in vitro susceptibility tests indicate the organism is susceptible.

Fusobacterium Infections

Alternative to penicillin G for the treatment of infections caused by Fusobacterium fusiforme (Vincent's infection).

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated gonorrhea caused by susceptible Neisseria gonorrhoeae. Tetracyclines are considered inadequate therapy and are not recommended by CDC for treatment of gonorrhea.

Empiric treatment of epididymitis most likely caused by N. gonorrhoeae or C. trachomatis; used in conjunction with IM ceftriaxone.

Granuloma Inguinale (Donovanosis)

Treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis. Doxycycline is the tetracycline recommended as drug of choice by CDC.

Helicobacter pylori Infection and Duodenal Ulcer Disease

Treatment of Helicobacter pylori infection and duodenal ulcer (active or a history of duodenal ulcer); eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Used in a multiple-drug regimen that includes tetracycline, metronidazole, and bismuth subsalicylate and a histamine H2-receptor antagonist. If initial 14-day regimen does not eradicate H. pylori, a retreatment regimen that does not include metronidazole should be used.

Leptospirosis

Tetracyclines are alternatives to penicillin G for treatment of leptosporosis. Doxycycline is the preferred tetracycline for treatment or prevention of these infections.

Listeria Infections

Alternative for treatment of listeriosis caused by Listeria monocytogenes. Not usually considered a drug of choice or alternative for these infections.

Malaria

Treatment of uncomplicated malaria caused by chloroquine-resistant Plasmodium falciparum or chloroquine-resistant P. vivax and when the plasmodial species has not been identified.

CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria are a regimen of oral quinine in conjunction with oral doxycycline, tetracycline, or clindamycin or a regimen of atovaquone and proguanil. A regimen of quinine and doxycycline (or tetracycline) generally preferred over quinine and clindamycin, except for young children or pregnant women who should not receive tetracyclines. Quinine in conjunction with tetracycline (or doxycycline) also a regimen of choice for chloroquine-resistant P. vivax malaria.

Treatment of severe malaria caused by P. falciparum; used in conjunction with IV quinidine gluconate initially and then oral quinine when an oral regimen is tolerated.

Active only against asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. vivax malaria or provide a radical cure; primaquine usually also is indicated to eradicate hypnozoites and prevent relapse in patients treated for P. vivax malaria.

Assistance with diagnosis or treatment of malaria available from the CDC Malaria Epidemiology Branch by contacting the CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.

Nocardiosis

Tetracyclines are alternatives to co-trimoxazole for treatment of nocardiosis caused by Nocardia.

Nongonococcal Urethritis

Treatment of nongonococcal urethritis (NGU) caused by Ureaplasma urealyticum, C. trachomatis, or Mycoplasma. Doxycycline usually is the tetracycline of choice for NGU.

Consider that some cases of recurrent urethritis following tetracycline treatment may be caused by tetracycline-resistant U. urealyticum.

Pasteurella multocida Infections

Treatment of infections caused by Pasteurella multocida. Tetracyclines (usually doxycycline) are alternatives to penicillin G.

Plague

Treatment of plague caused by Yersinia pestis, including naturally occurring or endemic bubonic, septicemic, or pneumonic plague and plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism. Regimen of choice is streptomycin or gentamicin; alternatives are doxycycline, tetracycline, ciprofloxacin, or chloramphenicol. For plague meningitis, some experts recommend that chloramphenicol be included in the treatment regimen.

Postexposure prophylaxis following a high-risk exposure to Y. pestis (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure in the context of biologic warfare or bioterrorism). Doxycycline may be drug of choice; alternatives are tetracycline, ciprofloxacin, or chloramphenicol. Prophylaxis not required for asymptomatic contacts of individuals with bubonic plague, but observe such contacts for 1 week and initiate treatment if symptoms occur.

Rat-bite Fever

Treatment of rat-bite fever caused by Streptobacillus moniliformis or Spirillum minus. Tetracyclines (usually doxycycline) are alternatives to penicillin G.

Relapsing Fever

Treatment of relapsing fever caused by Borrelia recurrentis. Tetracyclines are drugs of choice.

Rickettsial Infections

Treatment of rickettsial infections including Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Doxycycline is the drug of choice for most rickettsial infections.

Syphilis

Alternative to penicillin G for treatment of primary, secondary, latent, or tertiary syphilis (not neurosyphilis) in nonpregnant adults and adolescents hypersensitive to penicillins. Use tetracyclines only if compliance and follow-up can be ensured since efficacy not well documented.

Tularemia

Treatment of tularemia caused by Francisella tularensis, including naturally occurring or endemic tularemia and tularemia that occurs following exposure to F. tularensis in the context of biologic warfare or bioterrorism. Drugs of choice are streptomycin or gentamicin; alternatives are tetracyclines (usually doxycycline), ciprofloxacin, or chloramphenicol. Risk of relapse and primary treatment failure may be higher with the alternatives.

Postexposure prophylaxis of tularemia following a high-risk laboratory exposure to F. tularensis (e.g., spill, centrifuge accident, needlestick injury) or in individuals exposed to the organism in the context of biologic warfare or bioterrorism. Drugs of choice are doxycycline, tetracycline, or ciprofloxacin. Postexposure prophylaxis usually not recommended after exposure to natural or endemic tularemia (e.g., tick bite, rabbit or other animal exposure) and is unnecessary in close contacts of tularemia patients since human-to-human transmission does not occur.

Vibrio Infections

Treatment of cholera caused by Vibrio cholerae. Doxycycline and tetracycline are drugs of choice; used as an adjunct to fluid and electrolyte replacement in moderate to severe disease.

Treatment of severe V. parahaemolyticus infection when anti-infective therapy is indicated in addition to supportive care.

Treatment of infections caused by V. vulnificus. Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended. Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.

Yaws

Alternative to penicillin G for treatment of yaws caused by Treponema pertenue.

Yersinia Infections

Treatment of plague or postexposure prophylaxis of plague. (See Plague in Uses.)

Treatment of GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis. These GI infections usually are self-limited, but IDSA, AAP, and others recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs. Some clinicians suggest the role of oral anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.